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Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation
Open accessAbstract
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.).
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“achievable by point-by-point radiofrequency ablation, linear lesions encircling the pulmonary veins, or cryoballoon ablation, with similar outcomes.[732][733][734]”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [734]
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“It also seems even less common after cryoballoon ablation, 734”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [734]
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Metadata
- Authors
- Kuck, K.-H., Brugada, J., Fürnkranz, A., Metzner, A., Ouyang, F., Chun, K. R. J., Elvan, A., Arentz, T., Bestehorn, K., Pocock, S. J., Albenque, J.-P., & Tondo, C.
- Affiliations
- University of Milan (IT)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-06-09
- Volume
- 374
- Issue
- 23
- Pages
- 2235-2245
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2333001326
- Cited by
- 1,950
- References
- 22
- Citations by year
- 2026: 127 · 2025: 182 · 2024: 184 · 2023: 194 · 2022: 201 · 2021: 218 · 2020: 223 · 2019: 196 · 2018: 176 · 2017: 179 · 2016: 67
- FWCI
- 169.93
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Arrhythmias and Treatments
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Keywords
- paroxysmal atrial fibrillation, cryoballoon ablation, radiofrequency ablation, pulmonary vein isolation, catheter ablation, non-inferiority, drug-refractory atrial fibrillation, atrial flutter, atrial tachycardia, antiarrhythmic drug use, repeat ablation, treatment-related adverse events, mortality, cerebrovascular events
- MeSH terms
- Aged, Atrial Fibrillation, Cryosurgery, Female, Follow-Up Studies, Humans, Male, Middle Aged, Postoperative Complications, Recurrence, Reoperation, Single-Blind Method, Catheter Ablation, Disease-Free Survival, Kaplan-Meier Estimate
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