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Eur Heart J. 2014 Dec 14;35(47):3346-55. doi: 10.1093/eurheartj/ehu367. Epub 2014 Sep 2.

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

Author information

  • 1Arrhythmia and Electrophysiology Center, University of Milan, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.
  • 2The Sidney Kimell Medical College at Thomas Jefferson University, 1999 Sproul Rd, Suite 25, Broomall, PA 19008, USA michael.ezekowitz@comcast.net.
  • 3Department of Cardiovascular Medicine, Cleveland Clinic Heart and Vascular Institute, Cleveland, OH, USA.
  • 4Division of Clinical Sciences, St George's, University of London, London, UK.
  • 5Cardiology Division, Beijing AnZhen Hospital, Capital Medical University, Beijing, China.
  • 6Division of Cardiology and Arrhythmology, Hôpital Européen Georges Pompidou, Université Paris V René-Descartes, Paris, France.
  • 7Department of Medicine, Research Center, Montreal Heart Institute, Université de Montréal, Montreal, Canada.
  • 8Arrhythmia Clinical Unit of Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil.
  • 9Department of Cardiology, Heraklion University Hospital, Heraklion (Crete), Greece.
  • 10Centre for Cardiovascular Sciences, School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK SWBH NHS Trust, Birmingham, UK Department of Cardiovascular Medicine, Hospital of the University of Münster, Münster, Germany.
  • 11Global Medical Affairs, Bayer HealthCare, Berlin, Germany.
  • 12Global Research and Development Statistics, Bayer HealthCare, Berlin, Germany.
  • 13Janssen Scientific Affairs, LLC, Raritan, NJ, USA.
  • 14Department of Cardiology, Division of Clinical Electrophysiology, J.W. Goethe University, Frankfurt, Germany.

Abstract

AIMS:

X-VeRT is the first prospective randomized trial of a novel oral anticoagulant in patients with atrial fibrillation undergoing elective cardioversion.

METHODS AND RESULTS:

We 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).

CONCLUSION:

Oral rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt cardioversion.

NAME OF THE TRIAL REGISTRY:

Clinicaltrials.gov;

TRIAL REGISTRATION NUMBER:

NCT01674647.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

KEYWORDS:

Cardioversion; Oral anticoagulant; Stroke; Thromboembolism

PMID:
25182247
[PubMed - indexed for MEDLINE]
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