Cryoballoon versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: The Prospective, Randomised, Controlled, Non-Inferiority FreezeAF Study
Background—There is a lack of data regarding the comparative efficacy and procedural safety of open irrigated radiofrequency (RF) and cryoballoon catheter (CB) ablation for pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF).
Methods and Results—In a prospective, non-inferiority study 315 patients were randomly assigned to RF (n=159) or CB (n=156) ablation. The primary endpoint was freedom from atrial arrhythmia with absence of persistent complications. Patients were largely comparable between groups with more vascular disease in the RF group (8.2% vs. 2.6% CB; p=0.028). The primary endpoint at 12 months was achieved by 70.7% with RF and 73.6% with CB (multiple procedure success), including 31 redo procedures in each group (19.5% of RF vs. 19.9% of CB; p=0.933). For the intention-to-treat (ITT) population, non-inferiority of CB was revealed for the pre-defined inferiority margin (risk difference [RD] 0.029; 95% confidence interval [CI] -0.074 to 0.132; p < 0.001). Rates at 6 months were 63.1% and 64.1% for the RF and CB groups (single procedure success) and non-inferiority was confirmed (RD 0.010; 95% CI -0.097 to 0.116; p=0.002). Periprocedural complications for the index procedure were more frequent in the CB group (5.0% RF, 12.2% CB, p=0.022) with a significant difference in phrenic nerve palsies (0% RF, 5.8% CB, p=0.002).
Conclusions—This large, prospective, randomised, controlled study demonstrates non-inferiority of CB ablation versus RF ablation for treating patients with paroxysmal AF.
Clinical Trial Registration Information—clinicaltrials.gov. Identifier: NCT00774566.
- Received April 5, 2015.
- Revision received August 4, 2015.
- Accepted August 6, 2015.
Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDervis License (http://creativecommons.org/licenses/by-nc-nd/3.0/), which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.