McMaster University, Population Health Research Institute, Hamilton Health Sciences, Hamilton, Canada.
Southlake Regional Health Centre, Newmarket, Canada.
JAMA. 2014 Feb 19;311(7):692-700. doi: 10.1001/jama.2014.467.
Atrial fibrillation (AF) is the most common rhythm disorder seen in clinical practice. Antiarrhythmic drugs are effective for reduction of recurrence in patients with symptomatic paroxysmal AF. Radiofrequency ablation is an accepted therapy in patients for whom antiarrhythmic drugs have failed; however, its role as a first-line therapy needs further investigation.
To compare radiofrequency ablation with antiarrhythmic drugs (standard therapy) in treating patients with paroxysmal AF as a first-line therapy.
DESIGN, SETTING, AND PATIENTS: A randomized clinical trial involving 127 treatment-naive patients with paroxysmal AF were randomized at 16 centers in Europe and North America to received either antiarrhythmic therapy or ablation. The first patient was enrolled July 27, 2006; the last patient, January 29, 2010. The last follow-up was February 16, 2012.
Sixty-one patients in the antiarrhythmic drug group and 66 in the radiofrequency ablation group were followed up for 24 months.
The time to the first documented atrial tachyarrhythmia of more than 30 seconds (symptomatic or asymptomatic AF, atrial flutter, or atrial tachycardia), detected by either scheduled or unscheduled electrocardiogram, Holter, transtelephonic monitor, or rhythm strip, was the primary outcome. Secondary outcomes included symptomatic recurrences of atrial tachyarrhythmias and quality of life measures assessed by the EQ-5D tool.
Forty-four patients (72.1%) in the antiarrhythmic group and in 36 patients (54.5%) in the ablation group experienced the primary efficacy outcome (hazard ratio [HR], 0.56 [95% CI, 0.35-0.90]; P = .02). For the secondary outcomes, 59% in the drug group and 47% in the ablation group experienced the first recurrence of symptomatic AF, atrial flutter, atrial tachycardia (HR, 0.56 [95% CI, 0.33-0.95]; P = .03). No deaths or strokes were reported in either group; 4 cases of cardiac tamponade were reported in the ablation group. In the standard treatment group, 26 patients (43%) underwent ablation after 1-year. Quality of life was moderately impaired at baseline in both groups and improved at the 1 year follow-up. However, improvement was not significantly different among groups.
Among patients with paroxysmal AF without previous antiarrhythmic drug treatment, radiofrequency ablation compared with antiarrhythmic drugs resulted in a lower rate of recurrent atrial tachyarrhythmias at 2 years. However, recurrence was frequent in both groups.
clinicaltrials.gov Identifier: NCT00392054.
心房颤动（AF）是临床实践中最常见的节律障碍。抗心律失常药物可有效减少有症状阵发性 AF 患者的复发。射频消融是抗心律失常药物治疗失败患者的一种可接受的治疗方法；然而，作为一线治疗方法，其作用仍需进一步研究。
比较射频消融与抗心律失常药物（标准治疗）作为阵发性 AF 一线治疗的效果。
设计、地点和患者：一项随机临床试验纳入了 127 例未经治疗的阵发性 AF 患者，他们在欧洲和北美的 16 个中心被随机分为接受抗心律失常治疗或消融的两组。首例患者于 2006 年 7 月 27 日入组，最后一例患者于 2010 年 1 月 29 日入组。最后一次随访是在 2012 年 2 月 16 日。
抗心律失常药物组 61 例，射频消融组 66 例，随访 24 个月。
首次记录到 30 秒以上的心房性心律失常（有症状或无症状的 AF、心房扑动或心房颤动）的时间，通过计划或非计划心电图、动态心电图、远程心电图监测或节律条记录，这是主要结局。次要结局包括有症状的心房性心律失常复发和使用 EQ-5D 工具评估的生活质量。
抗心律失常组 44 例（72.1%）和消融组 36 例（54.5%）患者发生主要疗效结局（风险比[HR]，0.56 [95%CI，0.35-0.90]；P=0.02）。对于次要结局，药物组 59%和消融组 47%的患者首次出现有症状的 AF、心房扑动、心房颤动（HR，0.56 [95%CI，0.33-0.95]；P=0.03）。两组均无死亡或卒中报告；消融组报告 4 例心脏压塞。标准治疗组中有 26 例（43%）患者在 1 年后接受了消融。两组基线时生活质量均中度受损，随访 1 年时均有所改善。然而，组间改善无显著差异。
在无抗心律失常药物治疗的阵发性 AF 患者中，与抗心律失常药物相比，射频消融可使 2 年时复发性心房性心律失常的发生率降低。然而，两组的复发率都很高。
clinicaltrials.gov 标识符：NCT00392054。
