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.).
N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
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.
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.
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).
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.).
目前的指南建议采用导管消融的方法进行肺静脉隔离，以此作为治疗药物难治性阵发性心房颤动的手段。射频消融是最常用的方法，而冷冻球囊消融是第二种最常使用的技术。
我们进行了一项多中心、随机试验，旨在确定冷冻球囊消融是否不劣于射频消融在药物难治性阵发性心房颤动的有症状患者中的疗效。时间事件分析中的主要疗效终点是索引消融后 90 天内首次记录的临床失败（心房颤动复发、出现房扑或房性心动过速、使用抗心律失常药物或重复消融）。非劣效性边界预设为风险比 1.43。主要安全性终点是死亡、脑血管事件或严重与治疗相关的不良事件的复合终点。
共有 762 名患者接受了随机分组（378 名分配至冷冻球囊消融组，384 名分配至射频消融组）。平均随访时间为 1.5 年。主要疗效终点在冷冻球囊消融组发生在 138 例患者中，在射频消融组发生在 143 例患者中（1 年 Kaplan-Meier 事件发生率估计值分别为 34.6%和 35.9%，风险比为 0.96；95%置信区间[CI]为 0.76 至 1.22；非劣效性 P<0.001）。主要安全性终点在冷冻球囊消融组发生在 40 例患者中，在射频消融组发生在 51 例患者中（1 年 Kaplan-Meier 事件发生率估计值分别为 10.2%和 12.8%，风险比为 0.78；95%CI 为 0.52 至 1.18；P=0.24）。
在这项随机试验中，冷冻球囊消融在治疗药物难治性阵发性心房颤动患者方面不劣于射频消融，并且两种方法在总体安全性方面没有显著差异。（由美敦力公司资助；FIRE AND ICE 临床试验.gov 编号：NCT01490814。）
