The FIRE AND ICE AF Ablation Clinical Trial is the largest, prospective, 1:1 randomized, non-inferiority study (762 patients from 16 sites in 8 countries) that compared the efficacy and safety of PVI using cryoballoon versus radiofrequency (RFC) ablation with the CARTO® 3D mapping system in patients with paroxysmal atrial fibrillation (PAF).
Primary Efficacy Endpoint: Time to first documented recurrence of AF>30s/AT/AFL, prescription of AAD, and/or repeat ablation
Primary Safety Endpoint: Time to first all-cause death, all-cause stroke/TIA or treatment-related serious adverse events (AE)
Cryoballoon met the non-inferiority endpoint and did so with shorter and more consistent procedure times compared to radiofrequency.
The primary safety endpoint was achieved. There was no significant difference between the two methods with regard to overall safety.
RFC: 51 events vs. cryoballoon: 40 events (p=0.24)
One-year Kaplan-Meier event rate estimates:
12.8% RFC group and 10.2% cryoballoon group
In a predefined secondary analysis, relative to radiofrequency, cryoballoon demonstrated:
The authors stated:
"The extent of reduction in reinterventions and rehospitalizations is not only statistically significant but also clinically relevant. Our presented data are the main events that define the patients’ perception regarding the procedural success of an AF ablation procedure."3
A health economic analysis was performed by analyzing the rate of statistically different healthcare utilization (HCU) events from the FIRE AND ICE trial and then assigning payer costs for each event.
Overall payer costs were significantly lower in the cryoballoon group compared to the radio frequency group (RFC) across three healthcare systems.
Cryoballoon was the greater value to healthcare systems in the FIRE AND ICE trial and may enable global healthcare systems to treat more patients within existing healthcare budgets.
Fürnkranz A, et al. Rationale and Design of FIRE AND ICE: A Multicenter Randomized Trial Comparing Efficacy and Safety of Pulmonary Vein Isolation Using a Cryoballoon versus Radiofrequency Ablation with 3D-Reconstruction. J Cardiovasc Electrophysiol. 2014;25:1314-1320.
Kuck KH, et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016; 374(23): 2235-45.
Kuck KH, et al. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016; Oct 7;37(38):2858-2865
Chun KRJ, et al. The Impact of Cryoballoon Versus Radiofrequency Ablation for Paroxysmal Atrial Fibrillation on Healthcare Utilization and Costs: An Economic Analysis From the FIRE AND ICE Trial. J Am Heart Assoc. 2017 Jul 27;6(8).