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, Mauricio Scanavacca, Panos E. Vardas, Paulus Kirchhof, Melanie Hemmrich, Vivian Lanius, Isabelle Ling Meng, Peter Wildgoose, Martin Van Eickels, Stefan H. Hohnloser

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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.

Original languageEnglish
Pages (from-to)3346-3355
Number of pages10
JournalEuropean Heart Journal
Volume35
Issue number47
DOIs
Publication statusPublished - Dec 14 2014

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Keywords

  • Cardioversion
  • Oral anticoagulant
  • Stroke
  • Thromboembolism

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

Cappato, R., Ezekowitz, M. D., Klein, A. L., Camm, A. J., Ma, C. S., Le Heuzey, J. Y., Talajic, M., Scanavacca, M., Vardas, P. E., Kirchhof, P., Hemmrich, M., Lanius, V., Meng, I. L., Wildgoose, P., Van Eickels, M., & Hohnloser, S. H. (2014). Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation. European Heart Journal, 35(47), 3346-3355. https://doi.org/10.1093/eurheartj/ehu367