CRRF-PeAF: cryoballon versus RF-ablatie bij persisterend AF

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.