The 4-arm randomized pragmatic clinical trial compared the efficacy of SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, or sulfonylureas on the risk for MACE. Data from the US Department of Veterans Affairs (VA) were used to emulate the target trial.

Participants were from the VA Health Care System and had a record of use of any of the 4 drug classes from October 1, 2016, to September 30, 2021, and were followed until December 31, 2022. The primary outcome was MACE, which was the composite of stroke, myocardial infarction, and all-cause mortality.

The final cohort included 283,998 new users (mean age, 64 years; approximately 93% men) of second-line antihyperglycemics from October 1, 2016, to September 30, 2021, with a median follow-up of 3.85 years (IQR, 2.57-5.05). Among the participants, 46,516 initiated use of SGLT2 inhibitors, 26,038 initiated GLP-1 receptor agonists, 55,310 initiated DPP-4 inhibitors, and 156,134 initiated sulfonylureas.

In the intention-to-treat analyses, SGLT2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors were associated with a decreased risk for MACE compared with sulfonylureas (hazard ratio [HR], 0.77 [95% CI, 0.74-0.80]; HR, 0.78 [95% CI, 0.74-0.81]; and HR, 0.90 [95% CI, 0.86-0.93], respectively). SGLT2 inhibitors and GLP-1 receptor agonists were associated with a decreased risk for MACE vs DPP-4 inhibitors (HR, 0.86 [95% CI, 0.82-0.89] and HR, 0.86 [95% CI, 0.82-0.90], respectively). Regarding the risk for MACE in SGLT2 inhibitors vs GLP-1 receptor agonists, the HR was 0.99 (95% CI, 0.94-1.04).

In the per-protocol analysis, SGLT2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors were associated with a decreased risk for MACE vs sulfonylureas (HR, 0.77 [95% CI, 0.73-0.82]; HR, 0.77 [95% CI, 0.72-0.82]; and HR, 0.88 [95% CI, 0.83-0.93], respectively). SGLT2 inhibitors and GLP-1 receptor agonists were associated with a lower risk for MACE vs DPP-4 inhibitors (HR, 0.88 [95% CI, 0.83-0.93] and HR, 0.88 [95% CI, 0.82-0.93], respectively). The risk for MACE in SGLT2 inhibitors vs GLP-1 receptor agonists was associated with an HR of 1.01 (95% CI, 0.94-1.07).

Among several limitations, the study included US veterans who were mostly older, White, and men; residual confounding cannot be completely ruled out; and the results are based on observational data. Also, the cause of death is not assessed, and within-class differences in medications were not investigated.

“These data on differences in effectiveness of these antihyperglycemics on risk of MACE could help to guide choice of antihyperglycemic therapy in people with type 2 diabetes,” stated the investigators.

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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The researchers evaluated multiple approaches to assess the potential effect of the percutaneous microaxial LVAD compared with alternative treatments, including intra-aortic balloon pump (IABP) or no mechanical circulatory support (MCS) device, with use of an observational administrative database of Medicare fee-for-service beneficiaries receiving percutaneous coronary intervention (PCI) for AMICS.

The participants were hospitalized with AMICS and received PCI from October 1, 2015, to December 31, 2019. Outcomes included all-cause mortality and the composite of all-cause mortality or readmission at 30 days post-PCI.

The analysis included 23,478 patients (60.8% men), with a mean (SD) age of 73.9 (9.8) years.

Baseline severity markers such as intubation, treatment with vasopressors, and use of right-sided heart catheterization were more common in patients treated with the percutaneous microaxial LVAD. These differences and the absence of information on other known markers of illness severity suggested considerable potential for residual unmeasured confounding, according to the researchers.

After weighting, the 30-day mortality risk post-PCI was increased among patients who initially received a percutaneous microaxial LVAD vs those who did not (53.8% [95% CI, 52.0%-55.7%] vs 38.9% [95% CI, 38.1%-39.7%], respectively), as was the risk of all-cause mortality or readmission at 30 days (58.8% [95% CI, 57.1%-60.6%] vs 45.6% [95% CI, 44.8%-46.4%], respectively).

The adjusted risk of mortality or readmission at 30 days post-PCI was greater with the initial treatment with percutaneous microaxial LVAD vs the other treatments:

• 57.8% (95% CI, 56.1%-59.5%) for percutaneous microaxial LVAD
• 47.8% (95% CI, 46.4%-49.1%) for IABP
• 43.9% (95% CI, 42.9%-44.9%) with no MCS

For the instrumental variable analysis, an increased 30-day mortality risk was observed with percutaneous microaxial LVAD compared with no percutaneous microaxial LVAD (difference, 13.5% [95% CI, 3.9%-23.2%]). The difference for the composite outcome of 30-day mortality or readmission of percutaneous microaxial LVAD vs no percutaneous microaxial LVAD was 9.1% (95% CI, −0.9% to 19.1%).

Significant variation in longitudinal trends was found for hospitals for percutaneous microaxial LVAD use and baseline characteristics among the groups, indicating potential violation of the assumption of no unmeasured differences in time-varying confounding among difference-indifferences design (DiD)–defined groups.

The risk difference for percutaneous microaxial LVAD compared with no percutaneous microaxial LVAD regarding 30-day mortality was -4.7% (95% CI, -15.9% to 39.9%) with use of moderately increasing vs decreasing percutaneous microaxial LVAD use hospitals as the DiD and 9.7% (95% CI, -15.9% to 39.9%) when using rapidly increasing vs moderately increasing percutaneous microaxial LVAD use hospitals as the DiD. Wide CIs were observed for estimated DiD treatment effects.

The researchers noted that their analysis focused on causal questions that can be answered in observational studies. Also, data were unavailable regarding changes in hemodynamic measurements, markers of tissue perfusion, and response to treatment, and the population included only patients enrolled in Medicare fee-for-service.

“Our findings suggest that commonly used observational datasets cannot support a causal interpretation of the estimates produced by different analyses used for the evaluation of percutaneous mechanical support devices in cardiogenic shock,” wrote the investigators. “Randomized clinical trials will allow valid comparisons across candidate treatment strategies and help resolve ongoing controversies.”

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 characterize incidence, presentation, treatment, prevention, and prognosis of ICH in AMI. In-hospital mortality was the primary endpoint.

The investigators conducted a monocentric observational study that included electronic data on 5257 patients with AMI from October 2015 to October 2020, of whom 14 (0.27%; 3 women; age range, 45 to 77 years) subsequently experienced ICH. The study was conducted at the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. Among these 14 patients, 10 experienced ST-segment elevation myocardial infarction (STEMI) and 4 experienced non-STEMI, 8 had history of hypertension, 5 had history of hyperlipidemia, 4 had history of stroke, and 5 patients smoked.

According to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) score, 7 patients were high risk for bleeding. According to the CRUSADE score, 6 patients were high/very high risk for bleeding. Among all 14 patients with ICH, 4 scored high or very high on both tests. Among those scoring high or very high on ARC-HBR, 5 died. Among those scoring high or very high on CRUSADE, 3 died. Among those who scored high or very high on both tests, 2 died. This led investigators to claim CRUSADE and ARC-HBR scores effectively predict ICH following AMI, and work in tandem to assess patient risk.

Within 48 hours after AMI, 5 patients experienced bleeding. ICH ultimately presented in 8 patients with lobar hemorrhages, and in 4 patients with subarachnoid hemorrhages.

Overall, 8 patients died in-hospital.

Following sudden loss of consciousness, 8 of 9 patients who lost consciousness died in-hospital, all within 4 days of ICH onset. Among the patients who died, 2 were treated with conservative drug therapy, 1 was treated with thrombolysis, and 5 were treated with percutaneous coronary intervention therapy.

Among patients who died in-hospital vs those ultimately discharged, volume of ICH was significantly higher (7 of 8 patients who died in hospital had ICH volumes of >30 mL, suggesting 30 mL may be a threshold).

Study limitations include the single-center and retrospective design, underpowered sample size, limited generalizability, and possible underestimation of subclinical cerebral hemorrhage in all patients.

“The incidence of ICH following myocardial infarction is low; however, the mortality rate is extremely high, presenting considerable challenges for clinical treatment,” the investigators wrote. “The volume of ICH is closely related to patient outcomes, and early detection coupled with timely symptomatic treatment are essential for improving prognosis.”

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Researchers aimed to assess if targeted mild hypercapnia (partial pressure of arterial carbon dioxide [Paco₂], 50-55 mm Hg) vs targeted normocapnia (Paco₂, 35-45 mm Hg) would improve neurologic outcomes at 6 months in adults with coma who had been resuscitated after out-of-hospital cardiac arrest. Favorable neurologic outcome at 6 months was the primary outcome. Death within 6 months was the secondary outcome. Favorable neurologic outcome was defined as a score of at least 5/8 (1=death; 8=the best neurologic outcome) using the Glasgow Outcome Scale-Extended.

The researchers conducted the TAME  (Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest; ClinicalTrials.gov Identifier: NCT03114033) trial, which included 1700 patients from 63 intensive care units (ICUs) in 17 countries. Patients had coma and were at least 18 years of age. Patients resuscitated after out-of-hospital cardiac arrest with sustained return of spontaneous circulation for at least 20 minutes without chest compressions were randomly assigned in a 1:1 ratio to either 24 hours of targeted mild hypercapnia (n=847) beginning at randomization, or to targeted normocapnia (n=853). Patients with greater than 180 minutes between the return to spontaneous circulation and screening were excluded. At the time of randomization, PaCO₂ values were similar between groups.

Patients were predominantly middle-aged men with histories of hypertension (33.8%), diabetes (17.9%), or percutaneous coronary intervention (14.0%). Cardiac arrest occurred either in residence or public, with 88.1% witnessed by a bystander and 80.5% with a bystander who performed CPR. Median time from cardiac arrest to randomization was 151 minutes.

Assessors of prognosis and neurologic outcome were not aware of the intervention assignment nor were study authors during data analysis, however attending clinicians were aware. Data was missing for 7.6% of patients.

Researchers found that 332 of 764 patients in the mild hypercapnia group and 350 of 784 patients in the normocapnia group achieved a favorable neurologic outcome at 6 months (relative risk [RR], 0.98; 95% CI, 0.87-1.11; P =.76).

After randomization, death within 6 months occurred in 393 of 816 patients in the mild hypercapnia group and in 382 of 832 patients in the normocapnia group (RR, 1.05; 95% CI, 0.94-1.16). Researchers found no significant between-group differences in death due to cerebral causes or incidence of death before neurologic prognostication.

No significant between-group differences were found in the incidence of adverse events, and mild hypercapnia did not increase the incidence of adverse events.

Results suggest targeted mild hypercapnia did not improve neurologic outcomes at 6 months in this patient population, and greater understanding of the effect of PaCO₂ on cerebrovascular control is necessary.

Study limitations include lack of blinding of emergency department and ICU staff members to intervention assignments, and hypercapnia was common at randomization possibly attenuating between-group differences.

“In patients with coma who were resuscitated after out-of-hospital cardiac arrest, targeted mild hypercapnia did not lead to better neurologic outcomes at 6 months than targeted normocapnia,” the researchers wrote. Researchers added that targeted mild hypercapnia did not improve the risk of death within 6 months, or health-related quality of life.

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The open-label, prospective, randomized STREAM-2 (Strategic Reperfusion in Elderly Patients Early After Myocardial Infarction; ClinicalTrials.gov Identifier: NCT02777580) trial was conducted in 49 centers in 10 countries.

The participants were aged 60 years or older, weighed 55 kg or more, and presented within 3 hours after symptom onset with electrocardiographic evidence of STEMI (ST-segment elevation of ≥2 mm in 2 contiguous leads) and were eligible for randomization if they were unable to receive primary percutaneous coronary intervention (PCI) within 1 hour but before 3 hours after first medical contact.

The patients were randomly assigned 2:1 to a pharmaco-invasive strategy or primary PCI. Coronary angiography was performed 6 to 24 hours postrandomization.

The primary efficacy endpoints were reperfusion efficacy according to the proportion of patients with 50% or higher ST-segment-elevation resolution in the lead with worst ST-segment elevation, resolution of ST deviations after last angiography, and the composite of all-cause mortality, shock, heart failure, and reinfarction at 30 days.

A total 401 participants were allocated to a pharmaco-invasive strategy and 203 to primary PCI from August 1, 2017, to September 12, 2022. Their mean age was 70.5 years, 166 patients (27.5%) were aged 75 years or older, and 32.7% were women.

The median times from symptom onset to randomization were 97 minutes for the pharmaco-invasive group and 92 minutes for the primary PCI group. Bolus tenecteplase was administered a median of 10 minutes postrandomization, and arterial sheath insertion was performed after 81 minutes in the primary PCI arm.

During the prespecified times early after PCI or last angiography if no PCI was performed, 85.2% of participants in the pharmaco-invasive group vs 78.4% in the primary PCI group achieved 50% or higher ST-segment-elevation resolution. For the pharmaco-invasive group, the investigator-reported thrombolysis in myocardial infarction (TIMI) flow grade 3 after tenecteplase was 53.8% vs 18.9% before primary PCI. After PCI or at last angiography, the 2 groups had TIMI-3 flow grades of about 87%.

The combined clinical efficacy endpoint at 30 days was observed in 12.8% of patients in the pharmaco-invasive group and 13.3% in the PCI group (relative risk, 0.96; 95% CI, 0.62-1.48).

All-cause and cardiac deaths were 9.3% and 7.3% in the pharmaco-invasive group and 8.9% and 8.4% in the PCI group, respectively. The pharmaco-invasive arm had 6 intracranial hemorrhages (ICHs; 1.5%), of which 3 were fatal (0.75%). No ICHs occurred in the primary PCI group. The pharmaco-invasive group had 3 ischemic strokes (0.75%) vs 1 in the primary PCI group (0.5%). The major nonintracranial bleeding rate was 1.3% in the pharmaco-invasive group and 1.0% in the primary PCI group.

Among several limitations, the 95% CIs did not allow statistical confirmation of similarity between the 2 treatment groups. Also, the study was unblinded, bias in investigator reporting cannot be excluded, and natural evolution in some ST-segment changes in the pharmaco-invasive group cannot be ruled out.

“If timely PCI is unavailable, this pharmaco-invasive strategy is a reasonable alternative, provided that contraindications to fibrinolysis are observed and excess anticoagulation is avoided,” wrote the investigators.

Disclosure: The trial received funding from Boehringer Ingelheim. 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 determine the most effective DAPT strategies for STEMI and NSTE-ACS. Net adverse clinical events (NACE) (composite of major adverse cardiovascular events [MACE] and relevant bleeding events) was the primary outcome.

The systematic review and meta-analysis was conducted via a search of Cochrane CENTRAL, EMBASE, and PubMed databases from inception to February 2023 for randomized controlled trials (RCTs) on DAPT strategies. The investigators found 20 RCTs that included STEMI patients (n=24,745) or NSTE-ACS patients (n=37,891) receiving standard DAPT (12 months with clopidogrel or potent P2Y₁₂ inhibitors), short-term DAPT (≤6 months) then aspirin or potent P2Y₁₂ inhibitors, guided selection with platelet or genotype function tests, and unguided de-escalation from potent P2Y₁₂ inhibitors to clopidogrel or low-dose potent P2Y₁₂ inhibitors at 1 month.

Included RCTs reported on NACE, but studies with less than 90% of patients with ACS, DAPT duration greater than 18 months, or DAPT with cilostazol were excluded. All included studies had low risk of bias (Cochrane Collaboration risk of bias 2.0 tool), and there was no publication bias for any of the assessed outcomes.

Compared with standard DAPT using potent P2Y₁₂ inhibitors in patients with STEMI, a lower rate of NACE was associated with unguided de-escalation strategy without increased risk of MACE (hazard ratio [HR], 0.57; 95% CI, 0.34-0.96; I²=65.3%).

Unguided de-escalation strategy in patients with NSTE-ACS had a lower rate of NACE without increased risk of MACE compared with standard DAPT using potent P2Y₁₂ inhibitors (HR, 0.62; 95% CI, 0.50-0.78), the guided selection strategy (HR, 0.65; 95% CI, 0.47-0.90), and standard DAPT using clopidogrel (HR, 0.73; 95% CI, 0.55-0.98).

Compared with standard DAPT with P2Y₁₂ inhibitors, short DAPT followed by P2Y₁₂ inhibitors was associated with a lower rate of NACE (HR, 0.69; 95% CI, 0.48-0.99; I²=0%).

No significant differences were found between the DAPT strategies for MACE in STEMI, with moderate heterogeneity (I²=39.3%). Compared with unguided de-escalation strategy, standard DAPT with potent P2Y₁₂ inhibitors, and standard DAPT with clopidogrel in patients with STEMI, short DAPT followed by P2Y₁₂ was associated with a lower rate of major bleeding, with moderate heterogeneity (I²=25.8%).

No significant differences were found between DAPT strategies for MACE in NSTE-ACS, with high heterogeneity (I²=50.3%). Compared with standard DAPT with potent P2Y₁₂ inhibitors, standard DAPT with clopidogrel was associated with a lower rate of major bleeding, with high heterogeneity (I²=56.7%).

Some limitations of the study include the design, the potential influence of confounding factors, and differing definitions across trials.

“Unguided de-escalation strategy was associated with a reduced risk of NACE and may be the most effective DAPT strategy for STEMI and NSTE-ACS,” the investigators wrote. “…our results suggest that the risk of MACE is not increased with any of the DAPT strategies in STEMI patients, and that the risk of bleeding may be less with the short DAPT followed by potent P2Y12 inhibitors strategy compared with standard DAPT with potent P2Y12 inhibitors.”

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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Investigators in Denmark sought to determine if patients with first-time MI or HF have differing cardiovascular risk related to continuing or initiating NSAIDs. The primary outcome was a composite of all-cause death and new MI/HF admission.

The investigators conducted a cohort study using nationwide health registries from 1996 to 2018 that included all patients with first-time MI or HF who survived until 30 days after discharge (N=273,682). A total of 97,966 patients who receive NSAIDs were stratified by continuing users (17%) and initiating users (83%) determined by prescriptions filled less than 60 days before index diagnosis according to the Danish National Prescription Registry.

All NSAIDs are available by prescription in Denmark, over-the-counter sales of ibuprofen are restricted to individuals at least 18 years of age, 1 package/person/dispensing (since 2011), and pack sizes contain a maximum of 20 tablets (since 2013). Additionally, prescriptions are reimbursable so use of data from the Danish National Prescription Registry is a reasonable representation of NSAID use.

Continuing users vs initiators were older (median age, 72 vs 67 years), more often women (48% vs 39%), and had more severe comorbidity burden (20% vs 13%) reflected by prescribed opioids (27% vs 10%), prescribed acetaminophen (32% vs 13%), prescribed anti-ulcer medications (20% vs 12%), and osteoarthritis (22% vs 12%).

The investigators found the most frequently filled NSAID prescriptions (N=657,469) were ibuprofen (50%), diclofenac (20%), etodolac (8.5%), and naproxen (4.3%). Redeemed prescriptions (treatment intensity) declined during the study period from a median of 5 to 2. Continuing users vs initiators had a stronger overall treatment intensity (2 vs 1, in 2018).

The hazard ratio (HR) for the composite outcome was 1.25 (95% CI, 1.23-1.27) substantiated by initiator results (HR, 1.39; 95% CI, 1.36-1.41) and not by continuing users (HR, 1.03; 95% CI, 1.00-1.07).

The HR for the composite outcome among initiators was 1.63 (95% CI, 1.57-1.69) for diclofenac, 1.31 (95% CI, 1.27-1.35) for ibuprofen, and 1.19 (95% CI, 1.08-1.31) for naproxen.

Ibuprofen and naproxen showed no association with the composite outcome among continuing users (HR, 1.00; 95% CI, 0.96-1.05; and HR, 0.98; 95% CI, 0.86-1.12), and associated with a slightly increased outcome rate for diclofenac (HR, 1.11; 95% CI, 1.05-1.18).

These results were consistent with individual components of the composite outcome, for both MI and HF patients, through various sensitivity analyses.

Study limitations include the filled prescriptions being a proxy for adherence and possible unmeasured confounding.

“The persistent high-prevalent contraindicated NSAID use in patients with newly diagnosed MI or HF is a major public and clinical health concern that needs attention from healthcare authorities and relevant medical societies,” the investigators wrote. “…patients with [first-time] MI or HF represent a high-risk group, in which not even nonselective NSAIDs (ibuprofen and naproxen) seem safe to initiate and where other analgetic regimens therefore should be prioritized.”

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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Across an ample body of research, findings consistently show that women fare worse than men in a range of outcomes associated with cardiovascular disease (CVD). Among patients with myocardial infarction (MI), diagnosis and treatment are often delayed in women, who also experience higher rates of in-hospital mortality and complications associated with MI compared with men.¹ These delays in care may be partly related to a lack of awareness regarding unique aspects of MI presentation in women.

MI Symptoms in Women vs Men

“In general, when experiencing acute coronary syndrome (ACS) or MI, the majority of women present with the same symptoms as men, such as chest pain described as pain, pressure, tightness, or discomfort,” said Lena Mathews, MD, MHS, medical director of cardiac rehabilitation and assistant professor of medicine at Johns Hopkins University School of Medicine in Baltimore, Maryland. “However, women often have unique presentations of MI with additional symptoms such as palpitations, jaw or neck pain, shortness of breath, fatigue, or epigastric symptoms including indigestion.”²

In a 2022 meta-analysis, Cardeillac et al examined 15 prospective studies (N=10,730) and found that the following symptoms were more common among women vs men with suspected ACS: dyspnea (relative risk [RR], 1.13; 95% CI, 1.10-1.17), arm pain (1.30; 95% CI, 1.05-1.59], nausea and vomiting (1.40; 95% CI, 1.26-1.50), fatigue (1.08; 95% CI, 1.01-1.16), palpitations (1.67; 95% CI, 1.49-1.86), and pain in the shoulder (1.78; 95% CI, 1.02-3.13). Consistent results were observed in a subgroup of patients with confirmed acute coronary syndrome.³

These findings align with a 2018 study by Lichtman et al, in which similar rates of young women (87.0%) and young men (89.5%) with acute MI presented with chest pain; however, women were more likely to present with 3 or more additional non-chest symptoms compared to men (61.9% vs 54.8%; P <.001).² Adjusted analyses of data from patients with ST-segment-elevation AMI revealed that women were 1.5 times more likely than men to present without chest pain (95% CI, 1.03–2.22).²

According to Dr Mathews, differences in pathophysiology may represent 1 of the mechanisms driving these differences, “Men are more likely to have obstructive disease of epicardial vessels with plaque rupture while women are more likely to have MI with non-obstructive disease (MINOCA), spontaneous coronary artery dissection, stress cardiomyopathy, and plaque erosion as opposed to plaque rupture.”^4,5

She pointed to sex differences in pain perception as another potential factor driving MI disparities in women vs men, as “evidence shows that nervous system pain processing of visceral pain can be different in women.”¹

MI in Women Often Overlooked

Despite these findings, physician and public awareness of these differences remains subpar, resulting in diagnostic and treatment delays, and ultimately worse outcomes, for women experiencing MI.

“Women are less likely to attribute their symptoms to coronary artery disease or MI and instead attribute them to anxiety or stress, and thus may seek care only when their symptoms are severe and hard to ignore,” Dr Mathews explained. In addition, clinicians are more likely to categorize women as having a lower cardiovascular risk even in the presence of traditional risk factors, and they often fail to account for sex-specific risk factors that increase the risk for developing CVD, including premature menopause and pregnancy complications such as pre-eclampsia and gestational diabetes.⁶

In the study by Lichtman et al, women were more likely than men to perceive their AMI symptoms as stress or anxiety (20.9% vs 11.8%; P <.001), and providers viewed prodromal symptoms as non-heart-related in 53% of women vs 37% of men (P <.001).²

“Women who are having a heart attack tend to show up to ER later than men and, because they have atypical symptoms, clinicians are testing and treating them for MI later than their male counterparts,”⁷ said Leslie Cho, MD, director of the Women’s Cardiovascular Center at Cleveland Clinic in Cleveland, Ohio, and chair of the American College of Cardiology’s Cardiovascular Diseases in Women Council. “This has an enormous impact because time is muscle.”

Improving Awareness of MI in Women

To improve MI detection and outcomes in women, clinicians should remain aware that “women can have MI despite having no traditional risk factors such as coronary artery dissection,” and they should “investigate symptoms that indicate ischemia or MI in women and not dismiss them as non-cardiac symptoms,” Dr Mathews advised. Clinicians should also educate their patients—especially those with risk factors for MI—about symptoms of MI and increase awareness that women can have atypical symptoms.

Recent study results underscore the importance of efforts to spread awareness of CVD risk and symptoms in women. “Despite aggressive campaigns by the American Heart Association (AHA) and other organizations like the American College of Cardiology, only 44% of women surveyed in 2019 listed CVD as the leading cause of death for women,” Dr Cho said.⁸ “This is a stark decrease from 2009, when 65% of women identified CVD as the leading cause of death for women. The decline in awareness of CVD risk is alarming.”

Awareness of CVD risk is especially low among underrepresented minority women, particularly Black and Hispanic women, although CVD risk is higher among these groups compared to age-matched White women.⁸

Dr Cho further noted that if women are unaware of their heart disease risk, they are less likely to address hypertension, high cholesterol, and other morbidities that contribute to the development of CVD. “We need to keep educating our patients and physicians. We cannot be complacent,” she emphasized.

Remaining Research Gaps

Along with the critical need to educate physicians and increase public awareness about MI differences in women, there are numerous research questions that require ongoing investigation in this area.

For example, “Are gender differences in presentation of MI due to the underlying pathophysiology of coronary artery disease, due to the nervous system perception of pain, or due to differences in recognition of symptoms?” Dr Mathews asked. As women have been underrepresented in clinical trials investigating MI-specific treatments, there is also a need to examine whether these therapies work the same in women compared with men, and evidence-based management strategies are needed for management of unique presentations of MI in women vs men, such as MINOCA and coronary artery dissection.

“There is so much work that needs to be done in regards to gender differences in CVD – from the most basic fundamental things like understanding platelet differences, plaque and atherosclerosis differences, all the way to drug and device response differences between men and women, more research is warranted,” Dr Cho stated.

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Research has shown that MI is associated with dementia and cognitive decline; but, the magnitude and trajectory of cognitive changes are not well-documented. For the study, researchers sought to determine the association between incident MI and changes in cognitive function. 

The study population included patients from 6 US prospective cohort studies that ran from 1971 to 2019: the Atherosclerosis Risk in Communities (ARIC) Study, Coronary Artery Risk Development in Young Adults Study (CARDIA), Cardiovascular Health Study (CHS), Framingham Offspring Study (FHS), Multi-Ethnic Study of Atherosclerosis (MESA), and Northern Manhattan Study (NOMAS). Patients with a history of MI, dementia, or stroke at baseline were excluded from the study. Some other exclusion criteria were missing blood pressure measurements before the first cognitive assessment and lack of data regarding covariates of interest. 

The primary study outcome was the change in global cognition. The secondary outcomes were changes in memory and executive function. Incident MI was determined during the follow-up period. 

A total of 40,016 participants were identified from the 6 studies. After exclusion, 30,465 individuals remained, with an average age of 64 years (standard deviation [SD], 10 years). Of these patients, 56% were women, 69% were White, 29% were Black, and 8% were Hispanic. There were 1,033 patients who had 1 or more incident MI events and 137 had 2 MI events. 

When adjusting for a decline in cognition following MI, there were no significant associations with MI and global cognition (-0.18 points; 95% CI, -0.52 to 0.17 points), executive function (-0.17 points; 95% CI, -0.53 to 0.18 points), or memory (0.62 points; 95% CI, -0.07 to 1.31 points). 

Long-term follow-up revealed that patients with at least 1 MI event showed a faster decline in global cognition (-0.15 points per year; 95% CI, -0.21 to -0.10 points per year), memory (-0.13 points per year; 95% CI, -0.22 to -0.04 points per year), and executive function (-0.14 points per year; 95% CI, -0.20 to -0.08 points per year).

The interaction analysis revealed the potential for race and sex to influence the trajectory of change in the decline of global cognition following MI. This analysis suggested that the change in cognitive decline following MI was smaller for Black participants than White participants and smaller in women than in men. 

“Discussion of the potential cognitive ramifications of MI should be considered as a potential motivator when counseling patients at risk for MI,” the researchers wrote. “Additionally, individuals who have experienced an MI should be followed up for accelerated cognitive decline in the years after MI.”

Study limitations included the potential underestimation of acute cognitive changes immediately following the event, lack of data on incident dementia, and the inability to assess additional socioeconomic factors. 

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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Ruijun Xu, M.D., from Sun Yat-sen University in Guangzhou, China, and colleagues conducted a case-crossover study of 202,678 MI deaths in Jiangsu province, China, from 2015 to 2020 to examine the association of exposure to ETEs and PM_2.5 with MI mortality.

The researchers found that the odds ratio of MI mortality associated with heat waves and cold spells ranged from 1.18 to 1.74 and 1.04 to 1.12, respectively, using different ETE definitions. A significant association was seen for lag 01-day exposure to PM_2.5 with increased odds of MI mortality, which was attenuated at higher exposures. A significant synergistic interaction was seen for heat wave and PM_2.5 on MI mortality, which was higher for heat wave with greater intensities and longer durations. Up to 2.8 percent of the MI deaths were attributable to ETE and PM_2.5 exposure at levels exceeding the interim target 3 value of the World Health Organization air quality guidelines (37.5 µg/m³). Women and older adults were more vulnerable to ETEs and PM_2.5; there was no variation in the interactive effects of ETEs or PM_2.5 on MI mortality across sex, age, or socioeconomic status.

“Our findings provide crucial evidence that mitigating exposure to ETEs and PM_2.5 may be useful to prevent premature deaths from MI and highlight great public health significance to take particulate pollution into consideration when providing ETE warning services to the public,” the authors write.

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

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Matthew B. Allen, M.D., from Harvard Medical School in Boston, and colleagues examined the association between frailty and outcomes following cardiopulmonary resuscitation (CPR) for perioperative cardiac arrest. Analysis included 3,149 patients (≥50 years) undergoing noncardiac surgery (2015 through 2020) who received CPR on postoperative day 0.

The researchers found that when adjusting for race, American Society of Anesthesiologists physical status, sepsis, and emergency surgery, there was a positive association between frailty and mortality (adjusted odds ratio [aOR], 1.35; 95 percent confidence interval [CI], 1.11 to 1.65; P = 0.003). There was a steadily increasing probability of mortality and nonhome discharge with increasing Risk Analysis Index (RAI) >37 and 36, respectively. The association between frailty and mortality after CPR varied by procedure urgency (aOR for nonemergent procedures, 1.55 [95 percent CI, 1.23 to 1.97] versus aOR for emergent procedures, 0.97 [95 percent CI, 0.68 to 1.37]; P = 0.03 for interaction). There was increased odds of nonhome discharge noted for an RAI of ≥40 versus <40 (aOR, 1.85; 95 percent CI, 1.31 to 2.62; P < 0.001).

“Identifying patients who are undergoing surgery and have frailty may inform primary prevention strategies, guide shared decision-making regarding perioperative CPR, and promote goal-concordant surgical care,” the authors write.

Abstract/Full Text

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Standard modifiable risk factors for cardiovascular disease (termed SMuRFs) are targeted modalities for the prevention and treatment of cardiovascular events in those with acute coronary syndrome. Examples include diabetes, hypertension, hyperlipidemia, and smoking. OSA presents as a potential SMuRF, as 40-60% of those with cardiovascular disease present with OSA, as well as a growing body of evidence suggesting OSA as an independent risk factor for the long-term prognosis of cardiovascular disease.

For the study, researchers sought to interpret the prognostic strength of OSA as a potential risk factor in patients with acute coronary syndrome, stratified by the number of existing SMuRFs.

The researchers conducted a post hoc analysis on the OSA-ACS Project (ClinicalTrials.gov Identifier: NCT03362385), which is a single-center, prospective cohort study that investigated the association of OSA and cardio-cerebrovascular events in patients with acute coronary syndrome. The project consisted of patients aged 18 to 85 years who were hospitalized with acute coronary syndrome in Beijing Anzhen Hospital, Capital Medical University from January 2015 and December 2019. Patient specific SMuRFs were self-reported prior to admission. Those with incomplete sleep studies, diagnosed with central sleep apnea, or managed with regular continuous positive airway pressure were excluded from the study.

Patients were stratified according to the apnea-hypopnea index (AHI), which measures total number of apnea/hypopnea episodes occurring each hour during total time of polygraph recording. The OSA group consisted of an AHIA >15 events per hour, whereas the non-OSA group had <15 OSA events per hour. Primary outcomes were any major adverse cardiovascular and cerebrovascular events (MACCE) that occurred during follow-up at 1-month, 3 months, 6 months, 1-year, and every 6 months thereafter.

A total of 1,927 patients were included in the final analysis, that of which:

• 130 patients (6.7%) had no SMuRF,
• 1264 (65.6%) patients had 1–2 SMuRFs, and
• 533 (27.7%) patients had 3–4 SMuRFs.

A higher number of SMuRFs was associated with an increased AHI.

• Patients with no SMuRF: 14.5 (6.6–23.1)
• Patients with 1-2 SMuRFs: 15.6 (7.0- 28.8)
• Patients with 3-4 SMuRFs: 18.0 (8.5–36.2)

Kaplan-Meier analysis found no difference in the cumulative incidence of MACCE for patients with any different numbers of SMuRFs. Notably, however, a growing trend of cumulative incidence of MACCE was associated with increasing number of SMuRFs during the late follow-up period.

Cox regression analysis, stratified by number of SMuRFs, found OSA in individuals with 3-4 SMuRFs had a significant impact on the incidence of MACCE (adjusted HR, 1.65; 95% CI, 1.06–2.57; P =.026) and ischemia-driven revascularization (adjusted HR, 2.18; 95% CI, 1.03–4.65; P =.042).

Limitations of the study include the overestimation of the disease severity of OSA, as all patients enrolled had acute coronary syndrome. Additionally, as it was a single-center study recruiting patients from China, there is lack of generalizability; further cohort studies are needed to conclude its findings.

The researchers noted, “OSA is associated with an increased risk of MACCE and ischemia-driven revascularization among patients with 3–4 SMuRFs.” “Therefore, screening for OSA should be emphasized in ACS [acute coronary syndrome] patients with 3–4 SMuRFs, and intervention trials should be prioritized in these high-risk patients,” they concluded.

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Investigators obtained the SCA data for this study from the PRESTO (Prediction of Sudden Death in Multi-Ethnic Communities) study, an ongoing population-based study in Ventura County, CA. The investigators identified cases of presumed SCA via a review of prehospital emergency medical services reports requiring cardiopulmonary resuscitation and/or defibrillation. These cases were reviewed by a team of study physicians. SCA was defined as a sudden, unexpected pulseless collapse of likely cardiac origin. Cases in which the etiology of the SCA was due to noncardiac causes such as trauma, drug overdose, and chronic terminal illness were excluded from the study. The investigators’ primary outcome was the incidence of SCA. The secondary outcome was survival to hospital discharge following SCA.

There were 907 cases of SCA in the 2-year pandemic period and 1315 in the 4-year prepandemic period. Demographically, during the pandemic, the proportion of SCA cases in Hispanic patients significantly increased from 24.3% to 31.6% (P <.001), while Non-Hispanic White patients accounted for a smaller proportion of cases during the pandemic. When standardized by age, the overall annual incidence of SCA increased by 38%, from 39 per 100,000 people before the pandemic (95% CI, 37-41) to 54 per 100,000 people during the pandemic (95% CI, 50-57).

Among Hispanic patients, the incidence of SCA per 100,000 people increased by 77%, from 38 to 68 per 100,000 people (95% CI, 34-43, and 95% CI, 60-75, respectively; P <.001). Among non-Hispanic patients, the incidence increased by 26%, from 39 per 100,000 people to 50 (95% CI, 37-42, and 95% CI, 46-54, respectively; P <.001). Prior to the pandemic, the SCA incidence did not differ by ethnicity (P =0.62), but during the pandemic, the SCA incidence was significantly higher among Hispanic patients than among non-Hispanic patients (P <.001).

Some limitations of the study include lack of generalizability and the method of ethnicity data collection. Patients’ race had to be pulled from death certificates rather than self-reports, creating an opportunity for bias and mistakes in data. Additionally, autopsy data are available for less than 16% of the SCA cases, indicating the possibility that other non-cardiac causes of SCA were being underreported in the study.

“The first 2 years of the COVID-19 pandemic have led to persistently higher SCA incidence, with disproportionately higher increases among Hispanic [patient]s in this population,” the study authors wrote, “These findings implicate potential ethnicity-specific barriers for access to acute care during the pandemic and represent an urgent call to action at the community as well as health-system levels.”

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Amer Muhyieddeen, M.D., from Cedars-Sinai Medical Center in Los Angeles, and colleagues assessed COVID-19’s impact on racial disparities in AMI management and outcomes. Analysis included data from the first nine months of the COVID-19 pandemic, captured in the 2020 National Inpatient Sample data.

The researchers found that patients with concurrent AMI and COVID-19 had higher in-hospital mortality (adjusted odds ratio [aOR], 3.19), increased mechanical ventilation (aOR, 1.90), and higher initiation of hemodialysis (aOR, 1.38) versus patients without COVID-19. Compared to White patients, Black and Asian/Pacific Islander patients had higher in-hospital mortality (aOR, 2.13 and 3.41, respectively). Black, Hispanic, and Asian/Pacific Islander patients had higher odds of starting hemodialysis (aOR, 5.48, 2.99, and 7.84, respectively). Furthermore, they were less likely to receive percutaneous coronary intervention for AMI (aOR, 0.71, 0.81, and 0.82, respectively). Coronary artery bypass grafting was less likely among Black patients (aOR, 0.55).

“There are four main ways to address these disparities, which include improving access; providing culturally sensitive care; addressing social determinants of health; and policy changes,” senior author Martha Gulati, M.D., also from Cedars-Sinai Medical Center, said in a statement.

One author disclosed ties to Novartis and Esperion.

Abstract/Full Text

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The ongoing VICTORION-INCEPTION trial (ClinicalTrials.gov Identifier: NCT04873934) is planned to be completed in 2024. It is a phase 3b, randomized, parallel-group, open-label study that includes 384 patients aged at least 18 years from more than 60 locations across the United States.

Researchers aim to examine the effect of inclisiran added to usual care vs usual care alone on low-density lipoprotein cholesterol (LDL-C) concentrations among patients recently hospitalized for ACS who have LDL-C concentrations equal to at least 70 mg/dL despite statin therapy. Percentage change from baseline to Day 330 in LDL-C concentration and proportion of patients at Day 330 achieving LDL-C of less than 70 mg/dL are the primary endpoints.

Secondary outcomes of the study will be changes in intensity of lipid-lowering therapy from baseline to Day 330, the proportion of patients discontinuing statins at Day 330, the proportion of patients achieving prespecified LDL-C targets after Day 90 and Day 330, and absolute changes from baseline to Day 330 in LDL-C.

Inclusion criteria include ACS within 5 weeks (inpatient/outpatient) of enrollment and LDL-C concentration of at least 70 mg/dL or non-high-density lipoprotein cholesterol of at least 100 mg/dL despite statin therapy. Additionally, patients will have fasting triglyceride concentrations of less than 4.52 mmol/L at screening and estimated glomerular filtration rate of greater than 20 mL/min.

Patients will be randomly assigned in a 1:1 ratio to inclisiran plus usual care (n=192) or usual care alone (n=192). Inclisiran therapy will be inclisiran sodium 300 mg subcutaneously twice yearly after initial doses at baseline and 3 months. The researchers plan to discontinue inclisiran in patients with unexplained creatinine kinase values, changes in liver parameters meeting study drug interruption criteria, or with intolerable adverse events. Statin therapy and usual care will continue among patients in both groups.

The researchers noted that usual care may include anti-PCSK9 monoclonal antibodies in the usual care group only, or inclisiran in the usual care group if the treating physician prescribes it (acquired through commercial outlet). The discretion of the treating physician will be used for adjustments in therapy during the study other than for inclisiran in the inclisiran arm. LDL-C values obtained as part of the study will not be accessible by treating physicians, however at their discretion, physicians can perform these assessments.

Study limitations include patients in the usual care only arm receiving inclisiran by treating physicians.

Disclosure: This research is supported by Novartis Pharmaceuticals Corporation. 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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A post hoc analysis of the Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus-Eluting Stent for Acute Coronary Syndrome (TICO) trial was conducted to evaluate the effects of sex differences on clinical outcomes in patients with ACS treated with ticagrelor monotherapy following 3-month vs 12-month ticagrelor-based dual-antiplatelet therapy (DAPT).

The cohort of 3056 patients with ACS from TICO were classified into 2 groups based on sex. The primary outcome was NACE, which was defined as a composite of major bleeding events and major adverse cardiac and cerebrovascular events (MACCE; a composite of all-cause death, myocardial infarction [MI], stent thrombosis, stroke, and target-vessel revascularization) within 3 to 12 months after an index PCI.

Among the participants, 628 were women (mean age, 67.0±9.5 years) and 2428 were men (mean age, 59.4±10.5 years). The women had a greater risk of comorbidities, including hypertension, diabetes, chronic kidney disease, current smoking status, anemia, history of stroke, MI, PCI, or coronary bypass surgery, vs men.

Women had an increased risk for NACE (hazard ratio [HR], 1.89; 95% CI, 1.34-2.67; P <.001), MACCE (HR, 1.69; 95% CI, 1.07-2.68; P =.026), and major bleeding (HR, 2.04; 95% CI, 1.25-3.35; P =.005), compared with men. Women treated with ticagrelor-based 12-month DAPT consistently had a higher rate of the primary and key secondary outcomes among the groups after multivariate adjustment.

The risk for NACE was significantly decreased among women who received ticagrelor monotherapy after 3-month DAPT vs those treated with ticagrelor-based 12-month DAPT (HR, 0.47; 95% CI, 0.26-0.85), although it was comparable between men in the 2 treatment groups (HR, 0.77; 95% CI, 0.52-1.14). Ticagrelor monotherapy after 3-month DAPT was consistently associated with a favorable trend for MACCE risk in women and men. In addition, the trend in favor of ticagrelor monotherapy after 3-month DAPT for decreasing the bleeding risk consistently occurred in women (2.5% vs 5.2%; HR, 0.47; 95% CI, 0.20-1.10) and men (1.4% vs 2.4%; HR, 0.60; 95% CI, 0.33-1.09).

No significant interactions were observed between sexes and DAPT strategies for NACE, MACCE, or major bleeding events. Ticagrelor monotherapy vs ticagrelor-based 12-month DAPT had consistent treatment effects in both sexes in the propensity score-matched populations.

Ticagrelor-based 12-month DAPT was significantly associated with NACE in women and patients with chronic kidney disease in multivariable regression analyses.

Among several limitations, results from the sex-specific subgroups were not sufficiently powered to determine clear conclusions on the effect of ticagrelor monotherapy vs ticagrelor-based 12-month DAPT, and it remains to be determined whether the primary results of TICO are generally applicable to women. Also, because the treatment outcome by sex was not prespecified in TICO, the current findings are susceptible to type I error owing to multiple testing. Furthermore, the impact of residual confounders cannot be excluded.

“Among patients with ACS undergoing drug-eluting stent implantation, women demonstrated relatively higher risks of major bleeding and MACCE, resulting in a significantly higher risk of NACE than men,” wrote the researchers. “There was no significant heterogeneity in the impact of ticagrelor monotherapy after 3-month DAPT, compared with ticagrelor-based 12-month DAPT on NACE, major bleeding, and MACCE between both sexes. Ticagrelor monotherapy after 3-month DAPT was significantly associated with a lower risk of primary outcomes in women than ticagrelor-based 12-month DAPT.”

Disclosure: This study was funded by Biotronik. Please see the original reference for a full list of disclosures.

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Dimitrios Doudesis, Ph.D., from the University of Edinburgh in the United Kingdom, and colleagues developed machine learning models that integrate cardiac troponin concentrations at presentation or on serial testing with clinical features and computed the Collaboration for the Diagnosis and Evaluation of Acute Coronary Syndrome (CoDE-ACS) score, which identifies the probability of myocardial infarction. The models were trained on data from 10,038 patients and were validated externally using data from 10,286 patients from seven cohorts.

The researchers found that CoDE-ACS had excellent discrimination for myocardial infarction (area under the curve, 0.953), with good performance across subgroups. Compared with fixed cardiac troponin thresholds, CoDE-ACS identified more patients as low probability of having myocardial infarction at presentation (61 versus 27 percent), with similar negative predictive value, and identified fewer patients as high probability of myocardial infarction (10 versus 16 percent), with greater positive predictive value. Compared with those with intermediate or high probability, those identified as having a low probability of myocardial infarction had a lower rate of cardiac death at 30 days (0.1 versus 0.5 and 1.8 percent) and one year (0.3 versus 2.8 and 4.2 percent) from presentation.

“If adopted in practice, CoDE-ACS could reduce time spent in emergency departments, prevent unnecessary hospital admissions, and improve the early treatment of myocardial infarction, with benefits for both patients and health care providers,” the authors write.

Several authors disclosed ties to the biopharmaceutical industry.

Abstract/Full Text

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In 1998, a $400 million initiative to reduce health disparities through education and research was launched by President Clinton. One of these goals was to improve cardiovascular disease (CVD) outcomes in minority communities.

This study was designed to evaluate whether the program may have affected trends in PCI usage among Black and Hispanic populations. To that end, data from the Myocardial Infarction Data Acquisition System (MIDAS), which is a state-wide database from New Jersey, were assessed. Patients (N=124,334) with STEMI between 1994 and 2015 were evaluated for PCI receipt and mortality outcomes.

The patients were Black (n=7942; mean age, 62.1 years; 55.56% men), Hispanic (n=27,665; mean age, 64.7 years; 65.54% men), and White (n=88,727; mean age, 66.8 years; 63.36% men). Among Black patients, 9.75% had no insurance, 75.65% had hypertension, 39.23% had diabetes, and 30.22% had heart failure. Among Hispanic patients, 8.64% had no insurance, 60.89% had hypertension, 29.95% had diabetes, and 28.36% had heart failure. Among White patients, 4.45% had no insurance, 59.58% had hypertension, 25.4% had diabetes, and 29.23% had heart failure.

Overall, fewer Black (43.84%; P <.01) and Hispanic (44.36%; P <.01) patients received PCI compared with White patients (45.62%; P <.01).

Over time, the rates of PCI usage have been increasing, in which the disparities in usage have been gradually eliminated for Hispanic patients between 2000 and 2004 (P =.17) and have improved but remained lower among Black patients (P =.08) compared with White patients. By 2005 to 2009, the rates of PCI were higher among Hispanic patients compared with White patients (P =.02) and were similar between Black and White patients (P =.29). In 2010 to 2015, no differences were observed between the White and Hispanic (P =.05) or Black (P =.12) patients, but Hispanic patients were more likely to receive PCI than Black patients (P =.02).

There were overall downward trends for in-hospital mortality, all-cause 1-year mortality, and CVD-specific 1-year mortality rates.

In no time period did in-hospital mortality rates differ significantly between any groups. However, 1-year all-cause mortality was higher among Hispanic (odds ratio [OR], 0.88; P <.01) and Black (OR, 1.26; P <.01) patients in 1994 to 1999 compared with White patients and by 2010 to 2015, neither Hispanic (P =.26) nor Black (P =.16) patients were at higher mortality risk than White patients. Similar trends in 1-year CVD-specific mortality were observed.

This study may have been limited by not having access to data about medications, angiography, or risk factors.

“The federal initiative to eliminate racial and ethnic disparities launched in 1998 was associated with a reduction in disparity in access to PCI revascularization in patients with STEMI,” the study authors wrote. “This study provides an understanding of the effectiveness of our current efforts to combat health disparities and may give future directions to federal legislation.”

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Researchers conducted a meta-analysis to assess the relationship between SGLT2 inhibitor use and atherosclerotic cardiovascular disease events in patients with type 2 diabetes.

A literature search was performed in PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases, with the last search occurring in November 2022. Eligible studies were in English, had a comprehensive documentation of outcomes, and included patients aged 18 years or older with type 2 diabetes. The control group was defined as individuals who received placebo or active therapy using oral hypoglycemic drugs.

The primary outcome was the incidence of ACS (acute myocardial infarction and/or unstable angina), PAOD, and IS.

The analysis included 43 randomized controlled trials (RCTs) with 79,504 patients who had type 2 diabetes. Of these patients, 48,568 received SGLT2 inhibitors in combination with background treatment, and 30,936 patients used placebo or oral hypoglycemic drugs. The trials were published from 2010 to 2020 and reported on canagliflozin (10 studies), dapagliflozin (15 studies), empagliflozin (15 studies), and ertugliflozin (6 studies). The median follow-up was 1.9 years.

Among 35 studies reporting ACS as an adverse event, no significant heterogeneity was observed (I²=0%, P =.82 for the Q test). The overall risk ratio (RR) was not significant (0.97; 95% CI, 0.89-1.05), and ACS was not significantly different among the 4 SGLT2 inhibitor groups and the control group.

In 20 studies including PAOD as an adverse event, no significant heterogeneity occurred (I²=0%; P =.90 for the Q test). The RR was not significant (0.98; 95% CI, 0.78-1.24). PAOD was not different among the 4 SGLT2 inhibitor groups in the subanalysis.

IS was reported as an adverse event in 23 trials, with no significant heterogeneity (I²=0%; P =.96 for the Q test). The overall RR was not significant (0.95; 95% CI, 0.79-1.14). In subgroup analysis, IS was not significantly different among the 4 SGLT2 inhibitor groups and the control group.

Cardiovascular mortality was included as an adverse event in 23 studies, with no heterogeneity (I²=32%; P =.11 for the Q test). The overall RR was significant (0.85; 95% CI, 0.77-0.93). In the subgroup analysis, canagliflozin and empagliflozin had lower RRs, and dapagliflozin and ertugliflozin did not have a benefit for cardiovascular mortality.

In 38 studies with all-cause mortality as an adverse event, no significant heterogeneity was observed (I²=0%; P =.61 for the Q test). The overall RR was significant (0.88; 95% CI, 0.82-0.94). Subgroup analysis showed that empagliflozin had a lower risk of all-cause mortality, and canagliflozin, dapagliflozin, and ertugliflozin were similar to the control group.

A limitation of this study is that baseline variations in clinical settings, age, follow-up, and disease duration could have biased the findings. Also, discrepancies may have occurred in the number of cases reported for the same disease on ClinicalTrials.gov across funding organizations, and the investigators may have underestimated the actual incidence because they used a strict disease definition to prevent multiple counting of the same patient.

“…SGLT2i [inhibitor] use was associated with a reduction in cardiovascular mortality and all-cause mortality that are consistent with previous research,” wrote the study authors. “However, contrary to notions about the cardiovascular effects of SGLT2i, people with diabetes who are treated with these drugs do not have a significantly decreased chance of developing ACS, PAOD, or IS compared to the controls.”

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Up to 40% of patients with MI report symptoms of anxiety or depression. This study was designed to assess how the presence of anxiety or depression may affect recurrence or mortality following MI.

Data for this study were sourced from 4 national registries in Sweden. Among 192,059 MI events that occurred between 2006 and 2015, a total of 45,096 met the criteria for first-time MI and had sufficient data about anxiety and depression diagnoses or symptoms and follow-up.

Among the study population, 3427 patients had a previous diagnosis of anxiety or depression, 14,879 had self-reported symptoms of anxiety or depression, and 26,785 had neither. The cohorts had mean ages of 59.03 to 62.59 years, 62.1% to 79.4% were men, 27.6% to 44.9% were current smokers, and 39.4% to 40.8% had hypertension.

During a median follow-up of 960 days, 4.6% of patients died, 29.2% had an MI recurrence, 13.7% were hospitalized with heart failure, 3.1% had a stroke, and 1.4% had new-onset atrial fibrillation.

Patients with a history of diagnosed anxiety or depression had a 1-year mortality rate of 1.7%, a 5-year mortality rate of 5.8%, a 1-year MI recurrence rate of 30.2%, and a 5-year MI recurrence rate of 33.8%. Patients with self-reported symptoms of anxiety or depression had a 1-year mortality rate of 1.2%, a 5-year mortality rate of 5.4%, a 1-year MI recurrence rate of 26.2%, and a 5-year MI recurrence rate of 29.8%. Patients without anxiety or depression had a 1-year mortality rate of 0.8%, a 5-year mortality rate of 4.0%, a 1-year MI recurrence rate of 25.2%, and a 5-year MI recurrence rate of 28.3%.

The patients with a history of diagnosed anxiety or depression were at increased risk for all-cause mortality (adjusted hazard ratio [aHR], 1.86; 95% CI, 1.36-2.53), MI recurrence (aHR, 1.14; 95% CI, 1.06-1.22), the composite event of mortality and MI recurrence (aHR, 1.15; 95% CI, 1.07-1.23), and the composite event of mortality and all cardiovascular outcomes (aHR, 1.19; 95% CI, 1.12-1.26) at 1 year.

This study may have been limited as diagnoses of anxiety or depression made by primary care providers were not included.

These data indicate that a history of anxiety or depression or self-reported symptoms increases risk for mortality and cardiovascular outcomes at 1 year. “A detailed assessment of both psychiatric history and self-reported symptoms seems warranted during CR [cardiac rehabilitation], in part because patients with a psychiatric history have an elevated post-MI risk despite not reporting symptoms at the time of MI,” wrote the study authors.

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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Researchers aimed to explore incidence rates of in- and out-of-hospital deaths among adults with and without CHD in the US, as well as the role of income on fatal CHD rates.

A community-based cohort study was conducted using data from the Atherosclerosis Risk in Communities (ARIC) study.

Participants were evaluated at baseline, including cardiovascular risk factors, medical history, and sociodemographic data, such as household income and years of education. Patients were re-evaluated every 3 years for 9 years, with follow-up evaluations from 2011 to 2013, 2016 to 2017, and 2018 to 2019.

Data on CHD events were collected from hospital discharges, state death certificates, and follow-up. CHD events were defined as a probable or definite acute myocardial infarction or a fatal CHD during follow-up.

Income was stratified by less than $16,000; $16,000 to $25,000; $25,000 to $35,000; $35,000 to $50,000; and $50,000 or more.

Cardiovascular risk factors included total cholesterol, smoking status, prevalent diabetes, prevalent hypertension, and body mass index.

The analysis included 10,884 White participants (mean age, 54.2±5.7 years) and 4095 Black participants (mean age, 53.4±5.8 years). The total cohort included 57% women.

Researchers observed that the in-hospital incidence of fatal CHD for Black vs White participants was 2.2 vs 1.1 per 1000 person years, respectively, and the out-of-hospital incidence of fatal CHD was 1.3 vs 1.0 per 1000 person years, respectively.

The sex- and age-adjusted hazard ratio comparing incident fatal CHD in Black vs White participants out-of-hospital was 1.65 (95% CI, 1.32-2.07) and in-hospital was 2.37 (95% CI, 1.96-2.86).

In addition, income-controlled direct effects of race in Black vs White participants hazard ratios were 2.03 for fatal in-hospital CHD (95% CI, 1.61-2.55) and 1.33 for fatal out-of-hospital CHD (95% CI, 1.01-1.74).

The overall hazard ratio in Black vs White participants of fatal incident CHD in sex- and age-adjusted models was 2.02 (95% CI, 1.75-2.33), which reduced to 1.39 when income was included. Fatal CHD racial differences were not significant when both income and cardiovascular risk factors were included (hazard ratio, 1.01; 95% CI, 0.84-1.21).

Study limitations included patient segregation by site; inclusion of only baseline socioeconomic and cardiovascular risks factors; and not accounting for the role of racial differences in procedures and treatments.

“Black [patients] die from CHD at approximately twice the rate of White [patients], and the excess in mortality is seen irrespective of where these events occur, in or out of the hospital,” the study authors noted. They added, “Income plays a pronounced role in this disparity for both in- and out-of-hospital deaths, also suggesting a key role of healthcare access.”

Overall, the study authors suggested addressing the lack of health care coverage and diminished access to care for Black patients.

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Researchers used state-based laboratory and hospital-based surveillance data to conduct a self-controlled case series study to evaluate the short- and long-term associations between laboratory-confirmed IPD and AMI.

Data were obtained from the Tennessee Active Bacterial Core Surveillance (ABCS) System and Tennessee Hospital Discharge Data System. Eligible participants were aged 18 years or older on the date they had their first hospitalization for AMI between July 1, 2004, and December 31, 2018, and they had a laboratory-confirmed IPD-related hospitalization within 365 days before or after the admission date of the hospitalization for AMI.

Follow-up continued up to an initial AMI hospitalization and through December 31, 2019, death, residence in a county not included in the ABCS system network, or day 365 after initial AMI hospitalization, whichever occurred first.

The AMI assessment periods were the first through seventh day before IPD specimen collection (pre-IPD detection), days 0 through day 7 after IPD specimen collection (current IPD), 8 to 28 days after IPD-specimen collection (post-IPD), and a control period (all other follow-up).

The primary outcome was evidence of AMI with ST-elevation MI, non-ST-elevation MI, or unspecified MI.

The analysis included 324 patients who had a specimen collection within 1 year before or after the earliest admission date for AMI. Of the cohort, 4.3% had another AMI within a year after the earliest AMI.

Among 338 hospitalizations for AMI, 191 (56.5%) involved an admission during the pre-IPD detection (5.6%), current (48.8%), or post-IPD (2.1%) periods. Of the 165 AMIs in the current IPD period, 86.7% had a positive IPD specimen collection on the date of admission for the AMI hospitalization.

The AMI incidence rate was greater during the pre-IPD detection period and current IPD period (306 and 2547.2 AMI per 100 person-years, respectively) vs the pre-IPD control (22.9 per 100 person-years), post-IPD secondary risk (48.3 per 100 person-years), and post-IPD control (41.8 per 100 person-years) periods.

The AMI incidence was nearly 93 times greater in the current IPD period compared with the pre- and post-IPD control periods (95% CI, 72.2-119.7) in the self-controlled case series analysis that accounted for age, study year, and seasonality. A nonsignificant but increased incidence of AMI was observed 1 to 7 days before IPD detection and 8 to 28 days after IPD detection.

Sensitivity analyses yielded consistent results, including the analysis with only the pre-IPD control period as reference, in which the risk for AMI was significantly increased in the post-IPD control period (29 to 365 days after IPD specimen collection) vs the pre-IPD control period (incidence rate ratio, 2.95; 95% CI, 2.01-4.32).

The researchers noted that the use of laboratory-confirmed IPD from the ABCS active surveillance system limited the ability to characterize the risk for AMI in patients with noninvasive or less severe Streptococcus pneumoniae infections or other infections that may not have been detected. Also, ascertainment bias is possible from hospitalizations for AMI regarding comorbid conditions. In addition, the study authors were unable to evaluate stratified analyses according to IPD treatment type and pneumococcal vaccination status.

“Since IPD is vaccine-preventable, effective vaccination programs that prevent IPD may also reduce the risk of major acute cardiovascular events,” the investigators wrote.

Disclosure: One 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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Mitsuaki Sawano, M.D., Ph.D., from the Yale School of Medicine in New Haven, Connecticut, and colleagues examined sex differences in causes and timing of one-year outcomes after AMI in individuals aged 18 to 55 years using data from the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients study. Sex differences in all-cause and cause-specific hospitalizations were compared by calculating incidence rates (IRs) per 1,000 person-years and IR ratios. The sex differences were evaluated by calculating subdistribution hazard ratios accounting for deaths.

The researchers found that at least one hospitalization occurred among 905 of the 2,979 patients (30.4 percent) in the year after discharge. The leading causes of hospitalization were coronary-related (IR, 171.8 versus 117.8 among women versus men) and noncardiac hospitalization (IR, 145.8 versus 69.6). A sex difference was also seen for coronary-related hospitalizations and noncardiac hospitalizations (subdistribution hazard ratios, 1.33 and 1.51, respectively).

“The analysis by Sawano et al adds to decades worth of literature clearly illustrating that young women with AMI experience more adverse outcomes than men,” write the authors of an accompanying editorial. “The disparities are evident. Now it is time to stop adding insult to infarct and to solve these persistent sex gaps in cardiovascular care.”

Two authors disclosed financial ties to the pharmaceutical and medical technology industries; one author disclosed related patents.

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

Editorial (subscription or payment may be required)

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Researchers sought to compare the efficacy and safety of low-dose rivaroxaban vs enoxaparin in the acute phase of ACS in an open-label, prospective, multicenter noninferiority trail (ClinicalTrials.gov Identifier: NCT03363035). The primary efficacy endpoint was a combination of stroke, revascularization, myocardial infarction, or cardiac death (MACEs) during the 6-month follow-up. The primary safety endpoint was bleeding events.

The study took place January 2017 through May 2021, at 21 hospitals in China. Patients were at least 18 years of age, had been diagnosed with ACS, had ST-segment elevation myocardial infarction (STEMI) and missed the recommended time window for revascularization, had non-ST-segment elevation ACS without an indication for primary percutaneous coronary intervention and were waiting for selective revascularization, or had indication for short-term use of enoxaparin combined with DAPT.

Participants were randomly assigned in a 1:1:1 ratio to receive DAPT plus oral rivaroxaban 2.5 mg, rivaroxaban 5 mg, or subcutaneous enoxaparin 1 mg/kg twice daily for 3.7 mean days. Patients with contraindications for rivaroxaban or enoxaparin, who already received thrombolytic therapy or revascularization, who had revascularization therapy planned within 12 hours, and patients enrolled in another clinical study were excluded.

A total of 2046 patients completed the trial. Participants (mean age 65.8 [SD, 8.2] years; 29.5% women) were randomized to rivaroxaban 2.5-mg (n=683), rivaroxaban 5-mg (n=683), or enoxaparin 1-mg/kg (n=680). Baseline characteristics were similar among all groups. There were 71.1% of patients who received reperfusion therapy before discharge for the index diagnosis.

There were 32 bleeding events in the rivaroxaban 2.5-mg group, 36 in the rivaroxaban 5-mg group, and 46 in the enoxaparin group.

There was a similar incidence of MACE among all groups. Noninferiority for the primary efficacy endpoints was not reached in the rivaroxaban 2.5-mg group (hazard ratio [HR], 0.68; 95% CI, 0.36-1.30; P =.05) compared with the enoxaparin group. Noninferiority for the primary efficacy endpoints was reached in the rivaroxaban 5-mg group (HR, 0.60; 95% CI, 0.31-1.16, P =.02) compared with the enoxaparin group.

Some study limitations include the lack of generalizability and an underpowered sample size. Additionally, there was only a 6 month follow-up window.

“The data obtained from this small trial might be helpful for designing future noninferiority trials with sufficient sample sizes to test whether rivaroxaban 5 mg twice daily plus DAPT might be a reasonable alternative regimen to enoxaparin plus DAPT during the acute phase of ACS for patients who missed the primary reperfusion window or not,” the study authors wrote.

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Investigators from the Icahn School of Medicine at Mount Sinai in the United States searched publication databases for studies of bleeding and ischemic outcomes after PCI. A total of 5 randomized clinical trials (RCTs) published between 2018 and 2020 were included in the analysis.

The experimental arm of the included studies were 3 months of DAPT followed by P2Y₁₂ inhibitors (n=3) or 1 month of DAPT followed by P2Y₁₂ inhibitors (n=2). Three of the 4 trials used ticagrelor as the P2Y₁₂ inhibitor. The definition of C-PCI differed slightly across the trials, but in general comprised 3 or more vessels treated, 3 or more lesions treated, 2 or more stents implanted, and total stent length of 60 mm or longer.

The RCTs included a total of 34,615 patients, among whom 25.5% received C-PCI. The C-PCI cohort received short DAPT followed by P2Y₁₂ inhibitors (50.2%) or standard DAPT. Four of the trials recruited patients with chronic coronary syndrome and 1 recruited patients with acute coronary syndrome.

Primary bleeding events were reported by more C-PCI recipients (2.9%) than non-C-PCI recipients (2.2%; P <.001). Among the C-PCI cohort, risk for bleeding outcomes was lower among the P2Y₁₂ inhibitor recipients compared with standard DAPT recipients (hazard ratio [HR], 0.66; 95% CI, 0.44-0.98; I², 40.0%). This pattern was stronger among the subset of patients who received 3 months of DAPT before switching to P2Y₁₂ inhibitors.

Similarly, ischemic events occurred among more C-PCI recipients (3.1%) than non-C-PCI recipients (2.5%; P =.003). Risk for major adverse cardiovascular events tended to be reduced among the P2Y₁₂ inhibitor recipients compared with standard DAPT recipients (HR, 0.69; 95% CI, 0.48-1.00; I², 42.7%). The interaction between ischemic events and PCI complexity was significant (P =.028), in which the non-C-PCI cohort did not have different risk for ischemic events on the basis of DAPT regimen.

A similar trend was observed for the outcome of all-cause mortality, favoring the P2Y₁₂ inhibitors cohort (HR, 0.52; 95% CI, 0.32-0.87; I², 20.4%).

The findings of this analysis may have been limited by the heterogeneity observed and by the fact that some data were sourced from post-hoc analyses.

 “…our large collaborative meta-analysis of randomized trials demonstrates that a 1 to 3-month DAPT strategy followed by P2Y₁₂ inhibitor monotherapy, particularly with ticagrelor, is both safe and efficacious as compared with a standard DAPT regimen after C-PCI and non-C-PCI,” the study authors wrote.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

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Previous studies have robustly linked cigarette smoking at the time of stroke with increased risk for major CV events; however, little is known about specific risks of persistent smoking after ischemic stroke.

Researchers from the Medical University of South Carolina performed this post-hoc analysis using data from the Small Subcortical Strokes (SPS3; Clinical Trials.gov Identifier: NCT00059306) trial, which was a randomized, multicenter trial conducted at 82 centers in the Americas and Spain between 2003 and 2012.

In this analysis, smoking status from month 3 after ischemic stroke was related with CV outcomes and mortality through an average follow-up of 38.8-42.7 months. Major adverse CV events (MACE) were defined as all-cause mortality, ischemic or hemorrhagic stroke, and myocardial infarction.

The study population comprised 1,152 never smokers, 1,152 prior smokers, and 570 current smokers at the time of ischemic stroke. Among the current smokers, 162 had quit by 3 months after ischemic stroke and 408 were persistent smokers.

The patients were mean age, 57.8-64.4 years; 22.8%-53.0% were women; 51.8%-64.2% were White; and 48.4%-52.7% were randomly assigned to receive an intensive blood pressure intervention. In general, the current smokers were younger than the past or never smokers, more women were never smokers than current or former smokers, and more of the current smokers were White than the former or never smokers (all, P <.001).

The former smokers had an average 24.0-year smoking history, which was shorter than the current smokers (mean range, 32.1-35.6 years; P <.001). Among the current smokers, the proportion of persistent smokers decreased throughout follow-up, from 71.6% at 3 months, to 68.3%, 67.3%, and 66.0% at 6, 12, and 18 months, respectively. However, a proportion of patients who quit smoking by 3 months had resumed smoking by 6 (14.2%) or 12 (20.4%) months.

Overall, the primary outcome of MACE occurred among 14.2% of the never smokers, 16.2% of the former smokers, 12.4% of the current smokers who quit by 3 months, and 18.4% of the persistent smokers.

Compared with never smokers, persistent smoking was associated with increased risk for MACE (adjusted hazard ratio [aHR], 1.56; 95% CI, 1.16-2.09; P =.009).

Stratified by MACE events, compared with never smokers, no increased risk for stroke or myocardial infarction was observed during follow-up, however, the persistent smokers were at increased risk for mortality (aHR, 2.00; 95% CI, 1.28-3.13; P =.006).

In a subgroup analysis, age was found to have a significant interaction for the primary outcome (P <.001), in which increased risk for MACE among persistent smokers compared with never smokers was only significant among patients younger than age 60 (aHR, 1.76; 95% CI, 1.14-2.74) but not for those age 60 or older (aHR, 1.15; 95% CI, 0.76-1.73).

Researchers acknowledged, “[W]e demonstrated an association between persistent smoking after stroke and higher risk of composite outcome of death, stroke, and myocardial infarction.”

The limitations of this analysis included the modest sample size of patients who quit smoking after ischemic stroke and the fact that smoking status changed among many patients at every 3-month follow-up.

“Persistent smoking compared to never smoking after lacunar stroke was associated with a significant increase in the risk of major cardiovascular events and death,” the researchers wrote. “The overall rate of smoking cessation after ischemic stroke was low, highlighting the need for more targeted and effective smoking cessation strategies.”

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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Nutritional guidelines for patients with acute ischemic stroke receiving IVT are not well defined, despite data showing that nutrition status impacts clinical outcomes. Researchers aimed to determine the relationship between objective nutritional markers and stroke outcomes in patients receiving IVT.

Researchers used a multicenter database to identify patients who experienced acute ischemic strokes treated with IVT. Follow up brain imaging was conducted within 24 hours following IVT.

The database provided demographic, medical, stroke, and laboratory data for all participants. Researchers assessed malnutrition levels using the controlling nutritional status (CONUT) score and the prognostic nutritional index (PNI). The CONUT score was categorized into mild (2-4), moderate (5-8), and severe (9-12) malnutrition.

Outcome measures were based on END and were categorized by etiology: symptomatic hemorrhagic transformation (END-SHT) or stroke progression (END-prog) after IVT. In this study, the CONUT cutoff was 5 and the PNI cutoff was 42.3 for END-SHT.

The primary outcome measures were the incidence of END-SHT and the occurrence of hemorrhagic transformation (HT) after IVT.

Of the 10,808 patients experiencing an acute ischemic stroke, 808 patients who received IVT alone were included in the analysis. The average age of participants was 66.7 years and 513 (63.5%) were men. The median CONUT score was 1 (range, 0-2), the median PNI was 52.5 (range, 47.1-57.5), and 39.6% of patients had malnutrition (mild, 34.2%; moderate to severe, 5.4%).

The primary outcome results show that higher CONUT scores are associated with increased occurrence rates of END-SHT (normal, 21 [4.3%]; mild, 9 [3.3%]; moderate to severe, 32 [72.7%]; P <.001) and HT (normal, 46 [9.4%]; mild, 28 [10.1%]; moderate to severe, 32 [72.7%], P <.001).

Lower PNI scores were associated with higher rates of END-SHT when compared with high PNI scores (33 [28.4%] vs 29 [4.2%]; P <.001) and similar trends were observed for HT (33 [28.4%] vs 73 [10.5%]; P <.001). Patients with a low PNI also had increased rates of poor functional outcomes at 3 months when compared to patients with high PNI (70 [60.3%] vs 246 [35.5%]; P <.001].

Factors associated with high CONUT scores were poor functional outcomes at 3 months (normal, 166 [34.0%]; mild, 123 [44.6%]; moderate to severe, 27 [61.4%]) and increased rates of END-prog (normal, 28 [5.7%]; mild, 6 [2.2%]; moderate to severe, 5 [11.4%]).

Based on multivariable analysis, CONUT scores indicating moderate to severe nutritional status showed a significant association with END-SHT (odds ratio [OR],14.52; 95% CI, 3.15-66.95; P =.001) and HT (OR, 9.40; 95% CI, 2.74-32.20; P <.001).

Overall, researchers showed that objective nutritional status measurements, such as CONUT and PNI, are reliable predictors of stroke outcomes following IVT. “Our novel findings showed that the different predictive values of CONUT score and PNI highlight the need for constantly updating the IVT strategy and guidelines,” they noted.

Study limitations include the lack of patient information at later stroke stages or discharge, the inability to access dietary intake and weight change information, and a small sample size of patients with moderate to severe malnutrition.

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Christine Eileen McCarthy, M.B., B.Ch., from the National University of Ireland in Galway, and colleagues examined the association between a spectrum of sleep disturbance symptoms and the risk for acute stroke in an international case-control study of patients presenting with first stroke and controls matched by age and sex (INTERSTROKE).

Data were included for 4,496 matched participants: 1,799 experienced an ischemic stroke and 439 had an intracerebral hemorrhage. The researchers found that in the primary model, the odds of acute stroke were increased in association with short sleep (less than five hours) and long sleep (more than nine hours; odds ratios, 3.15 and 2.67, respectively), impaired quality (odds ratio, 1.52), difficulty getting to sleep or maintaining sleep (odds ratios, 1.32 and 1.33, respectively), unplanned napping and prolonged napping (more than one hour; odds ratios, 1.59 and 1.88, respectively), snoring, snorting, and breathing cessation (odds ratios, 1.91, 2.64, and 2.87, respectively). Significantly increased odds of acute stroke were also seen in association with a derived Obstructive Sleep Apnea score of 2 to 3 (odds ratio, 2.67) and cumulative sleep symptoms (more than five: odds ratio, 5.06), with a graded association for the latter. For most symptoms, significance was maintained following extensive adjustment; similar findings were seen for stroke subtypes.

“With these results, doctors could have earlier conversations with people who are having sleep problems,” McCarthy said in a statement. “Interventions to improve sleep may also reduce the risk of stroke and should be the subject of future research.”

The INTERSTROKE study was partially funded by grants from several pharmaceutical companies.

Abstract/Full Text

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Among individuals who experience a stroke, close to 75% will exhibit persistent deficits in motor control of their arm and hand, which are due, in part, to the failure of current neurorehabilitation approaches to significantly reduce upper limb impairment. Patients with chronic stroke exhibit a stereotypical motor syndrome of the upper limb that can be divided into quantifiable deficits:

• loss of strength;
• reduction in dexterity;
• intrusion of aberrant synergies; and
• disorders of muscle tone.

Among patients with stroke, this “paresis” phenotype has thus emerged from damage to the corticospinal tract (CST), disrupting connections between the cortex and the cervical spinal circuits that are responsible for control of arm and hand movements.

Since most cases of stroke damage to the CST are incomplete, researchers hypothesized that “voluntary motor control could be restored by amplifying the capacity of the residual CST.” In particular, they posited that “modulating the excitability of intact sublesional spinal circuits would increase their responsiveness to remaining CST neurons, thereby restoring the ability of these supraspinal inputs to drive movement.”

The current ongoing pilot study (ClinicalTrials.gov Identifier: NCT04512690) reports on results from the first 2 participants who had experienced a stroke and in whom electrical stimulation of the cervical spinal circuits was utilized to facilitate motor control of the arm and hand in chronic poststroke hemiparesis.

The first patient was a 31-year-old woman who had experienced a right thalamic hemorrhagic stroke secondary to a cavernous malformation 9 years prior to study participation. The second patient was a 47-year-old woman who had experienced a right ischemic middle cerebral artery (MCA) stroke secondary to a right carotid dissection, which created a large MCA territory infarct 3 years prior to study participation. In both of the participants, extensive damage to the CST was associated with chronic upper limb impairment. 

Researchers sought to evaluate whether electrical stimulation of the cervical spinal cord can activate muscles of the arm of the hand in individuals who experience hemiplegia after a stroke. A surgical procedure was performed in each participant in which a system was implanted that provides epidural electrical stimulation (EES) to the cervical spinal cord. The ability of the EES to engage arm and hand muscles, as well as to produce distinct kinematic movements, was then computed. 

The current pilot study was designed to calculate the immediate assistive effects of continuous SCS on poststroke motor deficits, including the following:

• muscle weakness;
• impairments in the dexterity of arm and finger movements;
• intrusion of aberrant flexor synergies; and
• abnormal tone.

The focus was on the measurement of immediate improvements that were attributable to the direct impact of SCS in facilitation of motor function in the arm and hand. Testing was initiated 4 days following implantation of the SCS leads and continued for 4 weeks. During this time, the participants underwent evaluation sessions 5 times per week, each of which lasted about 4 hours per day. The percutaneous leads were removed after 29 days.

Researchers found that continuous stimulation through selected contacts was associated with the following improvements:

Strength: grip force +40% in the first participant and +108% in the second participant;

Kinematics: +30% to 40% speed; and

Functional movements.

These improvements enabled the 2 participants to perform movements that they were unable to carry out without spinal cord stimulation. Both of the participants were able to retain some of these improvements without any stimulation. There were no serious adverse events reported in either patient.

The key limitation of this study is the fact that the results are presented for only 2 participants, thus preventing any definitive conclusions to be drawn regarding safety and efficacy. Absence of a protocol based upper limb behavioral intervention and the short 4-week duration of the study may have decreased the amount of recovery that the participants could experience.

According to the researchers, “While we cannot conclusively evaluate safety and efficacy from two participants, our data provide promising, albeit preliminary, evidence that spinal cord stimulation could be an assistive as well as a restorative approach for upper limb recovery after stroke.”

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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Stroke is one of the leading causes of death in the United States, with over 795,000 cases yearly. In particular, ischemic strokes have the highest prevalence, constituting 87% of all stroke cases.¹

Early administration of tissue plasminogen activator (tPA) has proven to limit the risk for damage and functional impairment in patients with acute ischemic stroke.^2-4 However, one of the most significant barriers to successful stroke management is administering tPA within the recommended window of 3 hours.⁵

The first mobile stroke unit (MSU) in the US was implemented in 2015 and allowed for earlier tPA administration, leading to significant improvements in functional outcomes for patients with stroke.

Recent pivotal studies, Berlin PRehospital Or Usual Delivery in Stroke Care (B_PROUD; ClinicalTrials.gov Identifier: NCT02869386) and Benefits of Stroke Treatment Delivered by a Mobile Stroke Unit Compared with Standard Management by Emergency Medical Services (BEST-MSU; ClinicalTrials.gov Identifier: NCT02190500), showed significant improvements in 90-day disability scores for patients with acute stroke treated on an MSU compared with emergency medical service (EMS) management in both Germany and the US. The B_PROUD study also showed that the median time from dispatch to initiation of thrombolysis for patients treated with an MSU was 20 minutes shorter than with conventional ambulances. ^6,7

While early studies show promising results for patients treated with MSUs, there are significant barriers to implementing and standardizing these services in the US. Many MSUs have not fully integrated into the existing EMS systems, making it difficult to streamline treatment processes. Additionally, most MSUs operate in densely populated cities. Research has suggested several methods for adapting these services to nonurban settings, such as air ambulances and various transport strategies, but further studies are necessary to prove these concepts.^8,9

As a relatively new addition to EMS, MSUs do not have national clinical guidelines for standardized care. There is a call to action for guideline committees, medical societies, and stroke leadership to update the level of evidence of MSUs to reflect more recent efficacy trials. Another step for MSU expansion is for regulatory bodies to establish a process to accredit MSU programs using standardized quality measures.⁸

Additionally, MSUs face issues receiving reimbursements from insurance.⁸ The lack of reimbursements for MSUs in the US increased reliance on grants to support program costs and has limited the expansion of this service across the nation.¹⁰ The body of data supporting MSU cost-effectiveness is still in its early stages and additional data is necessary to support the need for reimbursement. Recent data shows that MSU cost-effectiveness is due to the reduction in long-term disability costs and that MSUs yield a gain of 0.591 quality-adjusted life years per dispatch.¹¹

To discuss MSU implementation barriers, we spoke with James Grotta, MD, founder of the first MSU in the US and the director of stroke research at the Clinical Institute for Research and Innovation, Memorial Hermann-Texas Medical Center in Houston. We also spoke with Matthew T. Bender, MD, neurosurgeon and assistant professor in the division of stroke and cerebrovascular disease at the University of Rochester Medical Center in Rochester, New York, to gain insight on current barriers for treating acute ischemic strokes.

How similar is treating someone in an MSU compared with the emergency department? Is there something in the emergency department that’s not in an MSU?

Dr Grotta: For strokes, the answer is no. Everything that we need to treat a patient in the emergency room for a stroke, we can do in the MSU. In a hospital, there are other things we can do for patients with stroke — for example, a thrombectomy. Patients move from the emergency room into an endovascular suite. 

Essentially everything you need to do for a stroke is in the MSU. Now there are a host of other emergency procedures in the emergency room that could be done on an MSU.

Dr Bender: The MSU is essentially a stroke emergency department on wheels. Providers have all the tools needed to evaluate, stabilize, and treat a patient suffering a stroke. They have a narrower focus than emergency department providers and can defer non-neurologic diagnoses to the emergency room.

Could you elaborate on the gaps preventing timely administration and decision-making for tPA?

Dr Grotta: Most of the time, if the physician is on board the MSU, the CT scan comes up on the computer and you can see it right away. However, in some MSUs, often the physician is present through telemedicine. In some systems, the CT scan must be transmitted to a radiologist to be read. That might produce a few minutes of delay.

I think that’s an unnecessary step because you just have to read the CT to ensure there is no blood. That doesn’t usually require a neuroradiologist to read it. You get a more skilled reading from a neuroradiologist, but the neurologist can generally identify when treatment is appropriate.

The biggest thing we have shown is that treatment in the first hour after symptom onset is critically important. In that first hour, every little thing that takes up a few extra seconds makes a difference. 

Dr Bender: Stroke neurologists are making this decision via telemedicine. They need to formulate their own perspective based on the clinical scenario and imaging but then elicit pre–existing goals of care and obtain consent from the patient or family.

It requires efficiency and parallel processing. As a result of our study findings, the MSU team has reviewed additional parallel procedures to facilitate faster treatment decision times.¹²

What is the most significant barrier to treatment for patients with stroke and what do you propose to help address these barriers?

Dr Grotta: The most significant barrier is that patients do not call 911. If everybody called 911 when they had a stroke, we would be treating many more patients right now. 

Only 12% of patients with stroke get treated with tPA. Admittedly, some cannot be treated with tPA because they have contraindications like bleeding problems, the stroke is not severe enough, or some other illness that precludes it.

If everybody called 911 when symptoms came on, we could quadruple the number of patients currently being treated. Our treatment, tPA, is pretty good, so treating more patients with the existing treatment would make the most significant difference. 

We need to figure out how to alert patients that they are experiencing a stroke and there is research on alerting devices that people might wear.

Dr Bender: Early recognition of stroke symptoms and alerting emergency services remains the most significant barrier. 

Through a partnership with the Cabrini Foundation, we are working to increase awareness and recognition of stroke symptoms in underserved communities within the Rochester metropolitan area.

There are currently no clinical guidelines on a national level for MSUs. Based on your experience and research, what massive overhauls and protocols are needed for MSUs? Who would be the decision-makers for these guidelines?

Dr Grotta: In our health care system, it is all about money. I do not mean to say that negatively, but things that are reimbursed get done, and things that are not reimbursed do not get done. In a sense, MSUs are an expensive operation for a hospital to implement, but they are worth it because we have shown that they are quite effective.

It requires an investment upfront, and right now, there is no adequate reimbursement for MSUs because they are a new thing. Insurers and Medicare do not recognize MSUs as a place of service.

The other impediment is that there are 20 or 30 MSUs right now, and you have to take a year between the time you order an MSU before one rolls out. There is no economy of scale because there is not a huge demand.

If and when MSUs get reimbursement with Medicare, then we will be able to scale up our production capability. 

Dr Bender: We are at a stage where the MSU concept is spreading. To foster that growth, MSU-based stroke treatment needs to be recognized by third-party payors and the Centers for Medicare & Medicaid Services, which is reasonable given that randomized prospective data shows MSU care expedites thrombolysis and leads to better clinical outcomes for patients with stroke. 

What additional data or research is needed to help inform future clinical guidelines?

Dr Grotta: One of the things we have yet to show about MSUs is how we can help patients with large vessel occlusion.

Right now, the main benefit of MSUs is to get tPA in faster. However, some patients do not qualify for tPA or need treatment beyond tPA. Those are the patients with large vessel strokes.

Thrombectomy is another treatment for patients who have the biggest strokes where tPA often does not work, and we pull the clot out with a catheter. However, there are only some hospitals that do that. 

What MSUs can do is triage patients more effectively to these thrombectomy centers and get thrombectomy done faster. Nevertheless, that remains to be proven. 

Most importantly, having an MSU be used for just one disease does not make logical sense. We must find other emergency conditions that MSUs can help with.

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

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A common compilation of stroke is cognitive impairment, which can increase risk for institutionalization, disability, and mortality. However, transient cognitive impairment, which resolves during hospitalization, has not been sufficiently evaluated for its long-term implications.

This analysis was part of the PRospective Observational POLIsh Study (PROPOLIS) on post-stroke delirium conducted at Jagiellonian University Medical College in Poland. Adults (N=447) admitted within 48 hours of acute stroke or transient ischemic attack symptoms were evaluated for cognitive impairment using 2 Montreal Cognitive Assessment (MoCA) assessments at days 1-3 and 4-7. The outcomes of interest were discharge location, functional status, cognitive impairment, and mortality at 3 and 12 months. Transient cognitive impairment was defined by a decrease in MoCA scores by >2 points at the second assessment compared with the first.

The patients had the following characteristics:

• mean age, 69 (Interquartile range [IQR], 61-79);
• 51.45% were men;
• body mass index (BMI) was 26.67 (IQR, 23.88-29.74) kg/m²;
• duration of education was 11 (IQR, 10-13) years;
• 17.23% experienced delirium;
• 51.62% had another Trial of ORG 10172 in Acute Stroke Treatment (TOAST) etiology classification; and
• 46.53% had right hemisphere stroke.

Transient cognitive impairment was observed among 52.35% of patients; 30.20% were cognitively stable and 17.45% were cognitively impaired.

Compared with those in the cognitively stable group, predictors for transient cognitive impairment included in-hospital delirium (odds ratio [OR], 2.655; 95% CI, 1.284-5.494; P =.009), age (OR, 1.019; 95% CI, 1.003-1.036; P =.019), and education (OR, 0.928; 95% CI, 0.868-0.991; P =.026).

At 3 months, 23 patients had died and 21 were lost to follow-up, and at 12 months, 23 had died and 31 were lost to follow-up.

Transient cognitive impairment was associated with similar outcomes at 3 months compared with patients who were cognitively stable. Compared with those in the cognitively impaired cohort, patients with transient cognitive impairment were at lower risk for discharge to hospital or nursing home (adjusted OR [aOR], 0.410; 95% CI, 0.223-0.753; P =.004).

At the 12-month follow-up, no significant group differences were observed.

In a post-hoc analysis that excluded cases with delirium, transient cognitive impairment remained related with decreased risk for discharge to hospital or nursing home compared with the cognitively impaired group (OR, 0.473; P =.039).

In a second post-hoc analysis that stratified patients based on the first MoCA score, patients with transient cognitive impairment who had MoCA score >24 points were at lower risk for poor outcomes at 3 months compared with patients who were cognitively impaired (OR, 0.279; P =.041). Patients with MoCA <24 points were at lower risk for poor outcomes compared with patients who were cognitively stable (OR, 0.151; P =.012).

The major limitation of this study was that approximately 40% of the eligible patients were excluded primarily due to missing MoCA data.

Researchers concluded, “[T]ransient CI [cognitive impairment], which often occurs in the acute phase of stroke, does not increase the risk of long-term complications, regardless of the level of cognitive functioning in the acute stage of stroke. Differentiation between transient CI, delirium and permanent cognitive deficits seems important in clinical practice for proper assessment of long-term prognosis.”

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Andreas Fuchs, M.D., Ph.D., from the Copenhagen University Hospital-Rigshospitalet in Denmark, and colleagues defined the characteristics of subclinical coronary atherosclerosis associated with development of myocardial infarction in a prospective cohort study involving 9,533 asymptomatic persons aged 40 years or older without known ischemic heart disease.

Of the participants, 54, 36, and 10 percent had no subclinical coronary atherosclerosis, nonobstructive disease, and obstructive disease, respectively. The researchers found that 193 persons died and 71 had myocardial infarction within a median follow-up of 3.5 years. In persons with obstructive and extensive disease, the risk for myocardial infarction was increased (adjusted relative risks, 9.19 and 7.65, respectively). Persons with obstructive-extensive or obstructive-nonextensive subclinical coronary atherosclerosis had the highest risk for myocardial infarction (adjusted relative risks, 12.48 and 8.28, respectively). Persons with extensive disease had increased risk for the composite end point of death or myocardial infarction, regardless of the degree of obstruction (for example, adjusted relative risks, 2.70 and 3.15 for nonobstructive-extensive and obstructive-extensive, respectively).

“In asymptomatic middle-aged persons of the background population without known ischemic heart disease, obstructive subclinical coronary atherosclerosis has the highest risk for subsequent development of myocardial infarction,” the authors write.

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Researchers conducted an international, prospective, clinical, biobank, and cohort study to analyze blood biomarkers in patients who experienced out-of-hospital cardiac arrests between November 11, 2010 and January 10, 2013. They obtained data on participants from the Target Temperature Management After Out-of-Hospital Cardiac Arrest (TTM) trial.

They wanted to determine whether serum levels of biomarkers suggestive of AD, including blood phosphorylated tau (p-tau) and amyloid-β peptides 40 and 42 (Aβ40 and Aβ42), could effectively predict neurologic outcomes after cardiac arrest in patients with hypoxic-ischemic brain injury similar to biomarkers indicative of neural injury, such as neurofilament light (NfL) and total tau (t-tau).

Researchers divided the participants into 2 groups — 80 (86.25% men) into an initial discovery group and 717 (80.9% men) into the validation group. The mean age of the discovery cohort was 60.8, while the mean age of the validation group participants was 63.9.

Prospective collection of blood samples occurred 24, 48, and 72 hours following cardiac arrest and analyzed at later dates for specific biomarkers. NfL and t-tau were assessed between August 1 and 23, 2017. P-tau, Aβ40, and Aβ42 levels were assessed between July 1 and 15, 2021 and again between May 13 and 25, 2022.

Researchers divided the participants in the validation group into those with good neurologic outcomes (n=357) and those with poor neurologic outcomes (n=360). Good neurologic outcomes were defined as patients with scores of 2 or less on the Cerebral Performance Category scale, whereas poor neurologic outcomes were defined as patients with scores of 3 or higher on the Cerebral Performance Category scale.

Researchers further subdivided the patients in the good neurologic outcome group into those with low (<35 pg/mL) and high (>79 pg/mL) serum NfL levels, and the patients in the poor neurologic outcome group into those with low (<4212 pg/mL) and high (>4609 pg/mL) serum NfL levels.

In the discovery cohort, those with poor neurologic outcomes tended to be significantly older than those with good neurologic outcomes (62.8 years vs 58.8 years; P =.04). The researchers also observed a similar pattern in the validation cohort (68.0 years vs 59.9 years; P <.001).

Patients in the discovery cohort who eventually had poor neurologic outcomes demonstrated significant elevation in p-tau serum levels 24 hours after cardiac arrest. At 24 hours after cardiac arrest, no differences in the serum levels of Aβ40 and Aβ42 were observed between the poor and good neurologic outcome groups.

Serum p-tau levels 24 hours following cardiac arrest were highly predictive of neurologic outcomes 6 months later (area under the curve [AUC], 0.96; 95% CI, 0.95-0.97. P-tau demonstrated predictive values that were similar to serum NfL levels (AUC, 0.94; 95% CI, 0.92-0.96). In contrast, the predictive value of p-tau was significantly better than t-tau (AUC, 0.80; 95% CI, 0.77-0.84; P <.001) for neurologic outcomes 6 months following cardiac arrest.

As time went on, the predictive value of p-tau significantly decreased compared with t-tau and NfL at 48 and 72 hours after cardiac arrest. This rapid clearance of p-tau after 24 hours from insult suggested that this blood biomarker was not indicative of active, ongoing neuronal injury, an outcome better reflected by NfL levels.

In contrast, both at 48 hours and 72 hours after cardiac arrest, serum Aβ40 and Aβ42 levels were significantly elevated in those with poor neurologic outcomes; however, this association between these 2 blood biomarkers and neurologic outcomes was weak.

“Blood biomarkers indicative of AD pathology demonstrated different dynamics of change after cardiac arrest,” the researchers noted. “The increase of p-tau at 24 hours after cardiac arrest suggests a rapid secretion from the interstitial fluid following hypoxic-ischemic brain injury rather than ongoing neuronal injury like NfL or t-tau. In contrast, delayed increases of Aβ peptides after cardiac arrest indicate activation of amyloidogenic processing in response to ischemia,” they added.

Study limitations included the high number of p-tau and Aβ values in the validation cohort and the inability to determine if high p-tau levels actually predict AD onset within 24 hours following cardiac arrest. Additional limitations included the choice of immunoassay methods over mass spectrometry to calculate Aβ peptide levels.

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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Andrew D. Wiese, M.P.H., Ph.D., from the Vanderbilt University Medical Center in Nashville, Tennessee, and colleagues conducted a self-controlled case series analysis among 324 adults with evidence of an AMI hospitalization between 2003 and 2019 to examine whether laboratory-confirmed IPD was associated with the risk for AMI. Patients were followed starting one year before the earliest AMI and continued through the date of death, one year after AMI, or December 2019. Periods for AMI assessment included days 7 to 1 before IPD specimen collection, day 0 through 7 after IPD specimen collection, and days 8 to 28 after IPD specimen collection (pre-IPD detection, current IPD, and post-IPD, respectively), as well as a control period. Using within-person comparisons, the incidence rate ratios were calculated for each risk period compared to control periods.

The researchers found that compared with control periods, the incidence of AMI was significantly higher during the pre-IPD detection and current IPD periods (incidence rate ratios, 10.29 and 92.95, respectively) and was nonsignificantly elevated during the post-IPD risk period. The incidence of AMI was higher in the post-IPD control period (29 to 365 days after IPD; incidence rate ratio, 2.95).

“Our findings highlight the potential that the ongoing routine administration of pneumococcal conjugate vaccines to older adults, as currently recommended by the Centers for Disease Control and Prevention, could reduce the burden of cardiovascular events, including heart attack, in the populations,” a coauthor said in a statement.

One author disclosed financial ties to the pharmaceutical industry.

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There is mixed evidence supporting the efficacy of epinephrine for resuscitation after out-of-hospital cardiac arrest (OHCA), even though the drug is commonly used for this purpose. Investigators thus sought to determine the comparative efficacy and safety following treatments post out-of-hospital cardiac arrest (OHCA) of: (1) standard dose epinephrine (1 mg or 0.01-0.02 mg/kg); (2) high dose epinephrine (single dose ³5 mg or ³0.1mg/kg); (3) standard dose epinephrine plus vasopressin; and (4) placebo/no treatment. Primary endpoints included return of spontaneous circulation (ROSC), survival to hospital admission, survival to discharge, and survival with good functional outcome.

The researchers conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) in EMBASE, Web of Science, Cochrane, Scopus, Medline, and PubMed databases, without language restriction, from inception to June 2022. The researchers identified 18 RCTs (n=21,594) assessing epinephrine use during OHCA resuscitation in patients at least 16 years of age with nontraumatic OHCA.

The investigators found ROSC was increased with epinephrine plus vasopressin (odds ratio [OR], 3.54; 95% CI, 2.94-4.26), standard dose epinephrine (OR, 3.69; 95% CI, 3.32-4.10), and high dose epinephrine (OR, 4.27; 95% CI, 3.68-4.97) compared with placebo/no treatment. Compared with standard dose epinephrine, epinephrine plus vasopressin probably has no effect on ROSC (OR, 0.96; 95% CI, 0.83-1.12, moderate certainty), and high dose epinephrine probably increases the incidence of ROSC (OR, 1.16; 95% CI, 1.04-1.29, moderate certainty).

Survival to hospital admission was increased with epinephrine plus vasopressin (OR, 2.79; 95% CI, 2.27-3.44), standard dose epinephrine (OR, 3.00; 95% CI, 2.66-3.38), and high dose epinephrine (OR, 3.53; 95% CI, 2.97-4.20) compared with placebo/no treatment. Compared with standard dose epinephrine, epinephrine plus vasopressin probably has no effect on survival to hospital admission (OR, 0.93; 95% CI, 0.79-1.10, moderate certainty), and high dose epinephrine probably increases survival to hospital admission (OR, 1.18; 95% CI, 1.04-1.34, moderate certainty).

Investigators found no important difference in survival to hospital discharge with standard dose epinephrine (OR, 1.14; 95% CI, 0.90-1.44, low certainty) compared with placebo/no treatment. They noted an uncertain effect of epinephrine plus vasopressin (OR, 1.06; 95% CI, 0.66-1.71) and high dose epinephrine (OR, 1.10; 95% CI, 0.76-1.60) compared with placebo/no treatment (very low certainty) in improving survival to hospital discharge.

Standard dose epinephrine improved survival to discharge among patients with non-shockable rhythm (OR, 2.10; 95% CI, 1.21-3.63) but not those with shockable rhythm (OR, 0.85; 95% CI, 0.39-1.85) compared with placebo/no treatment.

Investigators found standard dose epinephrine compared with placebo/no treatment may have no effect on survival with good functional outcome, and the effect of high dose epinephrine on survival with good functional outcome compared with placebo/no treatment was uncertain. They noted high dose epinephrine compared with standard dose epinephrine may have no effect on survival with good functional outcome.

Researchers noted that 7 of the included trials had some risk of bias (varying between some concerns and high risk), and 11 trials had low risk.

Significant systematic review and meta-analysis limitations include the nature of review design, heterogeneity of enrolled patients, insufficient data for some meta-analyses and evaluation of longer-term functional status, lack of data on serious adverse events, unaccounted-for improvements in system care across decades of study results, selection bias, and the lack of protocols for vasopressin use in most trials.

“Use of standard dose epinephrine, high dose epinephrine, and epinephrine plus vasopressin increases ROSC and survival to hospital admission, but may not improve survival to discharge or functional outcome,” investigators concluded. They added that “Standard dose epinephrine improved survival to discharge among patients with non-shockable rhythm, but not those with shockable rhythm.”

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 conducted a meta-analysis to assess the efficacy and safety of adenosine vs placebo in patients with ACS who received percutaneous coronary intervention or thrombolysis. A systematic review was performed for all relevant randomized controlled trials (RCTs) in PubMed and Scopus.

Efficacy endpoints included major adverse cardiac events (MACE), all-cause death, nonfatal myocardial infarction, and heart failure. The rates of advanced atrioventricular blocks and ventricular fibrillation/sustained ventricular tachycardia (VF/SVT) were safety endpoints.

A total of 26 studies with 5843 patients were included in the meta-analysis. The mean follow-up was 7 months, the weighted mean age of participants was 60.6±2.4 years, 70.5% of the patients were men, and 19.8% had diabetes.

Adenosine therapy demonstrated no clinical advantage in any efficacy endpoint vs placebo in pooled analysis of the following factors:

• MACE (risk ratio [RR], 0.91; 95% CI, 0.79-1.05; P =.16)
• All-cause-death (RR, 0.90; 95% CI, 0.74-1.09; P =.28)
• Nonfatal myocardial infarction (RR, 1.0; 95% CI, 0.74-1.35; P =.44)
• Heart failure (RR, 0.94; 95% CI, 0.77-1.16; P = .59)

Adenosine was associated with an increased rate of advanced atrioventricular block (RR, 2.72; 95% CI, 1.56-4.74; P <.01) vs placebo, and a similar rate of VF/SVT was observed between the 2 groups (RR, 1.19, 95% CI, 0.74-1.90; P =.48).

Among secondary endpoints, adenosine was not associated with improvement in left ventricular ejection fraction (effect size [ES], 0.22; 95% CI, -0.04 to 0.47; P =.10) or reduced infarct size (ES, -0.09; 95% CI, -0.35 to 0.18; P =.53). A trend was found regarding an increased rate of ST-segment resolution in the adenosine group (RR, 1.11; 95% CI, 1.00-1.22; P =.05). Myocardial blush grade 0 to 1 (RR, 0.69; 95% CI, 0.53-0.90; P =.01) and thrombolysis in myocardial infarction flow grade 0 to 2 (RR, 0.67; 95% CI, 0.53-0.85; P <.01) were lower in the adenosine group.

In subgroup analysis using a mean ischemic time longer than 3 hours, a significantly higher rate of VF/SVT occurred in the adenosine-treated group (RR, 1.66; 95% CI, 1.14-2.42). In addition, a higher VF/SVT rate was observed in the studies in which adenosine was administered intravenously (RR, 1.19; 95% CI, 1.09-1.90).

Among several limitations, most of the RCTs are designed for surrogate endpoints, and the meta-analysis may be underpowered to detect significant differences in hard clinical endpoints. Also, different definitions for MACE and heart failure are used in the studies, which causes differences in the event rate reported.

“Despite improving surrogate parameters of myocardial perfusion, adenosine is not associated with any clinical benefit compared to placebo,” the investigators wrote.

Disclosure: One 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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Research has shown that cardiovascular events (CV) have been linked to the development of endophthalmitis among patients with AS.

The researchers sought to assess the association between endophthalmitis and the risk for acute MI in patients with AS, using a nationwide population-based Taiwanese database called the Longitudinal Health Insurance Database (LHID).

Patients who were diagnosed with AS at least 1 time during hospitalization and more than 3 times during outpatient visits were included in the study. Patient comorbidities were recorded at baseline and at the study endpoint.

A comorbidity was defined as receiving the same diagnosis at at least 3 medical visits within a year before the inclusion date or the date of the study endpoint. The Charlson comorbidity index revised score (CCI_R) was evaluated as well.

Of the 1,914,201 individuals registered in the Taiwan LHID, 19,996 patients with AS were included in the study, with 557 having endophthalmitis. The comparison cohort included 2228 patients with AS without endophthalmitis, who were matched for age, sex, comorbidities, and inclusion date with the study cohort.

At baseline, the mean patient age in the 2 cohorts was 37.72±18.92 years, and 55.12% were men. At study conclusion, 12.39% (n=69/557) of participants in the study cohort and 8.66% (n=193/2228) of those in the comparison cohort, respectively, reported experiencing an acute MI (hazard ratio, 1.631; P <.001).

Further, participants in the study vs comparison cohort reported higher rates of diabetes, hyperlipidemia, hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, as well as higher CCI_R scores. With an average follow-up of 9.91±8.57 years, researchers did not observe a difference in patients with AS with and those without endophthalmitis.

Study limitations included the retrospective design, the use of medical records from a nationwide database, and the inability to determine a causal relationship between endophthalmitis and incidence of acute MI in patients with AS. In addition, the study results might not be generalizable to other populations.

The researchers concluded, “Based on our study results, special attention and work-up are required for physicians when encountering a history of endophthalmitis in these special patient populations, especially when they are comorbid with other potential CV risk factors.”

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Researchers tested the hypothesis that patients with concomitant type 2 diabetes, high triglyceride levels, and low HDL cholesterol levels might benefit clinically from decreased triglyceride levels. The primary outcome was the first occurrence of a major adverse cardiovascular event, defined as a composite of nonfatal myocardial infarction, ischemic stroke, coronary revascularization, or death from cardiovascular causes.

The researchers conducted the double-blind, randomized, placebo-controlled  PROMINENT (Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes; ClinicalTrials.gov Identifier: NCT03071692) trial, a multinational event (24 countries) conducted from March 2017 to September 2020, sponsored by Kowa Research Institute, a subsidiary of Kowa, the developer and marketer of pemafibrate. The analysis was performed by the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, Boston, Massachusetts.

The trial included 10,497 patients (66.9% with previous cardiovascular disease) with type 2 diabetes, HDL cholesterol levels of 40 mg/dL or lower, and mild-to-moderate hypertriglyceridemia (triglyceride level, 200-499mg/dL). The patients were randomly assigned to either pemafibrate treatment (0.2 mg tablets twice daily; n=5240) or a matching placebo (n=5257). Baseline characteristics were balanced between the groups and representative of patients with type 2 diabetes and mixed dyslipidemia (median age, 64 years; 27.5% women; 19.4% Hispanic/Latinx).

Participants included men who were at least 50 years of age and women at least 55 years of age who had not had atherosclerotic cardiovascular disease, or anyone at least 18 years of age with atherosclerotic cardiovascular disease. Eligibility also included patients receiving a stable dose of a qualifying moderate- or high-intensity statin, who were untreated, or were receiving other lipid-lowering therapy and had a documented LDL concentration of 70 mg/dL or less in the previous 12 months.

Overall, at baseline 95.7% were receiving statin therapy and 80.1% were receiving an angiotensin-converting enzyme inhibitor or an angiotensin II-receptor blocker.

Those with type 1 diabetes, uncontrolled diabetes, severe heart failure or kidney disease, untreated hypothyroidism or hyperthyroidism, or a clinically significant liver disease were excluded.

The baseline median fasting levels were triglyceride (271 mg/dL), LDL cholesterol (78 mg/dL), and HDL cholesterol (33 mg/dL). Median follow-up was 3.4 years. Trial disruptions occurred with medication delivery due to the COVID-19 pandemic and conflict in the Ukraine. Researchers noted a mean adherence of 81.6% at the end of the trial.

Researchers found the effects of pemafibrate vs placebo at 4 months (triglycerides

-26.2%; VLDL cholesterol -25.8%; remnant cholesterol [cholesterol transported in triglyceride-rich lipoproteins after lipolysis and lipoprotein remodeling] -25.6%; apolipoprotein C-III -27.6%; apolipoprotein B +4.8%).

They noted a primary outcome event in the pemafibrate group (572 patients) and in the placebo group (560 patients) (hazard ratio, 1.03; 95% CI, 0.91-1.15) with no noticeable effect modification in any prespecified group.

There was no significant difference between groups in incidence of serious adverse events, however pemafibrate associated with higher incidence of venous thromboembolism and renal events and a lower incidence of nonalcoholic fatty liver disease.

“In this randomized, placebo-controlled trial involving patients with type 2 diabetes, mild-to-moderate hypertriglyceridemia, low levels of HDL cholesterol, and well-controlled levels of LDL cholesterol, pemafibrate did not reduce the risk of cardiovascular events,” the researchers wrote. “However, this agent was associated with lower triglyceride, VLDL cholesterol, remnant cholesterol, and apolipoprotein C-III levels.”

Disclosure: This research was supported by Kowa Research Institute. 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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The investigators sought to examine the treatment effect of a prasugrel- vs a ticagrelor-based strategy in patients with ACS receiving an invasive management procedure when both initial and recurrent nonfatal ischemic and bleeding events are taken into account. Although prasugrel has been shown to be superior to ticagrelor in time-to-first event analysis in patients presenting with ACS who are scheduled for invasive evaluation, the effect of a prasugrel-based approach compared with a ticagrelor-based approach on total ischemic and bleeding events has not been evaluated in this population.

In the post hoc analysis of the randomized, controlled ISAR-REACT-5 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment; ClinicalTrials.gov identifier: NCT01944800) trial, the primary endpoints were ischemic events (MI and stroke) and bleeding events (Bleeding Academic Research Consortium [BARC] type 3 to 5 bleeding). Definite or probable stent thrombosis was an additional endpoint. The researchers examined the effect of the prasugrel-based and ticagrelor-based strategies on these endpoints in both time-to-first event and total event analyses. A total of 4018 patients were included. Of these individuals, 2006 were assigned to the prasugrel group and 2012 to the ticagrelor group.

Results of study showed that 169 participants experienced a single nonfatal ischemic event, 23 participants experienced multiple nonfatal ischemic events, and 3826 participants experienced no ischemic events. The multiple ischemic events comprised 16 recurrent MI events, 2 recurrent stroke events, and 5 were a combination of first MI and first stroke events.

Further, a single BARC type 3 to 5 bleeding event was reported in 204 individuals, multiple BARC type 3 to 5 bleeding events were reported in 22 individuals, and 3792 individuals experienced no BARC type 3 to 5 bleeding events. Among the 22 patients who reported multiple BARC type 3 to 5 bleeding events, 7 patients experienced a second occurrence and 2 patients experienced a third occurrence. A combination of ischemic and bleeding events (≥1 ischemic event and ≥1 bleeding event) was reported in 41 participants.

Patients in the prasugrel treatment arm had a lower risk for MI compared with those in the ticagrelor arm with respect to both time-to-first event (hazard ratio [HR], 0.61; 95% CI, 0.44-0.85) and total event (HR, 0.62; 95% CI, 0.45-0.86) analyses. The risk for BARC type 3 to 5 bleeding was similar between the prasugrel and the ticagrelor groups on both time-to-first event (HR, 0.96; 95% CI, 0.75-1.25) and total events (HR, 0.99; 95% CI, 0.76-1.31).

Limitations of the study include it being a post hoc analysis of a randomized, controlled trial, which means all results should be regarded as hypothesis-generating. Further, this post hoc analysis has the limitations of an open-label study, although with blinded adjudication of endpoints.

“Given the importance of this topic, future studies to confirm these findings would be welcome,” the study authors wrote.

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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Investigators from Universitaria de Bologna in Italy and Yonsei University College of Medicine in South Korea searched publication databases for studies of post-PCI antiplatelet strategies among patients with ACS. A total of 6 trials were included.

The study population comprised 20,837 patients who received de-escalation therapy (n=10,392) or standard therapy (n=10,445). The trials evaluated the de-escalation strategies of standard DAPT therapy for 1 to 3 months, followed by ticagrelor monotherapy (n=3), aspirin plus clopidogrel (n=2), or aspirin plus reduced dose prasugrel (n=1).

During a 1-year follow-up, mortality occurred among 119 de-escalation recipients compared with 160 standard therapy recipients, indicating that de-escalation was associated with decreased mortality risk compared with standard treatment (odds ratio [OR], 0.75; 95% CI, 0.59-0.95; P =.02).

De-escalation therapy also associated with decreased risk for any bleeding (OR, 0.51; 95% CI, 0.37-0.68; P <.0001), major bleeding (OR, 0.59; 95% CI, 0.48-0.72; P <.0001), and net-adverse clinical outcomes (OR, 0.74; 95% CI, 0.64-0.84; P <.0001) and tended to associate with lower risk for cardiovascular mortality (OR, 0.55; 95% CI, 0.30-1.01; P =.05) compared with standard therapy.

No significant difference in myocardial infarction, definite or probable stent thrombosis, stroke, or major adverse cardiovascular event risks were observed on the basis of antithrombosis strategies.

In the network meta-analysis, ticagrelor monotherapy was associated with reduced risk for mortality (OR, 0.74; 95% CI, 0.56-0.96) and major bleeding (OR, 0.55; 95% CI, 0.42-0.72) compared with standard therapy, whereas the aspirin-based treatments were not favored over standard therapy.

The findings of this analysis may not be generalizable, as most of the included studies only recruited patients at lower risk for bleeding.

“…antiplatelet therapy de-escalation after 1 to 3 months of potent DAPT with either reduced potency DAPT or ticagrelor monotherapy was associated with lower rates of all-cause mortality, major bleeding, and NACE [net adverse clinical events], with nonsignificantly different rates of ischemic MACE compared with an uninterrupted 1-year course of aspirin plus prasugrel or ticagrelor, “ the study authors wrote. “Further studies are warranted to examine the optimal timing of DAPT de-escalation after PCI in ACS and to determine whether major differences in safety or effectiveness exist between a reduced potency DAPT versus a ticagrelor (or prasugrel) monotherapy de-escalation regimen.”

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

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Investigators sought to determine the real-life long-term impact of the initial statin dose following MI. The study’s primary outcome was major adverse cardiovascular or cerebrovascular events (MACCE) within 10 years.

The retrospective population-based study gathered information from Finnish national registries on 72,401 consecutive adult patients with MI (mean age, 68 years; 67% men) admitted from July 2004 through June 2018 and treated with statins soon after the MI event. Investigators identified patients from the Care Register for Healthcare in Finland which includes data from all 20 Finnish hospitals that treat patients with MI. They included only the first MI admission during the study period.

Patients treated with aortic or valvular surgery during the index admission, those who used a PCSK9 inhibitor, and those with missing follow-up data were excluded.

Multivariable regression was used to adjust for differences in revascularization, comorbidities, baseline features, and usage of additional evidence-based medications.

There was initial statin therapy (defined as medication purchase by prescription within 90 days following hospital discharge) in the study population (high-dose 26.3%, moderate-dose 69.2%, low-dose 4.5%) with median follow-up of 4.9 years. Statin therapy adherence was studied by yearly intervals during follow-up. There was an inverse relationship between therapy intensity decreasing and increasing age.

The most frequently used initial statin overall was simvastatin, and the most frequently used high-dose statin was atorvastatin. Patients with the fewest comorbidities most frequently were prescribed high-dose statin. Patients with the highest comorbidities most frequently were prescribed low-dose statin.

High-dose vs moderate-dose statin showed MACCE was less frequent (adjusted hazard ratio [aHR], 0.92; P <.0001; number needed to treat [NNT], 34.1). MACCE was less frequent in high-dose vs low-dose (aHR, 0.81; P <.001; NNT, 13.4) and in moderate-dose vs low-dose (aHR, 0.88; P <.0001; NNT, 23.4). Lower initial statin dose associated with atrial fibrillation and usage of oral anticoagulation.

High-dose vs moderate-dose revealed a lower frequency of stroke (a_{subdistribution[s]}HR, 0.86; P <.0001), recurrent MI (a_sHR, 0.91; P =.0001), and death (aHR, 0.87; P <.0001; NNT, 23.6).

Subgroups divided by sex, dementia, heart failure, atrial fibrillation, diabetes, revascularization, prior statin usage, usage of other evidence-based medications, or age all showed higher initial statin dose after MI was associated with better long-term outcomes. Statin therapy adherence decreased during follow-up (24.1% of all patients were noted as nonadherent 10 years after index MI). At 10 years, dosage of used statins was similar to initial dosage (high-dose 27.7%, moderate-dose 68.3%, low-dose 4.0%).

Study limitations include the retrospective design and residual confounding. Dosing instructions are also assumed by investigators and are not objective.

“…a higher initial statin dose after MI is dose-dependently associated with better long-term cardiovascular outcomes,” the investigators wrote. “Paradoxically, however, patients with the highest risk for adverse outcomes used the lowest intensity of statins.” They urged the significance of using high-dose statins soon after MI.

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Researchers conducted a systematic review and meta-analysis to assess the impact of DAPT duration after PCI regardless of OAC type in patients with an indication for this treatment.

An electronic database search was performed from January 1, 2000, to September 1, 2021, for randomized controlled trials (RCTs) of adult patients who received an abbreviated (<3 months) or prolonged (≥3 months) DAPT duration with concomitant indication for OAC therapy.

The 2 coprimary endpoints were major bleeding and major or clinically relevant nonmajor bleeding. The key safety endpoint was the composite of MACE at the longest follow-up.

A total of 5 RCTs with 7665 patients (3843 in the abbreviated DAPT group and 3822 in the prolonged DAPT group) were included. The overall mean age was 72 years, and the prolonged DAPT arm had a mean DAPT duration of 6 months. DOACs were used in 46.7% of cases, with apixaban accounting for 81.5% of DOAC use. Clopidogrel (79.2%) was the most frequently used single antiplatelet agent after DAPT discontinuation in the abbreviated DAPT arm.

The abbreviated regimen was associated with a significantly decreased risk for the coprimary endpoints of major or clinically relevant nonmajor bleeding (10.2% vs 16.3%; risk ratio [RR], 0.69; 95% CI, 0.52-0.91; P =.01; I²=76%; number needed to treat [NNT], 16.4) and major bleeding (3.4% vs 5.1%; RR, 0.70; 95% CI, 0.52-0.95; P =.01; I²=33%; NNT, 58.8), compared with a prolonged DAPT regimen. A sensitivity analysis including only patients who had received PCI demonstrated consistent results (RR for major or clinically relevant nonmajor bleeding, 0.67; 95% CI, 0.46-0.96; P =.03).

The meta-regression analysis for major or clinically relevant nonmajor bleeding and major bleeding showed a significantly increased protective effect with a P2Y₁₂ inhibitor as the drug to continue after DAPT discontinuation in the abbreviated DAPT cohort (RR, 0.59; 95% CI, 0.34-0.98; P =.05 for major or clinically relevant nonmajor bleeding and RR, 0.44; 95% CI, 0.22-0.87; P =.01 for major bleeding).

The abbreviated and prolonged DAPT regimens did not have a significant difference in the key safety endpoint of MACE (7.1% vs 7.0%; RR, 0.96; 95% CI, 0.70-1.33; P =.6; I²=60%). The finding was consistent when an alternative MACE endpoint that included only cardiovascular mortality was used (RR, 0.95; 95% CI, 0.75-1.2; P =.7; I²=60%).

The network meta-analysis also assessed bleeding and ischemic endpoints in periprocedural vs short (4-6 weeks) or prolonged DAPT (≥3 months). Periprocedural DAPT was the most beneficial treatment for reducing bleeding events (surface under cumulative ranking curve analysis for major or clinically relevant nonmajor bleeding and major bleeding: 97.1% and 92.0%, respectively).

Study limitations include use of an aggregate-data meta-analysis, and formal statistical significance is not maintained in the random-effects sensitivity analysis excluding 2 trials. In addition, heterogeneity is observed in the clinical endpoint definitions among the included studies, and mild heterogeneity occurred in the follow-up durations.

“Periprocedural DAPT and continuation with a P2Y₁₂ inhibitor rather than aspirin after DAPT discontinuation appear to augment the benefit of an abbreviated DAPT course but this is based on limited evidence at present,” the investigators wrote.

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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Managing UC symptoms with marijuana has been shown to improve abdominal pain, loss of appetite, and diarrhea. However, both marijuana use and UC can result in adverse cardiovascular outcomes.

Researchers conducted a retrospective study on the effects of marijuana use in patients hospitalized with NSTEMI and underlying UC. Using data from the 2016-2019 National Inpatient Sample (NIS), researchers identified 142,420,378 hospitalizations, 7010 of which involved adults aged 18 years and older admitted with comorbid UC and acute NSTEMI.

Of the 7010 individuals with comorbid UC and NSTEMI, 0.78% reported marijuana use. Marijuana users vs marijuana nonusers were younger (57.55 vs 70.58 years).

When analyzing outcomes, researchers observed that 7.99% of hospitalizations resulted in fatal outcomes; however, difference in mortality between marijuana users vs marijuana nonusers was not statistically significant (9.09% vs 7.99%). Multivariate analysis showed that marijuana use was not a risk factor for death in patients with UC and acute NSTEMI (odds ratio [OR], 1.11; P =.907).

Risk factors for mortality among inpatients with UC and NSTEMI included shock (OR, 5.88; P =.00), acute kidney injury (OR, 3.44; P =.00), and the need for mechanical ventilation for longer than 24 hours (OR, 3.44; P =.00).

The researchers also investigated the effect of marijuana use on hospital resource utilization. They found that marijuana use did not associate with increased total hospital charges (-$22,557.46; P =.42). Instead, factors that raised costs during hospitalizations included treatment provided in a teaching hospital with an urban location, the onset of shock, the need for mechanical ventilation longer than 24 hours, and the need for surgical intervention, namely, coronary artery bypass grafts (CABG).

Researchers also discovered that marijuana was associated with a lower average length of hospital stay by 3.4 days (P =.02).

Higher mean length of stay was associated with the following factors: mechanical ventilation longer than 24 hours (+7.35 days; P =.00), shock (+1.72 days; P =.01), ventricular arrhythmias (+1.90 days; P =.02), end-stage renal disease on hemodialysis (+5.20 days; P =.04), acute kidney injury (+2.11 days; P =.00), CABG (+5.62 days; P =.000), anemia (+1.09 days; P =.02), and elixhauser comorbidity (+0.48 days; P =.00).

“Marijuana is not associated with increase in mortality or total charges of hospitalization in UC patients admitted for acute NSTEMI,” the study authors wrote. “Additionally, it is associated with reduced LOS [length of stay] in these hospitalizations, likely due to the lower mean age resulting in quicker recovery and discharge.”

This article originally appeared on Gastroenterology Advisor.

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Patrick C. Demkowicz, from the Yale University School of Medicine in New Haven, Connecticut, and colleagues analyzed data from patients aged 75 years or older who were hospitalized for AMI at 94 U.S. hospitals from 2013 to 2016 to examine racial disparities in aging-specific functional impairments and mortality.

Of the 2,918 participants, 91.4 and 8.6 percent self-identified as White and Black, respectively. The researchers found that compared with White participants, Black participants were younger (80.8 versus 81.7 years) and more likely to be female (64.8 versus 42.5 percent). The likelihood of presenting with impairments in cognition, mobility, and vision was significantly increased among Blacks, and they were also more likely to report a disability in one or more activities of daily living and an unintentional loss of more than 10 lb in the year before hospitalization. Black participants had an unadjusted odds ratio of six-month mortality of 2.0 (95 percent confidence interval, 1.4 to 2.8), which was attenuated after adjustment for age and clinical characteristics (odds ratio, 1.7; 95 percent confidence interval, 1.2 to 2.5) and became nonsignificant after adjustment for functional/geriatric conditions (odds ratio, 1.5; 95 percent confidence interval, 1.0 to 2.2).

“Further attention is needed to develop and implement posthospital care programs that address the specific needs of older Black patients,” the authors write.

One author disclosed financial ties to Roivant Sciences; a second author disclosed receiving fees from CVS.

Abstract/Full Text

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Recognizing that chest pain is one of the most common reasons for ED visits and one of the most challenging conditions to assess, the members of the committee sought to streamline and improve the chest pain evaluation process. The ACC Heart House Roundtable “Emergency Department Evaluation of Patients with Possible Acute Coronary Syndrome” was convened on February 26, 2020, to bring together multidisciplinary stakeholders in an effort to include the varied perspectives that are involved in the care of patients with acute chest pain.

Participants were from medical specialties, including emergency medicine, cardiology, internal medicine, family medicine, nursing, hospital medicine, laboratory medicine, radiology, health systems administrators, insurance company representatives, and government regulators. Clinicians comprised physicians, nurses, and advanced practice providers. The goal of the meeting was to discuss optimal approaches to the evaluation and management of acute chest pain in the ED, with a particular focus on the implementation of protocols with the use of high-sensitivity cardiac troponin (hs-cTn).

In the Expert Consensus Decision Pathway, the guidance that follows was informed by the scientific evidence presented and the expert opinions considered at the Heart House Roundtable, along with subsequent review/deliberation on available evidence by the Expert Consensus Decision Pathway writing committee, as well as review of the 2021 American Heart Association (AHA)/ACC/multisociety chest pain guideline and other relevant international guidelines.

This document is a separate, independent endeavor that aims to address the questions raised during the meeting, along with other practical questions associated with the clinical application of the 2021 AHA/ACC/multisociety chest pain guideline. The writing committee comprised representatives from emergency medicine, hospital medicine, cardiology, and nursing.

The writing committee considered the following specific definitions and assumptions in the development of the consensus recommendations:

• Hs-cTn assays
• Clinical decision pathways (CDPs)
• Efficacy (the proportion of individuals meeting “rule-out” criteria based on the CDP algorithm)
• Limit of blank (the highest apparent cTn concentration found with a given assay when testing replicates of a sample known to contain no cTn, which is also known as a blank sample)
• Limit of detection (the lowest cTn concentration that can be reliably differentiated from the limit of blank when testing replicates of samples known to contain cTn)
• Limit of quantification (the lowest cTn concentration that can be reported reliably as a number)
• Minimally elevated hs-cTn or minor elevations in hs-cTn
• Elevated hs-cTn (hs-cTn values above the 99th percentile)
• Relative change in hs-cTn (percentage change in hs-cTn across serial measurements)
• Absolute change in hs-cTn
• Nonischemic electrocardiogram (ECG)

The Expert Consensus Decision Pathway is intended to parallel the usual course of assessment of patients in the ED with symptoms that require evaluation for possible acute coronary syndrome (ACS). The first step involves careful assessment of the ECG. Patients with nonischemic ECG can enter an accelerated CDP that is designed to provide rapid risk evaluation and exclusion of ACS. All patients who are classified as low risk with the use of hs-cTn-based CDPs supported by this document can generally be discharged directly from the ED without receiving any additional testing; however, outpatient testing may be considered in certain individuals.

In contrast, patients with substantially elevated initial hs-cTn values or those with significant dynamic changes over 1 to 3 hours are assigned to the abnormal/high-risk category. These individuals should be further classified according to the Universal Definition of Myocardial Infarction (MI) into type 1 or type 2 MI, or acute or chronic nonischemic cardiac injury. High-risk patients should be admitted to an inpatient facility for additional evaluation and treatment.

The initial clinical assessment of a patient with acute chest pain should focus on the rapid identification and treatment of those with life-threatening conditions, including ACS, aortic dissection, and pulmonary embolism. Those patients who are hemodynamically unstable, have significant arrhythmia, or have evidence of significant heart failure, however, should be evaluated and treated appropriately; they are not considered to be candidates for an accelerated CDP.

Disadvantages of these protocols include algorithm complexity, sensitivity to timing of blood draws, and the relegation of approximately one-fourth of patients to an observation zone in which limited evidence is available to guide subsequent assessment and treatment. An additional limitation of these algorithms is the fact that they may be susceptible to missing MIs among late presenters who are on a flat portion of a descending cTn trend, in which little or no change may be evident over 1 to 2 hours.

“This evaluation includes careful ECG review and, for appropriate patients, entry into a CDP that combines hs-cTn measurements with risk assessment and selective use of noninvasive testing,” the study authors wrote. “The CDP is used to help to guide triage, treatment, and disposition decisions. The CDP should be viewed as a tool to augment rather than replace the clinical judgment of the care team.”

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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Researchers conducted a retrospective cross-sectional analysis (N=8416; age range, 21-79 years; women, 51.5%) based on data from the 2017-2020 National Health and Nutrition Examination Survey (NHANES) to assess whether there was an association between sleep duration and risk of stroke. Participants self-reported sleep duration and history of stroke. Researchers stratified sleep duration into normal sleep duration (≥6 hours) and short sleep duration (<6 hours), and assessed risk of stroke with multivariate logistic regression.

At baseline, the average sleep duration was 7.529±1.651 hours. Participants who reported a history of stroke (n=377) recorded a mean sleep duration of 7.545±2.132 hours. Participants who did not report a history of stroke recorded a mean sleep duration was 7.528±1.626 hours (difference, 0.017 hours; 95% CI, -0.156 to 0.189; P <.001).

Overall, 913 (10.8%) participants self-reported short sleep duration and 7426 (88.2%) participants self-reported a normal sleep duration; 77 participants were unaccounted for. The researchers found that participants with short sleep duration had significantly lower odds of stroke (adjusted odds ratio, 0.574; 95% CI, 0.424-0.777; P <.001) vs participants with normal sleep duration after adjusting for baseline risk factors, including sex, age, body mass index (<25 kg/m² vs ≥25 kg/m²), ethnicity, and history of hypertension and diabetes.

“Contrary to previous reports, this study shows that sleep duration is positively associated with risk of stroke,” the researchers concluded. “Further long-term studies that … [use] non-self-reported measurements are required to elucidate effect of sleep quality and optimal sleep duration on the adverse CV [cardiovascular] outcomes.”

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Naomi Siddiquee, from the Medical College of Georgia at Augusta University, and colleagues used the United States Renal Data System to identify 1.06 million patients with ESRD starting dialysis between 2004 and 2015.

The researchers report that in the whole cohort, 0.6 percent of individuals had psoriasis and 17.1 percent had MI. However, among the 6,823 patients with psoriasis, 24 percent developed an MI. In unadjusted models, psoriasis was associated with an increased risk for MI (odds ratio, 1.34; 95 percent confidence interval, 1.26 to 1.42), but when controlling for demographics, dialysis modality, access type, and comorbidities, psoriasis was not associated with MI (odds ratio, 0.95; 95 percent confidence interval, 0.89 to 1.01).

“Contrary to prior research in the general population, in the ESRD population, psoriasis was not associated with an increased risk of MI after controlling for various demographic and clinical parameters,” the authors write. “These data emphasize the importance of an integrated approach since comorbidities may influence the choice of therapy for psoriasis and outcomes.”

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

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Researchers assessed long-term trends in clinical characteristics, treatment, and outcomes in patients with diabetes and AMI with use of data from the prospective AMIS Plus (National Registry of Acute Myocardial Infarction in Switzerland).

Participants with ST segment elevation MI or non-ST segment elevation MI were enrolled in the registry from January 2002 to December 2019.

The primary endpoint was MACCE, a composite of all-cause death, nonfatal MI, and cerebrovascular events. The analysis was grouped into 3-year periods, and patients’ baseline characteristics were compared between the first period (2002-2004) and last period (2017-2019).

The proportion of patients with diabetes did not change during the 18-year period (P =.15). Among 49,413 patients, 20.6% had diabetes, of whom 29.4% were women. The patients with diabetes were older (P <.001) and they had a higher body mass index (P <.001), compared with patients without diabetes.

Patients with diabetes had percutaneous coronary intervention (PCI; P <.001) less frequently during the index hospitalization and were more frequently treated with coronary artery bypass grafting (CABG; P <.001) vs patients without diabetes. The proportion of patients with diabetes who had PCI or CABG increased during the 18-year period (P <.001).

The overall MACCE rates were 9.5% and 5.2% in patients with diabetes and patients without diabetes, respectively (P <.001). Diabetes was an independent predictor of MACCE (adjusted odds ratio [aOR], 1.39; 95% CI, 1.27-1.52; P <.001), mortality (aOR, 1.40; 95% CI, 1.27-1.56, P <.001), myocardial infarction (aOR, 1.42; 95% CI, 1.17-1.74; P =.001), and cerebrovascular events (aOR, 1.43; 95% CI, 1.13-1.81, P =.003).

MACCE rates decreased from 11.8% (2002-2004) to 7.5% (2017-2019) among patients with diabetes, and MACCE rates decreased from 6.5% to 5.0% in the same period among patients without diabetes (P for trend <.001 for both). Although a decrease in mortality rates (9.4% to 5.9%; P for trend <.001) and recurrent myocardial infarction (3.4% to 0.9%; P for trend <.001) was observed over time, the rate of cerebrovascular events was stable (P for trend =.34).

Comparable trends were observed in both men and women with diabetes and in patients without diabetes. The highest rates of MACCE were found in women with diabetes, with statistically significant differences occurring between women and men with diabetes in 2008 to 2010 (13.7% vs 9.8%, P =.03) and 2011 to 2013 (11.1% vs 8.1%, P =.046).

Study limitations include the observational design, and that the diagnosis of diabetes is based on data available from medical records or by the treating physician during the index hospitalization. Also, data regarding the use of sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists are not available.

“…this study demonstrated a significant reduction in in-hospital rates of MACCE from 2002 to 2019 in patients with diabetes and AMI, mostly due to reduced rates of mortality and recurrent myocardial infarction,” the researchers wrote.

Disclosure: The AMIS Plus registry is funded by unrestricted grants from the Swiss Heart Foundation and from Abbott Medical AG, Amgen AG, AstraZeneca AG, Bayer AG, Biotronik AG, Boston Scientific AG, B. Braun Medical AG, Cordis-Cardinal Health GmbH, Daiichi Sankyo AG, Medtronic AG, Novartis Pharma AG, Sanofi-Aventis SA, Servier SA, SIS Medical Distribution AG, Terumo GmbH, and Vascular Medical GmbH. Please see the original reference for a full list of disclosures.

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Investigators sought to evaluate clinical characteristics, outcomes, and process metrics in patients with STEMI and compare patients living in rural vs urban settings in the United States (US). The primary outcomes were in-hospital mortality and time-to-reperfusion metrics.

They initiated a cross-sectional multicenter review of the National Cardiovascular Data Registry Chest Pain–MI Registry in 686 US hospitals from January 2019 through June 2020. This review included 70,424 adult patients with STEMI. Among these patients (median age 63 years [IQR, 54-73]; 29.2% women; 85.4% White, 9.6% Black, 7.5% Hispanic or Latino ethnicity, 3.0% Other) 28.0% lived in rural zip codes and 72.0% lived in urban zip codes. More White patients lived in rural areas (91.2% vs 83.1%), and more Black patients lived in urban areas (11.0% vs 5.9%). The most frequent comorbidities were diabetes, dyslipidemia, and hypertension.

The investigators noted that among patients living in rural areas, 37.6% were treated in rural hospitals, 46.8% in urban hospitals, and 15.6% in suburban hospitals. Of patients living in urban areas, 92.0% were treated in urban hospitals. Patients from urban areas were more likely to present to the emergency department (82.2% vs 56.7%) and those living in rural areas were more likely to present directly to the cardiac catheterization laboratory (34.7% vs 15.4%; all P <.001).

The investigators found that patients from rural settings (73.2%) were less likely to receive PPCI vs patients from urban settings (85.1%; P <.001) and more likely to receive fibrinolytics (rural 19.7% vs urban 2.7%; P <.001). Among the patients receiving PPCI, those in rural settings faced longer median time from first medical contact to catheterization activation (rural 30 minutes vs urban 22 minutes), longer median time from first medical contact to device (rural 99 minutes vs urban 81 minutes) including those who transferred to PPCI centers from other care centers (rural 125 minutes vs urban 103 minutes) and those who arrived directly at PPCI centers (rural 83 minutes vs urban 78 minutes; all P <.001).

The investigators noted that, among patients transferring in, those in rural settings faced longer median door-in-door-out time (rural 63 minutes vs urban 50 minutes). They observed patients from urban settings were more likely to present with heart failure (urban 8.1% vs rural 6.7%) and more had out-of-hospital cardiac arrest (urban 6.1% vs rural 4.9%; all P <.001). Analysis after multivariable adjustment showed no significant difference between rural and urban groups in in-hospital mortality (adjusted odds ratio, 0.97; 95% CI, 0.89-1.06).

Study limitations include possible hospital participation bias. Also, zip codes do not necessarily reflect accurate patient locations and there are approximately a fifth of patients who were excluded due to missing zip codes.

The investigators wrote that patients “living in rural settings less frequently received PPCI and more often received fibrinolysis for reperfusion. Despite delays and longer times to reperfusion in the rural cohort compared with the urban cohort, there was no difference in adjusted in-hospital mortality between the 2 groups.”

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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Mina Madan, M.D., from the Sunnybrook Health Sciences Centre in Toronto, and colleagues assessed contemporary care pathways and clinical outcomes among younger women with acute myocardial infarction (AMI). The analysis included 38,071 AMI patients (aged 18 to 55 years; 21.2 percent women) hospitalized from April 1, 2009, to March 31, 2019.

The researchers found that although most patients received coronary angiography (96 percent), coronary revascularization was less frequent among women than men (percutaneous coronary intervention: 61.9 versus 78.8 percent; surgery: 4.1 versus 6.0 percent). Compared with men, women had more normal coronary anatomy (5.8 versus 1.7 percent) and nonobstructive disease (22.8 versus 9.3 percent). The primary composite end point of one-year all-cause mortality or readmission for unstable angina, AMI, heart failure, or stroke was significantly increased among women (10.0 versus 7.9 percent; adjusted hazard ratio, 1.11). Women had higher all-cause readmission (25.8 versus 21.1 percent; adjusted hazard ratio, 1.34).

“This may reflect the higher risk profile we observed among younger women in our study compared with younger men or support the notion that younger women may benefit from earlier follow-up care and better support networks that could reduce the need for readmissions soon after discharge,” Madan said in a statement.

Abstract/Full Text

Editorial

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