Cryoballoon vs radiofrequency ablation in persistent atrial fibrillation: the CRRF-PeAF trial.

Methods

A prospective, multicentre, randomized, non-inferiority clinical trial was conducted to compare the efficacy and safety of cryoballoon vs radiofrequency ablation for persistent atrial fibrillation.

进行了一项前瞻性、多中心、随机、非劣效性临床试验，比较了冷冻球囊消融与射频消融治疗持续性心房颤动的有效性和安全性。

A total of 500 patients with persistent atrial fibrillation were randomized across 12 centres.

共有500名持续性房颤患者在12个中心进行了随机分组。

The primary endpoint was the occurrence of atrial tachyarrhythmias at 1 year with a 90-day blanking period after ablation.

主要终点事件是在消融后90天的空白期内，1年内发生房性心动过速的情况。

Results

The final analysis included 499 patients, with a median age of 69 years (interquartile range, 61-74); 249 patients were allocated to the cryoballoon group, and 250 to the radiofrequency group.

最终分析纳入了499名患者，中位年龄为69岁（四分位数间距，61-74岁）；其中249名患者被分配到冷冻球囊组，另外250名患者被分配到射频组。

In the intention-to-treatanalysis, the primary endpoint was observed in 56 patients (22.5%) in the cryoballoon group and 58 (23.2%) in the radiofrequency group, and the cryoballoon group demonstrated non-inferiority compared to the radiofrequency group for the primary endpoint (hazard ratio.99; 95% confidence interval, .69-1.43; P = .96).

在意向治疗分析中，冷冻球囊组有56名患者（22.5%）和射频组有58名患者（23.2%）观察到主要终点事件，冷冻球囊组在主要终点事件上显示出与射频组相比的非劣效性（风险比0.99；95%置信区间，0.69-1.43；P = .96）。

The radiofrequency group showed a greater reduction in left atrial size (left atrial volume index) at 1 year than the cryoballoon group [-11 mL/m2 (interquartile range, -19 to -4) vs -4 mL/m2 (interquartile range, -13 to 3), P < .001].

在1年时，射频消融组在左心房大小（左心房体积指数）上的减少比冷冻球囊组更大[-11 mL/m2（四分位数间距，-19至-4）vs -4 mL/m2（四分位数间距，-13至3），P < .001]。

Conclusions

In this randomized trial, cryoballoon ablation was non-inferior to radiofrequency ablation for the occurrence of atrial tachyarrhythmias at 1 year in patients with persistent atrial fibrillation.

在这项随机试验中，对于持续性房颤患者，冷冻球囊消融在1年内发生房性心动过速的非劣效性不劣于射频消融。