Aspirin vs. Clopidogrel Monotherapy Beyond 1 Month After Percutaneous Coronary Intervention in Patients With Diabetes　― Prespecified Subgroup Analysis of the STOPDAPT-3 Trial ―

Abstract

Background: No studies have compared aspirin to P2Y₁₂inhibitor monotherapy following short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients with diabetes.

Methods and Results: We conducted a prespecified diabetes subgroup analysis of the 1-year STOPDAPT-3 trial; patients were randomized at the time of index PCI, and outcomes from 30 days to 1 year were assessed using a 30-day landmark analysis comparing 1-month DAPT followed by aspirin monotherapy (aspirin group) to 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). The effect of aspirin relative to clopidogrel was not significant for the coprimary cardiovascular endpoint (composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) regardless of diabetes (aspirin/clopidogrel 5.3/5.6 vs. 3.9/3.7 per 100 person-years for diabetes vs. non-diabetes, respectively; hazard ratios [HRs] 0.96 [95% confidence interval {CI} 0.67–1.37] and 1.06 [95% CI 0.72–1.55], respectively; P_interaction=0.71), but there was a significant interaction between diabetes and the effect of aspirin relative to clopidogrel for the coprimary bleeding endpoint (Bleeding Academic Research Consortium 3 or 5; aspirin/clopidogrel 2.8/1.8 vs. 1.3/2.0 per 100 person-years diabetes vs. non-diabetes, respectively; HR 1.54 [95% CI 0.88–2.71] vs. 0.65 [95% CI 0.36–1.17], respectively; P_interaction=0.04).

Conclusions: From 30 days to 1 year after PCI, cardiovascular outcomes were similar between aspirin and clopidogrel regardless of diabetes. A nominal bleeding interaction was observed; given the exploratory and underpowered subgroup analyses, this finding should be interpreted cautiously.