The following is the summary of “Efficacy and safety of edoxaban in patients early after surgical bioprosthetic valve implantation or valve repair: A randomized clinical trial” published in the January 2023 issue of Thoracic and cardiovascular surgery by Shim, et al.
Patients undergoing bioprosthetic valve implantation or repair surgery should begin warfarin anticoagulation prior to surgery. It is not yet known if oral anticoagulants that do not target vitamin K can fully replace warfarin. The purpose of this study was to evaluate the efficacy and safety of edoxaban versus warfarin in patients shortly following bioprosthetic valve installation or repair surgery. This prospective, randomized (1:1), open-label clinical trial was undertaken from December 2017 through September 2019 to investigate the efficacy and safety of edoxaban in patients who had had a heart valve repair or bioprosthetic valve replacement.
For the first 3 months following bioprosthetic valve implantation or repair, patients were randomly randomized to take either edoxaban (60 mg or 30 mg once day) or warfarin. A composite of death, clinical thromboembolic events, and silent intracardiac thrombosis was used as the primary efficacy outcome. The incidence of serious bleeding was the key measure of safety. The adjusted intention-to-treat analysis comprised 218 out of 220 participants (109 in each group). In the primary efficacy outcome, 4 patients (3.7% of the total) receiving warfarin and 0 patients receiving edoxaban experienced adverse events (risk difference, -0.0367; 95% CI, -0.0720 to -0.0014; P<.001 for noninferiority).
Only 1 patient on warfarin (0.9% of patients) and 3 patients on edoxaban (2.8% of patients) had the primary safety outcome (risk difference, 0.0183; 95% CI, -0.0172 to 0.0539; P=.013 for noninferiority). During the first 3 months after surgical bioprosthetic valve implantation or repair, the risk of severe bleeding may be equivalent between edoxaban and warfarin.