6/28/23, 10:37 PM FIRE AND ICE Pathway Feedback Search Clinical Topics Home Studies FIRE AND ICE FIRE AND ICE Disease Atrial fibrillation Trial question Is cryoballoon ablation noninferior to radiofrequency ablation in patients with drug-refractory paroxysmal AF? Study design Multi-center Open label RCT Population Characteristics of study participants 38.8% female N = 762 61.2% male 762 patients (293 female, 457 male) Inclusion criteria: symptomatic patients with drug-refractory paroxysmal AF Key exclusion criteria: pregnancy or breastfeeding, any disease limiting life expectancy to < 1 year, substance misuse, active systemic infection, cryoglobulinemia, unstable angina pectoris, symptomatic carotid stenosis, or COPD with detected pulmonary hypertension Interventions N=378 cryoballoon (pulmonary vein isolation with cryoballoon ablation with fluoroscopic guidance) N=384 radiofrequency (radiofrequency ablation using electroanatomical navigation) Primary outcome Documented clinical failure (recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs, or repeat ablation) https://web.pathway.md/studies/recF1ItGSpSqSvnlY 1/2 6/28/23, 10:37 PM FIRE AND ICE Pathway 35.9 % 35.9 34.6 26.9 % 17.9 % Difference not exceeding nonferiority margin 9.0 % 0.0 % Cryoballoon Radiofrequency Difference not exceeding nonferiority margin in documented clinical failure (recurrence of AF, occurrence of atrial flutter or AT, use of antiarrhythmic drugs, or repeat ablation) (34.6% vs. 35.9%; HR 0.96, 96% CI 0.76 to 1.22) Secondary outcomes No significant difference in death, cerebrovascular events, or serious treatment-related adverse events at 1 year (10.2% vs. 12.8%; HR 0.78, 95% CI 0.52 to 1.18) Safety outcomes No significant difference in overall safety events. Conclusion In symptomatic patients with drug-refractory paroxysmal AF, cryoballoon was noninferior to radiofrequency with respect to documented clinical failure (recurrence of AF, occurrence of atrial flutter or AT, use of antiarrhythmic drugs, or repeat ablation). Reference Kuck KH, Brugada J, Furnkranz A et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. Open reference URL https://web.pathway.md/studies/recF1ItGSpSqSvnlY 2/2