比较抗心律失常药物治疗与射频导管消融治疗阵发性心房颤动的随机对照试验。

Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial.

机构信息

Cardiovascular Institute, Department of Medicine, Loyola University Medical Center, 2160 S First Ave, Bldg 110, Room 6232, Maywood, IL 60153, USA.

出版信息

JAMA. 2010 Jan 27;303(4):333-40. doi: 10.1001/jama.2009.2029.

DOI:10.1001/jama.2009.2029

PMID:20103757

Abstract

CONTEXT

Antiarrhythmic drugs are commonly used for prevention of recurrent atrial fibrillation (AF) despite inconsistent efficacy and frequent adverse effects. Catheter ablation has been proposed as an alternative treatment for paroxysmal AF.

OBJECTIVE

To determine the efficacy of catheter ablation compared with antiarrhythmic drug therapy (ADT) in treating symptomatic paroxysmal AF.

DESIGN, SETTING, AND PARTICIPANTS: A prospective, multicenter, randomized (2:1), unblinded, Bayesian-designed study conducted at 19 hospitals of 167 patients who did not respond to at least 1 antiarrhythmic drug and who experienced at least 3 AF episodes within 6 months before randomization. Enrollment occurred between October 25, 2004, and October 11, 2007, with the last follow-up on January 19, 2009.

INTERVENTION

Catheter ablation (n = 106) or ADT (n = 61), with assessment for effectiveness in a comparable 9-month follow-up period.

MAIN OUTCOME MEASURES

Time to protocol-defined treatment failure. The proportion of patients who experienced major treatment-related adverse events within 30 days of catheter ablation or ADT was also reported.

RESULTS

At the end of the 9-month effectiveness evaluation period, 66% of patients in the catheter ablation group remained free from protocol-defined treatment failure compared with 16% of patients treated with ADT. The hazard ratio of catheter ablation to ADT was 0.30 (95% confidence interval, 0.19-0.47; P < .001). Major 30-day treatment-related adverse events occurred in 5 of 57 patients (8.8%) treated with ADT and 5 of 103 patients (4.9%) treated with catheter ablation. Mean quality of life scores improved significantly in patients treated by catheter ablation compared with ADT at 3 months; improvement was maintained during the course of the study.

CONCLUSION

Among patients with paroxysmal AF who had not responded to at least 1 antiarrhythmic drug, the use of catheter ablation compared with ADT resulted in a longer time to treatment failure during the 9-month follow-up period.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00116428.

摘要

背景

尽管抗心律失常药物的疗效不一致且常伴有不良反应，但仍常用于预防复发性心房颤动（房颤）。导管消融术已被提议作为阵发性房颤的替代治疗方法。

目的

评估导管消融术与抗心律失常药物治疗（ADT）治疗有症状的阵发性房颤的疗效。

设计、地点和参与者：这是一项前瞻性、多中心、随机（2:1）、非盲、贝叶斯设计的研究，在 167 名患者中进行，这些患者对至少 1 种抗心律失常药物无反应，且在随机分组前 6 个月内至少经历了 3 次房颤发作。招募工作于 2004 年 10 月 25 日至 2007 年 10 月 11 日进行，最后一次随访时间为 2009 年 1 月 19 日。

干预措施

导管消融术（n=106）或 ADT（n=61），在 9 个月的随访期内评估疗效。

主要观察指标

根据方案定义的治疗失败时间。还报告了导管消融术或 ADT 后 30 天内发生的主要与治疗相关的不良事件的比例。

结果

在 9 个月的有效性评估期结束时，与 ADT 组的 16%相比，导管消融术组的 66%患者未发生方案定义的治疗失败。导管消融术与 ADT 的风险比为 0.30（95%置信区间，0.19-0.47；P<0.001）。ADT 组有 5 例（8.8%）和导管消融术组有 5 例（4.9%）患者在 30 天内发生与治疗相关的主要不良事件。与 ADT 相比，导管消融术组患者的生活质量评分在 3 个月时显著提高，且在研究过程中持续改善。