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Randomized Controlled Trial
. 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

Riccardo Cappato  1 , Francis E Marchlinski  2 , Stefan H Hohnloser  3 , Gerald V Naccarelli  4 , Jim Xiang  5 , David J Wilber  6 , Chang-Sheng Ma  7 , Susanne Hess  8 , Darryl S Wells  9 , George Juang  10 , Johan Vijgen  11 , Burkhard J Hügl  12 , Richard Balasubramaniam  13 , Christian De Chillou  14 , D Wyn Davies  15 , L Eugene Fields  16 , Andrea Natale  17 ; VENTURE-AF Investigators
Affiliations
Randomized Controlled Trial

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

Riccardo Cappato et al. Eur Heart J. .

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.

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Figures

Figure 1
Figure 1
Patient disposition during the study.
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References

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