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The ENBALV study provided the first large-scale evidence of the use of DOACs in patients who receive early anticoagulant therapy after bioprosthetic valve surgery. However, the evidence appears inconclusive on whether edoxaban is a potential treatment for the population.
“The incidence of embolic events is high early after bioprosthetic valve replacement,” said Dr. Chisato Izumi, MD, PhD, from the National Cerebral and Cardiovascular Center, in Japan1. “This may be due to thrombus formation on prosthetic valves, perioperative atrial fibrillation, or cardiac dysfunction.” Dr. Izumi explained that the administration of DOACs at the time of discharge after bioprosthetic valve replacement has been increasing in clinical practice despite this being an off-label strategy.
The phase 3, investigator-initiated ENBALV trial compared the DOAC edoxaban to the vitamin K agonist warfarin in patients who underwent bioprosthetic valve replacement (n=410). Patients were randomly assigned 1:1 and received therapy for 12 weeks. The primary efficacy outcome was a composite of stroke or systemic embolism, and the key safety endpoint was major bleeding.
Only four events had occurred in the edoxaban arm and warfarin arm, respectively, not displaying a significant difference between the study drugs in the primary endpoint (0.5% vs 1.5%; risk difference -1.03; 95% CI -4.34 to 1.95). There were numerically, but not significantly, more major bleeding events in the edoxaban arm than in the warfarin arm (4.1% vs 1.0%; risk difference 3.07; 95% CI -0.67 to 7.27).
Discussant Prof. Philippe Steg, MD, from Bichat Hospital, in France, commented that the event numbers were too low to conclude that edoxaban provided comparable efficacy to warfarin. “Next to that, warfarin treatment was poorly controlled in the trial. Bleeding appeared to be more common in the edoxaban arm.” All in all, he concluded that more work needs to be done to establish DOACs as a viable treatment option early after surgery in patients who undergo bioprosthetic valve replacement procedures.
Medical writing support was provided by Robert van den Heuvel.
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