Efficacy and Safety of Edoxaban in Patients Early after Surgical Bioprosthetic Valve Implantation or Valve Repair: A Randomized Clinical Trial

Abstract Objective Early warfarin anticoagulation is recommended in patients undergoing surgical bioprosthetic valve implantation or valve repair. It is unclear whether non-vitamin K antagonist oral anticoagulants can be a full alternative to warfarin. This study aimed to compare efficacy and safety of edoxaban with warfarin in patients early after surgical bioprosthetic valve implantation or valve repair. Methods The Explore the efficacy and safety of edoxabaN in patients After heart Valve repair or bioprosthetic vaLve rEplacement (ENAVLE) study was a prospective, randomized (1:1), open-label, clinical trial conducted from December 2017 to September 2019. Patients were randomly assigned to receive edoxaban (60 mg or 30 mg once daily) or warfarin for the first 3 months after surgical bioprosthetic valve implantation or valve repair. The primary efficacy outcome was a composite of death, clinical thromboembolic events or asymptomatic intracardiac thrombosis. The primary safety outcome was the occurrence of major bleeding. Results Of 220 participants, 218 (109 per group) were included in the modified intention-to-treat analysis. The primary efficacy outcome occurred in 4 patients (3.7%) taking warfarin and none taking edoxaban [risk difference, −0.0367; 95% confidence interval [CI], -0.0720 to -0.0014; P Conclusions Edoxaban is noninferior to warfarin for preventing thromboembolism and is potentially comparable for risk of major bleeding in the first 3 months after surgical bioprosthetic valve implantation or valve repair. Clinical trial registration Clinicaltrials.gov Identifier: NCT03244319.