Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: The Prospective, Randomized, Controlled, Noninferiority FreezeAF Study.
Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: The Prospective, Randomized, Controlled, Noninferiority FreezeAF Study.
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DOI：
10.1161/circulationaha.115.016871
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发表时间：
2015-10-06
期刊：
影响因子：
37.8
通讯作者：
Schmitt C
中科院分区：
文献类型：
--
作者：
Luik A;Radzewitz A;Kieser M;Walter M;Bramlage P;Hörmann P;Schmidt K;Horn N;Brinkmeier-Theofanopoulou M;Kunzmann K;Riexinger T;Schymik G;Merkel M;Schmitt C
补充数字内容可在文本中找到。开放式灌洗射频（RF）和低温球囊导管（CB）消融治疗阵发性心房颤动患者肺静脉隔离的比较疗效和程序安全性缺乏数据。在一项前瞻性、非劣效性研究中，315例患者被随机分配到RF （n=159）或CB （n=156）消融组。主要终点是无房性心律失常且无持续性并发症。RF组中血管疾病发生率较高的两组患者在很大程度上具有可比性（8.2% vs 2.6%， P=0.028）。12个月时，70.7%的RF和73.6%的CB（多个手术成功）达到了主要终点，包括每组31个重做手术（19.5%的RF和19.9%的CB； P=0.933）。对于意向治疗人群，CB的非劣效性显示为预定义的劣效性（风险差为0.029；95%置信区间为- 0.074至0.132；P<0.001）。6个月时RF组和CB组的成功率分别为63.1%和64.1%（单次手术成功），证实了非劣效性（风险差异为0.010；95%可信区间为- 0.097至0.116；P=0.002）。指数手术的围手术期并发症在CB组更常见（5.0% RF, 12.2% CB， P=0.022），膈神经麻痹（0% RF, 5.8% CB， P=0.002）差异有统计学意义。这项大型、前瞻性、随机、对照研究证明了CB消融与RF消融治疗阵发性心房颤动患者的非劣效性。URL: http://www.clinicaltrials.gov。唯一标识符：NCT00774566。
Supplemental Digital Content is available in the text. There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency (RF) and cryoballoon catheter (CB) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. In a prospective, noninferiority study, 315 patients were randomly assigned to RF (n=159) or CB (n=156) ablation. The primary end point was freedom from atrial arrhythmia with absence of persistent complications. Patients were largely comparable between groups with more vascular disease in the RF group (8.2% versus 2.6% for CB; P=0.028). The primary end point at 12 months was achieved by 70.7% with RF and 73.6% with CB (multiple procedure success), including 31 redo procedures in each group (19.5% of RF versus 19.9% of CB; P=0.933). For the intention-to-treat population, noninferiority of CB was revealed for the predefined inferiority margin (risk difference, 0.029; 95% confidence interval, −0.074 to 0.132; P<0.001). Rates at 6 months were 63.1% and 64.1% for the RF and CB groups (single procedure success), and noninferiority was confirmed (risk difference, 0.010; 95% confidence interval, −0.097 to 0.116; P=0.002). Periprocedural complications for the index procedure were more frequent in the CB group (5.0% RF, 12.2% CB; P=0.022) with a significant difference in phrenic nerve palsies (0% RF, 5.8% CB; P=0.002). This large, prospective, randomized, controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00774566.