Data_Sheet_1_Cryoballoon catheter ablation or drug therapy to delay progression of atrial fibrillation: A single-center randomized trial.docx

BackgroundDelaying atrial fibrillation (AF) progression is a key goal in cardiovascular treatment. However, numbers of previously published studies on delayed AF progression are relatively limited. The purpose of this study was to determine whether a cryoballoon catheter ablation (CA) strategy could delay AF progression compared to anti-arrhythmic drug (AAD) treatment in patients with paroxysmal AF.
MethodsA total of 204 subjects were enrolled in the trial, including 102 in the cryoballoon CA group and 102 in the AAD group. Participants were followed up with for 36 months. The primary study endpoint was the first occurrence of persistent atrial tachyarrhythmia, while secondary endpoints included the event rates of persistent atrial tachyarrhythmia at 1 and 2 years. The primary safety endpoint was serious adverse events.
ResultsOverall, the 36-month follow-up was completed by 154 subjects (75.5%). At 3 years, documented progression from paroxysmal AF to persistent atrial tachyarrhythmia had occurred in 2 of the 102 patients assigned to undergo cryoballoon CA [2.203% (95% confidence interval (CI), 0.554–8.537)] and in 17 of the 102 patients assigned to receive AADs [20.223% (95% CI, 13.040–30.604)] [hazard ratio (HR), 0.107; 95% CI, 0.043–0.262; P < 0.001]. Lower rates of progression in the cryoballoon CA group compared to the AAD group were already obvious at 1 year [1.053% (95% CI, 0.149–7.238) vs. 5.284% (95% CI, 2.233–12.237)] [HR, 0.193; (95% CI, 0.039–0.956; P = 0.09)] and 2 years [2.203% (95% CI, 0.554–8.537) vs. 12.430% (95% CI, 7.066–21.371)] (HR, 0.169; 95% CI, 0.057–0.501, P < 0.001). Serious adverse events occurred in 7 of the 102 patients (6.9%) in the cryoballoon CA group and 9 of the 102 patients (8.8%) in the AAD group.
ConclusionCryoballoon CA was superior to AAD therapy in preventing the occurrence of persistent atrial tachyarrhythmia in patients with paroxysmal AF who had not received prior rhythm control therapy. Serious adverse events were rare.