| Autor: |
Kuck, Karl-Heinz, Brugada, Josep, Fürnkranz, Alexander, Metzner, Andreas, Ouyang, Feifan, Chun, KR Julian, Elvan, Arif, Arentz, Thomas, Bestehorn, Kurt, Pocock, Stuart J, Albenque, Jean-Paul, Tondo, Claudio, FIRE AND ICE Investigators |
| Jazyk: |
angličtina |
| Rok vydání: |
2016 |
| ISSN: |
0028-4793 |
| Popis: |
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 |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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