Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation.


Kuck, KH; Brugada, J; Fürnkranz, A; Metzner, A; Ouyang, F; Chun, KR; Elvan, A; Arentz, T; Bestehorn, K; Pocock, SJ; Albenque, JP; Tondo, C; FIRE AND ICE Investigators, ; , COLLABORATORS; Kuck, KH; Metzner, A; Ouyang, F; Chun, J; Fürnkranz, A; Elvan, A; Arentz, T; Kühne, M; Sticherling, C; Gellér, L; Busch, M; Brugada, J; Mont, L; Barrera, A; Deneke, T; Albenque, JP; Kühlkamp, V; Tondo, C; Ruiz-Granell, R; Neuzil, P; Pérez-Castellano, N; (2016) Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. The New England journal of medicine, 374 (23). pp. 2235-45. ISSN 0028-4793 DOI: https://doi.org/10.1056/NEJMoa1602014

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Abstract

: 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.<br/> : 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.<br/> : 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&lt;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).<br/> : 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.).<br/>

Item Type: Article
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Medical Statistics
PubMed ID: 27042964
Web of Science ID: 377920500007
URI: http://researchonline.lshtm.ac.uk/id/eprint/2535708

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