Investigators used an administrative medical claims database to validate the association between herpes zoster ophthalmicus and stroke while rigorously controlling for both medical comorbidities and social factors. The team took a 2-step approach, first conducting a retrospective case-control study assessing the hazard for stroke and then a self-controlled case series comparing the incidence of stroke prior to and after diagnosing the disorder.

The case-control study included 25,720 individuals with herpes zoster ophthalmicus (average age, 71.7 years; 59.9% women) and 75,924 age- and sex-matched control group participants (average age, 71.8 years; 60% women). During the 1-year follow-up period, 6.7% of patients with herpes zoster ophthalmicus and 6.0% of control group participants had a stroke diagnosis. Individuals in the case group experienced an 18% higher risk of stroke compared with individuals in the control group during this period (hazard ratio [HR], 1.18; 95% CI, 1.12-1.25; P <.001), the report shows. 

The self-controlled case series analysis included 20,149 patients (average age, 71.6; 60.2% women) who were diagnosed with herpes zoster ophthalmicus. Among these participants, the risk of stroke was highest within the first month of diagnosis (relative risk [RR], 1.58; P<.001) and persisted for at least a year (RR, 1.33; 95% CI, 1.07–1.65; P=.009).

“Confirming this link between [herpes zoster ophthalmicus] and subsequent stroke has important implications for both treatment of the reactivated viral illness and prevention of stroke,” according to the study authors. “These results suggest that timely management is crucial, but begs the question as to what interventions work best to reduce morbidity and mortality from stroke in these patients.”

Study limitations include a retrospective nature and the use of an insurance-based data set, which may limit generalizability to uninsured populations.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.  

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Researchers performed the systematic review and meta-analysis using cohort and cross-sectional studies (n=41) that included patients with CAD. The primary CAD severity outcomes were coronary artery calcification (CAC), coronary artery stenosis, coronary plaque progression, multi-vessel CAD, and in-stent re-stenosis, while primary prognostic outcome was a major adverse cardiovascular event (MACE; all-cause death, stroke, myocardial infarction, and heart failure).

A pooled analysis of studies revealed that a higher triglyceride-glucose index is associated with a greater CAD risk, (odds ratio [OR], 1.94; 95% CI, 1.20-3.14; P =.007), according to the report. Higher triglyceride index also increased the likelihood of a stenotic coronary artery (OR, 3.49; 95% CI, 1.71-7.12; P =.0006), plaque progression (OR, 1.67; 95% CI, 1.28-2.19; P =.002), and multi-vessel involvement (OR, 2.33; 95% CI, 1.59-3.42; P <.0001).

A meta-analysis of 13 studies found a significantly higher MACE incidence among individuals with a higher triglyceride-glucose index and concomitant CAD (hazard risk [HR], 2.09; 95% CI, 1.68-2.62; P <.00001). A total of 4 studies analyzed triglyceride-glucose index as a continuous variable, and found the risk of MACE increased by 1.49 times per 1-unit/1-SD increment of the triglyceride-glucose index (95% CI, 1.21-1.83; P =.0001), and 1 study found that a 1-unit increment increase of the triglyceride-glucose index increased the HR of MACE by 1.85 (95% CI, 1.17-2.93; P =.008).

An inability to determine causality due to the cross-sectional nature of some studies and an inability to control for confounding factors, such as exercise and diet, are acknowledged limitations to the research.  

“In the whole-course management of CAD patients, monitoring changes in the [triglyceride-glucose] index over time may be helpful in ensuring comprehensive and effective treatment,” according to the study authors.

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Researchers reported findings from a prespecified exploratory analysis of the CHANCE-2 trial.

Participants were aged 40 years or older, had minor stroke or high-risk transient ischemic attack, were able to receive the study drug within 24 hours of symptom onset, and carried CYP2C19 loss of function alleles. The patients were classified based on the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) classification as having large-artery atherosclerosis (LAA), cardioembolism, small-vessel occlusion (SVO), stroke of other cause, and stroke of undetermined etiology.

The participants were randomly assigned in a 1:1 ratio to ticagrelor-aspirin (placebo clopidogrel plus a 180-mg loading dose of ticagrelor on day 1 followed by 90 mg twice daily on days 2-90) or to clopidogrel-aspirin (placebo ticagrelor plus a 300-mg loading dose of clopidogrel on day 1 followed by 75 mg daily on days 2-90).

The primary outcome was a new ischemic or hemorrhagic stroke at 90 days, and the primary safety outcome was severe or moderate bleeding according to Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries criteria at 90 days.

The cohort included 6336 patients, 1696 (26.8%) with LAA, 1750 (27.6%) with SVO, and 2890 (45.6%) with stroke of undetermined etiology, who were enrolled from September 23, 2019, to March 22, 2021.

Patients with LAA had the highest 3-month risk for recurrent stroke (10.2%), followed by those with stroke of undetermined etiology (5.4%) and those with SVO (5.3%). Ticagrelor-aspirin and clopidogrel-aspirin had a comparable effect in patients with LAA (hazard ratio [HR], 0.86; 95% CI, 0.63-1.18; P =.34) and stroke of undetermined etiology (HR, 0.80; 95% CI, 0.58-1.10; P =.17). However, ticagrelor-aspirin was more effective vs clopidogrel-aspirin in patients with SVO (HR, 0.51; 95% CI, 0.33-0.79; P =.002), with P =.08 for treatment × TOAST subtype interaction effect. The findings were comparable for ischemic stroke and composite vascular events.

Participants who had a different cause in the ticagrelor-aspirin group and the clopidogrel-aspirin group had similar rates of severe or moderate bleeding (0.3% vs 0.1% in those with LAA; 0.6% vs 0.7% in those with SVO; and 0.1% vs 0.2% in those with stroke of undetermined etiology; P =.47 for the treatment × cause subtype interaction). Similar findings occurred regarding mortality.

Ticagrelor-aspirin was associated with a higher risk of any bleeding in patients with SVO and stroke of undetermined etiology vs clopidogrel-aspirin treatment, although the interaction effect was nonsignificant (P =.18 for the treatment × cause subtype interaction).

The use of ticagrelor-aspirin therapy did not significantly increase the bleeding risk in patients with LAA vs clopidogrel-aspirin treatment (HR, 1.59; 95% CI, 0.87-2.90; P =.13).

Among several study limitations, 12% of participants had incomplete cause evaluations, which may have introduced bias, and all patients in CHANCE-2 were Chinese and had a high prevalence of LAA. Also, the interaction test was not significant, and so the observed differences in efficacy among different causes could be due to chance.

“Consistent with the overall results of the CHANCE-2 intention-to-treat population, the efficacy and safety of ticagrelor-aspirin vs clopidogrel-aspirin in preventing new stroke were similar in patients with different TOAST subtypes,” wrote the investigators. “There was no significant treatment-by-TOAST classification interaction.”Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Investigators sought to examine the effect of daily low-dose aspirin on risk for ischemic stroke and intracranial bleeding among healthy older individuals.

They conducted a secondary analysis of a randomized, double-blind, placebo-controlled trial (Aspirin in Reducing Events in the Elderly [ASPREE]) conducted between 2010 and 2014. ASPREE participants were community dwelling older individuals in the US or Australia at least 70 years of age and free of symptomatic cardiovascular disease. Follow-up lasted median 4.7 (IQR, 3.6-5.7) years.

Among 19,114 participants (median age, 74 [IQR, 71.6-77.7] years; 56.4% women; 91.3% White) 9525 individuals were randomly assigned to receive aspirin and 9589 individuals received matching placebo. The primary endpoints were survival, freedom from dementia, and physical disability.

Incidence of ischemic stroke was not significantly reduced with aspirin (hazard ratio [HR], 0.89; 95% CI, 0.71-1.11). Ischemic stroke occurred in 146 participants receiving aspirin and 166 receiving placebo. The aspirin group had 14 deaths vs 10 deaths in the placebo group.

Incidence of hemorrhagic stroke increased without statistical significance with aspirin (0.5% of participants) vs placebo (0.4%; HR, 1.33; 95% CI, 0.87-2.04). Hemorrhagic stroke occurred in 49 participants receiving aspirin and 37 receiving placebo. The aspirin group had 17 deaths vs 12 deaths in the placebo group.

A statistically significant increase occurred in intracranial bleeding (defined as the combination of hemorrhagic stroke and other causes of intracerebral hemorrhage) among individuals receiving daily aspirin (1.1% of participants) vs placebo (0.8%; HR, 1.38; 95% CI, 1.03-1.84). This increase was the result of the increase in the combination of subdural, extradural, and subarachnoid bleeding with aspirin (0.6% of participants) vs placebo (0.4%; HR, 1.45; 95% CI, 0.98-2.16).

Among individuals receiving 100 mg/daily low-dose aspirin over 5 years (n=1000), the investigators noted that in absolute numbers there were 2.5 fewer ischemic strokes at the expense of 3.5 cases of intracranial hemorrhage, which lacks statistical significance.

Study limitations include the low number of stroke and bleeding events during follow-up and lack of generalizability beyond a White population.

“This study found a significant increase in intracranial bleeding with daily low-dose aspirin but no significant reduction of ischemic stroke,” the investigators wrote. “These findings suggest that low-dose aspirin may have no role for the primary prevention of stroke and that caution should be taken with use of aspirin in older persons prone to head trauma.”Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Studies have shown that DAPT using clopidogrel plus aspirin is superior than aspirin alone to reduce the risk for stroke recurrence within the first 90 days in individuals after experiencing a minor ischemic stroke or transient ischemic attack (TIA). Individuals with CYP2C19 genetic polymorphisms responded poorly to clopidogrel, the efficacy of which depends on metabolic activation.

Ticagrelor is a reversible P2Y12 receptor antagonist, which does not require metabolic activation in the liver like clopidogrel. Researchers have not compared the efficacy and safety of DAPT using ticagrelor plus aspirin to DAPT using clopidogrel plus aspirin for the prevention of ischemic stroke recurrence.  

Researchers in China conducted a systematic review and meta-analysis of the literature published up until June 19, 2023 to evaluate available evidence and compare the efficacy and safety of ticagrelor plus aspirin vs clopidogrel plus aspirin in the prevention of stroke recurrence. They identified 7 eligible randomized controlled trials with a total of 41,745 participants, which they included in their network meta-analysis.

The 2 DAPTs did not differ significantly in their ability to prevent stroke recurrence (odds ratio [OR], 1.16; 95% CI, 0.93-1.44), ischemic stroke recurrence (OR, 1.16; 95% CI, 0.93-1.45; or major hemorrhage OR 1.22; 95% CI, 0.62-2.39).

Both DAPTs were more effective than aspirin alone in reducing stroke recurrence (OR of clopidogrel plus aspirin, 0.69; 95% CI, 0.60-0.80) and (OR of ticagrelor plus aspirin, 0.66; 95% CI, 0.49-0.87). Ticagrelor, in particular, was more effective than aspirin (OR, 0.80; 95% CI, 0.68-0.94).

In contrast, both DAPTs increased the incidence of major hemorrhage compared with aspirin alone (OR of clopidogrel plus aspirin, 2.05; 95% CI, 1.22-3.77 vs OR of ticagrelor, 2.55; 95% CI, 1.25-4.99). DAPT with ticagrelor plus aspirin increased the risk for any bleeding more so than DAPT with clopidogrel plus aspirin (OR, 1.97; 95% CI, 1.21-3.22).

The researchers analyzed a subgroup consisting of 4 randomized controlled trials with 16,115 (mainly Chinese) participants. They discovered that in this predominantly Asian cohort, compared with clopidogrel plus aspirin, ticagrelor plus aspirin successfully reduced ischemic stroke recurrence (OR, 0.77; 95% CI, 0.63-0.92) without consequently increasing the risk for major bleeding (OR, 0.94; 95% CI, 0.45-1.95).

“DAPT was superior to aspirin in stroke prevention, but little difference existed between the [2] DAPT regimens,” the researchers concluded.

Study limitations included the heterogeneity of study sample sizes and designs, treatment regimens, endpoint criteria, and follow-up durations for all included studies. Publication bias was another potential study limitation.

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Blood pressure variability has been linked to worse outcomes in patients with stroke and has also been acutely observed in a variety of illnesses. It is unclear whether this variance represents a diseased state, or a modifiable risk factor that can be targeted for intervention. As such, researchers investigated the incidence of blood pressure variability in patients with vs without stroke in an intensive care unit (ICU), as well as comparing outcomes.

The researchers conducted a retrospective analysis on adult patients admitted to the ICU at Beth Israel Deaconess Medical Center (BIDMC) from 2001 and 2012. Data was collected on individuals admitted to the ICU with the following International Classification of Diseases 9th Edition (ICD-9) diagnoses:

• ischemic stroke,
• intracerebral hemorrhage (ICH),
• subarachnoid hemorrhage (SAH),
• acute myocardial infarction,
• pulmonary embolism, sepsis,
• congestive heart failure,
• gastrointestinal bleed, or
• pneumonia.

To limit outlier readings, those with less than 10 blood pressure measurements were excluded.

The primary outcome of the study was death, occurring either in-hospital or after transfer out of the ICU. Secondary outcomes included favorable discharges, which consisted of discharge to a person’s home, acute rehabilitation, hospice or skilled nursing facility.

A total of 11,333 individuals were included in the analytic sample, that of which 2248 had stroke-related diagnoses and 9085 were admitted for nonstroke related diagnoses.

Compared with nonstroke admissions, patients with stroke were more likely to have higher blood pressure variability and minimum arterial pressure (MAP) readings (a measure of volume instability).

Overall, a higher blood pressure variability was linked to higher odds of in-hospital death, for all conditions with the exception of congestive heart failure. It also decreased odds of a favorable discharge among all conditions, with statistical significance in those with ischemic stroke, ICH, SAH, acute myocardial infarction, sepsis, and gastrointestinal bleed.

This finding was most notable amongst those with SAH and ICH; the highest tertile of blood pressure deviation was associated with an odds ratio of in-hospital death of 7.7 (95% CI, 3.0-19.9) in those with SAH and the lowest odds of a favorable discharge of 0.2 (95% CI, 0.16-0.4) in those with ICH.

Study limitations included a lack of generalizability, as this study was conducted at a single-center and differential misclassification was also plausible, as the researchers were reliant on ICD-9 codes for diagnosis.

“Higher BPV was associated with higher odds of in-hospital death and unfavorable discharge destination in stroke patients following adjustment for other markers of critical illness, though attenuated when accounting for markers of potential clinician-driven blood pressure goals, particularly in those with SAH,” the researchers wrote. They concluded, “Research is needed to better delineate the mechanisms underlying our findings, as well as determining how specific stroke features such as location and size affect BPV and its relation with outcomes.”

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Almost 30 million Americans take aspirin for primary or secondary prevention of cardiovascular disease (CVD) or colorectal cancer (CRC).¹ For decades, aspirin has been recommended as primary prevention for patients at risk for CVD, despite the attendant increased risk of major bleeding.² However, the results of recent clinical trials have challenged the clinical risk-to-benefit trade-off of daily aspirin use. 

The most recent recommendations from the US Preventive Services Task Force (USPSTF) have abandoned the routine recommendation for daily aspirin use for primary prevention of CVD.³ Continue reading to learn more about the potential benefits and harms of daily aspirin use. 

What Are the Potential Benefits of Daily Aspirin?

Aspirin has been used for its antipyretic and analgesic properties long before it came into use to prevent or treat CVD. After the discovery of aspirin’s antiplatelet and antithrombotic effects, researchers began to explore the possibility of using it to prevent and treat acute coronary syndrome and stroke.²

At low doses, aspirin is an irreversible inhibitor of cyclo-oxygenase-1 (COX-1), which inhibits platelet function.³ In patients with pre-existing CVD, aspirin can reduce the risk of experiencing a CVD event by 21% and all-cause mortality by 13%. However, the benefit of daily low-dose aspirin use in patients without pre-existing CVD (primary prevention) is less clear.^1,3 

Although the systematic review commissioned by the USPSTF found that daily low-dose aspirin is associated with a clinically significant reduction in absolute risk of CVD events, it is a modest reduction, with an odds ratio (OR) of 0.9.⁴

Daily Aspirin Use: Current USPSTF Recommendations to Prevent Cardiovascular Disease

New studies have highlighted the potential for daily aspirin to cause harm. In 2022, the USPSTF released new recommendations on the use of aspirin for the primary prevention of CVD.³ The new recommendations are as follows⁵:

• For adults between 40 and 59 years of age with a 10% or greater 10-year CVD risk, the Task Force recommends that the decision to start aspirin therapy be an individual one. This recommendation is offered as a grade C recommendation, with moderate certainty of a small benefit.⁵ 

• For adults older than 60 years, the Task Force recommends against starting low-dose aspirin therapy. This recommendation is offered as a grade D recommendation, which recommends against using aspirin for this population.⁵ 

These recommendations apply to adults older than 40 years of age without signs or symptoms of CVD and not at increased risk for bleeding.

What Changed From the Previous USPSTF Recommendations?

The 2016 USPSTF recommendations had stronger recommendations for the use of aspirin to prevent CVD and CRC. The new recommendations concluded that there was insufficient evidence that low-dose daily aspirin reduces the incidence of or mortality from CRC.³ Therefore, the new recommendations only address daily aspirin use for the primary prevention of CVD.  

The previous recommendations advised initiating daily aspirin use for adults aged 50 to 59 years with a 10% or greater 10-year CVD risk without increased risk for bleeding, who have a life expectancy of 10 years or greater, and who are willing to take daily low-dose aspirin for at least 10 years. This recommendation was also a higher grade (Grade B — high certainty of a moderate benefit) compared with the updated recommendations.⁶ 

In the 2016 USPSTF recommendations, the Task Force recommended an individual decision for initiating aspirin use for adults aged 60 to 69 years with a 10% or greater 10-year CVD risk. This recommendation was offered as a grade C recommendation.⁶ 

The previous recommendations cited insufficient evidence for daily aspirin use in adults younger than 50 years and older than 70 years.⁶ The updated recommendations have addressed patients as young as 40 years.³ 

Why Did the USPSTF Recommendations Change?

New data on the potential risk of aspirin have prompted the change in the USPSTF recommendations on daily aspirin use for primary prevention of CVD. The primary risk of daily aspirin use is an increased risk of major bleeding such as gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke.⁴ 

The factor contributing to the increased risk of bleeding is aspirin’s inhibition of platelet activity. Additionally, by inhibiting COX-1, aspirin may promote gastrointestinal bleeding by inhibiting the production of several prostaglandins that protect the gastrointestinal mucosa.³ 

Since the 2016 USPSTF recommendations, 3 trials have been published with a focus on special populations of patients, including those with older age, diabetes, and additional CVD risk factors.^7-9

Aspirin Use in Older Adults

A randomized, placebo-controlled clinical trial (ASPREE; ClinicalTrials.gov Identifier: 01038583) of more than 19,000 adults older than 70 years in Australia and the United States found that, compared with placebo, enteric-coated aspirin 100 mg resulted in a significantly higher risk of major bleeding. Additionally, aspirin 100 mg/d was not associated with a significantly lower risk of CVD compared with placebo.⁷ 

Aspirin Use in Adults With Diabetes 

A randomized, placebo-controlled trial (ASCEND; ClinicalTrials.gov Identifier: NCT00135226) of more than 15,000 adults with diabetes but without CVD found that, compared with placebo, aspirin 100 mg/d significantly reduced the risk of CV events (8.5% in the aspirin group vs 9.6% in the placebo group; P=.01). However, the authors concluded that these benefits were counterbalanced by the increased risk of bleeding (4.1% in the aspirin group vs 3.2% in the placebo group; P=.003).⁸  

Aspirin Use in Adults at Moderate Risk for CVD

The Aspirin to Reduce Risk of Initial Vascular Events (ARRIVE; ClinicalTrials.gov Identifier: NCT00501059) study was a randomized, placebo-controlled trial of more than 12,000 adults at moderate risk for CVD (defined as a 10% to 20% 10-year risk). Due to a lower-than-expected event rate, the authors were unable to address the role of aspirin in the primary prevention of CVD in a moderate-risk population. However, the results were consistent with the results from other trials with a low-risk population.⁹ 

Updated Evidence Report and Systematic Review for the USPSTF

The systematic review commissioned by the USPSTF included 11 randomized controlled trials (including the studies discussed above) and 1 pilot trial with more than 134,000 patients. The authors of this systematic review found that although low-dose aspirin was associated with a small reduction in CV events, it was also associated with small increases in major bleeding events.⁴ 

The results for aspirin use for the prevention of CRC were not as robust as those for primary CVD prevention and were highly variable.⁴ 

Authors of another systematic review and meta-analysis from 2019 on the association of aspirin use with CV events and bleeding events found that the absolute risk reduction of CV events (0.41%) did not outweigh the increased risk of major bleeding (0.47%).¹⁰ 

Implementing USPSTF Daily Aspirin Recommendations Into Practice 

The 2022 USPSTF recommendations align with the position of other professional organizations and guidelines, including^11-13:

• 2019 American College of Cardiology/American Heart Association (ACC/AHA) Guideline on the Primary Prevention of Cardiovascular Disease — available here¹¹; and
• 2021 European Society of Cardiology (ESC) Guidelines on Cardiovascular Disease Prevention in Clinical Practice — available here.¹²

The American Academy of Family Physicians (AAFP) has also released a statement supporting the USPSTF recommendations on aspirin use for the primary prevention of CVD.¹³ 

Shared Decision-Making

Aspirin use is no longer routinely recommended for any patient. Initiating daily aspirin use should be based on shared decision-making between patients and their health care providers. It is important to determine what factors are most important for patients when making this treatment decision.³ 

Patients who choose to initiate aspirin may place a higher value on aspirin’s benefit of decreasing the risk of CV events and stroke than the increased risk of bleeding. For these patients, clinicians can recommend low-dose aspirin (< 100 mg/d). The most common aspirin dosage for this purpose is 81 mg/d.³

Patients who choose not to initiate aspirin may place a higher value on the increased risk of bleeding and the increased pill burden of daily aspirin.³

Clinicians should educate patients about the increased risk of bleeding, including signs and symptoms to watch for, such as^3,14,15:

• Severe headache;
• Dizziness;
• Nausea and vomiting;
• Seizures; 
• Weakness on 1 or both sides;
• Fatigue; 
• Aphasia;
• Black, tarry stool;
• Coffee ground vomit;
• Abdominal cramping; and 
• Pallor. 

Re-evaluating Patients Taking Daily Aspirin

Patients currently taking aspirin daily should be regularly evaluated to ensure the benefit of treatment still outweighs the risk. The risk of serious bleeding increases with age. Modeling data from the USPSTF shows that it may be reasonable to stop daily aspirin use at the age of 75 years.³

Alternative Approaches to Primary CVD Prevention

Other approaches to the primary prevention of CVD should also be considered. Other therapies with a more favorable safety profile than aspirin include antihypertensive agents and statin therapy.¹

In the future, it may be possible to identify distinct populations of patients that may benefit from aspirin therapy, such as those with hyperactive platelets. However, more research is needed to determine the potential benefit to these patients.¹

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Severe symptomatic intracranial atherosclerotic stenosis is defined as 70% to 99% narrowing of the vertebral artery, middle cerebral artery, internal carotid artery, or basilar artery.

Patients with this condition who enrolled in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS; ClinicalTrials.gov Identifier: NCT00576693), a randomized controlled trial from November 2008 and April 2011, were randomly assigned to 1 of 2 treatment groups. One group received aggressive medical management alone and the other group received aggressive medical management plus percutaneous transluminal angioplasty and intracranial stenting. The outcomes of the SAMMPRIS trial indicated that aggressive medical management alone was superior to aggressive medical management plus stenting.

Recently, researchers in the United States analyzed the data from the previously completed SAMMPRIS trial to determine whether aggressive medical management decreased racial disparities in vascular risk factor management. They conducted a retrospective, observational study to compare outcomes after 1 year of treatment for 104 Black and 347 non-Black patients with severe symptomatic intracranial atherosclerotic stenosis.

Aggressive medical management consisted of a protocol to lower low-density lipoprotein (LDL) levels below 70 mg/dL and systolic blood pressure below 140 mmHg for patients without diabetes and below 130 mmHg for patients with diabetes. A lifestyle medication program addressed low physical activity levels, excess weight, smoking, diabetes, and elevated cholesterol levels. Moderate exercise less than 5 times per week or vigorous exercise less than 3 times per week were the target physical activity levels for the cohort.

Vascular risk factors for stroke assessed at baseline and 1 year included systolic and diastolic blood pressure, hemoglobin A1c, LDL, and physical activity levels. Physical activity levels were assessed using the Physician-based Assessment and Counseling for Exercise (PACE) questionnaire with scores of 4 or above indicating target physical activity levels.

At baseline, the researchers noted significant disparities in vascular risk factors existed between Black and non-Black patients. Compared with non-Black patients, Black patients were more likely to have hypertension (95.2% vs 87.5%; P =.027) and diabetes (52.9% vs 39.7%; P =.017) as well as higher average diastolic blood pressure (82.4 mmHg vs 79.5 mmHg; P =.035) and lower average PACE scores reflective of lower physical activity levels (2.7 vs 3.3; P =.002).    

After 1 year of aggressive medical management, the researchers did not observe any significant difference between Black and non-Black patients when comparing average diastolic blood pressure readings (74.7 mmHg vs 75.5 mmHg; P =.575) and average PACE scores (4.2 vs 4.1; P =.0593). No additional disparities between racial groups became apparent after 1 year.

“Significant differences in important risk factors (physical activity and diastolic blood pressure) at baseline between Black and non-Black patients resolved at 1 year, suggesting that aggressive medical management may have an important role in ameliorating disparities in risk factor control between Black and non-Black patients,” the researchers stated.

Study limitations included the retrospective, post hoc design of the study, the small sample size resulting in a low powered endpoint analysis, the potential for measurement or information bias, and lack of generalizability to all geographic populations due to the disproportionate ethnic diversity in the SAMMPRIS trial.

Disclosures: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see original source for full list of disclosures.

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Researchers conducted a multicenter study and reported on the occurrence and types of PSCI in patients with acute ischemic stroke, along with exploring sex differences in the sensitivity and specificity of cognitive screening tools for identifying PSCI.

Data from 9 cohorts of ischemic stroke patients (n=2343) were combined through the Meta-VCI-Map consortium. The researchers included patients with visible symptomatic infarcts on computed tomography scan/magnetic resonance imaging and cognitive assessment within 15 months poststroke.

PSCI was characterized by cognitive impairment in 1 or more domains, as assessed by neuropsychologic evaluation. These impairments align with the VASCOG criteria for Vascular Cognitive Disorders.

Of those included, women were older (mean [SD] age, 68.3 [12.3] years) compared with men (mean [SD] age, 64.9 [11.3] years). Additionally, stroke severity was higher in women than in men, defined by the National Institutes of Health Stroke Scale (NIHSS).

PSCI was present in 51% of both women and men, with age-adjusted differences of -1% [95% CI, -5 to 4]. There was no significant gender disparity in the prevalence of PSCI ([odds ratio] OR, 1.03; 95% CI, 0.87-1.21).

In comparison with women, men exhibited a lower likelihood of experiencing attention and executive functioning impairment (men; OR, 0.76; 95% CI, 0.61–0.96) as well as language impairment (men; OR, 0.67; 95% CI, 0.45–0.85). Conversely, men demonstrated an increased risk for verbal memory impairment (men; OR, 1.43; 95% CI, 1.17–1.75).

Of the 9 cohorts that underwent a multidomain neuropsychologic assessment, 4 cohorts (n=1814, missing score n=1) utilized the MMSE as a cognitive screening tool, while 3 other cohorts (n=278, missing score n=22) relied on the Montreal cognitive assessment (MoCA). In the remaining 2 cohorts (n=251), no cognitive screening test was available.

The MMSE results indicated higher sensitivity in detecting PSCI in women (0.53) compared with men (0.27; P =.02), although with lower specificity in women (0.80) compared with men (0.96; P =.01). Conversely, the MoCA demonstrated similar sensitivity and specificity in detecting PSCI in both women and men (0.91 vs 0.86; P =.62; .29 vs .28; P =.86, respectively).

The researchers concluded, “PSCI was equally common in women and men, but that the cognitive profiles differed between sexes. Women more often had impairment in the domains of attention, executive functioning, and language, whereas men more often had impairment in verbal memory. In addition, the MMSE had a higher sensitivity in women compared with men, but the specificity was lower in women compared with men.”

A potential limitation of this study included the underrepresentation of women in stroke research. Furthermore, a higher percentage of men compared to women were included within the analysis.

Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Thrombolytic agent rhPro-UK has shown efficacy in treating acute myocardial infarction and has potential in effectively treating AIS in a phase 2 randomized clinical trial. The next step in the drug-approval process requires comparison of rhPro-UK with a thrombolytic agent that is currently approved for AIS in a phase 3 randomized controlled trial.

Researchers in China conducted this randomized, alteplase-controlled, open-label, phase 3, clinical trial (PROST; ClinicalTrials.gov Identifier: NCT03541668) from May 2018 to May 2020 across 35 medical centers in China. They analyzed the data between June and October of 2020.

Out of 684 patients who were screened, the researchers enrolled 674 eligible patients between the ages of 18 and 80 years with a diagnosis of AIS in their study. Of the 674 eligible patients, the researchers randomly assigned 663 (24.3% women; mean age, 61 years) into 2 treatment groups — 330 into the rhPro-UK group and 333 into the alteplase group.

Both treatments were administered intravenously within 4.5 hours of onset of stroke symptoms. Patients in the rhPro-UK group received 35 mg of the drug with a 15 mg bolus within 3 minutes, while patients in the alteplase group received 0.9 mg per kg body weight at a maximum of 90 mg with 10% administered intravenously as a bolus followed by 90% infusion within 1 hour.

The average baseline score per the National Institutes of Health Stroke Scale (NIHSS) totaled 6.00, ranging from 5 to 9. A total of 23 patients died before the end of the study, while 619 patients (93.4%) of the remaining patients finished the 3-month follow-up.

The primary outcome of interest was an excellent functional outcome based on a modified Rankin Scale (mRS) score between 0 and 1 after 90 days. Secondary outcomes included the following:

• major neurologic improvements indicated by reduction in NIHSS scores of 4 or greater or a score between 0 and 1 within 24 hours after treatment administration
• a Barthel Index score between 75 and 100 after 90 days post-treatment
• functional independence indicated by a mRS score between 0 and 2 after 90 days post-treatment

The researchers also evaluated safety outcomes, including all-cause mortality between 7 and 90 days after treatment, incidence of systemic bleeding within 90 days of treatment, incidence of symptomatic intracranial hemorrhage (ICH) within 90 days, and recurrence of ischemic stroke within 7 days of treatment.

After 3 months, 215 patients (65.2%) in the rhPro-UK and 214 patients (64.3%) in the alteplase group achieved excellent functional outcomes per the mRS (risk difference [RD], 0.89; 95.4% CI, -6.52 to 8.29; P =.81). There was a 16.4% lower risk for systematic bleeding with intravenous thrombolysis with rhPro-UK compared with alteplase treatment.

Within 24 hours of treatment administration, 132 patients (40.0%) in the rhPro-UK group and 142 patients (42.6%) in the alteplase group demonstrated major neurologic improvement (RD, -2.64; 95% CI, -10.14 to 4.85; P =.49).

After 90 days, 251 patients (76.1%) in the rhPro-UK group and 250 patients (75.1%) in the alteplase group reached a mRS score between 0 and 2 (RD, 0.99; 95% CI, -5.56 to 7.53; P =.77). Similarly, after 90 days, 272 patients (82.4%) in the rhPro-UK group and 271 patients (81.4%) in the alteplase group scored between 75 and 100 on the Barthel Index (RD, 1.04; 95% CI, -4.82 to 6.90; P =.73).

Death within 90 days occurred in 14 patients (4.2%) in the rhPro-UK group and 9 patients (2.7%) in the alteplase group (P =.30). Both groups demonstrated 5 deaths related to thrombolysis (1.5% in each group), whereas the remaining 13 deaths weren’t related to thrombolysis.

Recurrent ischemic stroke occurred at similar rates in the 2 treatment groups — 2 patients (0.6%) in each group. Additionally, symptomatic ICH occurred at similar rates between the 2 treatment groups, according to the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST; P >.99), the European Cooperative Acute Stroke Study (ECASS III; P >.99), and the National Institute of Neurological Disorders and Stroke (NINDS; P =.49).

In contrast, systemic bleeding within 90 days occurred with a significantly higher incidence in the alteplase group compared to the rhPro-UK group (42.2% vs 25.8%; P <.001); however, serious systemic bleeding occurred at similar rates across the 2 groups (2.4% in the rhPro-UK group vs 2.7% in the alteplase group).

The researchers noted that “Reduced risk of systemic bleeding in patients treated with rhPro-UK, indicating fewer complications, may mean lowered possibilities of use of blood products or hemostatic drugs, shorter hospital stays, and lower expenses.”

Study limitations included missing data, use of a 10% noninferiority margin that is larger than the minimally clinically important difference suggested by consensus groups in 2005 and 2012, potential biases due to the open-label trial design. There was also a lack of mandated advanced imaging to ascertain perfusion lesion or vessel occlusion although use of CT scans perhaps made results more generalizable since this imaging is more widely available in smaller cities.

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The post hoc analysis of the Treat Stroke to Target trial (ClinicalTrials.gov Identifier: NCT01252875) assessed the outcomes of lowering LDL-C by more than 50% from baseline levels or less than 50% in patients assigned an LDL-C target level of less than 70 mg/dL, compared with a target level of 100±10 mg/dL.

All patients were enrolled from March 2010 to December 2018. Included patients had a proven ischemic stroke on neuroimaging (modified Rankin Scale score of 0 to 3) that occurred within the previous 3 months or a transient ischemic attack (TIA) within the prior 15 days with at least 1 motor deficit of the arm and leg or a speech disturbance that lasted more than 10 minutes.

The primary outcome was a composite of nonfatal cerebral infarction or stroke of undetermined cause, nonfatal myocardial infarction, hospitalization for unstable angina followed by urgent coronary artery revascularization, TIA with need for urgent carotid revascularization, or cardiovascular death including unexplained sudden death.

Of the 2860 patients who were followed for a median of 3.9 years (IQR, 2.1-6.8), 1430 were assigned an LDL-C target of 100±10 mg/dL (the control group; mean age, 67 years; 67.3% men). The LDL-C target of less than 70 mg/dL with less than 50% LDL-C reduction group included 692 patients (mean age, 66.9 years; 68.8% men), and the LDL-C target of less than 70 mg/dL with 50% or more LDL-C reduction group included 492 patients (mean age, 65 years; 70.3% men).

At enrollment, patients in the lower target group with a more than 50% decrease in LDL-C from baseline had a mean baseline LDL-C of 155±32 mg/dL, and participants with a less than 50% decrease in LDL-C from baseline had a mean baseline LDL-C of 121±34 mg/dL (136±38 mg/dL in the control group).

Participants in the lower target group with a more than 50% LDL-C decrease from baseline had decreased risk for a major cardiovascular event (hazard ratio [HR], 0.61; 95% CI, 0.43-0.88; P =.007), but patients with a less than 50% LDL cholesterol reduction from baseline did not (HR, 0.96; 95% CI, 0.73-1.26; P =.75), compared with patients in the control group.

A study limitation is that only the target LDL-C of less than 70 mg/dL group is randomized and the magnitude of LDL-C reduction from baseline (>50% and <50%) is not randomized. Also, 256 patients in the lower target group were excluded because they did not have sufficient follow-up LDL-C measurements.

“…when clinicians consider targeting an LDL cholesterol of less than 70 mg/dL, they should also be careful to reduce LDL cholesterol by more than 50%,” wrote the investigators.

Disclosure: This study received unrestricted grants from Pfizer, AstraZeneca, and Merck for French sites, and from Pfizer for South Korean sites, and Athera Pharmaceuticals for this post hoc analysis. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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The 2023 AHA/ACC/American College of Clinical Pharmacy (ACCP)/American Society for Preventive Cardiology (ASPC)/National Lipid Association (NLA)/Preventive Cardiovascular Nurses Association (PCNA) Guideline for the Management of Patients With Chronic Coronary Disease is intended to provide a patient-centered approach to managing patients with chronic coronary disease that integrates shared decision-making, social determinants of health, and team-based care. The main audience is clinicians in primary care and the cardiology specialty who care for patients with chronic coronary disease in the outpatient setting.

“[The guideline] aims to provide succinct recommendations in the domains of diagnostic evaluation, symptom relief, improvement in quality of life (QOL), and reduction of future atherosclerotic cardiovascular disease-related events and heart failure (HF) in patients with CCD [chronic coronary disease],” stated the writing committee.

The committee was comprised of general cardiologists, interventional cardiologists, cardiovascular surgeons, cardiac imaging experts, advance practice nurses, clinical pharmacists, health economists, and layperson/patient representatives.

The guideline is an update to and replaces the 2012 American College of Cardiology Foundation (ACCF)/AHA/American College of Chest Physicians (ACP)/American Association for Thoracic Surgery (AATS)/PCNA/Society for Cardiovascular Angiography and Interventions (SCAI)/Society of Thoracic Surgeons (STS) Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease and the 2014 ACC/AHA/AATS/PCNA/SCAI/STS Focused Update of the Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease.

Committee members performed an extensive literature search in MEDLINE, EMBASE, Cochrane Library, the Agency for Healthcare Research and Quality, and other databases for relevant human studies published in English from September 24, 2021, to May 2022. Additional studies published through November 2022 during the writing process also were considered.

Each recommendation was given a class of recommendation (COR) and level of evidence (LOE) grade. A number of the recommendations were published in previous guidelines, and other recommendations have been modified with formatting changes or adapted with substantive changes.

Among the top 10 take-home messages in the guidelines, according to the writing committee, nonpharmacologic therapies such as healthy dietary habits and exercise are recommended for all patients with chronic coronary disease. Lifestyle-related factors that can help lower elevated blood pressure (BP) include weight loss, a heart-healthy diet that is rich in fruits and vegetables, reduced dietary sodium, physical activity, and reduction or abstinence of alcohol.

A strong recommendation (COR 1) was issued for nonpharmacologic strategies as first-line treatment to lower BP in adults with chronic coronary disease and elevated BP (120-129/<80 mm Hg; LOE A). For adults with chronic coronary disease and hypertension, a BP target of less than 130/80 mm Hg is strongly recommended to reduce cardiovascular disease (CVD) events and all-cause death (LOE B-randomized [R]). Also, for adults with chronic coronary disease and hypertension (systolic BP ≥130 and/or diastolic BP ≥80 mmHg), guideline-directed management and therapy (GDMT) angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB), or beta blockers in addition to nonpharmacologic strategies are strongly recommended as first-line therapy for indications such as recent myocardial infarction (MI) or angina, with additional antihypertensive medications added as needed for optimal BP control (LOE B-R).

Habitual physical activities such as nonexercise lifestyle activities, aerobic exercise training, and resistance (strength) training are associated with improved outcomes in patients with CVD, and a change from sedentary lifestyle habits to at least lower-intensity physical activities can improve metabolic and cardiovascular health. For patients with chronic coronary disease who do not have contraindications, an exercise regimen is strongly recommended, including 150 minutes or more per week of moderate-intensity aerobic activities or 75 minutes or more per week of higher-intensity aerobic activities to improve functional capacity and QOL and to reduce hospital admission and mortality (LOE A). For patients with chronic coronary disease without contraindications, resistance (strength) training exercises are strongly recommended 2 days or more per week to improve muscle strength, functional capacity, and cardiovascular risk factor control (LOE B-R).

Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists can significantly lower the risk for major adverse cardiovascular events (MACE) in patients with chronic coronary disease and type 2 diabetes, with additional benefits for weight loss and progression of kidney disease. For patients with chronic coronary disease and HF with left ventricular ejection fraction (LVEF) of 40% or less, the committee issued a strong recommendation for use of an SGLT2 inhibitor to reduce the risk of cardiovascular death and HF hospitalization and to improve QOL, regardless of diabetes status (LOE A).

Among patients with chronic coronary disease and without previous MI or LVEF of  50% or less, the committee found no benefit for the use of beta-blockers in reducing MACE, without another primary indication for a beta-blocker (LOE B-not randomized [NR]).

For patients with chronic coronary disease and angina, antianginal therapy with a beta blocker, calcium channel blocker (CCB), or long-acting nitrate is strongly recommended for relief of angina or similar symptoms (LOE B-R). Among patients with chronic coronary disease and angina who are symptomatic after initial treatment, adding a second antianginal agent from a different therapeutic class (beta blockers, CCB, long-acting nitrates) is strongly recommended for relief of angina or equivalent symptoms (LOE B-R). Also, ranolazine is strongly recommended in patients who are still symptomatic after use of beta blockers, CCB, or long-acting nitrates (LOE B-R).

For lipid management, 3 strong recommendations (all LOE A) were provided. For patients with chronic coronary disease, high-intensity statins are strongly recommended to achieve a 50% or more decrease in low-density lipoprotein cholesterol (LDL-C) levels to lower the risk for MACE. In patients for whom high-intensity statins are contraindicated or not tolerated, moderate-intensity statins are strongly recommended with the goal of a 30% to 49% decrease in LDL-C levels to reduce the risk for MACE. Also, the committee strongly recommends that adherence to changes in lifestyle and effects of lipid-lowering medication should be assessed by measuring fasting lipids 4 to 12 weeks after statin initiation or dose adjustment and every 3 to 12 months afterward according to the need to assess response or adherence to treatment.

In patients with chronic coronary disease who receive percutaneous coronary intervention (PCI), dual antiplatelet therapy with aspirin and clopidogrel for 6 months after PCI followed by single antiplatelet therapy is indicated for reducing MACE and bleeding events (strong recommendation; LOE A). For patients with chronic coronary disease and no indication for oral anticoagulant therapy, low-dose aspirin 81 mg (75-100 mg) is strongly recommended to reduce atherosclerotic events (LOE A).

Among the recommendations for nutrition, the committee concluded that there is no benefit for using nonprescription or dietary supplements, including omega-3 fatty acids, vitamins C, D, and E, beta-carotene, and calcium, to lower the risk for acute CVD events in patients with chronic coronary disease (LOE B-NR). The committee also found that there is harm regarding the intake of trans fat for patients with chronic coronary disease, recommending that trans fat be avoided because it is associated with increased morbidity and mortality (LOE B-NR). The committee noted that the only omega-3 fatty acid formulation that can be recommended in patients with chronic coronary disease is icosapent ethyl (EPA only). A strong recommendation was given for emphasizing a diet that includes vegetables, fruits, legumes, nuts, whole grains, and lean protein to lower the risk for CVD events (LOE B-R).

For patients with chronic coronary disease who do not have a change in clinical or functional status, the committee concluded that routine periodic invasive coronary angiography should not be conducted to guide therapeutic decision-making (harm; LOE B-NR).

Regarding tobacco products, strong recommendations were given for assessing tobacco use at every health care visit for patients with chronic coronary disease, as well as advising those who regularly smoke tobacco to quit at every visit (both LOE A). Also, among patients with chronic coronary disease who regularly smoke tobacco, behavioral interventions are strongly recommended to maximize cessation rates combined with pharmacotherapy, including bupropion, varenicline, or combination long- and short-acting nicotine replacement therapy (LOE A). In addition, for patients who regularly smoke tobacco, the short-term use of nicotine-containing e-cigarettes may be considered to aid smoking cessation, although the risk for continued use and unknown long-term safety may outweigh the benefits (COR 2b; LOE B-R).

Among other topics addressed, the committee issued a strong recommendation that optimization of GDMT is recommended to reduce MACE in patients with chronic coronary disease (LOE A). The committee also gave a strong recommendation for invasive coronary angiography to assess coronary anatomy and guide potential revascularization in patients with chronic coronary disease with newly reduced left ventricular systolic function, clinical heart failure, or both (LOE A).

Among patients with chronic coronary disease who need revascularization for significant left main involvement associated with high-complexity coronary artery disease (CAD), coronary artery bypass grafting (CABG) is strongly recommended vs PCI to improve survival (LOE B-R). Also, among patients with chronic coronary disease who require revascularization for multivessel CAD and complex and diffuse CAD (SYNTAX score >33), CABG is reasonable vs PCI to improve survival (COR 2a; LOE B-R).

The committee also issued a strong recommendation that health care providers discuss out-of-pocket costs for medications when patients are initiating a new medication and at least annually afterward to preempt cost-related nonadherence (LOE B-NR).

Key areas of future research, according to the committee, include topics such as how advances in noninvasive imaging technology may affect detection of patients with chronic coronary disease and their eligibility for preventive therapy, as well as validated comprehensive risk scores for MACE in patients with chronic coronary disease. In addition, high-quality studies are needed to assess the effects of marijuana and other substances on cardiovascular outcomes in patients with chronic coronary disease, as well as the long-term effect of treatment of mental health conditions such as depression.

“The population of patients with CCD [chronic coronary disease] is heterogenous, and the risk of future cardiovascular events is not uniform across this patient population,” stated the committee. “Therefore, clinicians should prioritize therapies based on a patient’s future risk of CVD-related events.”

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Cande V. Ananth, Ph.D., M.P.H., from the Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, and colleagues conducted a sequential time-series analysis from 1990 to 2019 to examine mortality trends among men and women aged 25 to 84 years in the United States with CHD recorded as the underlying cause of death. The preventable fraction of CHD death attributable to alcohol, smoking, and high body mass index was estimated through the Global Burden of Disease.

The researchers found that the age-standardized CHD mortality rate declined from 210.5 per 100,000 in 1990 to 66.8 in 2019 (annual change, −4.04 percent; incidence rate ratio, 0.32) among women and from 442.4 to 156.7 per 100,000, respectively (annual change, −3.74 percent; incidence rate ratio, 0.36) among men. Among younger cohorts, a slowing of the decline in CHD mortality rates was seen. The decline was slightly attenuated with correction for unmeasured confounders through a quantitative bias analysis. With elimination of smoking, alcohol, and obesity, half of all CHD deaths could have been prevented, including 1,726,022 female and 2,897,767 male CHD deaths between 1990 and 2019.

“The ultimate goal is to help inform standards of care and public health priorities by determining which patients face the highest level of risk for cardiovascular events,” Ananth said in a statement. “Although increased screening and population-wide interventions are possible, the returns are likely to be minimal, at best, while costs will be prohibitively high. We need to maximize returns from our limited resources by identifying high-risk subsets of patients and targeting intervention to them.”

Abstract/Full Text (subscription or payment may be required)

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Investigators aimed to compare CEA plus standard medical therapy versus medical therapy alone for prevention of ipsilateral stroke in adult patients with severe carotid stenosis. The primary endpoint was acute ipsilateral ischemic stroke.

They conducted a retrospective observational, data-only (causal inference) cohort study that included 3824 patients aged at least 18 years (mean age, 73.7 years ) who  had severe (70% to 99%) carotid stenosis (no neurological symptoms within 6 months) with no prior ipsilateral carotid artery intervention. Using electronic medical-record data from January 2008 through December 2017, the investigators at Kaiser Permanente Northern California integrated health care delivery system applied causal inference methods to compare event-free survival over 8 years between patients with CEA within 12 months from cohort entry vs standard medical therapy alone.

Among patients with bilateral severe disease, 1 side was chosen at random, and only 1 severe stenosis per patient was included.

Among the included patients (57.9% men; 73% non-Hispanic White patients; 12.3% active smokers; 50.1% former smokers), 1467 patients received CEA (86% in the first 12 months), and 2357 received standard therapy alone. Median time to surgery was 2 months (IQR, 1-5 months).

During follow-up (median 68 months), 1760 patients died, 445 were lost to follow-up, and 158 (4.1%) experienced ipsilateral ischemic stroke. Overall, 1461 patients survived without experiencing stroke through the end of the study.

For each year of follow-up, compared with patients who received standard therapy alone, cumulative risk differences showed a protective effect from ipsilateral stroke over time starting in year 2 (risk difference [RD], 1.1%; 95% CI, 0.5%-1.6%; P <.001) in patients that received CEA, continuing to year 8 (RD, 2.6%; 95% CI, 0.3%-4.8%; P =.03).

Significant survival advantages were demonstrated via cumulative risk differences in the CEA group vs standard therapy alone group in the composite endpoint of stroke and death in year 2 (RD, 6.7%; 95% CI, 4.7%-8.7%) continuing to year 8 (RD, 13.7%; 95% CI, 8.4%-18.9%).

Study limitations include the disease severity being assigned by imaging reports, and assessment of documented transient ischemic stroke in the Kaiser electronic health records is unreliable.

“In this retrospective study utilizing techniques to mimic a clinical trial, carotid endarterectomy was found to be protective of stroke in patients with asymptomatic stenosis compared with medical therapy alone,” the investigators wrote. “Given that the protective effect is less than in previous trials, patient selection and stroke risk prediction are crucial to optimal resource utilization in this high-risk population.”

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The randomized, open-label, noninferiority ARAMIS (Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke; ClinicalTrials.gov Identifier: NCT03661411) trial evaluated the efficacy and safety of DAPT in 38 hospitals in China.

Eligible participants were aged 18 years or older and had an acute ischemic stroke with a National Institutes of Health Stroke Scale (NIHSS) score of 5 or less, with 1 or fewer points on single-item scores, and could begin to receive study treatment within 4.5 hours of stroke symptoms.

The patients were randomly assigned in a 1:1 ratio to receive DAPT or intravenous alteplase. The alteplase group received 0.9 mg/kg (10% as a bolus, 90% infused for 1 hour) to a maximum of 90 mg, followed by guideline-based antiplatelet treatment beginning 24 hours after intravenous thrombolysis. The DAPT group received a loading dose of 300 mg of clopidogrel on the first day, followed by 75 mg per day for 12 (±2) days; 100 mg of aspirin on the first day, followed by 100 mg daily for 12 (±2) days; and single antiplatelet therapy or DAPT based on guidelines until 90 days.

The primary outcome was excellent functional outcome at 90 days, which was a modified Rankin Scale (mRS) score of 0 to 1. The noninferiority margin of -4.5% was based on the Third International Stroke Trial.

The full analysis set included 719 patients (369 in the DAPT group [median age, 65 years; 69.5% men] and 350 in the alteplase group [median age, 64 years; 68.6% men]) who were enrolled from October 1, 2018, to April 18, 2022. Participants’ median NIHSS score was 2 (IQR, 1-3). The DAPT group had a median time from stroke onset to treatment of 182 (IQR, 133- 230) minutes vs 180 (IQR, 126-225) minutes in the alteplase group.

Regarding the primary outcome, the percentage of patients who had mRS scores of 0 or 1 at 90 days was 93.8% in the DAPT group and 91.4% in the alteplase group. The risk difference of an excellent outcome at 90 days was 2.3% (unadjusted 95% CI, -1.5% to 6.2%; P <.001 for noninferiority; adjusted 95% CI, -1.6% to 6.1%) in the full analysis set. Similar findings were observed in the per-protocol and as-treated analyses.

DAPT was noninferior to intravenous alteplase because the lower boundary of the 2-sided 95% (1-sided 97.5%) CI was greater than the prespecified value of -4.5%.

Patients in the DAPT group had early neurologic deterioration at 24 hours vs the alteplase group in the full analysis set (unadjusted risk difference, -4.5% [95% CI, -8.2% to -0.8%]; adjusted risk difference, -4.6% [95% CI, -8.3% to -0.9%]).

In the DAPT group, 1 patient had symptomatic intracerebral hemorrhage (sICH) and 6 patients had other bleeding events. In the alteplase group, 3 patients had sICH and 19 patients had other bleeding events.

Limitations include the noninferiority, open-label design and high crossover rate (20.4%). Also, patients with possible cardioembolism were excluded, and fewer women than men were enrolled. Furthermore, high rates of the primary endpoint in the DAPT and alteplase groups may have had a ceiling effect that limited the opportunity for either agent to show superiority to the other.

“Among patients presenting with minor nondisabling acute ischemic stroke within 4.5 hours of symptom onset, dual antiplatelet treatment was noninferior to intravenous alteplase with regard to excellent functional outcome at 90 days,” the study authors wrote.

Disclosure: The antiplatelet medications including aspirin and clopidogrel were donated by Shenzhen Salubris Pharmaceutical Co, Ltd. One of the study authors declared an affiliation with a biotech company. Please see the original reference for a full list of authors’ disclosures.

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In the original Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis trial (SAMMPRIS; ClinicalTrials.gov Identifier: NCT00576693), a randomized controlled trial conducted between 2008 and 2011, researchers compared aggressive medical management vs aggressive medical management plus percutaneous transluminal angioplasty and stenting (PTAS) in patients with severe symptomatic intracranial atherosclerotic stenosis and found that aggressive medical management was superior to PTAS.

In this post-hoc analysis, researchers assessed whether aggressive medical management amended disparities in vascular risk factors control between Black and non-Black patients.

A total of 104 Black patients and 347 non-Black patients were enrolled in the SAMMPRIS trial with complete risk factor data. For this exploratory outcome analysis, the primary end point — stroke or death within 30 days after enrollment or ischemic stroke between day 31 and the end of the follow-up period — was compared between Black and non-Black patients. Vascular factors analyzed at baseline and 1 year included blood pressure, low-density lipoprotein (LDL) cholesterol levels, high-density lipoprotein (HDL) cholesterol levels, hemoglobin A_1C (HbA_1C), physical activity, and medication.

Researchers found a higher number of stroke or death among Black patients compared with non-Black patients (n, 49 vs 178) who received aggressive medical management arm during 3 years of follow up (1 year, 14.6% vs 12.1%; 2 years, 19.0% vs 12.7%; 3 years, 22.8% vs 12.7%, respectively); however, there was no statistically significant difference (P =.28).

At baseline, significant differences between Black and non-Black patients included:

• History of hypertension: 95.2% vs 87.5%, respectively; P =.027
• History of diabetes: 52.9% vs 39.7%, respectively; P =.017
• Mean diastolic blood pressure (DBP): 82.4 mmHg vs 79.5 mmHg, respectively; P=.035
• Mean HDL: 41.2 mg/dL vs 38 mg/dL, respectively; P=.008
• Baseline PACE scores: 2.7 vs 3.3, respectively; P =.002

Compared with non-Black patients, Black patients were more likely to be prescribed diuretics, calcium channel blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers. There were no significant differences were found in mean systolic BP (SBP; P =.301) and LDL (P =.135) .

After 1 year, there was no longer a baseline disparity in DBP and PACE scores between Black and non-Black patients and still no significant differences in mean SBP, LDL, or HbA_1C. Notably, Black patients used more diuretics after receiving aggressive medical management.  

Key limitation includes the low power for the primary end point analysis due to the small sample size.

“[A] unique finding of this analysis is that after 1 year of AMM [aggressive medical management], the differences in DBP and physical activity score between Black and non-Black patients were no longer present,” the researchers conclude, and “protocol-driven intensive risk factor management may have an important role in ameliorating disparities in risk factor control between Black and non-Black subjects.”

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Ischemic and hemorrhagic strokes are among the top causes of disability and mortality worldwide, and relatively common in ICU admissions. UGIB is a common complication in ICU patients and is associated with a worse prognosis in stroke patients. As PPI use can lead to UGIB, researchers aimed to investigate their relationship to mortality, as well as UGIB and mortality in critically ill stroke patients.

A retrospective study was conducted based on the MIMIC-IV database, which contains information on patients admitted to ICUs at Beth Israel Deaconess Medical Center (BIDMC) between 2008 and 2019. Individuals with ischemic or hemorrhagic stroke or subarachnoid hemorrhage, diagnosed by International Classification of Diseases-9 (ICD-9), were included in the study. Those who had an ICU stay of less than 24 hours or had a nonfirst ICU admission were excluded from the study.

A UGIB diagnosis was based on symptoms after ICU admission, such as melena or hematemesis, or a positive fecal occult test. In-hospital mortality and 30-day mortality were the primary outcomes of the study.

A total of 5,716 patients diagnosed with stroke were included in the study, of which 1,019 died in the hospital, accounting for an in-hospital mortality rate of 17.8%. The mean [SD] age of admitted patients was 68.5[15.7] years, with an average length of ICU stay of 12.3[13.7] days. PPI use was accounted for up to 60.6% of patients, with UGIB occurring in only 109 patients (1.9%).

Multivariable logistic analysis found several independent risk factors for the occurrence of gastrointestinal bleeding in severe stroke patents, including chronic liver disease (OR, 1.039, P <.001), sepsis (OR, 2.455, P =.002), shock (OR, 2.041, P =.004), hemoglobin (OR,.850, P =.001), and BUN (OR, 1.012, P =.004).

Comparably, several risk factors for in-hospital mortality were identified by logistic analysis, with the most prominent being mechanical ventilation (OR, 3.313, P <.001), continuous renal replacement therapy (CRRT; OR, 2.208, P =.001), heart failure (OR, 1.418, P =.004), and shock (OR, 1.406, P =.013).

Of note, PPI use was not associated with the occurrence of UGIB, and UGIB itself was not associated with all-cause mortality.

Study limitations include the single-center design, so selection bias is possible. Additionally, functional outcomes of poststroke patients are unknown, as there was no long-term follow-up provided in the database.

PPI was not the risk factor for the occurrence of UGIB,” study authors wrote. “UGIB was also not associated with all-cause mortality. Definitive recommendations need further clinical trials to evaluate benefits of using PPI in critically ill stroke patients with low incidence of UGIB.”

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The presence of cerebral small vessel disease (cSVD), which is a major cause of lacunar stroke, is linked to vascular cognitive impairment and mood/mobility issues. To date, there is no specific treatment available to prevent the occurrence. For the study, researchers evaluated whether modulators of cerebrovascular endothelial function, such as the nitric oxide donor ISMN and the phosphodiesterase-3 inhibitor cilostazol, improve patients’ long-term outcome after experiencing a lacunar stroke.

The investigator-initiated, open-label, blinded endpoint, randomized, 2×2 factorial Lacunar Intervention Trial-2 (LACI-2; ClinicalTrials.gov Identifier: NCT03451591) was conducted at 26 stroke specialist hospitals located in the United Kingdom. The researchers aimed to recruit a total of 400 participants between February 5, 2018 and May 31, 2021, with a follow-up period of 12 months designated. Data analysis was carried out on August 22, 2022.

Participants were eligible for the trial if they had a clinical lacunar ischemic stroke, were independent, older than 30 years, and had compatible brain imaging findings as well as no contraindications to (or indications for) the study drugs included in the trial.

The patients received standard stroke prevention medication and were randomly assigned to 1 of 4 groups: ISMN 40 to 60 mg/day, cilostazol 200 mg/day, ISMN 40 to 60 mg/day plus cilostazol 200 mg/day, or no study drug.

Primary outcome included recruitment feasibility, including 12-month retention. Secondary outcomes included safety (death), efficacy (composite of vascular events, dependency, cognition, and death), medication adherence, tolerance, recurrent stroke, dependence, cognitive impairment, quality of life (QoL), and hemorrhage.

Out of the 400 anticipated participants, 363 (251 men, 112 women; median age, 65 [range, 56.0-72.0 years]) were recruited over 24 active months. Patients’ median National Institutes of Health score was 0 (range, 0-2.0). The median time that elapsed between stroke and study randomization was 79.0 days (range, 27.0-244.0 days).

At 12-month follow-up, 98.6% (358 of 363) of the participants were retained in the study. Overall, 94.5% (257 of 272) of the participants were receiving treatment with ≥50% of the study drug.

The researchers found that compared with participants not receiving that particular agent, neither ISMN (adjusted hazard ratio [aHR], 0.80; 95% CI, 0.59-1.09; P =.16) nor cilostazol (aHR, 0.77; 95% CI, 0.57-1.05; P =.10) alone was associated with a reduction in the composite outcome in 297 participants.

Further, ISMN decreased the occurrence of recurrent stroke in 353 participants (adjusted odds ratio [aOR], 0.23; 95% CI, 0.07-0.74; P =.01) and cognitive impairment in 308 individuals (aOR, 0.55; 95% CI, 0.36-0.86; P =.006). Treatment with cilostazol was linked to reduced dependence in 320 participants (aHR, 0.31; 95% CI, 0.14-0.72; P =.006).

Combination ISMN plus cilostazol reduced the composite outcome (aHR, 0.58; 95% CI, 0.36-0.92; P =.02), dependence (aOR, 0.14; 95% CI, 0.03-0.59; P = .008), and any cognitive impairment (aOR, 0.44; 95% CI, 0.23-0.85; P =.02). The combination therapy also improved quality of life (adjusted mean difference, 0.10; 95% CI, 0.03-0.17; P =.005) in 153 participants. No safety concerns were reported.

Study limitations included the fact that placebo treatment was not available. In addition, the COVID-19 pandemic affected study recruitment, as well as in-person follow-up. Further, comparison of the combination ISMN plus cilostazol therapy vs treatment with no agent(s) was underpowered.

“These results show that the LACI-2 trial was feasible and ISMN and cilostazol were well tolerated and safe,” the investigators noted. “These agents may reduce recurrent stroke, dependence, and cognitive impairment after lacunar stroke, and they could prevent other adverse outcomes in cSVD. Therefore, both agents should be tested in large phase 3 trials,” they concluded.

Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

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Salim S. Virani, M.D., Ph.D., from the Baylor College of Medicine in Houston, and colleagues conducted a comprehensive literature review to update and consolidate new evidence relating to the diagnosis and management of patients with stable ischemic heart disease.

The authors emphasize team-based, patient-centered care, which considers social determinants of health and associated costs, as well as incorporating shared decision-making in risk assessment, testing, and treatment. All patients with CCD are advised to undergo nonpharmacologic therapies, including healthy dietary habits and exercise. Patients with CCD without contraindications are encouraged to participate in habitual physical activity; for eligible patients, cardiac rehabilitation provides significant cardiovascular benefits. For select groups of patients with CCD, including those without diabetes, the use of sodium glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists is recommended. New recommendations have been developed for use of beta blockers in CCD. Statins remain the first-line therapy for lipid lowering in CCD; several adjunctive therapies may be used in select populations. In many circumstances, shorter durations of dual antiplatelets are safe and effective. Nonprescription or dietary supplements are not recommended in CCD.

“Our understanding about the role of social determinants of health, shared decision-making and the need to fully leverage a team-based approach to care has evolved and improved based on new evidence,” Virani said in a statement.

Abstract/Full Text

Editorial

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Stroke is one of the major causes of disability and mortality worldwide, and the prevalence of stroke is expected to increase due to an aging population. People who suffer from a stroke can experience a wide range of symptoms, including sleep disorders, which can increase the risk for subsequent stroke. Additionally, patients with preexisting sleep disorders are at a greater risk for stroke.¹

“Sleep disorders are associated with worsened stroke outcome, including both recurrent stroke and worsened functional recovery,” said Sandeep Prakash Khot, MD, MPH, associate professor of neurology at the University of Washington, and director of the Harborview Medical Center Consult Service in Seattle. 

As the incidence of stroke increases in the US, organizations such as the American Heart Association and American Stroke Association recommend that more sleep studies be conducted to help prevent stroke recurrence or transient ischemic attack (TIA).² 

While sleep is one of the most important physiological processes for healing, the relationship between sleep disorders and stroke is under continued investigation. 

Bidirectionality of Sleep Disorders and Stroke

Different types of sleep disorders are shown to be associated with stroke, including sleep-related breathing disorders, rapid eye movement (REM) sleep behavior disorders, and sleep-wake cycle disorders.³

Sleep-disordered breathing (SDB) is the most common sleep disorder experienced poststroke, with the most prevalent type being obstructive sleep apnea (OSA).⁴ “Obstructive sleep apnea is found in over 60% of stroke survivors in the acute setting, whereas insomnia, a sleep-wake cycle disorder, is prevalent in about 30% to 40% of stroke survivors,” Dr. Khot noted. 

OSA is an established modifiable risk factor for stroke and is estimated to double the risk for stroke.³ This direct relationship was established in the Sleep Heart Health study, which reported an association between OSA severity and stroke risk.⁵ More recently, evidence shows that some comorbidities, such as stroke and heart failure, may predispose an individual to develop OSA.⁶ 

The bidirectional nature of sleep disorders and stroke could potentially lie in mechanisms for individual comorbidities. A 2022 study published in the European Respiratory Review demonstrates that poststroke sleep architecture can impair breathing control mechanisms centrally and can impact upper airway muscle function. Additionally, patients with OSA who present with stroke have higher National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale scores upon discharge.⁶

A 2019 study published in Sleep Medicine Reviews reported that prolonged sleep duration, defined as at least 8 hours of sleep or more, was associated with a 3.90-fold increased risk for stroke. Researchers also found that the endogenous sleep rhythm is disrupted after stroke and can be associated with increased stroke severity and worsened outcome. This study also identified that shift work, a circadian rhythm disorder, was another risk factor for all-cause stroke (risk ratio [RR], 1.05; 95% CI, 1.01-1.09).⁷

Nonapnea sleep disorders, such as restless leg syndrome (RLS), REM sleep behavior disorder, and insomnia also increase the risk for an acute ischemic stroke. Sleep-related movement disorders were associated with an increased risk for all-cause stroke, with a hazard ratio of 2.29 (95% CI, 1.42-3.80).⁸

The Role of CPAP in Poststroke Treatment

Continuous positive airway pressure (CPAP) is the mainstay of treatment for OSA, but its role in poststroke treatment has conflicting recommendations. 

Many studies show that CPAP use in treating OSA for patients with stroke provides more benefits compared with those who do not receive or are noncompliant with treatment.⁹ Some studies suggest beneficial effects in sleepiness, depression, and functional recovery.^10-12 Other studies reported no apparent advantages in vascular event recurrence and no significant improvement in neurologic cognition, despite improvements in motor function.^13,10

“CPAP use after stroke is currently limited. Screening for OSA is rarely initiated after stroke, estimated to occur in only about 6% of patients within 3 months of stroke,” Dr. Khot explained. “Stroke patients with OSA are not like OSA patients in the general population in that they are not typically overweight, sleepy, or even likely to snore, which makes our clinical suspicion of the disease difficult and makes the screening questionnaire insensitive.” 

While an early diagnosis and treatment of OSA prior to stroke is strongly recommended, the role of screening and prevention for OSA is unclear poststroke. “Based on limited data, the American Stroke Association does not recommend routine screening in acute stroke but does suggest a role for stroke prevention,” Dr. Khot stated. “There may be more of an understanding that OSA is common and portends worse outcomes, but actual testing is rarely offered to many patients who might benefit, including those with refractory hypertension.”

Future Studies and Recommendations

One of the primary initial recommendations for people with sleep disorders and stroke is improving sleep hygiene by limiting noise and light in the bedroom. Another recommended therapy is cognitive-behavioral therapy (CBT) for patients with chronic sleep disorders. This therapy has been shown to reduce insomnia after stroke, although the long-term effects are not clear.¹

In addition to patient education and therapy recommendations, further research is necessary to answer unresolved questions in this area.

“It’s important to understand that along with the effect on stroke recovery, OSA is an independent risk factor for stroke and is known to worsen other common stroke risk factors, such as hypertension, diabetes, and atrial fibrillation. It may be that the changes are too well-established for studies to show a significant effect of CPAP or that CPAP is just not the best therapy for this population as it is in the general population. Thus, there is an important knowledge gap and a need for rigorous trials in the field,” said Dr. Khot, on the need for further CPAP research.

A 2021 study published in Stroke assessed the body of data surrounding CPAP and poststroke OSA and proposed some considerations for future studies. Some suggestions were to ensure that patients are using CPAP for at least 4 hours, to initiate therapy within 48 hours of stroke, and to include patients with varying OSA severity and compliance.¹⁴

The American Heart Association and American Stroke Association also recommend future studies to consider the following: 

• Selection of patients who would likely benefit from CPAP;
• Timing of CPAP treatment and testing relative to stroke onset;
• Home testing vs facility testing; and
• Dosing and type of CPAP.¹⁵ 

Dr. Khot highlights a particular ongoing study with the potential to have a profound clinical impact in treatment of sleep disorders and stroke, stating “There is a large multicenter trial called Sleep for Stroke Management and Recovery Trial or Sleep SMART (ClinicalTrials.gov Identifier: NCT03812653), which will evaluate in over 3000 participants the treatment of OSA with CPAP on both secondary prevention and acute stroke recovery. The study is part of a network of hospitals across the country called NIH StrokeNET.”

Other ongoing studies highlighted by the American Heart Association and American Stroke Association include the Recovery in Stroke Using PAP (RISE-UP) trial (ClinicalTrials.gov Identifier: NCT04130503) and the Addressing Sleep Apnea Post Stroke/TIA (ASAP) trial (ClinicalTrials.gov Identifier: NCT04322162). The RISE-UP trial is determining the optimal timing of CPAP initiation poststroke and the ASAP trial is focused on assessing a quality improvement initiative in the Veterans Affairs Medical Administration.¹⁵ 

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Sleep apnea is considered a modifiable risk factor for stroke. While CPAP is the standard treatment for sleep apnea, its use among patients with comorbid stroke is not universally agreed upon. For the study, researchers assessed the practicality and efficacy of CPAP treatment among patients with sleep apnea and stroke.

The researchers from China searched PubMed, EMBASE, and the Cochrane Library from inception to July 28, 2022 for randomized controlled trials (RCTs) comparing CPAP vs standard treatments for sleep apnea in patients with a history of comorbid stroke or TIA. Primary outcomes included CPAP treatment feasibility and changes in patients’ neurologic function and functional status throughout the intervention. Secondary outcomes included recurrent vascular events, changes in cognitive function, depression, sleepiness, and changes on the apnea-hypopnea index (AHI).

A total of 14 eligible RCTs were included in the meta-analysis, consisting of pooled information on 1065 individuals with stroke or TIA — 564 in the intervention group and 501 in the control group. Half of included studies did not differentiate between ischemic or hemorrhagic stroke types, whereas 4 studies included patients with ischemic stroke, 2 included patients with either ischemic stroke or TIA, and 1 study included patients with only TIA.

Participants in the intervention group received CPAP treatment of variable duration, ranging from 72 hours to 24 months. In 5 of the 14 studies, early intervention with CPAP treatment was initiated within 7 days following stroke, whereas CPAP treatment in the remaining 7 studies was initiated between 7 days to 6 months following stroke.

Among the 8 RCTs that reported on CPAP adherence, patients used CPAP treatment for an average of greater than 4 hours per night in 7 studies and less than 4 hours per night in 1 study.

A total of 7 studies used the National Institute of Health Stroke Scale to determine the efficacy of CPAP treatment on neurologic function, while 2 studies used the Canadian Neurological Scale. Functional status was assessed using the Barthel Index in 7 studies, while the remaining 2 used the motor section of the Functional Independence Measure and the physical function subscale in Utrecht Scale for Evaluation of Rehabilitation.  

Study participants with comorbid stroke and sleep apnea who were treated with CPAP demonstrated improvement in neurologic function compared with participants in the control group (standardized mean difference [SMD], 0.28; 95% CI, 0.02-0.53; P =.03). However, use of CPAP did not significantly change functional status between the groups (SMD, 0.25; 95% CI, -0.01 to 0.51; P =.06).

Recurrent vascular events did not occur at higher rates in the control group compared with the CPAP group (11.38% vs. 7.95%; risk ratio, 0.70; 95% CI, 0.37-1.32; P =.27).

CPAP intervention did not significantly improve cognitive function (SMD, 0.34; 95% CI, -0.38 to 1.07; P =.35), depression (SMD, -0.42; 95% CI, -0.86 to 0.03; P =.07), or sleepiness (SMD, -0.49; 95% CI, -1.06 to 0.08; P =.09) compared with the control group.

The only notable change among secondary outcomes was significant AHI reduction in the CPAP group compared with the control group (mean change, -20.59 events/h; 95% CI, -26.30 to -14.87; P <.01).

In addition to the heterogeneity among trials, these results were further limited by moderate risk of bias among all included studies, small sample sizes, and variations in the clinical presentation of stroke among each study population.

“CPAP therapy is [a] feasible modality in patients with stroke associated with SA [sleep apnea] and improves neurological outcomes in these patients,” the researchers noted. “However, this finding should be interpreted with caution because of the substantial heterogeneity of trials and low literature quality,” they added.

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Studies show that CVD risk increases after menopause, potentially secondary to decreased female sex hormone levels that have cardioprotective effects or hemorheological changes in blood viscosity and hematocrit levels increasing the risk for endothelial injury. This information prompted the question of whether early menopause induced by hysterectomy before age 50 increased the risk for early-onset CVD.

To answer this question, researchers in South Korea conducted a longitudinal, population-based cohort study on 135,575 women between the ages of 40 to 49 who were evaluated between January 1, 2011 to December 31, 2014 and followed until December 31, 2020 for a median of 7.9 years. Data analysis took place between December 20, 2021 and February 17, 2022.

The researchers matched the women into pairs based on specific variables. Of these 135,575 women, 55,539 (median age, 45) were included in the hysterectomy group and 55,539 in the nonhysterectomy group. They compared the risk for incidental CVD — a combination of myocardial infarction, coronary artery revascularization, and stroke.

Women in the hysterectomy group demonstrated increased risk for incidental CVD compared with the nonhysterectomy group (115 vs 96 per 100,000 person-years; hazard ratio [HR], 1.25; 95% CI, 1.09-1.44; P =.002).

When the researchers broke down the incidental CVD into each of the 3 composite subgroups, they discovered that myocardial infarction and coronary artery revascularization occurred at similar incidences in both the hysterectomy and nonhysterectomy groups. In contrast, incidence of stroke occurred at significantly higher rates in the hysterectomy group compared with the nonhysterectomy group (HR, 1.31; 95% CI, 1.12-1.53; P <.001)

The researchers analyzed the data after excluding women who also underwent simultaneous oophorectomy and discovered similar findings that women who underwent hysterectomy only still demonstrated increased risk for incidental CVD (HR, 1.24; 95% CI, 1.06-1.44; P =.004). This finding suggests that the uterus itself may exert cardiovascular protective effects independent of female sex hormones produced by the ovaries.

“In this cohort study of Korean women, we noted that hysterectomy in women younger than 50 years was independently associated with an increased risk of stroke,” the researchers noted. “Although we found that widely performed hysterectomy with a broad indication for benign diseases at premenopausal ages slightly increases the risk of CVD, the incidence is not high, so a change in clinical practice may not be needed,” they added.

The study had several limitations including its retrospective, observational design, the lack of generalizability to populations outside of South Korean women, and potential inaccuracies with medical coding. Other limitations included the inability to assess severity of underlying diseases, lack of stratification into age groups with narrower age ranges, and lack of access to relevant data, such as family history, body mass index, blood viscosity, ferritin levels, and female sex hormones.

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Felice Gragnano, M.D., Ph.D., from the University of Campania Luigi Vanvitelli in Naples, Italy, and colleagues conducted a patient-level meta-analysis of data obtained from seven randomized trials comparing P2Y₁₂ inhibitor monotherapy to aspirin monotherapy for the prevention of cardiovascular events in patients with established CAD. The analysis included 24,325 participants: 12,178 were assigned to receive P2Y₁₂ monotherapy (62.0 percent clopidogrel and 38.0 percent ticagrelor), and 12,147 were assigned to receive aspirin.

The researchers found that over two years, the risk for the primary outcome (composite of cardiovascular death, myocardial infarction, and stroke) was lower with P2Y₁₂ inhibitor monotherapy than with aspirin (hazard ratio, 0.88), which was mainly due to less myocardial infarction (hazard ratio, 0.77). The risk for major bleeding was comparable between the groups, and net adverse clinical events were lower with P2Y₁₂ inhibitors (hazard ratio, 0.89). Across prespecified subgroups and types of P2Y₁₂ inhibitors, the treatment effect was consistent.

“Based on available randomized evidence, long-term P2Y₁₂ inhibitor monotherapy may be warranted instead of long-term aspirin monotherapy for secondary prevention in patients with CAD,” the authors write.

Several authors disclosed ties to the pharmaceutical industry.

Abstract/Full Text (subscription or payment may be required)

Editorial (subscription or payment may be required)

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Jia Zhang, M.D., from The China National Clinical Research Center for Neurological Diseases in Beijing, and colleagues conducted a randomized, double-blind trial involving patients with minor stroke or TIA who carried the CYP2C19 loss-of-function allele. Participants were randomly assigned to receive ticagrelor-ASA or clopidogrel-ASA. Data were included for 6,412 patients: 876 were classified as obese and 5,536 were classified as nonobese.

The researchers found that among patients with obesity, ticagrelor-ASA was associated with a significantly lower rate of stroke within 90 days compared with clopidogrel-ASA (5.4 versus 11.3 percent; hazard ratio, 0.51; 95 percent confidence interval, 0.30 to 0.87), but not among those without obesity (6.0 versus 7.0 percent; hazard ratio, 0.84; 95 percent confidence interval, 0.69 to 1.04). No differences were seen in the rates of severe or moderate bleeding by body mass index group.

“Body mass index influences the efficacy of ticagrelor-ASA versus clopidogrel-ASA among patients with minor ischemic stroke or TIA who carry a CYP2C19 loss-of-function allele,” the authors write. “Clopidogrel appears to lose its efficacy among patients with obesity.”

Abstract/Full Text

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The population-based case-control study assessed the association between BNT162b2 or CoronaVac vaccinations and risk for MI and stroke after SARS-CoV-2 infection in patients with CVD. Data were from electronic health records in Hong Kong.

Cases were patients with CVD who had an MI or stroke within 28 days after SARS-CoV-2 infection between January 1, 2022, and August 15, 2022. Control individuals were defined as all other patients with CVD who attended any health services and were not cases. Ten control patients were randomly matched with each case.

The final cohort included 808 cases matched with 7771 control patients. Each group had a mean age of 81.73 years and 54.3% were men.

BNT162b2 and CoronaVac vaccination was associated with a significantly decreased risk for MI or stroke, and higher effectiveness occurred with an increasing number of doses. For patients that received BNT162b2, risk for stroke or MI decreased from an adjusted odds ratio (aOR) of 0.49 (95% CI, 0.29-0.84) to 0.30  (95% CI, 0.20-0.44) in patients that received 1 dose and 0.17 (95% CI, 0.08-0.34) in patients that received 3 doses. CoronaVac had similar results, with aOR decreasing from 0.69 (95% CI, 0.57-0.85) to 0.42 (95% CI, 0.34-0.52) in patients that received 1 dose and 0.32 (95% CI, 0.21-0.49) in patients that received 3 doses.

Patients who had 2 doses of CoronaVac and a third dose of BNT162b2 had decreased risk for MI and stroke (aOR, 0.09; 95% CI, 0.02-0.40) compared with patients who were unvaccinated.

BNT162b2 was associated with risk for MI within 28 days after SARS-CoV-2 infection (aOR, 0.47; 95% CI, 0.28-0.81) following 1 dose, and the risk was 0.12 (95% CI, 0.06-0.24) for 3 doses. For CoronaVac, the risk for MI within 28 days after SARS-CoV-2 infection was 0.73 (95% CI, 0.58-0.92) for 1 dose and 0.19 (95% CI, 0.12-0.30) for 3 doses.

A single dose of BNT162b2 or CoronaVac had no statistically significant association with the risk for stroke within 28 days after SARS-CoV-2 infection, with ORs of 0.75 (95% CI, 0.43-1.30) and 1.01 (95% CI, 0.79-1.29), respectively. After 3 doses of each vaccine, the risk decreased to 0.13 (95% CI, 0.07-0.25) and 0.19 (95% CI, 0.13-0.30), respectively.

Two doses of CoronaVac and a third dose of BNT162b2 also were associated with a low risk for MI (OR, 0.16; 95% CI, 0.04-0.53) and stroke (OR, 0.28; 95% CI, 0.11-0.72) within 28 days post-SARS-CoV-2 infection.

Limitations of the study include potential lack of generalizability and that information on patients who used private medical services is not included. Other limitations include difficulty in distinguishing whether MI or stroke was directly caused by the infection or from other causes.

“Vaccination of BNT162b2 or CoronaVac can reduce the risk of MI or stroke after SARS-CoV-2 infection among patients with CVD, and the risk decreased with additional vaccine doses,” wrote the investigators. “Therefore, it is important for patients with CVD to receive vaccination to prevent the potential severe CVD complications if infected.”

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Is there a magic pill for the world’s leading cause of death? Some experts believe a combination medicine, or “polypill,” can offer dynamic protection against heart disease. However, critics are wary about broadly dispensing treatment without individualized care and monitoring. Could a polypill erase disparities in underserved populations, or does it just put a Band-Aid on a larger problem? Here’s how the research stacks up.

What Is a Polypill?

A polypill contains 3 to 4 low-dose pharmaceuticals designed to decrease multiple cardiovascular risk factors at once.¹ Cardiovascular polypills usually contain at least 1 antihypertensive and 1 statin, and may or may not have other additions like aspirin and folic acid. Researchers introduced the polypill concept in 2003, advocating for the proactive treatment of everyone older than 54 years, regardless of their lipid levels or blood pressure.Using data from clinical trials and meta-analyses, early polypill researchers predicted an 88% reduction in ischemic heart disease and an 80% decrease in occurrence of stroke with mass administration.¹

Today, proponents of polypill therapy say it improves adherence through the simplicity of a single daily pill. Other advantages of this fixed low dose include an optimal safety profile and a decreased need for follow-up visits for dose adjustments.² As an effective preventative tool against stroke, polypill therapy also has the potential for significant cost savings, both in health care dollars and quality years of life. However, the jury is still out on how polypill therapy will affect large populations in the absence of supervised care.

Is Polypill Therapy Effective?

Large-scale trials of cardiovascular polypills have not entirely lived up to their originator’s predictions. Nonetheless, polypills have demonstrated significant benefits in stroke prevention. For example, in the 2016 HOPE-3 trial, a polypill containing candesartan, hydrochlorothiazide, and rosuvastatin produced a 44% decrease in stroke risk compared with placebo.¹ Another study, known as the Polylran study in 2019, found that a polypill had a 56% reduction in nonfatal strokes and a 62% reduction in fatal strokes.¹ Finally, the 2021 TIPS study demonstrated that an aspirin-containing polypill led to similar effects, lowering stroke occurrence by 58% compared with placebo.¹

In 2019, the New England Journal of Medicine published a randomized, controlled trial on 303 low-income adults from Alabama receiving care through a federally-qualified community health center.² Participants had an average annual income below $15,000 and were randomly assigned to receive standard care or a polypill. Each polypill contained 10 mg atorvastatin, 2.5 mg amlodipine, 25 mg losartan, and 12.5 mg hydrochlorothiazide and cost $26 per month. After 1 year of treatment, those taking the polypill had an average systolic blood pressure reduction of 9 mm Hg, compared to just 2 mm Hg in the standard care group. The polypill group also experienced an average 15 mg/dL low-density lipoprotein cholesterol (LDL-C) level decrease versus 4 mg/dL for the standard care group.

The researchers concluded, “A polypill-based strategy led to greater reductions in systolic blood pressure and LDL cholesterol level than were observed with usual care in a socioeconomically vulnerable minority population.”²

The New England Journal of Medicine later published a phase 3 randomized controlled trial of older adults with a recent history of myocardial infarction in 2022.³ The researchers randomly assigned 2499 participants to receive either polypill treatment or standard care for a median of 36 months. This polypill contained aspirin, ramipril, and atorvastatin. Participants in the polypill group had a lower frequency of cardiovascular events than those receiving standard care during the study period. The researchers attributed some of this benefit to better compliance with polypill therapy. Overall, patients with high adherence to their prescribed medications experienced a 27% lower cardiovascular risk.

Overcoming Barriers With Polypill Therapy

Public health officials have identified glaring disparities among underserved populations. Various socioeconomic factors lead to marked outcome differences, including a 2-fold higher incidence of fatal cardiovascular heart disease events in non-Hispanic Black men versus non-Hispanic White men between the ages of 45 to 64 years and a 1.44-fold higher risk for Black women versus White women of the same age group.⁴

The American Heart Association has identified 7 core health behaviors and factors that define heart health. These include smoking, physical activity, diet, body mass index, cholesterol levels, blood pressure, and glucose control. Perhaps one of the biggest contributors to higher stroke risk is poor diet quality, with observational studies noting a dose-response relationship between healthy eating and cardiovascular death and disability.⁴

Diet quality directly correlates with socioeconomic status, race, ethnicity, education level, and the use of food assistance programs. Racially-segregated neighborhoods, food insecurity, and food deserts remain despite the efforts of government food assistance programs. A polypill may help decrease some stroke risk, but it doesn’t address these critical issues.

The obvious benefits of polypill therapy include measurable outcome differences in stroke risk and better adherence to proven preventative medications. However, nutrition, smoking, and physical activity still warrant attention as their impacts are far-reaching beyond cardiovascular health, extending to general well-being and other disease prevention. As more research on polypill therapy continues to unfold, it may very well earn a place in the primary prevention of strokes, especially when combined with risk modification programs and the continued promotion of healthier living.⁵

Where Do We Go From Here?

Polypill therapy promises a simple solution for a serious problem. In underserved communities plagued with heart-related death and disability, polypill therapy shows clear potential to make a lasting impact. However, any benefits from polypill therapy must not overshadow the continued need for individualized healthcare and comprehensive lifestyle programs. Pairing thoughtful administration of polypill therapy with community and personalized risk reduction can build a bridge between the best of both worlds.

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Muhammad Taha Hagar, M.D., from the Medical Center-University of Freiburg in Germany, and colleagues enrolled patients with severe aortic valve stenosis and clinically indicated CT for transcatheter aortic valve replacement planning in a prospective study. A dual-source photon-counting CT scanner was used to examine all participants using a retrospective electrocardiography-gated contrast-enhanced UHR scanning protocol. As part of their clinical routine, patients also underwent invasive coronary angiography (ICA). Area under the receiver operating characteristic curve (AUC) was used to compare UHR CCTA to ICA.

The researchers found that the prevalence of CAD and prior stent placement was 35 and 22 percent, respectively, among 68 participants. Image quality was excellent overall (median score, 1.5). For detection of CAD, the AUC of UHR CCTA was 0.93 per participant, 0.94 per vessel, and 0.92 per segment. The sensitivity, specificity, and accuracy, respectively, were 96, 84, and 88 percent per participant; 89, 91, and 91 percent per vessel; and 77, 95, and 95 percent per segment.

“It appears that the spectrum of patients benefiting from undergoing noninvasive CCTA has been significantly broadened by photon-counting detector technology,” Hagar said in a statement. “This is excellent news for these patients and the imaging community.”

Several authors disclosed ties to pharmaceutical and medical device companies, including Bayer Healthcare, which funded the study.

Abstract/Full Text

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Jiangwei Sun, Ph.D., from the Karolinska Institute in Stockholm, and colleagues examined the risk of stroke among patients with a biopsy-confirmed IBD in Sweden between 1969 and 2019 and five matched reference individuals per patient randomly selected from the general population and IBD-free full siblings. Stroke was identified from the Swedish National Patient Register. The analysis included 85,006 patients with IBD; 406,987 matched reference individuals; and 101,082 IBD-free full siblings.

The researchers identified 3,720 incident strokes in IBD patients and 15,599 in reference individuals (incidence rates, 32.6 and 27.7 per 10,000 person-years, respectively; adjusted hazard ratio, 1.13). Even 25 years after diagnosis, the elevated adjusted hazard ratio remained increased, corresponding to one additional stroke case per 93 IBD patients. The excess adjusted hazard ratio was mainly due to ischemic stroke (adjusted hazard ratio, 1.14) and not hemorrhagic stroke. Across IBD subtypes, the risk of ischemic stroke was significantly increased (adjusted hazard ratios, 1.19, 1.09, and 1.22 for Crohn disease, ulcerative colitis, and IBD-unclassified, respectively). When IBD patients were compared to their siblings, the results were similar.

“These results show that people with inflammatory bowel disease and their doctors should be aware of this long-term increased risk,” Sun said in a statement. “Screening and management of stroke risk factors may be more urgent in people with inflammatory bowel disease.”

Several authors disclosed ties to the pharmaceutical industry; the study was funded by Forte.

Abstract/Full Text (subscription or payment may be required)

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Vincent M. Timpone, M.D., from the University of Colorado Hospital in Aurora, and colleagues evaluated the association between incomplete neurovascular imaging workup during emergency department encounters for TIA and odds of subsequent stroke. Analysis included 111,417 patients with a TIA diagnosis who underwent brain computed tomography or brain magnetic resonance imaging during or within two days of the encounter identified through the Medicare Standard Analytical Files for calendar years 2016 and 2017.

The researchers found that 37.3 percent of patients had an incomplete neurovascular imaging workup. Within 90 days of the TIA encounter, a new stroke diagnosis occurred in 4.4 percent of patients with complete neurovascular imaging versus 7.0 percent of patients with incomplete neurovascular imaging. When adjusting for patient (age, sex, race and ethnicity, high-risk comorbidities, median county household income) and hospital (region, rurality, number of beds, major teaching hospital designation) characteristics, incomplete neurovascular imaging was associated with increased likelihood of stroke within 90 days (odds ratio, 1.3).

“Increased access to urgent neurovascular imaging in patients with TIA may represent a target that could facilitate detection and treatment of modifiable stroke risk factors,” the authors write.

Abstract/Full Text (subscription or payment may be required)

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Among patients with hypertension, home BP measurements, compared with office BP measurements, may be more effective at indicating risk for future cardiovascular (CV) events and hypertensive organ damage. Investigators aimed to analyze associations between CV events and the pathological threshold of average peak home BP in patients with at least 1 CV risk factor.

The investigators used data from the prospective, observational, multicenter nationwide J-HOP (Japan Morning Surge-Home Blood Pressure) study that enrolled patients from 2005 to 2012 (follow-up through March 2015) and included an extended long-term follow-up (6.2 years) conducted December 2017 to May 2018. The study included 4231 ambulatory outpatients (mean age, 64.9±10.9 years; 46.7% men; 79% receiving antihypertension medication) with at least 1 risk factor for cardiovascular disease. Patients were enrolled by 75 physicians in 71 institutions.

The investigators divided patients into quintiles (Q) of peak home SBP. For 13 days, participants were instructed to take their own BP measurements 3 times in the morning and 3 times in the evening (78 measurements overall; actual number of measurements, 69±14). There were significant differences in the average peak home SBP ranging from 135.4 mm Hg to 186.2 mm Hg.

During extended follow-up analysis of risk for stroke, coronary artery disease (CAD), and atherosclerotic cardiovascular disease (ASCVD; fatal or nonfatal) there were 94 strokes and 124 CAD events. Pathological threshold of average peak home SBP for 5-year stroke risk was determined to be 176 mm Hg. Patients with average peak home SBP in the highest quintile vs lowest quintile had an adjusted hazard ratio (aHR) of 4.39 for risk for stroke (95% CI, 1.85-10.43) and an aHR of 2.04 for risk for ASCVD (95% CI, 1.24-3.36).

The number of times peak home SBP exceeded 175 mm HG had a linear association with risk for stroke. This risk was greatest in the first 5 years (aHR, 22.66; 95% CI, 2.98-172.10). The highest risk for stroke was in patients with morning and evening values in the highest quintile of average peak home SBP (Q5; ≥173.0 mm Hg) vs all other quintiles. Patients in the lowest quintile (Q1; average peak home SBP <142.7 mm Hg) experienced few stroke events. After 5 years, patients with average peak home SBP in Q4 had a cumulative stroke incident rate approaching that of patients in Q5.

Findings remained consistent regardless of data being stratified by only morning vs only evening readings of average peak home SBP, by patient age (<65 years vs ≥65 years), or by whether or not patients had history of ASCVD. The researchers found no relation between CAD risk and quintiles of average peak home SBP.

Study limitations include lack of generalizability and the presence of pharmacological antihypertensive agents in nearly 80% of participants. There may also be an unaccounted for risk for BP surge for measurements taken in a sitting position.

“Peak home BP was a strong risk factor for stroke, especially within the first 5 years,” the investigators wrote. “We propose exaggerated peak home SBP > 175 mm Hg as an early and strong novel risk factor for stroke.”

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Individuals who experience poststroke depression report feelings of anxiety, unwillingness to communicate, hopelessness, and insomnia, all of which might have a negative effect on their activities of daily living and their rehabilitation following stroke. Among survivors of stroke, poststroke depression has been associated with an increased risk for mortality as well.

Using the network meta-analysis method, researchers sought to evaluate the true impact of acupuncture in alleviating the symptoms of poststroke depression. Additionally, they sought to explore the difference in effectiveness between the use of acupuncture combined with various pharmacotherapies and nonpharmacotherapies, in an effort to offer optimized guidance and advice for clinicians.

From inception through March 2023, the researchers conducted a search of 6 databases and 3 clinical trials. All studies that compared the use of needle-based acupuncture (either alone or in combination with other therapies) with pharmacotherapy, other nonpharmacotherapy, or invalid groups (eg, placebo, waitlist, and blank control) were included. Study inclusion criteria, based on the PICOS (Population [P], Intervention [I], Comparison [C], Outcomes [O], and Study [S]) design, were as follows:

• P: Participants ≥18 years of age who had been clinically diagnosed with stroke and exhibited any degree of stroke impairment severity
• I: Acupuncture treatments alone or combined with other treatments
• C: Pharmacotherapy, other nonpharmacotherapy, or invalid groups
• O: Primary outcome was efficacy of poststroke depression evaluated on scales that measured symptoms of depression; secondary outcomes included effectiveness for neurologic function and quality of life
• S: Only a randomized controlled trial (RCT)

Ultimately, a total of 62 studies involving 5,500 participants, all of which were published between 2003 and 2022, were included in the review. All of the studies had been conducted in China. Other than usual care, there were 12 different treatments included:

• Acupuncture plus repetitive transcranial magnetic stimulation (RTMS)
• Acupuncture plus traditional Chinese medicine (TCM) plus Western medicine
• Acupuncture plus TCM
• Acupuncture plus Tai Chi
• Acupuncture plus cognitive therapy
• TCM
• Acupuncture and moxibustion (AM)
• Acupuncture plus Western medicine
• AM plus WM
• Acupuncture
• Western medicine
• Usual care

The researchers found that compared with Western medicine alone — defined as pharmacotherapy for poststroke depression — the following treatments were superior for the alleviation of symptoms of poststroke depression:

• acupuncture alone;
• acupuncture combined with RTMS;
• TCM alone; or
• TCM combined with Western medicine

Additionally, compared with usual care, the use of acupuncture alone or in combination with other therapies was shown to significantly decrease scores on the Hamilton Depression Rating scale. Based on the Surface Under the Cumulative Ranking curve, acupuncture plus RTMS exhibited the highest probability of improving symptoms of depression, with a probability of 49.43% reported.

Study limitations included only using studies published in China in the meta-analysis and the use of the risk of bias tool to evaluate the quality of the RCTs included in the analysis, which showed that the overall quality of the RCTs was not high.

“This is the first review to compare the effectiveness of acupuncture with other therapies for PSD [poststroke depression] using a net­work meta-analysis, which may provide novel and useful guidance for clinicians and readers,” the researchers acknowledged.

They concluded, “Nonetheless, more high-quality studies are needed to provide sufficient evidence.”

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In the past 15 years, virtual reality (VR) technology has gained traction as a valuable tool in neurorehabilitation.¹ In patients with multiple sclerosis (MS), for example, several studies published in 2023 demonstrated improvements in manual dexterity and upper limb motor function, as well as measures of daily functioning, quality of life, mood, and treatment satisfaction, following VR training.^1-3

Additionally, in a 2022 meta-analysis published in the journal Neurological Sciences, researchers found that home-based VR training was associated with improvements in postural balance in patients with MS, Parkinson disease, and stroke.⁴

In a 2020 multicenter, single-blind randomized controlled trial published in Developmental Medicine & Child Neurology, the researchers compared the effects of a VR rehabilitation intervention combined with conventional occupational therapy to conventional therapy alone in children with cerebral palsy. The VR group showed greater improvements in upper-limb dexterity functions, activities of daily living, and forearm supination.⁵

Upon the completion of a 6-week home-based VR exercise program, some older adults with mild cognitive impairment reported physical benefits, and a few noted cognitive benefits, according to a 2020 study published in the Journal of Aging and Physical Activity. ⁶ The intervention was also shown to be safe and feasible, although no significant change in physical or cognitive outcome measures was observed.

To learn more about the state of research and practice of VR technology in neurorehabilitation, we spoke with the following experts:

• Hillel M. Finestone, MDCM, FRCPC, professor in the division of physical medicine and rehabilitation at the University of Ottawa and director of stroke rehabilitation research at Elisabeth Bruyere Hospital in Ontario, Canada

• Lisa Sheehy, PhD, physiotherapist and research associate at the Bruyère Research Institute at the University of Ottawa

• Sean Dukelow, PhD, professor in the department of clinical neuroscience at the University of Calgary in Alberta, Canada, and medical director of stroke rehabilitation for the Calgary Stroke Program

What are some positive ways that VR has transformed the neurorehabilitation space, especially in terms of patient engagement and commitment to treatment?

Dr. Finestone: In general, patients enjoy the ‘exer-gaming’ activities provided by VR technology. Some of them said it was less boring and that ‘the time goes quicker.’ Of course, the response depends on the game itself — some are very simplistic and can be perceived as ‘boring,’ but that is typically not the case.

Dr. Dukelow: I think of VR as a tool that we can use to gamify the rehabilitation experience, which can help with patient engagement. In a typical rehabilitation setting, VR can be used to augment things that a clinician might be working on with a patient. One of the exciting facets of VR is that it may be used to do things that are unique and difficult to pull off in a standard rehabilitation setting or a completely natural environment. One example might be trying to train a patient to scan for objects in an area where they have lost visual fields or have attentional impairment — this is something that can fairly easily be accomplished in VR.

Many patients really enjoy VR because of the game-based approach. It has a bit of an addictive side to it — consider the amount of people who loved to play games like Tetris and Candy Crush in the past. Certainly, we now have a whole generation of people who grew up with video games coming through the health care system, so the idea of doing some of the rehabilitation by playing a VR game isn’t so foreign.

What are the differences and potential barriers in getting adults vs children to use VR in rehabilitation therapy?

Dr. Dukelow: I think one of the barriers to VR engagement has been the use of headsets in older adults, which could cause some problems with nausea. Traditionally, this has been dealt with by slightly less immersive VR systems — think big screens — but the newer headsets have higher refresh rates, so we are seeing less of those issues. 

Can you discuss the neurobiologic mechanism that makes VR successful in neurorehabilitation?

Dr. Sheehy: Use of VR follows many of the principles of motor learning — that is, repetition, task-specific practice, meaningful practice, augmented feedback, observational learning, and motivation. There are studies that show enhanced neural activity in the affected brain due to participation in VR therapy.⁷

What makes VR use in neurorehabilitation such an intriguing option to clinicians? 

Dr. Sheehy: VR can be implemented by therapists, rehabilitation assistants, family members, or volunteers. It can be used as a therapy modality or as an adjunctive therapy, or to provide extra rehabilitative exercise. It can be used for inpatients, outpatients, in the community, and in the home. It can be used for people with sub-acute and chronic conditions.

Dr. Dukelow: As I mentioned, VR is an intriguing option for clinicians because it can augment what they are doing in their 1-on-1 or group therapy sessions in the real world, and it can go beyond what the clinician is able to do in the real world. I’m not sure there is a well-established mechanistic explanation for why VR may be outperforming other therapies. Some have suggested that it has to do with increased engagement. We know that if a patient is more engaged and motivated, they are more likely to do their exercises.

In neurorehabilitation, how much you do matters, but most clinicians would argue what you do matters too.

Can you describe the evolution of VR-based interventions for physical and cognitive rehabilitation for various neurologic conditions?

Dr. Dukelow: In general, when a technology initially comes into neurorehabilitation, it often gets tested by an individual or group of people who have access to a certain patient population and think they might benefit from that technology. Over time, as the technology becomes more widely available, more and more people see it and think of its potential applications for other populations. You see a ‘creep’ or ‘spread’ in the indication.

This has happened for lots of different interventions in the neurorehabilitation space, from electrical stimulation, to robotics, to non-invasive brain stimulation. When a technology is non-invasive like VR, then it is very easy for clinicians to try it for different conditions. I think it’s important to state here that, at some point, the new technology needs to be properly tested in well-conducted clinical trials to see if it actually improves these conditions.

What are some conversations you’ve had with patients newly exposed to VR technology?

Dr. Sheehy: Most patients enjoy VR, and it inspires them to do more therapy. This also goes for patients who are older — even in their 90’s — or who have no previous experience with VR or with computers at all. Some who are very tech-adverse or too overwhelmed with their new reality are not interested. Those with a lot of gaming experience tended to find it dull and rather unpolished.

Patients prefer the games that are most intuitive and the most “gamified” — i.e., the scoring system reflects success — and some participants in our research had the most difficulty with games that incorporated complex visuospatial tracking.⁶

Dr. Dukelow: Quite honestly, these are usually pretty short conversations. Of course, we have to walk through the potential risks and benefits of any treatment, but generally people are keen to try it out because the risks are minimal. Do we have people who aren’t interested? Sure, we have an occasional person who isn’t at all interested in video games or trying something tech-related, but most people want to give it a shot.

Which patient population do you believe will benefit the most from VR, and which population do you think should be the main focus of research in this area?

Dr. Finestone: I think VR-enhanced neurorehabilitation is a useful adjunct to traditional rehabilitation methods. I don’t think it can completely replace physiotherapists and occupational therapists. I do think that most neurorehabilitation patients would benefit from this technology. My vision for the future is that there will be specific games that target specific neurologic losses and disabilities.

For instance, a patient who has loss of balance due to a cerebellar infarct will be challenged with VR games targeting gait, sitting, and standing balance, and other similar activities. A patient with hemiparesis will play games targeting the weakened right arm and leg. There are currently specific exercise programs, particularly with physiotherapy, which are VR-based.

Dr. Dukelow: VR is a tool, and rehabilitation tools have the ability to cross different patient populations. With that lens, I think we are seeing that there are potential benefits for cognition, gait, and balance, and I think there exists considerable potential for motor recovery. You’ll notice these areas cross patient populations.

Would I like to see more efforts and funding put into stroke? Selfishly, as a stroke specialist, I would say yes, but I think there is significant potential in the other patient groups that you have brought up, and these patients also have tremendous needs for better interventions. In an ideal world, we would see high-quality clinical trials evaluating VR in all of these patient groups.

Editor’s Note: This interview was edited for clarity and length.

The post The Future of Virtual Reality in Neurorehabilitation: An Expert Roundtable appeared first on The Cardiology Advisor.

Michelle W.J. Heijman, Ph.D., from Radboud University Medical Center in Nijmegen, Netherlands, and colleagues examined whether colchicine reduces TKRs and THRs in an exploratory analysis of the Low-Dose Colchicine 2 randomized trial involving 5,522 patients with chronic coronary artery disease at 43 centers in Australia and the Netherlands. Participants were randomly assigned to 0.5 mg colchicine or placebo once daily (2,762 and 2,760 patients) during a median follow-up of 28.6 months.

The researchers found that TKR or THR was performed in 2.5 and 3.5 percent of patients in the colchicine and placebo groups, respectively, during the trial (incidence rate, 0.90 versus 1.30 per 100 person-years; hazard ratio, 0.69). Similar results were obtained in sensitivity analyses when patients with gout at baseline were excluded and when joint replacements that occurred in the first three and six months of follow-up were not included.

“We showed that colchicine, 0.5 mg daily, was associated with a lower incidence of TKR and THR compared with placebo in patients with chronic coronary artery disease,” the authors write. “This suggests that colchicine may slow the progression of osteoarthritis, but this needs to be confirmed in an appropriately designed prospective placebo-controlled trial.”

Abstract/Full Text (subscription or payment may be required)

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Poststroke cognitive impairment is known to be associated with poor health-related outcomes among survivors of stroke. In fact, it is frequently reported along with various stroke-associated deficits and such comorbidities as depression, thus rendering diagnosis and treatment more complex.

Recognizing that the implementation of protocols to assess and treat poststroke cognitive impairment according to locally available resources is needed, researchers sought to conduct a literature review of randomized controlled clinical trials, case-control studies, retrospective and prospective analyses, review articles, editorials, and clinical guidelines on the natural history, incidence and prevalence, diagnosis, and management of poststroke cognitive impairment.

The definition of poststroke cognitive impairment used in this review referred to “any severity of cognitive impairment, regardless of cause, noted after an overt stroke.”

Poststroke cognitive impairment that occurs following a stroke typically is observed in the first year and is reported in up to 60% of stroke survivors. Approximately 38% of these individuals have mild cognitive impairment, whereas 7% to 41% have dementia.

Comorbidities that are reported among patients with poststroke cognitive impairment and dementia are known to be associated with diminished quality of life. These poststroke outcomes, along with their approximate incidence or prevalence within 12 months of stroke occurrence, include the following:

• Poststroke cognitive impairment: 22% to 80%
• Poststroke dementia: 7% to 41%
• Sleep disorders: 50% to 60%
• Fatigue: 45% to 55%
• Physical/functional disability: 40% to 60%
• Multimorbidity: >40%
• Apathy: 30% to 40%
• Depression: 30% to 35%
• Anxiety: 20% to 25%

Risk factors for poststroke cognitive impairment include the following:

• Older age
• Race/ethnicity
• Stroke severity
• “Strategic” stroke location
• Preexisting cognitive impairment
• Recurrence of stroke
• Vascular comorbidities
• Concomitant neurodegenerative disease
• Diabetes

Alternative diagnoses for poststroke cognitive impairment should be explored and managed accordingly:

• Depression
• Delirium
• Infections
• Metabolic disturbances
• Polypharmacy and side effects of medications
• Vision impairments
• Hearing impairments
• Prestroke cognitive decline

In some instances, cognitive impairment is reversible early after stroke occurrence; however, up to one-third of patients with stroke have been shown to develop dementia within 5 years.

Although the pathophysiology of poststroke cognitive impairment has not yet been fully elucidated, it is probably associated with an acute stroke — either ischemic or hemorrhagic — precipitating a number of pathologic events, frequently along with preexisting microvascular and neurodegenerative alterations. 

An unmet need exists for prospective studies designed to assess the trajectory of poststroke cognitive impairment and the role played by acute vascular events in an individual being predisposed to Alzheimer disease and associated dementias, along with high-quality, randomized clinical trials that are directed toward the management of this occurrence.

The researchers noted that “The comprehensive management of patients with poststroke cognitive impairment should involve an interdisciplinary collaboration of the patient and their caregivers with health professionals, including neurologists, occupational therapists, speech therapists, nurses, neuropsychologists, gerontologists and primary care physicians.”

“Perhaps the most pressing need, however, is the development of effective and culturally relevant treatments for PSCI [poststroke cognitive impairment] through the conduct of adequately powered clinical trials of cognitive rehabilitative techniques, pharmaceutical agents, and lifestyle modifications in diverse groups of patients,” the researchers concluded.

Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

The post AHA Releases Scientific Statement on Assessing Poststroke Cognitive Impairment appeared first on The Cardiology Advisor.

Currently, there is no recommended BP level range in patients who have experienced an acute ischemic stroke. Although elevations of BP in the acute phase post stroke is common as a compensatory mechanism to increase blood flow to the ischemic areas, BP management continues to be an unsettled matter.

For the study, researchers sought to investigate admission BP levels in those with acute ischemic stroke to assess optimal BP values for best clinical outcomes.

The researchers conducted a retrospective observational study using data from the stroke center of Jiangsu Province Hospital of Chinese Medicine from December 2020 to July 2021. Inclusion criteria consisted of those who experienced an acute ischemic stroke and seen within 72 hours of symptom onset, ischemic lesions on imaging, and have had serial BP measurements every 4 hours during the first 24 hours and every 8 hours thereafter.

Individuals who have had terminal diseases, or treated with reperfusion therapy were excluded from the study. Potential risk factors for stroke, such as age, hypertension, diabetes mellitus, dyslipidemia, coronary artery disease, and smoking were included as covariates.

Primary outcome was severity of neurologic deficit, measured 3 months after onset of symptoms by using the modified Rankin Scale (mRS) (0-2 considered favorable; ≥3 considered poor outcome).

A total of 649 patients were include in the study. Out of 649 patients, 92 (14.18%) were considered to have poor outcomes and 557 (85.82%) had favorable outcomes.

A “U-curve pattern” was found in relationship to systolic BP (SBP) and functional prognosis, with extremes of BP associated with poorer outcomes. Diastolic blood pressure was not statistically significant for prognosis. Patients with mean SBP that was above 150 mmHg and below 135 mmHg had a higher mRS score and morality rate when compared with those with mean SBP between 135 mmHg and 150 mmHg.

Threshold analysis using linear regression found that when BP was <138 mmHg, odds of outcomes negatively correlated with BP (Odds ratio [OR], 0.936; 95% CI, 0.882-0.992; P = .0258). Conversely, when BP >135 mmHg, incidence of poor outcomes increased with increasing SBP (OR, 1.036; 95% CI, 1.008-1.066; P = .0125).

Piecewise linear regression according to best range of fitting results found optimal BP range to be 135-150 mmHg. Lower and higher pressures were associated with functional outcomes (BP <135 mmHg; OR, 1.9; 95% Cl, 1.11-3.36; P =.021; BP >150 mmHg; OR, 1.95; 95% CI, 1.12-3.37; P =.017).

Likewise, adjusted regression models for use of antihypertensive therapy found a significant increase of probability of poor functional outcomes in patients with SBP <135 mmHg or >145 mmHg, confirming the U-shaped pattern.

A study limitation included sampling error, as this was a single study conducted on a relatively small cohort.

The researchers concluded, “The result of the present study indicates that maintenance of mean BP between 135 mmHg and 150 mmHg in AIS [acute ischemic stroke] patients during hospitalization is associated with promising short- or long-term clinical outcomes.”

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Eliza C. Miller, M.D., from Columbia University in New York City, and colleagues assessed whether APOs are associated with younger age at first stroke. Analysis included 144,306 Finnish women (316,789 births) who gave birth after 1969, with 17.9 percent having at least one pregnancy with an APO.

The researchers found that women with APOs had more comorbidities, including obesity, hypertension, heart disease, and migraine. APO was associated with lower age at first stroke, with median age at first stroke of 58.3 years for patients with no APO, versus 54.8 years in those with one APO and 51.6 years in those with recurrent APOs. Risk of stroke was greater in women with one APO (adjusted hazard ratio, 1.3) and recurrent APOs (adjusted hazard ratio, 1.4) versus those with no APO when adjusting for sociodemographic characteristics and stroke risk factors. Compared to those without APO, women with recurrent APOs had doubled the stroke risk before age 45 (adjusted odds ratio, 2.1).

“This emphasizes the need for women to share their pregnancy history with their doctors, especially if they experience neurologic symptoms concerning for stroke or transient ischemic attack that tends to resolve within minutes to hours,” a author said in a statement.

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Asundexian is an investigational oral Factor XIa (FXIa) inhibitor. According to Bayer, asundexian acts selectively on the coagulation cascade, thereby offering the potential to prevent events without the increased bleeding risk.

The Company is currently enrolling patients in the phase 3 OCEANIC-AF study (ClinicalTrials.gov Identifier: NCT05643573). In OCEANIC-AF, the safety and efficacy of asundexian will be compared with apixaban in patients with atrial fibrillation at risk for stroke.

“This designation provides an opportunity to accelerate the development of asundexian and quickly address current patient needs,” said Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “Asundexian is currently investigated as a candidate in an entirely new class of antithrombotic treatment options aiming to selectively modulate coagulation, address patients with concerns of bleeding, and focus on indications where current anticoagulation is not used.”

The FDA’s Fast Track designation helps to accelerate the development and review of products for serious and life-threatening conditions where no treatment exists or where the investigational therapy is likely to provide an advantage over currently available treatments.

Asundexian was previously fast tracked for secondary prevention in patients after a noncardioembolic ischemic stroke. The phase 3 OCEANIC-STROKE study (ClinicalTrials.gov Identifier: NCT05686070) will investigate the efficacy and safety of asundexian for prevention of ischemic stroke compared with placebo on top of standard of care antiplatelet therapy in patients after a noncardioembolic ischemic stroke or high-risk transient ischemic attack.

The post Asundexian Fast Tracked for Stroke, Systemic Embolism Prevention in Afib Patients appeared first on The Cardiology Advisor.

Jiahui Fan, from the Shanghai Fourth People’s Hospital in China, and colleagues presented the geographical distribution and trends of ischemic stroke disease burden worldwide from 1990 to 2019 using age-standardized mortality rates (ASMRs) and disability-adjusted life years (ASDR) based on the GBD2019 database. The death number of ischemic stroke accounted for by seven major risk factors was analyzed and predicted for 2020 to 2030.

The researchers found that the global number of ischemic stroke deaths increased from 2.04 to 3.29 million between 1990 and 2019, and is expected to increase to 4.90 million by 2030. ASMRs and ASDRs for ischemic stroke showed consistent downward trends over time, with more pronounced trends seen for women, young people, and those in high sociodemographic index regions. Major contributors to the increased disease burden of ischemic stroke seen now, and predicted in the future, include two behavioral factors — smoking and a diet high in sodium — and five metabolic factors: high systolic blood pressure, high low-density lipoprotein cholesterol, kidney dysfunction, high fasting plasma glucose, and high body mass index.

“This increase in the global death toll of ischemic stroke along with a predicted further increase in the future is concerning, but ischemic stroke is highly preventable,” a coauthor said in a statement.

Abstract/Full Text

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Anterior and posterior circulation ischemic strokes may be caused by structural bone and cartilage anomalies. Proper diagnosis of bony strokes through computed tomography (CT)- and magnetic resonance imaging (MRI)-angiography and treatment may reduce or eliminate risk for recurrence of such strokes.

This retrospective diagnostic workup was designed to describe bony strokes to raise awareness of the condition. Researchers reviewed the medical records from patients (N=4,200) who presented with stroke at the Technical University of Munich in Germany between 2017 and 2022. A total of 6 patients who had bony stroke were identified and discussed in this case report.

Patient 1 was a man of 20-30 years of age. He presented with occlusion of the left middle cerebral artery. He experienced a recurrence 9 months later. At a 6-month follow-up, an asymptomatic, partially thrombosed pseudoaneurysm was observed by CT- and MRI-angiography. Reevaluation of imaging data revealed a close anatomical relationship between the affected artery and an elongation of the styloid process and vascular eagle syndrome was diagnosed. The patient underwent surgical removal of the styloid process and was clinically stable at a 6-month follow-up.

Patients 2 and 3 were found to have bow hunter syndrome. Patient 2 was a 70–to-80-year-old man who presented with an acute posterior circulation wake-up stroke. The patient had had 4 ischemic strokes and one transient ischemic attack and had a history of 4 events in the previous year. All events had occurred in the morning and began after use of a new pillow.

Reclination and slight rotation of the head was found by CT-angiography to cause occlusion of the left vertebral artery (VA) which was ultimately related with an osteophytic alteration in the fifth cervical vertebrae. The patient was offered surgical intervention but declined.

Patient 4 was a man aged 50 to 60 years old who presented for a consultation after 3 recurrent ischemic strokes within 5 months. Upon reevaluation of CT scans, a bony spur that made immediate contact with the left VA was observed. The left VA was confirmed to have high-grade stenosis and the patient underwent coil occlusion of the vessel. The patient was stable at a 9-month follow-up.

Patients 5 and 6 were found to have compression caused by thyroid cartilage. Patient 5 was a man aged 50-to-60 years old who presented with a total of 6 ischemic strokes in the posterior cerebral circulation within 23 months. High-grade atherosclerotic stenosis was thought to be the cause; however, an emergency CT-angiography revealed the compression was caused by thyroid cartilage. The patient underwent emergency surgical bypass from the anterior occipitalis to the V3 segment of the right VA. No recurrences occurred during a 24-month follow-up.

The researchers concluded, “Due to the possibly high risk of stroke recurrence and potentially causative treatment options, bony strokes seem to be highly relevant for clinical practice. In patients with recurrent strokes in one vascular territory, the presence of a symptomatic anatomic bone or cartilage anomaly may be considered as a differential diagnosis after sufficient exclusion of competing etiologies of an ischemic stroke.”

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Jiayi Huang, from the University of Hong Kong, and colleagues assessed the association between statin use and AF-related outcomes among patients with AF. The analysis included 51,472 patients with newly diagnosed AF (2010 to 2018) categorized by statin therapy use (11,866 individuals) and statin nonuse (39,606 individuals).

The researchers found that during a median follow-up of 5.1 years, previous statin use was significantly associated with a lower risk for ischemic stroke (IS)/systemic embolism (SE), versus statin nonuse (subdistribution hazard ratio [SHR], 0.83). Similar patterns were seen for the associations between previous statin use and hemorrhagic stroke (HS; SHR, 0.93) and TIA (SHR, 0.85). Statin use of six or more years predicted a lower risk for IS/SE, HS, and TIA (SHRs, 0.57, 0.56, 0.58, respectively) versus short-term statin use (three months to less than two years). In stratified analyses, a lower risk for IS was found to be associated with statin use consistently.

“These data support the use of statins to prevent stroke and transient ischemic attack in patients with new-onset atrial fibrillation,” Huang said in a statement. “The findings have important clinical implications particularly given that in atrial fibrillation patients, ischemic strokes are often fatal or disabling, and have a high risk of recurrence.”

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The parallel-group, open-label, randomized AMETIS (Anesthesia Management in Endovascular Therapy for Ischemic Stroke; ClinicalTrials.gov Identifier: NCT03229148) trial compared general anesthesia with procedural sedation for mechanical thrombectomy in patients with large-vessel occlusion acute ischemic stroke at 10 university medical centers in France.

Eligible participants were aged 18 years or older, had an occlusion of the intracranial internal carotid artery and/or the proximal middle cerebral artery, and a decision for thrombectomy based on international guidelines. The patients were randomly assigned in a 1:1 ratio to receive general anesthesia with tracheal intubation or procedural sedation.

The primary outcome was a composite of functional independence at 90 days (score of 0, 1, or 2 on the modified Rankin Scale) and absence of major periprocedural complications at 7 days. Major complications were procedure-related serious adverse events (vessel perforation or dissection), pneumonia, myocardial infarction, cardiogenic acute pulmonary edema, and progression to malignant stroke.

A total of 273 patients met the criteria for inclusion in the modified intention-to-treat population from August 31, 2017, through February 8, 2020 (135 for general anesthesia and 138 for procedural sedation). The patients’ mean age was 71.6 (SD, 13.8) years and 52% were women.

The primary composite outcome occurred in 28.2% of patients who received general anesthesia and 36.2% of patients who received procedural sedation (absolute difference, 8.1 percentage points; 95% CI, −2.3 to 19.1; relative risk [RR], 1.29; 95% CI, 0.91-1.82; P =.15).

At 90 days, the rates of functional independence were 33.3% in the general anesthesia group and 39.1% in the procedural sedation group (RR, 1.18; 95% CI, 0.86-1.61; P =.32). The rate of patients who were without major periprocedural complications was 65.9% in the general anesthesia group and 67.4% in the procedural sedation group (RR, 1.02; 95% CI, 0.86-1.21; P =.80). A significant relationship was observed between major periprocedural complications and functional independence at 90 days (odds ratio, 6.81; 95% CI, 3.40-13.60; P <.001).

In the general anesthesia group, the percentage of patients with hypotension was 87.4% compared with 44.9% in the procedural sedation group (P <.001). Overall, death within 90 days occurred in 17.6% of patients, including 25 in the general anesthesia group and 23 in the procedural sedation group.

Subgroup analyses for the primary endpoint showed evidence of a differential effect among patients older than or younger than 70 years.

The investigators noted that the anesthesia protocol was based on individual clinician expertise instead of being guided by a standardized protocol, and substantial variability in blood pressure control across study sites cannot be excluded. Also, the relatively small sample size could have caused potential between-group differences to be missed, and the observed between-group effect was lower than the anticipated absolute risk reduction of 20 percentage points.

“In conclusion, our trial showed that among patients with anterior circulation large-vessel occlusion acute ischemic stroke, general anesthesia and procedural sedation for mechanical thrombectomy were associated with similar rates of functional independence and major periprocedural complications,” wrote the researchers.

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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There has been some evidence that stroke risk may be associated with sleep characteristics; however, data are not robust.

The INTERSTROKE study was a large international case-control study where researchers recruited patients with stroke and matched them with nonstroke control individuals. In this analysis, data from a supplementary questionnaire about sleep, which was introduced in 2012, were evaluated for trends in sleep disturbance in the setting of stroke.

This study comprised 2,243 stroke cases and 2,253 control individuals. The patients with stroke and control individuals were:

• mean age, 63 (Standard deviation [SD], 14) and 62 (SD, 14) years (P <.001),
• 58% and 58% were men,
• they had a body mass index (BMI) of 26.4 (SD, 5.0) and 25.8 (SD, 4.8) kg/m² (P <.001),
• 78% and 70% had a modified Rankin Scale (mRS) score of 0 (P <.001), and
• 83% and 73% were mainly inactive (P <.001), respectively.

Study cohorts were recruited in Western Europe/North America/Australasia (25%), South Asia (23%), China (18%), Eastern/Central Europe/Middle East (16%), Africa (7.9%-8.1%), South America (5.8%), and South East Asia (3.6%).

Overall, patients with stroke self-rated their overall sleep quality as poorer than the control individuals and more reported waking more than once, difficulty falling asleep, snoring, snorting, breathing cessation, and napping with longer-duration naps (all P <.001).

In the fully adjusted models, compared with sleeping for 7 hours per night, sleeping less than 5 (adjusted odds ratio [aOR], 1.99; 95% CI, 1.17-3.38), 5 (aOR, 2.06; 95% CI, 1.42-2.99), 9 (aOR, 1.41; 95% CI, 1.01-1.98), or more than 9 (aOR, 2.14; 95% CI, 1.46-3.15) hours a night increased risk for all stroke.

Stroke risk was also associated with breathing problems during sleep, specifically snoring (aOR, 1.75; 95% CI, 1.44-2.12), snorting or gasping (aOR, 2.41; 95% CI, 1.91-3.05), and breathing cessation or choking (aOR, 2.52; 95% CI, 1.92-3.31) compared with no such breathing difficulty during sleep.

In univariate analyses, stroke was associated with:

• fair or bad sleep compared with good sleep (odds ratio [OR], 1.73),
• sleep onset latency compared with no latency (OR, 1.55),
• waking more than once compared with once or fewer (OR, 1.61), and
• long unplanned napping (OR, 2.88), long planned napping (OR, 1.78), and short unplanned napping (OR, 2.05), compared with no napping.

However, in all stroke cases except for long unplanned napping (absolute risk reduction [aRR], 1.65), risks were attenuated in the fully adjusted models.

Overall, risk for stroke increased with the burden, or number, of sleep problems from an OR of 1.63 for 2-3 problems to an OR of 5.38 for more than 5.

Significant interactions were observed between sleep duration and snoring (P =.002), ethnicity (P <.001), and region (P <.001).

The major limitation of the study was that data were based on subjective reporting.

The researchers concluded, “[O]ur results suggest that individual and cumulative symptoms of sleep disturbance may be important modifiable risk factors for stroke, and/or their presence identifies individuals at increased risk of stroke.”

Disclosures: This research was supported by Astra Zeneca, Boehringer Ingelheim, Pfizer, MERCK, Sharp and Dohme. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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Compared with non-Hispanic White individuals, Mexican Americans have been found to have worse neurologic, functional, and cognitive stroke outcomes. As data on preferred language use and stroke outcome is inconclusive, researchers aimed to examine whether language preference is associated with 90-day post stroke outcomes among Mexican Americans.

For the study, the researchers evaluated patients who were Mexican American and participated in the Brain Attack Surveillance in Corpus Christi (BASIC) project between 2009 and 2018. Those included had an ischemic or hemorrhagic stroke and survived 90 days post incident, as well as completed baseline and outcome interviews.

Primary outcomes included the National Institute of Health Stroke Scale (NIHSS), activities of daily living/instrumental activities of daily living (ADL/IADL), and the modified Mini-Mental State Examination (MSE). Patients were classified as either Spanish only speakers or others (English only or bilingual). Stroke outcomes categorized by English and Spanish speakers were examined using weighted Tobit regression.

A total of 1,096 patients who were Mexican American with a recorded first-ever stroke were included in the study, that of which 926 were English or bilingual speakers and 170 were Spanish speakers. Compared with English or bilingual speakers, Spanish speakers were found to be older (median age, 77 vs 64 years; P <.01), had higher initial NIHSS values (P = .02), and had a higher prevalence of atrial fibrillation (P <.01).

Fully adjusted models found that Spanish speakers had worse neurologic outcomes (mean difference, 1.93; 95% CI, 0.77 to 3.10; P <.01), but no notable difference in functional outcome (mean difference, 0.05; 95% CI, -0.12 to 0.22; P = .53), or cognitive outcome (mean difference, -1.28; 95% CI, -3.70 to 1.15;  P = 30).

After the researchers adjusted for immigration status, they found similar results, with the only significant difference being neurologic outcome (mean difference, 2.13; P <.01). As immigration status correlates to preferred interview language, multicollinearity within models was checked for immigration status, language preference, and level of education, however no relationship found.

“Our results demonstrate worse 90-day post stroke neurological outcomes among Spanish-only speaking MA [Mexican Americans] compared to MA who spoke English. We found no difference in 90-day post stroke cognitive or functional outcomes,” the researchers stated.

They concluded that “Improving the report of language preference and immigration status in stroke studies could help better characterize what is driving differences and disparities among populations.”

Study limitations included self-reported language preference and the lack of information on language used by providers to evaluate patient-provider language discordance.

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Data are limited on the long-term outcomes following a TIA or minor ischemic stroke. Additionally, previous studies tend to group together all noncardioembolic strokes despite the underlying pathology. For the study, researchers assessed the 5-year risk for major vascular events in patients with TIA or minor ischemic stroke compared with patients without atherosclerosis.

The researchers used TIAregistry.org, an international registry of patients with a recent TIA or minor ischemic stroke, for analysis. Patient data was collected from 61 centers in 21 countries in Asia, Europe, Latin America, and the Middle East. Follow up occurred at 1, 3, and 12 months after the baseline, and yearly for 5 years.

Participants were adult patients with either focal retinal or brain ischemia with a resolution of symptoms or a minor ischemic stroke modified Rankin scale (mRS) score of 0 to 1.

Patients were assessed for the 5 disease categories in the ASCOD grading system (atherosclerosis, small vessel disease, cardiac pathology, other causes, and dissection). Only patients with grade A1 (atherosclerosis with luminal stenosis of 50% or greater) and A2 (atherosclerosis with luminal stenosis of greater than 30% and less than 50%) were considered for analysis.

The primary outcome was a combined incidence of nonfatal stroke, nonfatal acute coronary syndrome, or cardiovascular death within 5 years. Secondary outcomes were individual factors from the primary outcome, bleeding, all-cause death, and mRS score.

Of the 4,789 patients in the database, 3,847 patients from 42 centers participated in the 5-year follow-up period. There were 1,406 (36.5%) of 3,847 patients with no atherosclerosis (grade A0) and 998 (25.9%) with atherosclerotic stenosis ipsilateral to the ischemic area (grade A1 or A2).

For the primary outcome, the researchers found an event rate of 7.7% (95% CI, 6.3-9.2; 101 events) for patients with an ASCOD of A0 and 19.8% (95% CI, 17.4-22.4; 189 events) for patients with an ASCOD of grade A1 or A2.

When compared with patients with grade A0, patients with grade A1 or A2 had an increased risk for the primary composite outcome (Hazard ratio [HR], 2.77; 95% CI, 2.18-3.53; P <.0001) and an increased risk for stroke (HR, 2.74; 95%CI, 2.07-3.62; P <.0001).

Aside from age, male sex, and multiple infarctions confirmed by neuroimaging, most risk factors associated with an ASCOD score of A1 or A2 were modifiable. Examples of these factors include hypertension, dyslipidemia, being overweight, and smoking cigarettes (all P <.025).

Preventative treatment should focus on targeting patients with atherosclerosis, rather than giving the same treatment to those with TIA or minor ischemic strokes regardless of atherosclerotic status.

“Our findings could facilitate the design of future clinical trials evaluating drugs addressing complications of atherosclerosis in patients with TIA or minor ischaemic stroke, supporting a focus on patients with atherosclerosis rather than including all patients in these trials,” study authors concluded. Study limitations were including only highly specialized TIA and stroke study centers and incomplete atherosclerotic information for many patients.

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Nada El Husseini, M.D., from Duke University Medical Center in Durham, North Carolina, and colleagues performed a scoping literature review of studies on the incidence and prevalence, natural history, diagnosis, and management of PSCI on behalf of the American Heart Association.

The researchers found that PSCI is common, especially in the first year after stroke, and varies from mild to severe. In some cases, cognitive impairment is reversible early after stroke, but up to one-third of individuals with stroke develop dementia within five years. This is likely attributable to acute stroke precipitating a series of pathological events, often in the context of preexisting microvascular and neurodegenerative changes, although the pathophysiology is not yet fully elucidated. Integral components of care for individuals with PSCI include screening for associated comorbidities and interdisciplinary management.

“Cognitive impairment is an often under-reported and under-diagnosed — yet very common condition that stroke survivors frequently deal with,” El Husseini said in a statement. “Stroke survivors should be systematically evaluated for cognitive impairment so that treatment may begin as soon as possible after signs appear.”

Abstract/Full Text

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The use of endovascular therapy has become standard care among patients who experience an ischemic stroke due to cerebral large vessel occlusion. Current guidelines recommend that imaging selection criteria for endovascular therapy include 1 of the following 2 events:

• Alberta Stroke Program Early Computed Tomography Score (ASPECTS) value of ≥6 (which is a measure of infarct size on a scale of 0-10, in which lower values are indicative of a larger infarct); this measure typically suggests small- to medium-sized infarctions
• Mismatch between clinical state and perfusion imaging within 6-24 hours

Recognizing that both of the above criteria generally exclude large-sized infarcts, researchers sought to evaluate whether endovascular therapy is beneficial for patients with a large infarction.

They conducted the multicenter, prospective, open-label Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core trial (ANGEL-ASPECT; ClinicalTrials.gov Identifier: NCT04551664) in China. The study included patients with acute large vessel occlusion in the anterior circulation and an ASPECTS value of 3-5 or an infarct-core volume between 70-100 mL. All participants were randomly assigned, in a 1:1 ratio, “within 24 hours from the time they were last known to be well” to receive endovascular therapy plus medical management or medical management alone.

The primary study outcome was the score on the modified Rankin Scale (mRS) at 90 days.

The primary study objective was to establish whether an ordinal shift in the distribution of scores on the mRS at 90 days had transpired between the 2 treatment arms.

All imaging was conducted at baseline, at 36±12 hours, and at 7±1 days following randomization or at hospital discharge.

A total of 456 patients (median age, 68 years; 38.7% women) were enrolled in ANGEL-ASPECT, with 231 patients randomly assigned to the endovascular-therapy arm and 225 patients assigned to the medical-management-alone arm.

In the endovascular-therapy arm, 1 of the 231 patients was not included in the intention-to-treat analysis.

In both of the treatment arms, approximately 28% of participants received intravenous (IV) thrombolysis.

The trial was stopped early, since evidence of the efficacy of endovascular therapy was observed following the second interim analysis on May 17, 2022.

According to the primary outcome analysis, a shift in the distribution of scores on the mRS at 90 days in favor of significantly better outcomes with endovascular therapy compared with medical management alone was observed (generalized odds ratio, 1.37; 95% CI, 1.11-1.69; P =.004).

Based on the secondary outcome analysis, the proportion of patients with a score of 0-2 on the mRS at 90 days was 30.0% in the endovascular-therapy arm vs 11.6% in the medical-management-alone arm (relative risk [RR], 2.62; 95% CI, 1.69-4.06).

In addition, the percentage of patients with a score of 0-3 on the mRS at 90 days was 47.0% in the endovascular-therapy cohort compared with 33.3% in the medical-management cohort (RR, 1.50; 95% CI, 1.17-1.91).

The occurrence of symptomatic intracranial hemorrhage within 48 hours following randomization was reported in 6.1% of patients in the endovascular-therapy group vs 2.7% in the medical-management-alone group (RR, 2.07; 95% CI, 0.79-5.41; P =.12). The occurrence of any intracranial hemorrhage within 48 hours was reported in 49.1% of those who received endovascular therapy compared with 17.3% of those who received medical management alone (RR, 2.71; 95% CI, 1.91-3.84; P <.001).

Several limitations of the present study warrant mention. To begin, the percentage of patients who received IV thrombolysis was low, which may have negatively impacted the medical-management group. Additionally, urokinase instead of alteplase, which is likely more effective, was used as thrombolysis in a small proportion of patients. Further, no patients with an ASPECTS value of >5 and an infarct-core volume of 70 to 100 mL participated in the trial.

“Among patients in China with acute ischemic stroke and a large infarct core due to large-vessel occlusion in the anterior circulation, endovascular therapy within 24 hours after stroke onset resulted in a better functional outcome at 3 months than medical management alone,” the researchers explained. “Intracranial hemorrhages were more common with endovascular therapy,” they concluded.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Depression and anxiety affect around a third and a quarter of patients who are recovering from stroke, respectively. These symptoms can have negative impacts on recovery outcomes. As such, addressing mental health concerns can be an important component of poststroke care among many patients.

For the study, a substudy of the PRECISE project — an observational cohort study derived from a national-wide register, the Australian Stroke Clinical Registry (AuSCR) —, researchers evaluated mental health treatment in a poststroke setting. Adults (N=7214) who were admitted to 45 hospitals in Australia between 2012 and 2016 with stroke or transient ischemic attack (TIA) were evaluated for mental health care receipt in the 18 months following stroke. Self-reported anxiety or depression was based on EuroQOL, 5–dimensions, 3-level (EQ-5D-3L) responses.

These were the characteristics of patients who did (n=2675) and did not (n=4539) receive mental health treatment were:

• median age, 69.6 (IQR, 59.4-78.3) and 72.4 (IQR, 62.6-79.8) years (P <.001);
• 50% and 38% were women (P <.001);
• 65% and 66% had an ischemic stroke (P <.001);
• 51% and 55% were able to walk independently on admission (P <.001); and
• 57% and 28% had self-reported anxiety or depression (P <.001), respectively.

Among those who self-reported symptoms of anxiety or depression, 54% received any mental health treatment and 50% received pharmaceuticals poststroke. In the entire cohort, 37% received any mental health treatment poststroke compared with 28% prestroke; and 34% and 26% received pharmaceuticals, respectively.

Receipt of mental health treatment was explained by clinical factors (28%), demographic characteristics (2%), and structural factors (2%). In the full model, 23 predictors explained 32% of the variance (c², 130.73; P <.001).

The strongest predictors for receiving mental health treatment poststroke were:

• receipt of mental health medication prestroke (adjusted odds ratio [aOR], 17.58; 95% CI, 15.05-20.55),
• self-reported anxiety or depression (aOR, 2.55; 95% CI, 2.24-2.90),
• prestroke Medicare mental health uptake (aOR, 1.80; 95% CI, 1.37-2.38), and
• female gender (aOR, 1.30; 95% CI, 1.13-1.48).

Meanwhile, patients with TIA (aOR, 0.64; 95% CI, 0.49-0.83), ischemic stroke (aOR, 0.71; 95% CI, 0.56-0.89), and the ability to walk at admission (aOR, 0.85; 95% CI, 0.74-0.97) were less likely to receive mental health care.

In a sensitivity analysis that excluded patients who had a history of mental health treatment, patients who had continuity of primary care were less likely to receive mental health treatment poststroke (OR, 0.81; 95% CI, 0.67-0.97).

Overall, receipt of mental health services did not associate with survival or health care utilization outcomes. However, patients who self-reported anxiety or depression were associated with increased hospital utilization (hazard ratio [HR], 1.06; 95% CI, 1.01-1.11).

The major limitation of this study was the use of self-reported symptoms of anxiety and depression.

The researchers concluded, “[A]pproximately 1 in 2 people living with stroke with self-reported anxiety/depression are not receiving mental health treatment, and those who do are mostly receiving medication only. Health professionals should screen for mental health problems and introduce treatment options, with particular attention to individuals who are at risk of not receiving treatment.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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Previous research has found that among patients with posterior circulation stroke, objective gait abnormality was the most common presenting feature.

In a case-control study, researchers sought to assess whether objective gait abnormality could be a cost-effective prognostication tool for posterior circulation stroke.

To calculate the probability of objective gait abnormality in patients with posterior circulation stroke and mimics, the researchers used confidence intervals (CI), sensitivity (SE), specificity (SP), positive predictive value (PPV), and negative predictive value (NPV).

The researchers defined cases of posterior circulation stroke as “acute ischemic strokes isolated to the posterior cerebral, basilar, or vertebral artery territories.” They defined mimics as “acutely vertiginous patients from other causes.”

The study included a total of 82 patients with posterior circulation stroke (average age, 67; women, 51%) and 104 patients with mimics (average age, 63; women, 51%) with gait assessment at admission.

The findings revealed objective gait abnormality in 69 (84.1%) of posterior circulation stroke cases vs 18 (17.3%) mimics (odds ratio [OR], 25.4; CI, 11.62-55.35; SE 84%; SP 82%; PPV 79%; NPV 87%).

When the researchers stratified by dizziness, objective gait abnormality was recorded in 38 (86%) posterior circulation stroke cases vs 18 (17.3%) mimics (OR, 30.3; CI, 11.13-82.23; SE 86%; SP 83%; PPV 68%; NPV 94%).

Upon stratifying for subjective gait abnormality, the researchers found objective gait abnormality was recorded in 48 (92%) posterior circulation stroke cases vs 16 (21.6%) mimics (OR, 43.5; CI, 13.63-138.83; SE 92%; SP 78%; PPV 75%; NPV 94%).

Overall, at NYU Langone Hospitals, objective gait abnormality was 25.4 times more likely than mimics in patients with posterior circulation stroke. When presenting with dizziness or subjective gait abnormality, these patients were 30.3 times or 43.5 times more likely to have objective gait abnormality. Upon arrival, NPV increased to 94% in patients with dizziness and subjective gait abnormality.

The researchers concluded, “Gait assessment can be used as a cost-effective screening tool to rule out PCS [posterior circulation stroke] on arrival.”

The researchers’ findings warrant further research before clinicians recommend the use of gait assessment as a screening tool for posterior circulation stroke in clinical practice.

This article originally appeared on Neurology Advisor.

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Wells Andres, M.D., from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and colleagues estimated trends in stroke prevalence using data from the National Health and Nutrition Examination Surveys. The analysis included data from 2,197 participants from the 1999 to 2018 survey cycles aged 20 years and older who self-reported a history of stroke.

The researchers found that the overall crude and age-standardized prevalence of stroke was 2.84 and 3.10 percent, respectively, from 1999 to 2018, corresponding to 7.3 million affected individuals. From 1999-2002 to 2015-2018, the overall prevalence of stroke was stable. Over time, crude estimates of the number of affected individuals with stroke increased, while age-standardized estimates were stable. Compared with other racial and ethnic groups, the age-standardized prevalence of stroke was higher among non-Hispanic Black individuals; prevalence was similar by sex. Higher prevalence was seen for older versus younger individuals. In each age group and racial and ethnic group, the prevalence of stroke was stable from 1999-2002 to 2015-2018, but increases over time were seen for men (from 2.29 to 2.94 percent, respectively).

“Although the burden of stroke has increased since 1973 to 1991, it has stabilized in recent years,” the authors write.

One author disclosed financial ties to the pharmaceutical industry.

Abstract/Full Text

More Information

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Although the link between chronic inflammatory disorders and cardiovascular (CV) disease has been well established, few analyses have evaluated the risk for ischemic heart disease and the risk for stroke among individuals with chronic inflammatory conditions, including FMF.

Using the Clalit Health Services database, researchers of the population-based study sought to assess the rates and risk for stroke among patients with FMF, as well as to examine predictors for stroke.

All individuals with an initial diagnosis of FMF between January 2000 and December 2016, were included in the study. Study participants were matched with control participants who did not have FMF, based on sex, age, and location of residence. Follow-up was conducted until initial diagnosis of stroke or death, whichever occurred first.

A total of 9769 patients with FMF and 9769 control participants without FMF were included in the analysis. At the index date of the study, the mean participant age was 25.7±18.0 years. Overall, the percentage of men in both groups was 49.0%.

In the FMF vs control group, a significantly higher percentage of participants were from North Africa, the Middle East, and Turkey.

Regarding baseline CV risk factors between the groups, the only significant difference was with regard to history of smoking, which was reported more often among individuals with FMF vs those without (10.0% vs 9.1%, respectively; P =.032).

Researchers noted higher frequency in the FMF vs control group of amyloidosis (0.7% vs 0.3%); chronic kidney failure (3.8% vs 2.0%); need for dialysis (1.1% vs 0.2%); and kidney transplantation (0.6% vs 0.1%; P <.001 for all).

In the FMF group, 78.1% (n=7630) of the participants received treatment with colchicine, with a median duration of treatment of 10.2 years (range, 3.7-17.6 years).

Median follow-up was 12.4 years in the FMF cohort vs 12.5 years in the control cohort. During follow-up, a total of 208 participants with FMF vs 148 control participants were diagnosed with stroke, which resulted in stroke incidence rates per 10,000 person-years of 19.8 (95% CI, 17.2-22.7) and 13.9 (95% CI, 11.8-16.4), respectively. The crude hazard ratio (HR) was 1.42 (95% CI, 1.15-1.76; P <.001).

Following adjustments for sex and age (HR, 1.46; 95% CI, 1.18-1.80; P <.001) and for baseline CV risk factors (HR, 1.44; 95% CI, 1.16-1.78; P <.001), the results remained statistically significant. Participants with FMF vs control participants were diagnosed with stroke at a significantly younger age (59.8±15.9 vs 65.3±14.9 years, respectively; P <.001).

According to multivariate analysis, patients with FMF and disease-associated comorbidities, such as amyloidosis and kidney complications (HR, 2.16; 95% CI, 1.38-3.38; P <.001), and those with FMF without any disease-related complications (HR, 1.32; 95% CI, 1.04-1.67; P <.05) had an elevated risk for stroke. Patients with vs without FMF who had disease-associated comorbidities had a higher incidence rate of stroke (128.0 vs 15.4 stroke events per 10,000 person-years, respectively), which resulted in a higher difference in incidence rate (67.7 vs 3.7 stroke events per 10,000 person-years, respectively).

Study limitations included the inability to clinically differentiate between patients with FMF according to signs/symptoms of disease, frequency/severity of attacks, and levels of inflammatory markers; and the inability to retrieve any genetic information regarding participants’ baseline mutations due to privacy policies.

“North African and Middle Eastern origins are associated with higher stroke rates, illustrating a phenotypic-genotypic relation. Clinicians should be aware of these findings when managing these patients,” the study authors explained. “Further studies are warranted to decide on an effective primary prevention and screening strategy,” they concluded.

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