P1003Effect of concomitant antiplatelet agents on clinical outcomes in the Edoxaban versus Warfarin in subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF) randomised trial

Abstract

Background: In the ENSURE-AF study (NCT02072434), the oral factor Xa inhibitor edoxaban showed similar efficacy and safety profiles vs enoxaparin- warfarin (enox-warf) in patients undergoing electrical cardioversion of nonvalvular atrial fibrillation. Purpose: This ancillary analysis compares the primary efficacy and safety endpoints for patients receiving concomitant antiplatelet therapy (APT) vs those who did not in the ENSURE-AF study. Methods: The primary efficacy endpoint was a composite of stroke, systemic embolic events (SEE), myocardial infarction (MI), and cardiovascular death analysed during the overall study period, 28 days on study drug after cardioversion + 30 days of follow-up. The primary safety endpoint was the composite of major and clinically relevant nonmajor bleeding analysed during the on-treatment period from the time of first dose to last dose of study drug taken. Results: Of 2199 patients enrolled in ENSURE-AF, 1095 were randomised to edoxaban and 1104 to enox-warf. Patients receiving concomitant APT were older more naïve to vitamin K antagonist, had lower creatinine clearance, and more likely with medical history of coronary artery disease, hypertension, diabetes or ischemic stroke/transient ischemic attack than those who were not receiving APT. Absolute primary efficacy and safety event rates were higher in the subgroup receiving concomitant APT, however given the low overall ischemic event rates differences with regard to concomitant APT were nonsignificant (Table). Conclusion: In the ENSURE-AF study, edoxaban had comparable efficacy and safety to optimised usual anticoagulation with enox-warf. Absolute event rates were higher among patients receiving concomitant APT in both the edoxaban and enox-warf arms.