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Randomized Controlled Trial
. 2023 Jan;165(1):58-67.e4.
doi: 10.1016/j.jtcvs.2021.01.127. Epub 2021 Feb 9.

Efficacy and safety of edoxaban in patients early after surgical bioprosthetic valve implantation or valve repair: A randomized clinical trial

Chi Young Shim  1 , Jiwon Seo  1 , Young Jin Kim  2 , Seung Hyun Lee  3 , Raffaele De Caterina  4 , Sak Lee  5 , Geu-Ru Hong  6 ; Explore the Efficacy and Safety of Edoxaban in Patients after Heart Valve Repair or Bioprosthetic Valve Replacement (ENAVLE) study group
Collaborators, Affiliations
Free article
Randomized Controlled Trial

Efficacy and safety of edoxaban in patients early after surgical bioprosthetic valve implantation or valve repair: A randomized clinical trial

Chi Young Shim et al. J Thorac Cardiovasc Surg. 2023 Jan.
Free article

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 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.

Keywords: NOACs; efficacy; non-vitamin K antagonist oral anticoagulants; oral anticoagulants; safety; valve surgery; warfarin.

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Comment in

  • Commentary: The best is yet to come.
    Dufendach KA, Chu D. Dufendach KA, et al. J Thorac Cardiovasc Surg. 2023 Jan;165(1):68-69. doi: 10.1016/j.jtcvs.2021.02.028. Epub 2021 Feb 17. J Thorac Cardiovasc Surg. 2023. PMID: 33726913 No abstract available.
  • Commentary: Battle of the bioprosthetic valve blood thinners.
    Alnajar A, Rao JS, Cayetano SM, Lamelas J. Alnajar A, et al. J Thorac Cardiovasc Surg. 2023 Jan;165(1):69-70. doi: 10.1016/j.jtcvs.2021.02.064. Epub 2021 Feb 22. J Thorac Cardiovasc Surg. 2023. PMID: 33745710 No abstract available.

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