Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation

Karl-Heinz Kuck, Josep Brugada, Alexander Fürnkranz, Andreas Metzner, Feifan Ouyang, K R Julian Chun, Arif Elvan, Thomas Arentz, Kurt Bestehorn, Stuart J Pocock, Jean-Paul Albenque, Claudio Tondo, FIRE AND ICE Investigators, Karl-Heinz Kuck, Andreas Metzner, Feifan Ouyang, Julian Chun, Alexander Fürnkranz, Arif Elvan, Thomas Arentz, Michael Kühne, Christian Sticherling, Laszlo Gellér, Matthias Busch, Josep Brugada, Lluis Mont, Alberto Barrera, Thomas Deneke, Jean-Paul Albenque, Volker Kühlkamp, Claudio Tondo, Ricardo Ruiz-Granell, Petr Neuzil, Nicasio Pérez-Castellano, Karl-Heinz Kuck, Josep Brugada, Alexander Fürnkranz, Andreas Metzner, Feifan Ouyang, K R Julian Chun, Arif Elvan, Thomas Arentz, Kurt Bestehorn, Stuart J Pocock, Jean-Paul Albenque, Claudio Tondo, FIRE AND ICE Investigators, Karl-Heinz Kuck, Andreas Metzner, Feifan Ouyang, Julian Chun, Alexander Fürnkranz, Arif Elvan, Thomas Arentz, Michael Kühne, Christian Sticherling, Laszlo Gellér, Matthias Busch, Josep Brugada, Lluis Mont, Alberto Barrera, Thomas Deneke, Jean-Paul Albenque, Volker Kühlkamp, Claudio Tondo, Ricardo Ruiz-Granell, Petr Neuzil, Nicasio Pérez-Castellano

Abstract

Background: Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation. Radiofrequency ablation is the most common method, and cryoballoon ablation is the second most frequently used technology.

Methods: We conducted a multicenter, randomized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation. The primary efficacy end point in a time-to-event analysis was the first documented clinical failure (recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs, or repeat ablation) following a 90-day period after the index ablation. The noninferiority margin was prespecified as a hazard ratio of 1.43. The primary safety end point was a composite of death, cerebrovascular events, or serious treatment-related adverse events.

Results: A total of 762 patients underwent randomization (378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation). The mean duration of follow-up was 1.5 years. The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 34.6% and 35.9%, respectively; hazard ratio, 0.96; 95% confidence interval [CI], 0.76 to 1.22; P<0.001 for noninferiority). The primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 10.2% and 12.8%, respectively; hazard ratio, 0.78; 95% CI, 0.52 to 1.18; P=0.24).

Conclusions: In this randomized trial, cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation, and there was no significant difference between the two methods with regard to overall safety. (Funded by Medtronic; FIRE AND ICE ClinicalTrials.gov number, NCT01490814.).

Source: PubMed

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