Cryoballoon vs radiofrequency ablation in persistent atrial fibrillation: the CRRF-PeAF trial

Abstract Background and Aims There are limited prospective data on the efficacy, safety, and impact on reverse remodelling of cryoballoon ablation as compared to radiofrequency ablation for persistent atrial fibrillation. Methods A prospective, multicentre, randomized, non-inferiority clinical trial was conducted to compare the efficacy and safety of cryoballoon vs radiofrequency ablation for persistent atrial fibrillation. A total of 500 patients with persistent atrial fibrillation were randomized across 12 centres. The primary endpoint was the occurrence of atrial tachyarrhythmias at 1 year with a 90-day blanking period after ablation. Results The final analysis included 499 patients, with a median age of 69 years (interquartile range, 61–74); 249 patients were allocated to the cryoballoon group, and 250 to the radiofrequency group. In the intention-to-treat analysis, the primary endpoint was observed in 56 patients (22.5%) in the cryoballoon group and 58 (23.2%) in the radiofrequency group, and the cryoballoon group demonstrated non-inferiority compared to the radiofrequency group for the primary endpoint (hazard ratio .99; 95% confidence interval, .69–1.43; P = .96). The radiofrequency group showed a greater reduction in left atrial size (left atrial volume index) at 1 year than the cryoballoon group [−11 mL/m2 (interquartile range, −19 to −4) vs −4 mL/m2 (interquartile range, −13 to 3), P < .001]. Conclusions In this randomized trial, cryoballoon ablation was non-inferior to radiofrequency ablation for the occurrence of atrial tachyarrhythmias at 1 year in patients with persistent atrial fibrillation.