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, X-VeRT Investigators

Research output: Contribution to journalArticlepeer-review

272 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)3346-55
Number of pages10
JournalEuropean Heart Journal
Volume35
Issue number47
Early online date2 Sep 2014
DOIs
Publication statusPublished - 14 Dec 2014

Keywords

  • Administration, Oral
  • Aged
  • Atrial Fibrillation
  • Electric Countershock
  • Factor Xa Inhibitors
  • Female
  • Hemorrhage
  • Humans
  • Male
  • Middle Aged
  • Morpholines
  • Stroke
  • Thiophenes
  • Thromboembolism
  • Treatment Outcome
  • Vitamin K

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