Cryoballoon ablation achieved a 69.9% treatment success rate at 12 months compared with 7.3% for antiarrhythmic drug therapy (absolute difference 62.6%, p < 0.001) in patients with paroxysmal AF.
RCT (n=245)
2:1
Does cryoballoon ablation improve treatment success at 12 months compared to antiarrhythmic drug therapy in patients with symptomatic paroxysmal atrial fibrillation who have failed at least one antiarrhythmic drug?
Cryoballoon ablation is a safe and significantly more effective alternative to antiarrhythmic medication for achieving treatment success in patients with symptomatic paroxysmal AF who have failed prior drug therapy.
Effect estimate: Absolute difference 62.6%
Absolute Event Rate: 69.9% vs 7.3%
p-value: p=< 0.001
OBJECTIVES: This study sought to assess the safety and effectiveness of a novel cryoballoon ablation technology designed to achieve single-delivery pulmonary vein (PV) isolation. BACKGROUND: Standard radiofrequency ablation is effective in eliminating atrial fibrillation (AF) but requires multiple lesion delivery at the risk of significant complications. METHODS: Patients with documented symptomatic paroxysmal AF and previously failed therapy with ≥ 1 membrane active antiarrhythmic drug underwent 2:1 randomization to either cryoballoon ablation (n = 163) or drug therapy (n = 82). A 90-day blanking period allowed for optimization of antiarrhythmic drug therapy and reablation if necessary. Effectiveness of the cryoablation procedure versus drug therapy was determined at 12 months. RESULTS: Patients had highly symptomatic AF (78% paroxysmal, 22% early persistent) and experienced failure of at least one antiarrhythmic drug. Cryoablation produced acute isolation of three or more PVs in 98.2% and all four PVs in 97.6% of patients. PVs isolation was achieved with the balloon catheter alone in 83%. At 12 months, treatment success was 69.9% (114 of 163) of cryoblation patients compared with 7.3% of antiarrhythmic drug patients (absolute difference, 62.6% p 75% reduction in PV area during 12 months of follow-up. Twenty-nine of 259 procedures (11.2%) were associated with phrenic nerve palsy as determined by radiographic screening; 25 of these had resolved by 12 months. Cryoablation patients had significantly improved symptoms at 12 months. CONCLUSIONS: The STOP AF trial demonstrated that cryoballoon ablation is a safe and effective alternative to antiarrhythmic medication for the treatment of patients with symptomatic paroxysmal AF, for whom at least one antiarrhythmic drug has failed, with risks within accepted standards for ablation therapy. (A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [Stop AF; NCT00523978).
Packer et al. (Thu,) conducted a rct in Symptomatic paroxysmal atrial fibrillation (n=245). Cryoballoon ablation vs. Antiarrhythmic drug therapy was evaluated on Treatment success at 12 months (Absolute difference 62.6%, p=< 0.001). Cryoballoon ablation achieved a 69.9% treatment success rate at 12 months compared with 7.3% for antiarrhythmic drug therapy (absolute difference 62.6%, p < 0.001) in patients with paroxysmal AF.