Physicians' Academy for Cardiovascular Education

NOAC non-inferior to VKA for net adverse clinical events in AF patients after TAVI

News - Aug. 28, 2021

Edoxaban Versus Vitamin K Antagonists After Transcatheter Aortic Valve Implantation in Patients with Atrial Fibrillation – The ENVISAGE-TAVI AF Trial

Presented at the ESC congress 2021 by: George Dangas, MD, PhD New York, NY, USA

Introduction and methods

The ENVISAGE-TAVI AF trial was a prospective, open-label, blinded evaluation, non-inferiority trial that compared edoxaban-based regimen vs. VKA-based regimen in AF patients. Patients who underwent successful completion of TAVI were enrolled and randomized from evening of TAVI to 5 days to either edoxaban 60 mg/day with or without antiplatelet therapy or to vitamin K antagonists (with a target INR of 2-3) with or without antiplatelet therapy. Primary endpoint was net adverse clinical events (NACE), including ischemic and bleeding endpoints. Safety endpoint was major bleeding.

Main results


This non-inferiority trial demonstrated that edoxaban resulted in similar rate of NACE as VKA in AF patients who had undergone successful TAVI. Major bleeding rates were higher in those receiving edoxaban, which were mainly driven by major GI bleeding.

The results of were simultaneously presented in N Eng J Med

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