Similar number of cardiovascular events and reduced bleeding with abbreviated dual antiplatelet therapy after PCI

Reference

Valgimigli M, Frigoli E, Heg D, et al, for the MASTER DAPT Investigators. Dual antiplatelet therapy after PCI in patients at high bleeding risk. N Engl J Med 2021(18);385:1643-1655.

Synopsis

In this multicenter noninferiority trial from Europe, investigators examined the safety and effectiveness of abbreviated dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients at high risk of bleeding. Patients with a high bleeding risk who had undergone successful PCI with implantation of sirolimus-eluting stents were randomized to receive abbreviated DAPT or standard therapy. Patients were screened for inclusion 30 days to 44 days after the index PCI procedure and those with post-PCI ischemic or active bleeding events were excluded. Patients in the abbreviated group (n = 2295) immediately discontinued DAPT and were continued on single antiplatelet therapy (either aspirin or a P2Y12 inhibitor) for the duration of the trial. Those in the standard therapy group (n = 2284) continued DAPT for 5 more months (3 more months if they were also receiving oral anticoagulation). The 2 groups were similar at baseline: mean age was 76 years, two-thirds were men, and approximately half had a coronary intervention for acute coronary syndrome. Overall, 98% of patients in the abbreviated group stopped DAPT immediately and 99.6% in the standard group continued DAPT for a median of 157 days. In the per-protocol analysis, net adverse clinical events (composite of all-cause death, myocardial infarction, stroke, and major bleeding) were similar in the 2 groups (7.5% in the abbreviated group vs 7.7% in the standard group; P < .001 for noninferiority). Major cardiac and cerebral events were also similar (6.1% vs 5.9%; P = .001 for noninferiority). In the intention-to-treat population, patients in the abbreviated group had a reduced incidence of clinically relevant bleeding (6.5% vs 9.4%; hazard ratio 0.68; 95% CI 0.55 - 0.85; P < .001 for superiority). Of note, the number of net adverse clinical events and major cardiac and cerebral events was lower than expected, thus the trial may not have been adequately powered to show a difference if one truly exists.