Karl-Heinz Kuck1, Josep Brugada1, Alexander Fürnkranz1, Andreas Metzner1, Feifan Ouyang1, K R Julian Chun1, Arif Elvan1, Thomas Arentz1, Kurt Bestehorn1, Stuart J Pocock1, Jean-Paul Albenque1, Claudio Tondo1. 1. From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg (K.-H.K., A.M., F.O.), Cardioangiologisches Centrum Bethanien, Medical Department III am Markus Krankenhaus, Frankfurt (A.F., J.C.), Herz-Zentrum, Bad Krozingen (T.A.), and Technische Universität Dresden, Dresden (K.B.) - all in Germany; Hospital Clinic, University of Barcelona, Barcelona (J.B.); Isala Klinieken, Zwolle, the Netherlands (A.E.); London School of Hygiene and Tropical Medicine, London (S.J.P.); Clinique Pasteur, Toulouse, France (J.-P.A.); and Centro Cardiologico Monzino, University of Milan, Milan (C.T.).
Abstract
BACKGROUND: Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation. Radiofrequency ablation is the most common method, and cryoballoon ablation is the second most frequently used technology. METHODS: We conducted a multicenter, randomized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation. The primary efficacy end point in a time-to-event analysis was the first documented clinical failure (recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs, or repeat ablation) following a 90-day period after the index ablation. The noninferiority margin was prespecified as a hazard ratio of 1.43. The primary safety end point was a composite of death, cerebrovascular events, or serious treatment-related adverse events. RESULTS: A total of 762 patients underwent randomization (378 assigned tocryoballoon ablation and 384 assigned to radiofrequency ablation). The mean duration of follow-up was 1.5 years. The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 34.6% and 35.9%, respectively; hazard ratio, 0.96; 95% confidence interval [CI], 0.76 to 1.22; P<0.001 for noninferiority). The primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 10.2% and 12.8%, respectively; hazard ratio, 0.78; 95% CI, 0.52 to 1.18; P=0.24). CONCLUSIONS: In this randomized trial, cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation, and there was no significant difference between the two methods with regard to overall safety. (Funded by Medtronic; FIRE AND ICE ClinicalTrials.gov number, NCT01490814.).
RCT Entities:
BACKGROUND: Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation. Radiofrequency ablation is the most common method, and cryoballoon ablation is the second most frequently used technology. METHODS: We conducted a multicenter, randomized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation. The primary efficacy end point in a time-to-event analysis was the first documented clinical failure (recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs, or repeat ablation) following a 90-day period after the index ablation. The noninferiority margin was prespecified as a hazard ratio of 1.43. The primary safety end point was a composite of death, cerebrovascular events, or serious treatment-related adverse events. RESULTS: A total of 762 patients underwent randomization (378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation). The mean duration of follow-up was 1.5 years. The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 34.6% and 35.9%, respectively; hazard ratio, 0.96; 95% confidence interval [CI], 0.76 to 1.22; P<0.001 for noninferiority). The primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 10.2% and 12.8%, respectively; hazard ratio, 0.78; 95% CI, 0.52 to 1.18; P=0.24). CONCLUSIONS: In this randomized trial, cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation, and there was no significant difference between the two methods with regard to overall safety. (Funded by Medtronic; FIRE AND ICE ClinicalTrials.gov number, NCT01490814.).
Authors: Alexander C Perino; George C Leef; Andrew Cluckey; Fahd N Yunus; Mariam Askari; Paul A Heidenreich; Sanjiv M Narayan; Paul J Wang; Mintu P Turakhia Journal: Am Heart J Date: 2018-10-29 Impact factor: 4.749
Authors: Aditi S Vaishnav; Edris Alderwish; Kristie M Coleman; Moussa Saleh; Parth Makker; Kabir Bhasin; Neil E Bernstein; Nicholas T Skipitaris; Stavros E Mountantonakis Journal: J Interv Card Electrophysiol Date: 2020-06-30 Impact factor: 1.900
Authors: Tina Baykaner; Albert J Rogers; Gabriela L Meckler; Junaid Zaman; Rachita Navara; Miguel Rodrigo; Mahmood Alhusseini; Christopher A B Kowalewski; Mohan N Viswanathan; Sanjiv M Narayan; Paul Clopton; Paul J Wang; Paul A Heidenreich Journal: Circ Arrhythm Electrophysiol Date: 2018-05