Prasugrel or ticagrelor monotherapy vs dual antiplatelet treatment after percutaneous coronary intervention in acute coronary syndromes: a landmark analysis from the NEO-MINDSET trial

BACKGROUND AND AIMS: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention in patients with acute coronary syndrome remains uncertain. This analysis examined the temporal patterns of ischaemic and bleeding risks of early aspirin withdrawal compared with DAPT. METHODS: NEO-MINDSET randomized 3410 acute coronary syndrome patients undergoing successful percutaneous coronary intervention with drug-eluting stents within 4 days of hospital admission to either potent P2Y12 inhibitor monotherapy (prasugrel or ticagrelor) or standard DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. This prespecified landmark analysis examined early (0-30 days) and late (31-365 days) follow-up events. Co-primary outcomes were (i) the composite of all cause death, myocardial infarction, stroke, or urgent target-vessel revascularization (ischaemic outcome) and (ii) Bleeding Academic Research Consortium type 2, 3, or 5 bleeding. RESULTS: At 30 days, the composite ischaemic outcome occurred in 3.3% of patients receiving monotherapy vs 1.8% with DAPT (risk difference 1.5%, 95% confidence interval .4%-2.6%; P = .006). Bleeding occurred in .6% vs 1.5% (risk difference -.8%, 95% confidence interval -1.5%-.1%; P = .018). In the landmark analysis between Days 31 and 365, ischaemic outcome rates were similar between study groups (3.8% each; P = .977), while bleeding remained less frequent with monotherapy (1.3% vs 3.5%; risk difference -2.2%, 95% confidence interval -3.2%-1.1%; P > .001). CONCLUSIONS: This prespecified 30-day landmark analysis suggests an excess of ischaemic risk with monotherapy vs DAPT in the first 30 days but not thereafter, whereas an aspirin-free strategy was consistently associated with fewer bleeding events within and after 30 days.