Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial.
Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial.
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DOI：
10.1093/eurheartj/ehw285
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发表时间：
2016-10-07
影响因子：
39.3
通讯作者：
FIRE AND ICE Investigators
中科院分区：
文献类型：
--
作者：
Kuck KH;Fürnkranz A;Chun KR;Metzner A;Ouyang F;Schlüter M;Elvan A;Lim HW;Kueffer FJ;Arentz T;Albenque JP;Tondo C;Kühne M;Sticherling C;Brugada J;FIRE AND ICE Investigators
随机 FIRE AND ICE 试验的主要安全性和有效性终点最近证明，冷冻球囊与射频电流 (RFC) 导管消融治疗药物难治性症状性阵发性房颤 (AF) 患者的非劣效性。当前研究的目的是使用关键的二次分析来评估对患者日常临床管理很重要的结果参数。具体来说，这项冷冻球囊与 RFC 导管消融的随机试验对再干预、再住院和生活质量进行了检查。患者（冷冻球囊组中的 374 名受试者和 RFC 组中的 376 名受试者）在修改后的意向治疗队列中进行了评估。指数消融后，超过 1000 天的对数秩检验表明，在重复消融（11.8% 冷冻球囊 vs. 17.6% RFC；P = 0.03）、直流电复律（3.2% 冷冻球囊 vs. 6.4% RFC；P = 0.04）、全因治疗方面，冷冻球囊消融存在统计学上的显着差异。再住院 （32.6% 冷冻球囊 vs. 41.5% RFC；P = 0.01），以及心血管再住院（23.8% 冷冻球囊 vs. 35.9% RFC；P < 0.01）。通过 Short Form-12 健康调查和 EuroQol 五维问卷测量，各组之间的生活质量调查（精神和身体）没有统计学差异。从指数消融后 6 个月开始，所有患者的精神和身体生活质量均得到改善，并在整个 30 个月的随访期间得到维持。与 RFC 消融相比，接受冷冻球囊治疗的患者在随访期间的重复消融、直流电复律、全因再住院和心血管再住院次数显着减少。房颤消融后，两组患者的生活质量评分均有所改善。 ClinicalTrials.gov 标识符：NCT01490814。
The primary safety and efficacy endpoints of the randomized FIRE AND ICE trial have recently demonstrated non-inferiority of cryoballoon vs. radiofrequency current (RFC) catheter ablation in patients with drug-refractory symptomatic paroxysmal atrial fibrillation (AF). The aim of the current study was to assess outcome parameters that are important for the daily clinical management of patients using key secondary analyses. Specifically, reinterventions, rehospitalizations, and quality-of-life were examined in this randomized trial of cryoballoon vs. RFC catheter ablation. Patients (374 subjects in the cryoballoon group and 376 subjects in the RFC group) were evaluated in the modified intention-to-treat cohort. After the index ablation, log-rank testing over 1000 days of follow-up demonstrated that there were statistically significant differences in favour of cryoballoon ablation with respect to repeat ablations (11.8% cryoballoon vs. 17.6% RFC; P = 0.03), direct-current cardioversions (3.2% cryoballoon vs. 6.4% RFC; P = 0.04), all-cause rehospitalizations (32.6% cryoballoon vs. 41.5% RFC; P = 0.01), and cardiovascular rehospitalizations (23.8% cryoballoon vs. 35.9% RFC; P < 0.01). There were no statistical differences between groups in the quality-of-life surveys (both mental and physical) as measured by the Short Form-12 health survey and the EuroQol five-dimension questionnaire. There was an improvement in both mental and physical quality-of-life in all patients that began at 6 months after the index ablation and was maintained throughout the 30 months of follow-up. Patients treated with cryoballoon as opposed to RFC ablation had significantly fewer repeat ablations, direct-current cardioversions, all-cause rehospitalizations, and cardiovascular rehospitalizations during follow-up. Both patient groups improved in quality-of-life scores after AF ablation. ClinicalTrials.gov identifier: NCT01490814.
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影响因子：
158.5
作者：
Kuck, Karl-Heinz;Brugada, Josep;Tondo, Claudio
通讯作者：
Tondo, Claudio
影响因子：
2.9
作者：
Opolski, Grzegorz;Januszkiewicz, Lukasz;Kazmierczak, Jaroslaw
通讯作者：
Kazmierczak, Jaroslaw
影响因子：
6.1
作者：
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Vardas, Panos E.
影响因子：
37.8
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
通讯作者：
Schmitt C
影响因子：
4.5
作者：
Bharmal, Murtuza;Thomas, Joseph, III
通讯作者：
Thomas, Joseph, III