Don`t Stop Anticoagulation for A-Fib Ablation: Study

By Will Boggs MD

NEW YORK - Uninterrupted anticoagulation appears safe for patients undergoing catheter ablation for nonvalvular atrial fibrillation (NVAF), according to results of the VENTURE-AF study.

"Uninterrupted anticoagulation should become the standard of care during ablation procedures for atrial fibrillation," Dr. Andrea Natale, from Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, told Reuters Health by email.

And rivaroxaban (Xarelto, Janssen) is equivalent to the vitamin K antagonist (VKA) warfarin, Natale said.

Traditionally, anticoagulation for catheter ablation of NVAF has consisted of interruption of the VKA with heparin bridging, but recent reports suggest greater safety and effectiveness of uninterrupted anticoagulation.

Dr. Natale and the VENTURE-AF investigators randomly assigned 248 NVAF patients to uninterrupted rivaroxaban (20 mg once-daily) or to an uninterrupted VKA prior to catheter ablation and for four weeks afterward.

The safety population included 244 patients who received at least one dose of the assigned drug, and the per-protocol population included 221 patients who also underwent catheter ablation. All patients received heparin on the day of their ablation.

Twenty-one bleeding events occurred with rivaroxaban and 18 with warfarin. None of the rivaroxaban patients experienced a thromboembolic event, whereas the VKA group experienced one ischemic stroke (27 days after ablation) and one vascular death (14 days after ablation), according to the May 14 European Heart Journal online report.

One patient in the rivaroxaban group and three in the VKA group experienced serious adverse events leading to drug discontinuation. Similar numbers of serious adverse events leading to hospitalization occurred in the rivaroxaban (n=11) and VKA (n=17) groups.

VENTURE-AF was intentionally designed as an exploratory study due to an expected low event rates, so there was no formal statistical analysis of superiority or noninferiority.

"I would favor Xarelto over (warfarin) because it has a more stable effect and patients do not have to worry about doing blood tests and avoiding things that could change the effect and blood thinning range of warfarin," Dr. Natale concluded.

Dr. Jalaj Garg, from Lehigh Valley Health Network, Allentown, Pennsylvania, recently reviewed the use of new oral anticoagulants (NOACs) during AF ablation. He told Reuters Health by email, "Although results in this study do suggest that there were minimal major and minor bleeding, I think it's too premature to transition to NOACs especially in a setting of lack of any potential reversal agent. I think large randomized controlled trials with adequate power and study design (comparing noninferiority or superiority of NOACs versus VKA) are needed to answer this question."

Dr. Garg said, "So far, studies have shown that both these agents are associated with comparable rates of thromboembolic events, major bleeding, and strokes. Physicians can decide upon the usage of VKA or rivaroxaban according to patient factors (higher risk of bleeding), need for regular INR (international normalized ratio) monitoring, whether patients were on any previous anticoagulant agents, and cost issues."

All authors received research grant support from Janssen Scientific Affairs, a Johnson & Johnson Company, and Bayer HealthCare Pharmaceuticals, the developers and marketers of rivaroxaban and the sponsors of the trial.

SOURCE: https://bit.ly/1EVHVnR

Eur Heart J 2015.

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