One-Month Outcomes of Aspirin-Free Strategy for Percutaneous Coronary Intervention With or Without Proton-Pump Inhibitors　― A Post Hoc Subgroup Analysis of STOPDAPT-3 ―

Abstract

Background: There are no previous reports exploring the interaction of proton-pump inhibitors (PPI) on the early effect of aspirin-free strategy compared with dual antiplatelet therapy (DAPT) after PCI.

Methods and Results: Among 5,654 patients who were discharged alive within 30 days after randomization in ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 (STOPDAPT-3), 4,958 patients received PPI prescriptions (PPI subgroup; no-aspirin group, n=2,356; and DAPT group, n=2,602), and 696 patients did not (no-PPI subgroup; no-aspirin group, n=482; and DAPT group, n=214). The co-primary bleeding endpoint was Bleeding Academic Research Consortium type 3 or 5 bleeding, and the co-primary cardiovascular endpoint was a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke. No significant interaction was observed between PPI prescription and antiplatelet regimen on the bleeding endpoint (PPI: hazard ratio [HR] 0.90; 95% confidence interval [CI] 0.66–1.22; no-PPI: HR 0.52; 95% CI 0.17–1.54; P interaction=0.34). For the cardiovascular endpoint, there was a lower risk of no aspirin relative to DAPT in the no PPI subgroup (0.41% vs. 3.27%; HR 0.13; 95% CI 0.03–0.60), but not in the PPI subgroup (HR 1.29; 95% CI 0.86–1.93) with a significant interaction (P interaction=0.005).

Conclusions: There was no interaction for bleeding between PPI prescription and antiplatelet regimen, but a significant interaction for cardiovascular events, requiring cautious interpretation due to the small no-PPI subgroup and baseline imbalances.