Janssen and Bayer HealthCare announced results from the VENTURE-AF trial that compared Xarelto (rivaroxaban) as an alternative to vitamin K antagonists (VKA) to reduce the risk of blood clots in patients with non-valvular atrial fibrillation (NVAF) undergoing catheter ablation. Findings from the study were presented at Heart Rhythm 2015 and published in the European Heart Journal.
VENTURE-AF (ActiVe-Controlled Multi-CENTer StUdy with Blind-Adjudication Designed to Evaluate the Safety of Uninterrupted Rivaroxaban and Uninterrupted Vitamin K Antagonists in Subjects Undergoing CathEter Ablation for Non-Valvular Atrial Fibrillation) was a Phase 3b prospective, randomized, open-label, active-controlled study (n=248) in patients with occasional or persistent NVAF across 37 centers. Patients were randomized to Xarelto 20mg once daily or dose-adjusted VKA therapy for 4 weeks prior to the procedure, and continued with treatment after the procedure for 4 weeks. The primary endpoint was the occurrence of major bleeding events within 30 days from the procedure as defined by one of three scales (GUSTO, ISTH, and TIMI).
There was one major bleed in the VKA group treated during or prior to the procedure, as defined by the ISTH scale vs. no bleeds in the Xarelto group. In addition, there were no major bleeds in either group according to the GUSTO- and TIMI-defined scales. Both treatment groups experienced comparable rates of serious adverse events.
The VENTURE-AF study is part of the EXPLORER global cardiovascular research program for Xarelto.
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