Edoxaban antithrombotic therapy in diabetic patients with atrial fibrillation and stable coronary artery disease: the EPIC-CAD trial

Abstract

Abstract Aims The appropriate antithrombotic regimen for diabetic patients with atrial fibrillation (AF) and stable coronary artery disease (CAD) who are at high atherothrombotic risk remains uncertain. We evaluated whether the effects of different antithrombotic strategies differ according to diabetes status. Methods and results The EPIC-CAD (Edoxaban versus Edoxaban with Antiplatelet Agent in Patients with Atrial Fibrillation and Chronic Stable Coronary Artery Disease) was a randomized trial comparing edoxaban monotherapy with dual antithrombotic therapy (edoxaban plus a single antiplatelet agent) in patients with AF and stable CAD. The primary outcome was a composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, and major or clinically relevant non-major bleeding at 12 months. Among 1040 randomized patients, 421 (40.5%) had diabetes. There were no differences in the incidence of the primary outcome between diabetic and non-diabetic patients [9.7% vs. 11.6%; hazard ratio (HR) 0.82; 95% confidence interval (CI) 0.56-1.20; P = 0.30]. The incidence of the primary outcome at 12 months was significantly lower with edoxaban monotherapy than with dual antithrombotic therapy in both diabetic (6.3% vs. 13.7%; HR 0.44; 95% CI 0.23-0.83; P = 0.01) and non-diabetic patients (6.7% vs. 16.3%; HR 0.39; 95% CI 0.23-0.65; P < 0.001), with no significant interaction between diabetic status and randomized treatment strategy (P for interaction = 0.78). Conclusion The risk of primary outcome was similar between diabetic and non-diabetic patients with AF and CAD. Irrespective of diabetes status, edoxaban monotherapy led to a lower risk of a primary outcome at 12 months than dual antithrombotic therapy. Clinical trial registration EPIC-CAD ClinicalTrials.gov number: NCT03718559.