Edoxaban was comparable to warfarin in preventing stroke or systemic embolism and intracardiac thrombus in patients with non-valvular atrial fibrillation (AFib) within three months after bioprosthetic valve surgery, based on preliminary findings from the ENBALV trial presented at AHA 2024.

The randomized, multi-center trial out of Japan randomized approximately 400 adults who had bioprosthetic heart valve replacement surgery at the aortic and/or mitral position to receive either edoxaban (60 mg or 30 mg taken orally, once daily) or warfarin for 12 weeks following surgery.

Results found edoxaban was equally or more effective than warfarin at preventing stroke and blood clots. According to researchers, 0.5% of patients receiving edoxaban experienced a stroke or systemic embolism compared with 1.5% of patients receiving warfarin. The incidence of major bleeding and clinically relevant bleeding was numerically higher in patients assigned to the edoxaban group compared with the warfarin group, however, no fatal bleeding or intracranial hemorrhage was observed with edoxaban. One fatal intracranial hemorrhage occurred in the warfarin group.

"Our findings show that edoxaban could help prevent blood clots and stroke as effectively as warfarin, indicating it may be a viable post-surgery treatment alternative to consider for patients who have received a bioprosthetic heart valve replacement," said lead study author Chisato Izumi, MD, PhD. "Edoxaban could make life easier for patients recovering from heart valve surgery. Since this medication does not require regular blood tests to monitor anticoagulation activity and can be taken in a fixed dose, without fears of interaction with food or other medications, it reduces the burden on patients and improves their quality of life, especially in those crucial first few months after surgery."

Looking ahead, Izumi and colleagues note that future research is needed to understand which patients have the highest risk of bleeding with the use of edoxaban and how to mitigate this risk while still offering effective treatment options in post-surgery treatment and recovery. They add that the effectiveness and safety of other direct oral anticoagulants besides edoxaban also warrants further investigation.