Edoxaban Antithrombotic Therapy for Atrial Fibrillation and Stable Coronary Artery Disease
Min Soo Cho, Do‐Yoon Kang, Jung-Min Ahn, Sung-Cheol Yun, Yong‐Seog Oh, Chang Hoon Lee, Eue‐Keun Choi, Ji Hyun Lee, Chang Hee Kwon, Gyung‐Min Park, Hyung Oh Choi, Kyoung‐Ha Park, Kyoung‐Min Park, Jongmin Hwang, Ki‐Dong Yoo, Young–Rak Cho, Ji Hyun Kim, Ki Won Hwang, Eun‐Sun Jin, Osung Kwon, Ki‐Hun Kim, Seung-Jung Park, Duk‐Woo Park, Gi‐Byoung Nam
Abstract
BACKGROUND: Despite consistent recommendations from clinical guidelines, data from randomized trials on a long-term antithrombotic treatment strategy for patients with atrial fibrillation and stable coronary artery disease are still lacking. METHODS: -VASc score (scores range from 0 to 9, with higher scores indicating a greater risk of stroke). The primary outcome was a composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, and major bleeding or clinically relevant nonmajor bleeding at 12 months. Secondary outcomes included a composite of major ischemic events and the safety outcome of major bleeding or clinically relevant nonmajor bleeding. RESULTS: -VASc score was 4.3. At 12 months, a primary-outcome event had occurred in 34 patients (Kaplan-Meier estimate, 6.8%) assigned to edoxaban monotherapy and in 79 patients (16.2%) assigned to dual antithrombotic therapy (hazard ratio, 0.44; 95% confidence interval [CI], 0.30 to 0.65; P<0.001). The cumulative incidence of major ischemic events at 12 months appeared to be similar in the trial groups. Major bleeding or clinically relevant nonmajor bleeding occurred in 23 patients (Kaplan-Meier estimate, 4.7%) in the edoxaban monotherapy group and in 70 patients (14.2%) in the dual antithrombotic therapy group (hazard ratio, 0.34; 95% CI, 0.22 to 0.53). CONCLUSIONS: In patients with atrial fibrillation and stable coronary artery disease, edoxaban monotherapy led to a lower risk of a composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, or major bleeding or clinically relevant nonmajor bleeding at 12 months than dual antithrombotic therapy. (Funded by the CardioVascular Research Foundation and others; EPIC-CAD ClinicalTrials.gov number, NCT03718559.).