title: Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation.
abstract: OBJECTIVE
  X-VeRT is the first prospective randomized trial of a novel oral anticoagulant in patients with atrial fibrillation undergoing elective cardioversion.
  
  
  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).
  
  
  CONCLUSIONS
  Oral rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt cardioversion.
  Clinicaltrials.gov;
  
  
  BACKGROUND
  NCT01674647.
authors.affiliation: Arrhythmia and Electrophysiology Center, University of Milan, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Cappato
authors.affiliation: The Sidney Kimell Medical College at Thomas Jefferson University, 1999 Sproul Rd, Suite 25, Broomall, PA 19008, USA michael.ezekowitz@comcast.net.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Ezekowitz
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic Heart and Vascular Institute, Cleveland, OH, USA.
authors.forename: Allan L
authors.initials: AL
authors.lastname: Klein
authors.affiliation: Division of Clinical Sciences, St George's, University of London, London, UK.
authors.forename: A John
authors.initials: AJ
authors.lastname: Camm
authors.affiliation: Cardiology Division, Beijing AnZhen Hospital, Capital Medical University, Beijing, China.
authors.forename: Chang-Sheng
authors.initials: CS
authors.lastname: Ma
authors.affiliation: Division of Cardiology and Arrhythmology, Hôpital Européen Georges Pompidou, Université Paris V René-Descartes, Paris, France.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Le Heuzey
authors.affiliation: Department of Medicine, Research Center, Montreal Heart Institute, Université de Montréal, Montreal, Canada.
authors.forename: Mario
authors.initials: M
authors.lastname: Talajic
authors.affiliation: Arrhythmia Clinical Unit of Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil.
authors.forename: Maurício
authors.initials: M
authors.lastname: Scanavacca
authors.affiliation: Department of Cardiology, Heraklion University Hospital, Heraklion (Crete), Greece.
authors.forename: Panos E
authors.initials: PE
authors.lastname: Vardas
authors.affiliation: Centre 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.
authors.forename: Paulus
authors.initials: P
authors.lastname: Kirchhof
authors.affiliation: Global Medical Affairs, Bayer HealthCare, Berlin, Germany.
authors.forename: Melanie
authors.initials: M
authors.lastname: Hemmrich
authors.affiliation: Global Research and Development Statistics, Bayer HealthCare, Berlin, Germany.
authors.forename: Vivian
authors.initials: V
authors.lastname: Lanius
authors.affiliation: Global Medical Affairs, Bayer HealthCare, Berlin, Germany.
authors.forename: Isabelle Ling
authors.initials: IL
authors.lastname: Meng
authors.affiliation: Janssen Scientific Affairs, LLC, Raritan, NJ, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Wildgoose
authors.affiliation: Global Medical Affairs, Bayer HealthCare, Berlin, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: van Eickels
authors.affiliation: Department of Cardiology, Division of Clinical Electrophysiology, J.W. Goethe University, Frankfurt, Germany.
authors.forename: Stefan H
authors.initials: SH
authors.lastname: Hohnloser
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001281:Atrial Fibrillation / Q000628:therapy*; D004554:Electric Countershock / Q000379:methods*; D065427:Factor Xa Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage* / Q000009:adverse effects; D000069552:Rivaroxaban; D020521:Stroke / Q000517:prevention & control; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D013923:Thromboembolism / Q000517:prevention & control; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors*
chemical_list: D065427:Factor Xa Inhibitors; D009025:Morpholines; D013876:Thiophenes; D014812:Vitamin K; D000069552:Rivaroxaban
keywords: Cardioversion; Oral anticoagulant; Stroke; Thromboembolism