An Open-Label Randomized Trial Comparing Oral Anticoagulation with and without Single Antiplatelet Therapy in Patients with Atrial Fibrillation and Stable Coronary Artery Disease Beyond One Year after Coronary Stent Implantation: The OAC-ALONE Study

Background: Despite recommendations in the guidelines and consensus documents, there has been no randomized controlled trial evaluating oral anticoagulation (OAC) alone without antiplatelet therapy (APT) in patients with atrial fibrillation (AF) and stable coronary artery disease (CAD) beyond 1 year after coronary stenting. Methods: This study was a prospective, multicenter, open-label, non-inferiority trial, comparing OAC alone to combined OAC and single APT among AF patients beyond 1 year after stenting in a 1:1 randomization fashion. The primary endpoint was a composite of all-cause death, myocardial infarction (MI), stroke, or systemic embolism. The major secondary endpoint was a composite of primary endpoint or major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) classification. Although the trial was designed to enroll 2,000 patients during 12 months, enrollment was prematurely terminated after enrolling 696 patients in 38 months. Results: Mean age was 75.0±7.6 ...