DOAC versus VKA after bioprosthetic valve replacement
AHA 2024 – In ENBALV, treatment with edoxaban early after bioprosthethic valve replacement reduced the incidence of stroke or systemic embolism compared with warfarin.
This summary is based on the presentation of Chisato Izumi, MD, PhD (Suita, Japan) at the AHA Scientific Sessions 2024 - Efficacy and Safety of Edoxaban in Anticoagulant Therapy Early after Surgical Bioprosthetic Valve Replacement: ENBALV trial.
Introduction and methods
There is a high incidence of thromboembolic events early after bioprosthethic valve (BPV) replacement. The current guidelines recommend anticoagulation therapy with vitamin K antagonists (VKA) after BPV surgery. However, VKA have several disadvantages compared with direct oral anticoagulants (DOACs), raising the hypothesis that the availability of DOACs in this patient population could reduce the burden on patients and medical staff.
The goal of the ENBALV study was to investigate the efficacy and safety of the DOAC edoxaban compared with the VKA warfarin in patients early after BPV replacement.
ENBALV was an investigator-initiated, multicenter, randomized, open-label trial, in which 389 patients who underwent BPV replacement at the aortic and/or mitral position were randomized to edoxaban (60 mg or 30 mg) once daily or warfarin once-daily for 12 weeks.
The primary endpoint was a composite of stroke or systemic embolism. The key secondary safety endpoint was major bleeding.
Main results
- At 12 weeks, the primary outcome occurred in 1 patient (0.5%) in the edoxaban group and 3 patients (1.5%) in the warfarin group (risk difference: -1.03%; 95%CI: -4.34 to 1.95).
- There was a higher incidence of major bleeding in the edoxaban group compared with the warfarin group at 12 weeks (4.1% vs. 1.0%; risk difference: 3.07; 95%CI: -0.67 to 7.27).
- No fatal bleeding/intracranial hemorrhage was observed in the edoxaban group, whereas 1 fatal intracranial hemorrhage occurred in the warfarin group.
Conclusion
In ENBALV, treatment with edoxaban vs. warfarin reduced the primary composite endpoint of stroke or systemic embolism in patients early after BPV surgery. Edoxaban was associated with a higher incidence of major bleeding.
“Since edoxaban does not require regular and frequent blood testing, it could simplify the care process during unstable condition immediately after open-heart surgery and reduce the burden on patients and medical staff,” said Chisato Izumi.
- Our reporting is based on the information provided at the AHA Scientific Sessions 2024 -