- Question
- In patients with atrial fibrillation and stable coronary artery disease, is edoxaban monotherapy better than edoxaban combined with an antiplatelet agent?
- Design
- Multicenter, randomized, open-label, adjudicator-masked trial conducted at 18 sites in South Korea, with 1040 patients assigned to one of two groups and followed for 12 months.
- Population
- Adults with atrial fibrillation and stable coronary artery disease (previously revascularized or medically managed); mean age 72.1 years, 22.9% women, and mean CHA2DS2-VASc score of 4.3.
- Intervention
- Edoxaban monotherapy (524 patients).
- Control
- Dual antithrombotic therapy: edoxaban plus a single antiplatelet agent (516 patients).
- Primary outcome
- Composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, and major or clinically relevant nonmajor bleeding at 12 months.
- Results
- The primary outcome occurred in 34 patients (Kaplan-Meier estimate 6.8%) on monotherapy and 79 (16.2%) on dual therapy (HR 0.44; 95% CI 0.30 to 0.65; P<0.001). The incidence of major ischemic events at 12 months was similar between groups.
- Safety
- Major or clinically relevant nonmajor bleeding occurred in 23 patients (4.7%) on monotherapy and 70 (14.2%) on dual therapy (HR 0.34; 95% CI 0.22 to 0.53).
- Conclusion
- In patients with atrial fibrillation and stable coronary artery disease, edoxaban monotherapy lowered the risk of the composite of clinical events and bleeding at 12 months compared with dual antithrombotic therapy.
- Why it matters
- It provided randomized evidence on a question previously informed mostly by recommendations and observational data, supporting routine avoidance of an added antiplatelet agent in this population to reduce bleeding without increasing major ischemic events.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026