Findings from the ENVISAGE-TAVI AF trial presented at ESC Congress 2021 and published in the New England Journal of Medicine found edoxaban was non-inferior to vitamin K antagonists (VKAs) in terms of adverse clinical events in patients with an indication for oral anticoagulation for atrial fibrillation (AFib) following TAVI. However, researchers noted an increased risk of major bleeding with edoxaban compared with VKAs, mainly due to gastrointestinal bleeding.

The trial enrolled 1,426 AFib patients from 173 medical centers in 14 countries on three continents. The average age was 82 years and 47.5% were women. Participants were randomly assigned to either edoxaban or the locally available VKA (warfarin and its analogues) between 12 hours and five days after successful completion of TAVI. The primary efficacy endpoint was a composite of adverse clinical events, including all-cause death, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis and major bleeding. The primary safety endpoint was the incidence of major bleeding according. The average follow-up was 18 months.

Overall results found the composite of adverse clinical events was 17.5% per year in the edoxaban group compared with the 16.5% per year in the VKA group. The rate of major bleeding was 9.7% per year in the edoxaban group compared with 7.0% per year in the VKA 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," said principal investigator George Dangas, MD, PhD, FACC. "On the other hand, we need to be attentive to the higher bleeding risks with edoxaban. Based on secondary analyses, it seems that lowering the edoxaban dosage when indicated and avoiding patients on mandatory antiplatelet therapy is reasonable safety advice from a clinical point of view."

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: ESC Congress, ESC21, Atrial Fibrillation, Arrhythmias, Cardiac, ACC International

< Back to Listings