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Eur Heart J. 2015 Jul 21;36(28):1805-11. doi: 10.1093/eurheartj/ehv177. Epub 2015 May 14.

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

Author information

1
Arrhythmia and Electrophysiology Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy Gavazzeni Hospital, Second Arrhythmia and EP Unit, Bergamo, Italy.
2
Section of Cardiac Electrophysiology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
3
Department of Cardiology, Division of Clinical Electrophysiology, JW Goethe University, Frankfurt, Germany.
4
Heart and Vascular Institute, Penn State University College of Medicine, Hershey, PA, USA.
5
Biostatistics and Programming, Janssen Research & Development, LLC, Raritan, NJ, USA.
6
Department of Medicine, Cardiovascular Institute, Loyola University, Chicago, IL, USA.
7
Cardiology Division, Beijing AnZhen Hospital, Capital Medical University (CMU), Beijing, China.
8
Medical Affairs, Bayer Healthcare Pharmaceuticals, Berlin, Germany.
9
Cardiac Electrophysiology, Swedish Heart & Vascular Institute, Seattle, WA, USA.
10
Heart and Arrhythmia Care of New York, Manhasset, NY, USA.
11
Division of Cardiac Electrophysiology, Jessa Hospitals, Hasselt, Belgium.
12
Department of Cardiology and Rhythmology, Marienhaus Klinikum St. Elisabeth, Neuwied, Germany.
13
Department of Cardiology, Royal Bournemouth Hospital, Bournemouth, United Kingdom.
14
Départment de Cardiologie, CHU de Nancy, Nancy, France.
15
Waller Department of Cardiology, St. Mary's Hospital, Imperial College NHS Trust, London, United Kingdom.
16
Medical Affairs, Janssen Scientific Affairs, LLC, Raritan, NJ, USA.
17
Texas Cardiac Arrhythmia Institute at St. David's Medical Center, 3000 N. I-35, Suite 720, Austin, TX 78705, USA dr.natale@gmail.com.

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.

KEYWORDS:

Atrial fibrillation; Catheter ablation; Oral anticoagulant; Thromboembolism; Uninterrupted

PMID:
25975659
PMCID:
PMC4508487
DOI:
10.1093/eurheartj/ehv177
[Indexed for MEDLINE]
Free PMC Article

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