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Edoxaban monotherapy led to better health outcomes than edoxaban plus antiplatelet therapy in patients with high-risk atrial fibrillation (AF) and stable coronary artery disease (CAD) in the large EPIC-CAD trial. Ischemic event rates were similar between the two study arms, but the risk for bleeding was significantly reduced in the monotherapy arm.
In the EPIC-CAD trial (NCT03718559), 1,038 participants with high-risk AF and stable CAD were randomly assigned to edoxaban monotherapy or to dual antithrombotic therapy (i.e. edoxaban plus a single anti-platelet agent). The primary endpoint was a composite of all-cause death, stroke, systemic embolic events, myocardial infarction, unplanned urgent revascularization, major bleeding, and clinically relevant non-major bleeding after 1 year of therapy. Dr. Gi-Byoung Nam, MD, from the Ulsan University Hospital, in South Korea, presented the primary results of the study, which were simultaneously published in the New England Journal of Medicine1,2.
Dual antithrombotic therapy led to more AEs than edoxaban monotherapy, as was revealed by the primary outcome (16.2% vs 6.8%; HR 0.44; 95% CI 0.30–0.65; P<0.001)1. The incidence of major ischemic events was similar between the two study arms (1.8% vs 1.6%; HR 1.23; 95% CI 0.48–3.10), whereas major or clinically relevant non-major bleeding was more common in the dual antithrombotic therapy arm than in the monotherapy arm (14.2% vs 4.7%; HR 0.34; 95% CI 0.22−0.53).
The EPIC-CAD study suggests that edoxaban monotherapy is linked to a lower risk for adverse clinical events as compared with dual antithrombotic therapy with edoxaban and an antiplatelet agent in patients with AF and stable CAD. “The effect appeared to be driven by a decreased risk for bleeding events in the monotherapy arm,” concluded Dr. Nam.
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