Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation
Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation
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DOI：
10.1056/nejmoa1602014
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发表时间：
2016-06-09
影响因子：
158.5
通讯作者：
Tondo, Claudio
中科院分区：
文献类型：
--
作者：
Kuck, Karl-Heinz;Brugada, Josep;Tondo, Claudio
背景目前的指南建议通过导管消融的方法隔离肺静脉作为药物难治性阵发性房颤的治疗方法。射频消融是最常见的消融方法，冷球消融是第二常用的消融技术。方法我们进行了一项多中心随机试验，以确定冷球消融在有症状的药物难治性阵发性房颤患者中是否不亚于射频消融。时间-事件分析的主要疗效终点是指数消融90天后首次记录的临床失败(房颤复发、房扑或房性心动过速、抗心律失常药物的使用或重复消融)。非劣势边际被预先指定为危险比1.43。主要安全终点是死亡、脑血管事件或与治疗相关的严重不良事件的组合。结果共762名患者接受了随机分组(378名患者被分配到冷冻消融组，384名患者被分配到射频消融组)。平均随访时间为1.5年。冷冻组和射频组的主要疗效终点分别为138例和143例(1年Kaplan-Meier事件发生率估计分别为34.6%和35.9%；危险比为0.96；95%可信区间[CI]为0.76至1.22；P<；0.001为非劣势)。主要安全终点：冷冻组40例，射频组51例(1年Kaplan-Meier事件发生率估计，分别为10.2%和12.8%；风险比，0.78；95%CI，0.52~1.18；P=0.24)。结论在本次随机试验中，冷冻组治疗药物难治性阵发性房颤的疗效不逊于射频消融组，两种方法总体安全性无显著差异。(由美敦力资助；FIRE和ICE ClinicalTrials.gov编号，NCT01490814。)
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.)