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Uninterrupted rivaroxaban feasible in patients undergoing catheter ablation for AF

BOSTON — In patients undergoing catheter ablation for nonvalvular atrial fibrillation, uninterrupted rivaroxaban use was feasible and associated with similar event rates as uninterrupted warfarin, according to results from the VENTURE-AF study.

Researchers conducted the first randomized study to evaluate the safety and efficacy of uninterrupted use of a novel oral anticoagulant in patients with nonvalvular AF undergoing catheter ablation.

Andrea Natale, MD, FHRS, FACC, FESC

Andrea Natale

“The approach of stopping a blood thinner and bridging with [enoxaparin] was used due to bleeding concerns with an uninterrupted approach,” Andrea Natale, MD, FHRS, FACC, FESC, cardiac electrophysiologist and executive medical director at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said in an interview with Cardiology Today at the Heart Rhythm Society Annual Scientific Sessions. “However, we learned that [enoxaparin] could be even worse, so many years ago we began using uninterrupted [warfarin] and found that it was safe and significantly reduced periprocedural stroke. Now that the new anticoagulants have become available, data on these medications for this use are needed.”

Natale and colleagues randomly assigned 248 patients (mean age, 59 years; 71% men; 74% with paroxysmal AF; mean CHA2DS2-VASc score, 1.6) to uninterrupted rivaroxaban (Xarelto, Janssen Pharmaceuticals) 20 mg/day or uninterrupted warfarin. Both groups received their medications before and for 4 weeks after their procedure.

The primary endpoint was major bleeding events after catheter ablation. Secondary endpoints included thromboembolic events — a composite of stroke, systemic embolism, MI and vascular death — and other bleeding or events attributable to the procedure.

“VENTURE-AF was specifically designed as an exploratory study, and thus no formal statistical superiority or noninferiority analysis was planned,” Natale told Cardiology Today.

The incidence of major bleeding was low, at 0.4%, with one incident in the warfarin group and none in the rivaroxaban group. The incidence of thromboembolic events also was low, at 0.8%, with one ischemic stroke and one vascular death, both in the warfarin group.

Both groups had similar numbers of any adjudicated events (rivaroxaban, 26; warfarin, 25), any bleeding events (rivaroxaban, 21; warfarin, 18) and any other procedure-attributable events (five each), according to the researchers.

“The VENTURE-AF results provide physicians with additional insights that may help them manage nonvalvular [AF] patients who are scheduled for catheter ablation,” Natale said. “[They] may make physicians more comfortable that this approach is safe and effective. The findings extend to any ablation tool utilized for nonvalvular [AF] and also apply to any patient undergoing the procedure.” – by Erik Swain

References:

Cappato R, et al. Eur Heart J. 2015;doi:10.1093/eurheartj/ehv177.

Natale A, et al. Abstract LBCT01-02. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015; Boston.

Disclosure: The study was funded by Janssen Scientific Affairs and Bayer HealthCare Pharmaceuticals. Natale reports receiving consultant fees/honoraria from Biosense Webster, Biotronik, Boston Scientific, Janssen Pharmaceuticals, Medtronic and St. Jude Medical, and receiving a research grant from Bayer HealthCare and Johnson & Johnson.

BOSTON — In patients undergoing catheter ablation for nonvalvular atrial fibrillation, uninterrupted rivaroxaban use was feasible and associated with similar event rates as uninterrupted warfarin, according to results from the VENTURE-AF study.

Researchers conducted the first randomized study to evaluate the safety and efficacy of uninterrupted use of a novel oral anticoagulant in patients with nonvalvular AF undergoing catheter ablation.

Andrea Natale, MD, FHRS, FACC, FESC

Andrea Natale

“The approach of stopping a blood thinner and bridging with [enoxaparin] was used due to bleeding concerns with an uninterrupted approach,” Andrea Natale, MD, FHRS, FACC, FESC, cardiac electrophysiologist and executive medical director at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said in an interview with Cardiology Today at the Heart Rhythm Society Annual Scientific Sessions. “However, we learned that [enoxaparin] could be even worse, so many years ago we began using uninterrupted [warfarin] and found that it was safe and significantly reduced periprocedural stroke. Now that the new anticoagulants have become available, data on these medications for this use are needed.”

Natale and colleagues randomly assigned 248 patients (mean age, 59 years; 71% men; 74% with paroxysmal AF; mean CHA2DS2-VASc score, 1.6) to uninterrupted rivaroxaban (Xarelto, Janssen Pharmaceuticals) 20 mg/day or uninterrupted warfarin. Both groups received their medications before and for 4 weeks after their procedure.

The primary endpoint was major bleeding events after catheter ablation. Secondary endpoints included thromboembolic events — a composite of stroke, systemic embolism, MI and vascular death — and other bleeding or events attributable to the procedure.

“VENTURE-AF was specifically designed as an exploratory study, and thus no formal statistical superiority or noninferiority analysis was planned,” Natale told Cardiology Today.

The incidence of major bleeding was low, at 0.4%, with one incident in the warfarin group and none in the rivaroxaban group. The incidence of thromboembolic events also was low, at 0.8%, with one ischemic stroke and one vascular death, both in the warfarin group.

Both groups had similar numbers of any adjudicated events (rivaroxaban, 26; warfarin, 25), any bleeding events (rivaroxaban, 21; warfarin, 18) and any other procedure-attributable events (five each), according to the researchers.

“The VENTURE-AF results provide physicians with additional insights that may help them manage nonvalvular [AF] patients who are scheduled for catheter ablation,” Natale said. “[They] may make physicians more comfortable that this approach is safe and effective. The findings extend to any ablation tool utilized for nonvalvular [AF] and also apply to any patient undergoing the procedure.” – by Erik Swain

References:

Cappato R, et al. Eur Heart J. 2015;doi:10.1093/eurheartj/ehv177.

Natale A, et al. Abstract LBCT01-02. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015; Boston.

Disclosure: The study was funded by Janssen Scientific Affairs and Bayer HealthCare Pharmaceuticals. Natale reports receiving consultant fees/honoraria from Biosense Webster, Biotronik, Boston Scientific, Janssen Pharmaceuticals, Medtronic and St. Jude Medical, and receiving a research grant from Bayer HealthCare and Johnson & Johnson.

    Perspective
    John D. Day MD, FHRS, FACC

    John D. Day

    • Outside of cardiology, most physicians are frightened of doing procedures in patients on warfarin. The same holds true for the novel oral anticoagulants. In extreme cases, some physicians may even stop these medication for 7 to 10 days. Paradoxically, in cardiology, especially electrophysiology, we have shown that it is actually safer if you don’t stop it.

      Let me explain. For patients with AF, studies show that when you stop these anticoagulants, there is often a rebound hypercoagulable state that occurs. When this happens, the risk for a stroke increases dramatically. By performing pacemaker or ablation procedures with uninterrupted warfarin, complications can be reduced.

      This study is an extension of the previous work done by the authors in performing AF ablation procedures in patients on warfarin. This time, it was a well-designed study looking at performing AF ablation procedures with uninterrupted rivaroxaban. As with warfarin, it is very safe to perform these procedures with uninterrupted rivaroxaban. 

      Hopefully, these data can be translated to other physicians performing procedures for patients with AF. In many procedures, the real risk is not that of bleeding but rather that of stroke from discontinuing oral anticoagulation therapy.

      • John D. Day, MD, FHRS, FACC
      • Director of Heart Rhythm Services
        Intermountain Heart Institute, Murray, Utah
        President, Heart Rhythm Society
    • Disclosures: Day reports no relevant financial disclosures.

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