Miyamoto Koji, Kanaoka Koshiro, Yodogawa Kenji, Fujimoto Yuhi, Fukunaga Hiroshi, Asano So, Nagase Takahiko, Terasawa Muryo, Kusume Takahiro, Takada Yasuyuki, Takarada Ken, Sagawa Yuichiro, Shigeta Takatoshi, Ooka Junichi, Ishikura Masahiro, Yoh Masue, Takahashi Hiroki, Inoue Yuko, Nagase Satoshi, Aiba Takeshi, Kataoka Naoya, Takagi Masahiko, Yamagami Shintaro, Nishiuchi Suguru, Sasaki Yasuhiro, Kobori Atsushi, Yamauchi Yasuteru, Yazaki Yoshinao, Satomi Kazuhiro, Nitta Junichi, Mizuno Shingo, Murakami Masato, Ashikaga Keiichi, Kishihara Jun, Fukaya Hidehira, Iwasaki Yu-Ki, Shimizu Wataru, Kusano Kengo
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, 6-1, Kishibeshimmachi, Suita, Osaka 564-8565, Japan.
Department of Medical and Health Information Management, Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan.
Eur Heart J. 2025 Jul 24. doi: 10.1093/eurheartj/ehaf451.
There are limited prospective data on the efficacy, safety, and impact on reverse remodelling of cryoballoon ablation as compared to radiofrequency ablation for persistent atrial fibrillation.
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. A total of 500 patients with persistent atrial fibrillation were randomized across 12 centres. The primary endpoint was the occurrence of atrial tachyarrhythmias at 1 year with a 90-day blanking period after ablation.
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. In the intention-to-treat analysis, 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). 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].
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.
与射频消融治疗持续性心房颤动相比，关于冷冻球囊消融的疗效、安全性及对逆向重构的影响的前瞻性数据有限。
开展一项前瞻性、多中心、随机、非劣效性临床试验，比较冷冻球囊与射频消融治疗持续性心房颤动的疗效和安全性。共有500例持续性心房颤动患者在12个中心进行随机分组。主要终点为消融后1年发生房性快速性心律失常，消融后有90天的空白期。
最终分析纳入499例患者，中位年龄69岁（四分位间距为61 - 74岁）；249例患者被分配至冷冻球囊组，250例被分配至射频组。在意向性分析中，冷冻球囊组有56例患者（22.5%）达到主要终点，射频组有58例（23.2%），冷冻球囊组在主要终点方面显示出与射频组非劣效（风险比0.99；95%置信区间为0.69 - 1.43；P = 0.96）。射频组在1年时左心房大小（左心房容积指数）的减小幅度大于冷冻球囊组[-11 mL/m2（四分位间距为-19至-4） vs -4 mL/m2（四分位间距为-13至3），P < 0.001]。
在这项随机试验中，对于持续性心房颤动患者，冷冻球囊消融在1年时发生房性快速性心律失常方面不劣于射频消融。
