Edoxaban for the Prevention of Thromboembolism in Patients with AtrialFibrillation and Bioprosthetic Valves.

Abstract

Atrial fibrillation (AF) and valvular heart disease (VHD) frequently coexist and independently increase mortality1. Bioprosthetic valve implantation (surgical or transcatheter), is a common, increasingly utilized treatment for VHD2. Patients with AF and bioprosthetic valves require anticoagulation to prevent thromboembolic events. Non-vitamin K oral anticoagulants (NOACs) are safe and efficacious alternatives to vitamin K antagonists for anticoagulation in AF. However, guidelines recommend against NOACs in patients with bioprosthetic valves, citing a lack of supporting data. Only one of the first three warfarin-controlled pivotal NOAC trials in AF included patients with bioprosthetic valves (n>80)3. The Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial, which compared edoxaban (a direct oral factor Xa inhibitor) to warfarin in AF patients4, did not exclude patients with bioprosthetic valves, thus providing an opportunity to analyze this high-risk subgroup.