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 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, –0.0720 to –0.0014; P < .001 for noninferiority). The primary safety outcome occurred in 1 patient (0.9%) taking warfarin and 3 patients (2.8%) taking edoxaban (risk difference, 0.0183; 95% confidence interval, –0.0172 to 0.0539; P = .013 for noninferiority). Conclusions: Edoxaban is noninferior to warfarin for preventing thromboembolism and is potentially comparable for risk of major bleeding during the first 3 months after surgical bioprosthetic valve implantation or valve repair.
|Journal||Journal of Thoracic and Cardiovascular Surgery|
|Publication status||Published - 2023 Jan|
Bibliographical noteFunding Information:
The ENAVLE study was supported by a research grant from Daiichi-Sankyo . All analyses were conducted independently, and all authors had full access to the data. The authors are fully responsible for the study design; the collection, analysis, and interpretation of the data; and the writing of the manuscript. The sponsor played no role in the decision to submit the manuscript for publication.
Dr De Caterina reports institutional grants from BMS / Pfizer and Daiichi-Sankyo ; consultancy and speaker's fees from Boehringer-Ingelheim, Bayer, BMS/Pfizer, Daiichi Sankyo, Novartis, Portola, and Roche. All other authors reported no conflicts of interest.
© 2021 The American Association for Thoracic Surgery
All Science Journal Classification (ASJC) codes
- Pulmonary and Respiratory Medicine
- Cardiology and Cardiovascular Medicine