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The X-VERT Trial: A comparison of oral rivaroxaban once daily with dose-adjusted Vitamin K Antagonists in patients with nonvalvular atrial fibrillation undergoing elective cardioversion

ESC Congress 2014 - Hot Line report



 

Presentation

By Riccardo Cappato, FESC (San Donato Milanese, Italy)
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List of Authors:

Riccardo Cappato 1, Michael D Ezekowitz 2, Allan L Klein 3, A. John Camm 4, Chang-Sheng Ma 5, Jean-Yves Le Heuzey 6, Mario Talajic 7, Maurício Scanavacca 8, Panos E. Vardas 9, Paulus Kirchhof 10, Melanie Hemmrich 11, Vivian Lanius 12, Isabelle Ling Meng 11, Peter Wildgoose 13, Martin van Eickels 11, Stefan H. Hohnloser 14, on behalf of the X-VeRT Investigators

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 (2 strokes) of 978 patients (0.51%) in the rivaroxaban group and in 5 (2 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, 4 patients experienced primary efficacy events following early cardioversion (0.71%) and 1 following delayed cardioversion (0.24%).
In the VKA group, 3 patients had primary efficacy events following early cardioversion (1.08%) and 2 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 6 patients (0.6%) in the rivaroxaban group and 4 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 prompter cardioversion.

Clinicaltrials.gov ID: NCT01674647


Discussion

By Christoph Bode, FESC (Freiburg, Germany)
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References


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SessionTitle:

Hot Line: Coronary artery disease and atrial fibrillation

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.