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

Abstract

AimsVENTURE-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 resultsTrial 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.ConclusionIn 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 RegistryClinicaltrials.gov trial registration number is NCT01729871.

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

“…W obserwacyjnych kohortach pacjentów poddawanych ablacji przezcewnikowej w doświadczonych ośrodkach, u których stosowano nieprzerwane leczenie za pomocą NOAC, nie uzyskano danych wskazujących na niekorzystny wpływ takiego postępowania na bezpieczeństwo leczenia [761,763,766,767]. Wyniki pierwszej kontrolowanej próby klinicznej, w której porównywano nieprzerwane leczenie za pomocą NOAC i VKA u pacjentów poddawanych ablacji AF, do której włączono ok. 200 osób, niedawno opublikowano [768], podobnie jak kilka doniesień z obserwacyjnych baz danych [761,769,770]. Trwają kolejne próby kliniczne służące porównaniu nieprzerwanego leczenia za pomocą VKA i NOAC u pacjentów z AF poddawanych ablacji, np.…”

Atrial Fibrillation Catheter Ablation: Overcoming Complications and Improving Success

“…This recommendation was in part put forth through studies such as the COMPARE trial, 7 Re-Circuit study, 8 and Venture-AF. 9 The COMPARE trial investigators showed that AF ablation without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with ''bridging'' with low-molecular-weight heparin. The ReCircuit trial was a head-to-head comparison study on the performance of AF ablation on patients receiving uninterrupted dabigatran versus uninterrupted warfarin that found that the incidence of major bleeding events during and up to eight weeks following ablation was significantly lower among the study patients taking dabigatran than those taking warfarin.…”

The year in cardiology 2015: arrhythmias and device therapy.

“…14 During the year 2015, several subgroup analyses of the large NOAC trials have surfaced, including bleeding management and outcome with apixaban, 15 the management of rivaroxaban around catheter ablation for AF (VENTURE-AF), 16 and the outcome of amiodarone co-medication in patients receiving edoxaban, 17 to name just a few. Virtually, all subgroups of the large NOAC trials indicate a consistent benefit and safety of these drugs compared with warfarin, further underlining their overall superiority.…”