Clopidogrel Monotherapy and Bleeding Risk Post-PCI in Patients With Diabetes

Switching to clopidogrel monotherapy after 1 month of dual antiplatelet therapy (DAPT), compared with remaining on DAPT, is associated with lower rates of major bleeding among patients with diabetes who have received percutaneous coronary intervention (PCI). These findings were published in JACC: Cardiovascular Interventions.

Data for this post-hoc subgroup analysis were sourced from the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2) and STOPDAPT-2 for Patients With Acute Coronary Syndrome (ACS) trials which were prospective, multicenter, open-label trials conducted in 2015 to 2017 and 2018 to 2020, respectively. In this analysis, the effects of treatment with 1-month DAPT with clopidogrel plus aspirin followed by 11 months of clopidogrel monotherapy compared with 12 months of DAPT after receiving a cobalt-chromium everolimus-eluting stent were evaluated. Cardiovascular and bleeding outcomes were compared between patients with (n=2030) and without (n=3967) diabetes.

The diabetic and nondiabetic cohorts included patients with a mean age of 68.3 (SD, 10.6) and 67.5 (SD, 11.7) years (P =.01), who were 79.0% and 78.1% men (P =.47), with BMIs of 24.7 (SD, 3.7) and 24.0 (SD, 3.5; P <.001), of whom 60.5% and 73.3% presented with acute coronary syndrome (P <.001), and of whom 23.0% and 14.3% received a prior PCI (P <.001), respectively.

During the PCI procedure, significant group differences were observed on the basis of diabetes status for approach, staged procedure, number of procedures, number of target lesions, number of vessels treated, use of intravascular imaging, number of implanted stents, stent diameter, and stent length.

The cumulative 1-year incidence for the composite outcome (cardiovascular-associated death, myocardial infarction, definite stent thrombosis, stroke, and thrombolysis in myocardial infarction bleeding events) occurred among 3.85% of the diabetes and 2.48% of the nondiabetes groups (hazard ratio [HR], 1.56; 95% CI, 1.16-2.10; P =.004). Stratified by composite cardiovascular and bleeding outcomes, the composite risk for cardiovascular events was higher among the cohort with diabetes (HR, 1.87; 95% CI, 1.33-2.65; P <.001) but the composite risk for bleeding events did not differ between groups (HR, 0.98; 95% CI, 0.56-1.72; P =.94).

Among the diabetic cohort, risk for the composite primary endpoint did not differ between clopidogrel and DAPT groups (HR, 0.87; 95% CI, 0.56-1.37; P =.55). Similar trends were observed in the nondiabetic cohort (HR, 0.99; 95% CI, 0.67-1.48; P =.97).

Conversely, clopidogrel receipt decreased risk for the composite bleeding outcome among patients with diabetes (HR, 0.20; 95% CI, 0.06-0.68; P =.01) but not among those without diabetes (HR, 0.51; 95% CI, 0.25-1.01; P =.054).

Results of the exploratory subgroup analysis that stratified by insulin use status were consistent with the main analysis.

This study may be underpowered, as it is a post-hoc analysis and the results should be considered as exploratory.

“Clopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT with aspirin and clopidogrel reduced major bleeding events without an increase in cardiovascular events regardless of diabetes,” the study authors wrote. “However, the results of this post hoc subgroup analysis should be considered hypothesis generating, especially in patients with acute coronary syndrome, because of the inconclusive result in the STOPDAPT-2 ACS trial.”

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