Edoxaban versus enoxaparin –warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial

Publication date: Available online 30 August 2016 Source:The Lancet Author(s): Andreas Goette, Jose L Merino, Michael D Ezekowitz, Dmitry Zamoryakhin, Michael Melino, James Jin, Michele F Mercuri, Michael A Grosso, Victor Fernandez, Naab Al-Saady, Natalya Pelekh, Bela Merkely, Sergey Zenin, Mykola Kushnir, Jindrich Spinar, Valeriy Batushkin, Joris R de Groot, Gregory Y H Lip Background Edoxaban, an oral factor Xa inhibitor, is non-inferior for prevention of stroke and systemic embolism in patients with atrial fibrillation and is associated with less bleeding than well controlled enoxaparin–warfarin therapy. Few safety data about edoxaban in patients undergoing electrical cardioversion are available. Methods We did a multicentre, prospective, randomised, open-label, blinded-endpoint evaluation trial in 19 countries with 239 sites comparing edoxaban 60 mg per day with enoxaparin–warfarin in patients undergoing electrical cardioversion of non-valvular atrial fibrillation. The dose of edoxaban was reduced to 30 mg per day if one or more factors (creatinine clearance 15–50 mL/min, low bodyweight [≤60 kg], or concomitant use of P-glycoprotein inhibitors) were present. Block randomisation (block size four)—stratified by cardioversion approach (transoesophageal echocardiography [TEE] or not), anticoagulant experience, selected edoxaban dose, and region—was done through a voice-web system. The primary efficacy endpoint was a composite of stroke, system...
Source: The Lancet - Category: Journals (General) Source Type: research