# Cryoballon- versus radiofrequentieablatie bij paroxysmaal atriumfibrilleren: NEJM FIRE AND ICE-trial

*geplaatst 2016-06-09 · Atriumfibrilleren · The New England journal of medicine · doi 10.1056/NEJMoa1602014 · https://hartvaat.nl/2016/06/09/cryoballon-versus-radiofrequentieablatie-bij-paroxysmaal-atriumfibrilleren-nejm-/*

Landmark NEJM-trial die cryoballonablatie vergeleek met radiofrequentieablatie voor pulmonaalvene-isolatie bij paroxysmaal AF. Toonde non-inferioriteit van de cryoballontechniek — bepalend voor de hedendaagse ablatiepraktijk.

## English: Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation.

The FIRE AND ICE trial demonstrated that cryoballoon ablation was noninferior to radiofrequency ablation for pulmonary vein isolation in patients with drug-refractory paroxysmal atrial fibrillation. The study established cryoablation as an equally effective and potentially simpler alternative for the treatment of paroxysmal AF.

## Abstract (original, from the publication)

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.).

Auteurs: 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

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Bron: The New England journal of medicine, https://doi.org/10.1056/NEJMoa1602014. Bijgewerkt 2026-07-03T13:25:30Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.