FIRE AND ICE
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
39.0% female
61.0% male
N = 750
750 patients (293 female, 457 male).
Inclusion criteria: symptomatic patients with drug-refractory paroxysmal AF.
Key exclusion criteria: pregnancy or lactation; any disease limiting life expectancy to < 1 year; substance misuse; active systemic infection; cryoglobulinemia; unstable angina pectoris; symptomatic carotid stenosis; COPD with detected pulmonary hypertension.
Interventions
N=376 cryoballoon (pulmonary vein isolation with cryoballoon ablation with fluoroscopic guidance).
N=374 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)
34.6%
35.9%
35.9 %
26.9 %
17.9 %
9.0 %
0.0 %
Cryoballoon
Radiofrequency
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority 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.
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