The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Short-Duration Triple Antithrombotic Therapy for Atrial Fibrillation Patients Who Require Coronary Stenting: Results of the SAFE-A Study

DOI: 10.4244/EIJ-D-19-00920

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
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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.

 

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