• European heart journal · Dec 2014

    Randomized Controlled Trial Multicenter Study Comparative Study

    Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation.

    • Riccardo Cappato, Michael D Ezekowitz, Allan L Klein, A John Camm, Chang-Sheng Ma, Jean-Yves Le Heuzey, Mario Talajic, Maurício Scanavacca, Panos E Vardas, Paulus Kirchhof, Melanie Hemmrich, Vivian Lanius, Isabelle Ling Meng, Peter Wildgoose, Martin van Eickels, Stefan H Hohnloser, and X-VeRT Investigators.
    • Arrhythmia and Electrophysiology Center, University of Milan, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.
    • Eur. Heart J. 2014 Dec 14; 35 (47): 3346-55.

    AimsX-VeRT is the first prospective randomized trial of a novel oral anticoagulant in patients with atrial fibrillation undergoing elective cardioversion.Methods And ResultsWe assigned 1504 patients to rivaroxaban (20 mg once daily, 15 mg if creatinine clearance was between 30 and 49 mL/min) or dose-adjusted vitamin K antagonists (VKAs) in a 2:1 ratio. Investigators selected either an early (target period of 1-5 days after randomization) or delayed (3-8 weeks) cardioversion strategy. The primary efficacy outcome was the composite of stroke, transient ischaemic attack, peripheral embolism, myocardial infarction, and cardiovascular death. The primary safety outcome was major bleeding. The primary efficacy outcome occurred in 5 (two strokes) of 978 patients (0.51%) in the rivaroxaban group and in 5 (two strokes) of 492 patients (1.02%) in the VKA group [risk ratio 0.50; 95% confidence interval (CI) 0.15-1.73]. In the rivaroxaban group, four patients experienced primary efficacy events following early cardioversion (0.71%) and one following delayed cardioversion (0.24%). In the VKA group, three patients had primary efficacy events following early cardioversion (1.08%) and two following delayed cardioversion (0.93%). Rivaroxaban was associated with a significantly shorter time to cardioversion compared with VKAs (P < 0.001). Major bleeding occurred in six patients (0.6%) in the rivaroxaban group and four patients (0.8%) in the VKA group (risk ratio 0.76; 95% CI 0.21-2.67).ConclusionOral rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt cardioversion.Name Of The Trial RegistryClinicaltrials.gov;Trial Registration NumberNCT01674647.Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

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