Aspirin versus clopidogrel beyond 1 month after percutaneous coronary intervention in high bleeding risk patients with or without acute coronary syndrome: a subgroup analysis from the STOPDAPT-3 trial.

There were no previous studies comparing aspirin monotherapy with clopidogrel monotherapy beyond 30 days after percutaneous coronary intervention (PCI) in patients with high bleeding risk (HBR) with or without acute coronary syndrome (ACS). We conducted a subgroup analysis in patients with HBR stratified by ACS in the 1-year follow-up of the STOPDAPT-3 trial, which randomly compared 1-month dual antiplatelet therapy with aspirin and prasugrel followed by aspirin monotherapy (aspirin group) with 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). This subgroup analysis compared aspirin with clopidogrel in HBR patients with or without ACS by the 30-day landmark analysis. The co-primary endpoints were the cardiovascular (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke), and bleeding endpoints (Bleeding Academic Research Consortium 3 or 5). Among 3156 patients with HBR, there were 1711 patients with ACS (aspirin group: N = 847, clopidogrel group: N = 864) and 1445 patients with non-ACS (aspirin group: N = 727, clopidogrel group: N = 718). The risks of aspirin compared to clopidogrel were not significant for cardiovascular and bleeding endpoints beyond 30 days and up to 1 year in both ACS and non-ACS (ACS: HR 0.89, 95%CI 0.61–1.30; non-ACS: HR 1.16, 95%CI 0.73–1.84; P interaction = 0.39, and ACS: HR 0.73, 95%CI 0.40–1.33; non-ACS: HR 1.62, 95%CI 0.87–3.01; P interaction = 0.07, respectively). In patients with HBR, aspirin compared with clopidogrel was associated with similar cardiovascular and bleeding outcomes beyond 30 days and up to 1 year after PCI regardless of ACS or non-ACS.