Cited by 422Atrial Fibrillation Management and OutcomesCardiac Arrhythmias and TreatmentsVenous Thromboembolism Diagnosis and Management

Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation

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Cappato, Riccardo, Marchlinski, Francis E., Hohnloser, Stefan H., Naccarelli, Gerald V., Xiang, Jim, Wilber, David J., Ma, Chang-Sheng, Hess, Susanne +9 more·2015·European Heart Journal

Abstract

AIMS: VENTURE-AF is the first prospective randomized trial of uninterrupted rivaroxaban and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) undergoing catheter ablation (CA). METHODS AND RESULTS: Trial size was administratively set at 250, the protocol-specified target. Events were independently and blindly adjudicated. We randomly assigned 248 NVAF patients to uninterrupted rivaroxaban (20 mg once-daily) or to an uninterrupted VKA prior to CA and for 4 weeks afterwards. The primary endpoint was major bleeding events after CA. Secondary endpoints included thromboembolic events (composite of stroke, systemic embolism, myocardial infarction, and vascular death) and other bleeding or procedure-attributable events. Patients were 59.5 ± 10 years of age, 71% male, 74% paroxysmal AF, and had a CHA2DS2-VASc score of 1.6. The average total heparin dose used to manage activated clotting time (ACT) was slightly higher (13 871 vs. 10 964 units; P < 0.001) and the mean ACT level attained slightly lower (302 vs. 332 s; P < 0.001) in rivaroxaban and VKA arms, respectively. The incidence of major bleeding was low (0.4%; 1 major bleeding event). Similarly, thromboembolic events were low (0.8%; 1 ischemic stroke and 1 vascular death). All events occurred in the VKA arm and all after CA. The number of any adjudicated events (26 vs. 25), any bleeding events (21 vs. 18), and any other procedure-attributable events (5 vs. 5) were similar. CONCLUSION: In patients undergoing CA for AF, the use of uninterrupted oral rivaroxaban was feasible and event rates were similar to those for uninterrupted VKA therapy. NAME OF THE TRIAL REGISTRY: Clinicaltrials.gov trial registration number is NCT01729871.

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Authors
Cappato, R., Marchlinski, F. E., Hohnloser, S. H., Naccarelli, G. V., Xiang, J., Wilber, D. J., Ma, C.-S., Hess, S., Wells, D. S., Juang, G., Vijgen, J., Hügl, B. J., Balasubramaniam, R., De Chillou, C., Davies, D. W., Fields, L. E., & Natale, A.
Affiliations
  • Centro Cardiologico Monzino (IT)
  • Hospital of the University of Pennsylvania (US)
  • Goethe University Frankfurt (DE)
  • Pennsylvania State University (US)
  • Janssen (United States) (US)
  • Loyola University Chicago (US)
  • Bayer (Germany) (DE)
  • Jessa Hospital (BE)
  • Royal Bournemouth Hospital (GB)
  • St Mary's Hospital (GB)
  • Johnson & Johnson (Germany) (DE)
  • St David's Medical Center (US)
Corresponding author
Natale, Andrea
Venue
European Heart Journal
Published
2015-05-14
Volume
36
Issue
28
Pages
1805-1811
ISSN
  • 0195-668X (ISSN-L)
  • 1522-9645
OpenAlex
W2120775803
Cited by
422
References
32
Citations by year
2026: 7 · 2025: 16 · 2024: 24 · 2023: 22 · 2022: 27 · 2021: 43 · 2020: 54 · 2019: 46 · 2018: 74 · 2017: 50 · 2016: 42 · 2015: 16 · 2014: 1
FWCI
44.06
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • European Heart Journal (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • HAL (submittedVersion)
Funders
  • Janssen Scientific Affairs
  • Bayer HealthCare
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Arrhythmias and Treatments
  • Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
Keywords
rivaroxaban, vitamin K antagonists, non-valvular atrial fibrillation, catheter ablation, oral anticoagulation, major bleeding, thromboembolic events, activated clotting time, heparin
MeSH terms
Rivaroxaban, Anti-Arrhythmia Agents, Atrial Fibrillation, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Prospective Studies, Pulmonary Veins, Recurrence, Reoperation, Vitamin K, Single-Blind Method, Blood Loss, Surgical, Treatment Outcome, Catheter Ablation, Operative Time, Factor Xa Inhibitors

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