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N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.

Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation.

Author information

1
From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg (K.-H.K., A.M., F.O.), Cardioangiologisches Centrum Bethanien, Medical Department III am Markus Krankenhaus, Frankfurt (A.F., J.C.), Herz-Zentrum, Bad Krozingen (T.A.), and Technische Universität Dresden, Dresden (K.B.) - all in Germany; Hospital Clinic, University of Barcelona, Barcelona (J.B.); Isala Klinieken, Zwolle, the Netherlands (A.E.); London School of Hygiene and Tropical Medicine, London (S.J.P.); Clinique Pasteur, Toulouse, France (J.-P.A.); and Centro Cardiologico Monzino, University of Milan, Milan (C.T.).

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.).

PMID:
27042964
DOI:
10.1056/NEJMoa1602014
[Indexed for MEDLINE]
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