1. Department of Cardiology, Faculty of Medicine, University of Tsukuba, Japan, Japan 2. Department of Cardiology, Ibaraki Prefectural Central Hospital, Japan. 3. Department of Biostatistics, Tsukuba Clinical Research & Development Organization, University of Tsukuba, Japan 4. Department of Biostatistics, Faculty of Medicine, University of Tsukuba, Japan
As a public service to our readership, this article - peer reviewed by the Editors of EuroIntervention - has been published immediately upon acceptance as it was received. The content of this article is the sole responsibility of the authors, and not that of the journal or its publishers.
Please note that supplementary movies are not available online at this stage. Once a paper is published in its edited and formatted form, it will be accompanied online by any supplementary movies.
Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com
Aims: We aimed to determine whether shortening the duration of P2Y12 inhibitor therapy can reduce the risk of bleeding without increasing the risk of major adverse cardiovascular events following coronary stenting in patients with atrial fibrillation (AF).
Methods and results: The SAFE-A is randomized controlled trial that compared 1-month and 6-month P2Y12 inhibitor therapy, in combination with aspirin and apixaban for patients with AF who require coronary stenting. The primary endpoint was the incidence of any bleeding events, defined as Thrombosis in Myocardial Infarction with major/minor bleeding, bleeding with various Bleeding Academic Research Consortium grades, or bleeding requiring blood transfusion within 12 months after stenting. The study aimed to enroll 600 patients, but enrollment was slow. Enrollment was terminated prematurely after enrolling 210 patients (72.7±8.2 years; 81% men). The incidence of the primary endpoint did not differ between the 1-month and 6-month groups (11.8% vs 16.0%; hazard ratio, 0.70; 95% confidence interval, 0.33–1.47; P = 0.35).
Conclusions: The study evaluated the safety of withdrawing the P2Y12 inhibitor from triple antithrombotic prescription 1 month after coronary stenting. However, enrollment was prematurely terminated because it was slow. Therefore, statistical power was not sufficient to assess the differences in the primary endpoint.