BACKGROUND: Among patients with atrial fibrillation and stable coronary artery disease, those with histories of atherothrom-botic disease are at high-risk for future ischemic events. This study investigated the efficacy and safety of rivaroxaban mono-therapy in patients with atrial fibrillation, coronary artery disease, and histories of atherothrombotic disease. METHODS AND RESULTS: This was a post hoc subanalysis of the AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial. Patients with non-valvular atrial fibrillation and coronary artery disease were recruited and randomized to receive the rivaroxaban monotherapy or combination therapy with rivaroxaban plus antiplatelet drug. For the purpose of this sub-study, participants were divided into 2 subgroups, including the atherothrom-bosis group (those with histories of myocardial infarction, stroke, and/or peripheral artery disease; n=1052, 47.5%) and non-atherothrombosis group (n=1163, 52.5%). The efficacy end point included cardiovascular events or all-cause death, while the safety end point was major bleeding. Net adverse events consisted of all-cause death, myocardial infarction, stroke, or major bleeding. In the atherothrombosis group, rivaroxaban monotherapy was significantly associated with a lower risk of net adverse events when compared with combination therapy (hazard ratio [HR], 0.50; 95% CI, 0.34– 0.74; P<0.001), with a decrease in both efficacy (HR, 0.68; 95% CI, 0.47– 0.99; P=0.044) and safety (HR, 0.37; 95% CI, 0.19– 0.71; P=0.003) end points. By contrast, there were no differences between treatment outcomes for the non-atherothrombosis group. CONCLUSIONS: Rivaroxaban monotherapy significantly reduced net adverse events as compared with combination therapy for patients with atrial fibrillation, coronary artery disease, and prior atherothrombotic disease. REGISTRATION: URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000016612. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02642419.
All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine