Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk

作者：Marco Valgimigli, Enrico Frigoli, Dik Heg, Jan G.P. Tijssen, Peter Jüni, Pascal Vranckx, Yukio Ozaki, Marie‐Claude Morice, Bernard Chevalier, Yoshinobu Onuma, Stephan Windecker, Pim A.L. Tonino, Marco Roffi, Maciej Lesiak, Felix Mahfoud, Jozef Bartúnek, David Hildick‐Smith, Antonio Hugo Bezerra Colombo, Goran R. Stankovic, Andrés Íñiguez, Carl Johann Schultz, Ran Kornowski, Paul Jau Lueng Ong, Mirvat A. Alasnag, Alfredo E. Rodríguez, Aris Moschovitis, Peep Laanmets, Michael Edward Donahue, Sergio Leonardi, Pieter Cornelis Smits · 发表于：New England Journal of Medicine · 年份：2021 · DOI：10.1056/nejmoa2108749 · 被引用次数：589 · 研究领域：Antiplatelet Therapy and Cardiovascular Diseases、Atrial Fibrillation Management and Outcomes、Coronary Interventions and Diagnostics

BACKGROUND: The appropriate duration of dual antiplatelet therapy in patients at high risk for bleeding after the implantation of a drug-eluting coronary stent remains unclear. METHODS: One month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, we randomly assigned patients at high bleeding risk to discontinue dual antiplatelet therapy immediately (abbreviated therapy) or to continue it for at least 2 additional months (standard therapy). The three ranked primary outcomes were net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding; cumulative incidences were assessed at 335 days. The first two outcomes were assessed for noninferiority in the per-protocol population, and the third outcome for superiority in the intention-to-treat population. RESULTS: Among the 4434 patients in the per-protocol population, net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and in 172 (7.7%) in the standard-therapy group (difference, -0.23 percentage points; 95% confidence interval [CI], -1.80 to 1.33; P<0.001 for noninferiority). A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cereb...