Clinical question: How does edoxaban compare with enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing cardioversion?
Background: Studies on non–vitamin K antagonist oral anticoagulants (NOACs) for patients with nonvalvular atrial fibrillation undergoing cardioversion are limited.
Study design: Multicenter, prospective, randomized trial.
Setting: Nineteen countries at 239 study sites.
Synopsis: This trial compared edoxaban with enoxaparin-warfarin. The study was stratified by cardioversion approach, anticoagulant experience, selected edoxaban dose, and region. There were 2,199 patients, mean age was 64, mean CHA2DS2-VASc score was 2.6, and mean therapeutic time on warfarin was 70.8%.
The primary efficacy endpoint was a composite of stroke, systemic emboli, myocardial infarction, and cardiovascular mortality, which occurred in 5 (1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin-warfarin group (odds ratio, 0.46; 95% CI, 0.12-1.43).
The primary safety endpoint was major and clinically relevant nonmajor bleeding for patients receiving at least one dose of the study drug, occurring in 16 (1%) of 1,067 patients given edoxaban versus 11 (1%) of 1,082 patients given enoxaparin-warfarin (OR, 1.48; 95% CI, 0.64-3.55).
Bottom line: In patients with nonvalvular atrial fibrillation undergoing cardioversion, edoxaban had low rates of major bleeding and thromboembolism similar to enoxaparin-warfarin therapy.
Citation: Goette A, Merino JL, Ezekowitz MD, et al. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016;388(10055):1995-2003.
Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.