Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation

• Published in: European heart journal 2014-12, Vol.35 (47), p.3346-3355
• Main Authors: Cappato, Riccardo, Ezekowitz, Michael D, Klein, Allan L, Camm, A John, Ma, Chang-Sheng, Le Heuzey, Jean-Yves, Talajic, Mario, Scanavacca, Maurício, Vardas, Panos E, Kirchhof, Paulus, Hemmrich, Melanie, Lanius, Vivian, Meng, Isabelle Ling, Wildgoose, Peter, van Eickels, Martin, Hohnloser, Stefan H
• Format: Article
• Language: English
• Subjects: Administration, Oral; Aged; Atrial Fibrillation - therapy; Electric Countershock - methods; Factor Xa Inhibitors - administration & dosage; Factor Xa Inhibitors - adverse effects; Female; Hemorrhage - chemically induced; Humans; Male; Middle Aged; Morpholines - administration & dosage; Morpholines - adverse effects; Rivaroxaban; Stroke - prevention & control; Thiophenes - administration & dosage; Thiophenes - adverse effects; Thromboembolism - prevention & control; Treatment Outcome; Vitamin K - antagonists & inhibitors
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/ehu367

X-VeRT is the first prospective randomized trial of a novel oral anticoagulant in patients with atrial fibrillation undergoing elective cardioversion. 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). Oral rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt cardioversion. Clinicaltrials.gov; NCT01674647.