加拿大英属哥伦比亚大学Jason G. Andrade团队比较了冷冻消融或药物治疗心房颤动的预后。2020年11月16日，该研究发表在《新英格兰医学杂志》上。

指南建议在房颤患者考虑进行导管消融之前，先尝试一种或多种抗心律不齐药物。但一线消融可能更有效地维持窦性心律。

研究组招募了303例有症状、阵发性、未经治疗的房颤患者，将其随机分配，分别接受低温球囊消融术或抗心律失常药物治疗以控制初始心律。所有患者均接受了植入式心脏监测设备以监测房性心律失常，随访期为12个月。主要终点为导管消融或开始使用抗心律失常药物后91-365天首次有记录的任何房性心动过速（心房颤动、心房扑动或房性心动过速）的复发。次要终点包括无症状性心律不齐、房颤负担和生活质量。

在1年时，消融组154例患者中有66例（42.9％）发生了房性快速性心律失常复发，抗心律不齐药物组149例患者中有101例（67.8％），风险比为0.48，组间差异显著。消融组患者中有症状的房性快速性心律失常发生率为11.0％，抗心律不齐药物组患者中为26.2％，风险比为0.39。消融组患者心房颤动的中位持续时间百分比为0%，抗心律不齐药物组为0.13%。消融组中有5例患者（3.2％）发生了严重不良事件，抗心律不齐药物组中有6例患者（4.0％）。

研究结果表明，对于症状性阵发性心房颤动的初治患者，通过持续性心律监测，采用导管低温球囊消融术治疗后的房颤复发率显著低于抗心律不齐药物治疗。

附：英文原文

Title: Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation | NEJM

Author: Jason G. Andrade, M.D.,, George A. Wells, Ph.D.,, Marc W. Deyell, M.D.,, Matthew Bennett, M.D.,, Vidal Essebag, M.D., Ph.D.,, Jean Champagne, M.D.,, Jean-Francois Roux, M.D.,, Derek Yung, M.D.,, Allan Skanes, M.D.,, Yaariv Khaykin, M.D.,, Carlos Morillo, M.D.,, Umjeet Jolly, M.D.,, Paul Novak, M.D.,, Evan Lockwood, M.D.,, Guy Amit, M.D.,, Paul Angaran, M.D.,, John Sapp, M.D.,, Stephan Wardell, M.D.,, Sandra Lauck, Ph.D.,, Laurent Macle, M.D.,, and Atul Verma, M.D.

Issue&Volume: 2020-11-16

Abstract:

Background

Guidelines recommend a trial of one or more antiarrhythmic drugs before catheter ablation is considered in patients with atrial fibrillation. However, first-line ablation may be more effective in maintaining sinus rhythm.

Methods

We randomly assigned 303 patients with symptomatic, paroxysmal, untreated atrial fibrillation to undergo catheter ablation with a cryothermy balloon or to receive antiarrhythmic drug therapy for initial rhythm control. All the patients received an implantable cardiac monitoring device to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug. The secondary end points included freedom from symptomatic arrhythmia, the atrial fibrillation burden, and quality of life.

Results

At 1 year, a recurrence of atrial tachyarrhythmia had occurred in 66 of 154 patients (42.9%) assigned to undergo ablation and in 101 of 149 patients (67.8%) assigned to receive antiarrhythmic drugs (hazard ratio, 0.48; 95% confidence interval [CI], 0.35 to 0.66; P<0.001). Symptomatic atrial tachyarrhythmia had recurred in 11.0% of the patients who underwent ablation and in 26.2% of those who received antiarrhythmic drugs (hazard ratio, 0.39; 95% CI, 0.22 to 0.68). The median percentage of time in atrial fibrillation was 0% (interquartile range, 0 to 0.08) with ablation and 0.13% (interquartile range, 0 to 1.60) with antiarrhythmic drugs. Serious adverse events occurred in 5 patients (3.2%) who underwent ablation and in 6 patients (4.0%) who received antiarrhythmic drugs.

Conclusions

Among patients receiving initial treatment for symptomatic, paroxysmal atrial fibrillation, there was a significantly lower rate of atrial fibrillation recurrence with catheter cryoballoon ablation than with antiarrhythmic drug therapy, as assessed by continuous cardiac rhythm monitoring.

DOI: 10.1056/NEJMoa2029980

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2029980