Catheter ablation is proven to be a more effective therapy for symptomatic paroxysmal atrial fibrillation (AF) non-responsive to the medication when compared with antiarrhythmic drug therapy. However, the efficacy and safety of cryoballoon ablation as initial first-line therapy for symptomatic paroxysmal AF has not been established. This study aims to investigate the safety and efficacy of cryoballoon ablation for AF.
This multicenter trial included a total of 203 patients aged 18-80 years with paroxysmal AF who had not previously received rhythm-control therapy. The participants were randomly assigned in a 1:1 ratio to receive antiarrhythmic drugs or pulmonary vein isolation with a cryoballoon. The primary outcome of the study was a composite of procedure-related and cryoballoon system-related serious adverse events.
Of the 203 patients included in the study, 104 underwent ablation, and 99 received drug therapy. The initial success of the procedure in the ablation group was achieved in 97% of the patients. The treatment success, as estimated by the Kaplan-Meiser estimate, was achieved in 74.6% of patients in the ablation group and 45.0% of patients in the drug therapy group.
The research concluded that cryoballoon ablation was superior to drug therapy as the first-line prevention of arrhythmia recurrence in patients with symptomatic paroxysmal atrial fibrillation.