Edoxaban is “noninferior” to warfarin and other vitamin K antagonists (VKAs) as a treatment option for patients with atrial fibrillation (AFib) after transcatheter aortic valve replacement (TAVR), according to new findings presented at ESC Congress 2021.
The analysis, which was also published in the New England Journal of Medicine, examined data from nearly 1,500 AFib patients who were chosen at random to either receive edoxaban, a direct oral anticoagulant (DOAC), or a VKA.
All patients underwent a successful TAVR procedure. The mean patient age was 82.1 years old, and 52.5% were men. The average follow-up period was 18 months.
A previous study had found that edoxaban was noninferior to warfarin in the prevention of stroke, the authors explained, but that analysis had not included TAVR patients.
The rate of the study’s primary outcome—a composite of all-cause mortality, myocardial infarction, stroke, thromboembolism, valve thrombosis and major bleeding—was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the VKA group. The authors did note, however, that the major bleeding rate on its own was much higher in the edoxaban group.
“Overall, this trial showed the noninferiority of edoxaban compared to warfarin (or similar analogues) with respect to the composite efficacy endpoint of adverse clinical events,” principal investigator George Dangas, MD, PhD, of the Zena and Michael A. Wiener Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai, said in a statement. “On the other hand, we need to be attentive to the higher bleeding risks with edoxaban.”
Read the full study in the New England Journal of Medicine here. More information related to ESC Congress 2021, a virtual conference hosted by the European Society of Cardiology, is available here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.