The EPIC-CAD trial, recently published in The New England Journal of Medicine, evaluated the efficacy and safety of edoxaban monotherapy compared to dual antithrombotic therapy in patients with stable coronary artery disease (CAD) and high-risk atrial fibrillation (AF). This open-label, adjudicator-masked, randomized trial involved 1,040 patients.
Key Findings:
- Primary Outcome: At 12 months, the composite of death from any cause was significantly lower in the edoxaban monotherapy group (6.8%) compared to the dual therapy group (16.2%). The hazard ratio (HR) was 0.44 (95% CI: 0.30–0.65, P < 0.001), indicating a 56% lower risk of death with edoxaban monotherapy.
- Secondary Outcomes:
- The incidence of major ischemic events (e.g., myocardial infarction, stroke, systemic embolism) was similar between both groups at 12 months.
- The risk of major bleeding or clinically relevant non-major bleeding was significantly lower in the edoxaban group (4.7%) compared to the dual therapy group (14.2%), with an HR of 0.34 (95% CI: 0.22–0.53, P < 0.001).
Conclusion:
In patients with atrial fibrillation and stable coronary artery disease, edoxaban monotherapy demonstrated a lower risk of all-cause mortality and major bleeding compared to dual antithrombotic therapy. These results suggest that edoxaban monotherapy could be a safer and more effective antithrombotic strategy in this high-risk patient population, providing protection against bleeding without compromising the prevention of ischemic events.
This trial emphasizes the potential benefits of simplifying antithrombotic regimens for patients with AF and stable CAD, focusing on reducing bleeding risks while maintaining efficacy in preventing major ischemic events.