Rationale and design of the eXplore the efficacy and safety of once-daily oral riVaroxaban for the prEvention of caRdiovascular events in patients with nonvalvular aTrial fibrillation scheduled for cardioversion trial: A comparison of oral rivaroxaban once daily with dose-adjusted vitamin K antagonists in patients with nonvalvular atrial fibrillation undergoing elective cardioversion

Michael D. Ezekowitz, Riccardo Cappato, Allan L. Klein, A. John Camm, Chang Sheng Ma, Jean Yves Le Heuzey, Mario Talajic, Maurício I. Scanavacca, Panos E. Vardas, Paulus Kirchhof, Stefan H. Hohnloser, Melanie Hemmrich, Vivian Lanius, Isabelle Ling Meng, Peter Wildgoose, Martin Van Eickels

Research output: Contribution to journalArticle

Abstract

Background Anticoagulation before, during, and after cardioversion is effective in reducing stroke risk in patients with atrial fibrillation. Objective The objective of this study is to explore the efficacy and safety of rivaroxaban 20 mg once daily (15 mg if creatinine clearance is 30-49 mL/min) compared with dose-adjusted vitamin K antagonists (VKAs; international normalized ratio 2.0-3.0) in patients scheduled for elective cardioversion. Methods This is a prospective, randomized, open-label, parallel group comparison of approximately 1,500 patients from 17 countries with hemodynamically stable nonvalvular atrial fibrillation of >48 hours or unknown duration. Patients will be randomized 2:1 (rivaroxaban:VKA) using 2 cardioversion strategies: the first approach is early cardioversion with the precardioversion anticoagulation goal of 1 to 5 days using rivaroxaban or usual therapy (heparin + VKA). In these patients, transesophageal echocardiography will be encouraged to exclude atrial thrombi. The alternative approach is delayed cardioversion. Rivaroxaban or VKA will be administered for 21 to 56 days before cardioversion. All patients will receive study treatment for 6 weeks postcardioversion. The primary efficacy end point is a composite of all strokes, transient ischemic attacks, noncentral nervous system systemic emboli, myocardial infarctions, and cardiovascular deaths. Each primary end point component will be evaluated separately, and additional composites will be investigated. The principal safety end point is major bleeding. Clinical context This will be the first prospective study of a novel oral anticoagulant in the setting of cardioversion. It will provide important information regarding the use of rivaroxaban in the periods preceding and after cardioversion in a broad patient population.

Original languageEnglish
Pages (from-to)646-652
Number of pages7
JournalAmerican Heart Journal
Volume167
Issue number5
DOIs
Publication statusPublished - 2014

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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