Dulai Rajdip, Sulke Neil, Freemantle Nick, Lambiase Pier D, Farwell David, Srinivasan Neil T, Tan Stuart, Patel Nikhil, Graham Adam, Veasey Rick A
Cardiology Research Department, Eastbourne District General Hospital, East Sussex Hospitals NHS Trust, Eastbourne, United Kingdom.
Institute of Cardiovascular Science, University College London, London, United Kingdom.
JAMA. 2024 Sep 2;332(14):1165-73. doi: 10.1001/jama.2024.17921.
There are concerns that pulmonary vein isolation for atrial fibrillation may have a profound placebo effect, but no double-blind randomized clinical trials have been conducted.
To determine whether pulmonary vein isolation is more effective than a sham procedure for improving outcomes in atrial fibrillation.
DESIGN, SETTING, AND PARTICIPANTS: Double-blind randomized clinical trial conducted at 2 tertiary centers in the UK between January 2020 and March 2024 among patients with symptomatic paroxysmal or persistent atrial fibrillation. Major exclusion criteria included long-standing persistent atrial fibrillation, prior left atrium ablation, other arrhythmias requiring ablative therapy, a left atrium of 5.5 cm or larger, and ejection fraction of less than 35%.
Participants were randomly assigned to receive pulmonary vein isolation with cryoablation (n = 64) or a sham procedure with phrenic nerve pacing (n = 62).
The primary end point was atrial fibrillation burden at 6 months, excluding a 3-month blanking period. Secondary outcomes included quality-of-life measures, time to events, and safety. Atrial fibrillation burden was measured by an implantable loop recorder.
A total of 126 participants were randomized (mean age, 66.8 years; 89 men [70.63%]; 20.63% with paroxysmal atrial fibrillation). The absolute mean atrial fibrillation burden change from baseline to 6 months was 60.31% in the ablation group and 35.0% in the sham group (geometric mean difference, 0.25; 95% CI, 0.15-0.42; P < .001). The estimated difference in the overall Atrial Fibrillation Effect on Quality of Life score at 6 months, favoring catheter ablation, was 18.39 points (95% CI, 11.48-25.30 points). The Short Form 36 general health score also improved substantially more with ablation, with an estimated difference of 9.27 points at 6 months (95% CI, 3.78-14.76 points).
Pulmonary vein isolation resulted in a statistically significant and clinically important decrease in atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life, compared with a sham procedure.
ClinicalTrials.gov Identifier: NCT04272762.
有人担心房颤的肺静脉隔离术可能具有显著的安慰剂效应，但尚未进行双盲随机临床试验。
确定肺静脉隔离术在改善房颤预后方面是否比假手术更有效。
设计、地点和参与者：2020年1月至2024年3月在英国2个三级中心对有症状的阵发性或持续性房颤患者进行的双盲随机临床试验。主要排除标准包括长期持续性房颤、既往左心房消融、其他需要消融治疗的心律失常、左心房直径5.5 cm或更大以及射血分数低于35%。
参与者被随机分配接受冷冻消融肺静脉隔离术（n = 64）或膈神经起搏假手术（n = 62）。
主要终点是6个月时的房颤负荷，不包括3个月的空白期。次要结局包括生活质量指标、事件发生时间和安全性。房颤负荷通过植入式环形记录仪测量。
共有126名参与者被随机分组（平均年龄66.8岁；89名男性[70.63%]；20.63%为阵发性房颤）。消融组从基线到6个月时房颤负荷的绝对平均变化为60.31%，假手术组为35.0%（几何平均差异为0.25；95%CI，0.15 - 0.42；P <.001）。6个月时，有利于导管消融的房颤对生活质量总体评分的估计差异为18.39分（95%CI，11.48 - 25.30分）。简短健康调查问卷36项的总体健康评分在消融后也有更大改善，6个月时估计差异为9.27分（95%CI，3.78 - 14.76分）。
与假手术相比，肺静脉隔离术在6个月时导致房颤负荷在统计学上有显著且临床上重要的降低，症状和生活质量有实质性改善。
ClinicalTrials.gov标识符：NCT04272762。
