Rivaroxaban versus warfarin for NVAF patients scheduled for catheter ablation: New insights

May 20, 2015

Nonvalvular atrial fibrillation (NVAF) patients taking uninterrupted rivaroxaban or warfarin had a low rate of major bleeding and thromboembolic complications, according to data presented at Heart Rhythm 2015, the Heart Rhythm Society's 36th Annual Scientific Sessions, and published in the European Heart Journal.

Nonvalvular atrial fibrillation (NVAF) patients taking uninterrupted rivaroxaban or warfarin had a low rate of major bleeding and thromboembolic complications, according to data presented at Heart Rhythm 2015, the Heart Rhythm Society's 36th Annual Scientific Sessions, and published in the European Heart Journal.

In the VENTURE-AF phase 3b study, 248 patients undergoing catheter ablation for NVAF were randomly assigned to either uninterrupted once-daily rivaroxaban (Xarelto) or uninterrupted warfarin (Coumadin), a vitamin K antagonist (VKA). Catheter ablation is a frequently used interventional procedure to remove abnormal tissue in the heart that is causing the irregular heartbeat.

It is the first global, prospective, randomized trial of any novel oral anticoagulant (NOAC) in this high-risk patient population.

Over the past 10 years, the number of catheter ablation procedures has risen dramatically in the United States, with more than 93,000 procedures performed from 2000 to 2010. Current guidelines recommend uninterrupted anticoagulation before, during and after the procedure to help prevent life-threatening blood clots.

Related:DVT patients taking rivaroxaban had fewer hospital admissions, costs, similar subsequent hospital visits vs. standard of care

For patients treated during or after the catheter ablation procedure, there was 1 major bleed in the VKA group, as defined by the ISTH scale, compared to zero for rivaroxaban. There were no major bleeds in either group using GUSTO- and TIMI-defined scales. The majority of bleeding that occurred in the study was mild or insignificant. There was one ischemic stroke and 1 vascular death in the VKA arm compared to none for rivaroxaban. Serious adverse events were comparable between both treatment strategies with 17 in the rivaroxaban group and 20 in the VKA group. VENTURE-AF was intentionally designed as an exploratory study and thus no formal statistical superiority or non-inferiority analysis was planned.

Related: What is new in the anticoagulant antidote market?

Dr Natale“The results of VENTURE-AF provide healthcare providers with additional insights that may help them manage NVAF patients who are scheduled for catheter ablation,” said Andrea Natale, MD, FACC, FHRS, FESC, cardiac electrophysiologist and executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas, and lead investigator of VENTURE-AF.

Given the dose adjustments often needed for patients on vitamin K antagonists, such as warfarin, to ensure the medicine is working effectively, rivaroxaban may offer a simpler approach in this setting, according to Dr Natale.

VENTURE-AF is a part of the EXPLORER global cardiovascular research program for Xarelto. The EXPLORER program includes 11 trials assessing the safety and efficacy of Xarelto in high-risk patient populations, including those with chronic heart failure, coronary artery disease, peripheral artery disease, acute coronary syndrome and embolic stroke of undetermined source.

“The VENTURE-AF study was a prospective look at the promising data that had been observed in a sub-analysis of the landmark ROCKET-AF trial,” Dr Natale said. “It was intentionally designed as an exploratory study and thus no formal statistical superiority or non-inferiority analysis was planned.”

The study was sponsored by Janssen Pharmaceuticals and Bayer HealthCare.

Read next:Study evaluates use of novel oral anticoagulants in ICU