- Question
- Is cryoballoon ablation noninferior to radiofrequency ablation for treating symptomatic paroxysmal atrial fibrillation that is refractory to drug therapy?
- Design
- Multicenter, randomized, noninferiority trial with 762 patients and blinded outcome assessment (PROBE design, per the registry). Mean follow-up was 1.5 years.
- Population
- Patients with symptomatic paroxysmal atrial fibrillation refractory to antiarrhythmic drug therapy.
- Intervention
- Pulmonary-vein isolation by cryoballoon ablation (378 patients).
- Control
- Pulmonary-vein isolation by radiofrequency ablation with an irrigated catheter (384 patients).
- Primary outcome
- First documented clinical failure after a 90-day period following the index ablation: atrial fibrillation recurrence, atrial flutter or atrial tachycardia, antiarrhythmic drug use, or repeat ablation. The prespecified noninferiority margin was a hazard ratio of 1.43.
- Results
- The primary endpoint occurred in 138 patients in the cryoballoon group and 143 in the radiofrequency group (1-year Kaplan-Meier estimates 34.6% and 35.9%; HR 0.96; 95% CI 0.76 to 1.22; P<0.001 for noninferiority).
- Safety
- The primary safety endpoint (composite of death, cerebrovascular events, or serious treatment-related adverse events) occurred in 40 patients with cryoballoon and 51 with radiofrequency (10.2% vs. 12.8% at 1 year; HR 0.78; 95% CI 0.52 to 1.18; P=0.24).
- Conclusion
- Cryoballoon ablation was noninferior to radiofrequency ablation for efficacy, with no significant difference in overall safety.
- Why it matters
- It provided randomized evidence that both technologies are comparable options for pulmonary-vein isolation, allowing the choice to be guided by center experience and patient characteristics.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026