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

doi:10.1093/eurheartj/ehu367

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

Cardiovascular Sciences

Research output: Contribution to journal › Article › peer-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 language	English
Pages (from-to)	3346-55
Number of pages	10
Journal	European Heart Journal
Volume	35
Issue number	47
Early online date	2 Sept 2014
DOIs	https://doi.org/10.1093/eurheartj/ehu367
Publication status	Published - 14 Dec 2014

Bibliographical note

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

Access to Document

10.1093/eurheartj/ehu367

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., & X-VeRT Investigators (2014). Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation. European Heart Journal, 35(47), 3346-55. https://doi.org/10.1093/eurheartj/ehu367

@article{d55e8273788d4a758398432edaa4628a,

title = "Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation",

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.",

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",

author = "Riccardo Cappato and Ezekowitz, {Michael D} and Klein, {Allan L} and Camm, {A John} and Chang-Sheng Ma and {Le Heuzey}, Jean-Yves and Mario Talajic and Maur{\'i}cio Scanavacca and Vardas, {Panos E} and Paulus Kirchhof and Melanie Hemmrich and Vivian Lanius and Meng, {Isabelle Ling} and Peter Wildgoose and {van Eickels}, Martin and Hohnloser, {Stefan H} and {X-VeRT Investigators}",

year = "2014",

month = dec,

day = "14",

doi = "10.1093/eurheartj/ehu367",

language = "English",

volume = "35",

pages = "3346--55",

journal = "European Heart Journal",

issn = "0195-668X",

publisher = "Oxford University Press",

number = "47",

}

Cappato, R, Ezekowitz, MD, Klein, AL, Camm, AJ, Ma, C-S, Le Heuzey, J-Y, Talajic, M, Scanavacca, M, Vardas, PE, Kirchhof, P, Hemmrich, M, Lanius, V, Meng, IL, Wildgoose, P, van Eickels, M, Hohnloser, SH & X-VeRT Investigators 2014, 'Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation', European Heart Journal, vol. 35, no. 47, pp. 3346-55. https://doi.org/10.1093/eurheartj/ehu367

TY - JOUR

T1 - Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation

AU - Cappato, Riccardo

AU - Ezekowitz, Michael D

AU - Klein, Allan L

AU - Camm, A John

AU - Ma, Chang-Sheng

AU - Le Heuzey, Jean-Yves

AU - Talajic, Mario

AU - Scanavacca, Maurício

AU - Vardas, Panos E

AU - Kirchhof, Paulus

AU - Hemmrich, Melanie

AU - Lanius, Vivian

AU - Meng, Isabelle Ling

AU - Wildgoose, Peter

AU - van Eickels, Martin

AU - Hohnloser, Stefan H

AU - X-VeRT Investigators

PY - 2014/12/14

Y1 - 2014/12/14

N2 - 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.

AB - 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.

KW - Administration, Oral

KW - Aged

KW - Atrial Fibrillation

KW - Electric Countershock

KW - Factor Xa Inhibitors

KW - Female

KW - Hemorrhage

KW - Humans

KW - Male

KW - Middle Aged

KW - Morpholines

KW - Stroke

KW - Thiophenes

KW - Thromboembolism

KW - Treatment Outcome

KW - Vitamin K

U2 - 10.1093/eurheartj/ehu367

DO - 10.1093/eurheartj/ehu367

M3 - Article

C2 - 25182247

SN - 0195-668X

VL - 35

SP - 3346

EP - 3355

JO - European Heart Journal

JF - European Heart Journal

IS - 47

ER -

Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation

Abstract

Bibliographical note

Keywords

Access to Document

Fingerprint

Cite this