Division of Cardiology, Department of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.
Division of Cardiology, Department of Medicine, University of California, Los Angeles, Los Angeles, California, USA.
J Am Coll Cardiol. 2021 Feb 16;77(6):667-676. doi: 10.1016/j.jacc.2020.11.068.
Although observational studies have shown percutaneous patent foramen ovale (PFO) closure to be a safe means of reducing the frequency and duration of migraine, randomized clinical trials have not met their primary efficacy endpoints.
The authors report the results of a pooled analysis of individual participant data from the 2 randomized trials using the Amplatzer PFO Occluder to assess the efficacy and safety of percutaneous device closure as a therapy for episodic migraine with or without aura.
The authors analyzed individual patient-level data from 2 randomized migraine trials (the PRIMA [Percutaneous Closure of Patent Foramen Ovale in Migraine With Aura] and PREMIUM [Prospective Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects with Migraine and PFO Using the Amplatzer PFO Occluder Compared to Medical Management] studies). Efficacy endpoints were mean reduction in monthly migraine days, responder rate (defined as ≥50% reduction in monthly migraine attacks), mean reduction in monthly migraine attacks, and percentage of patients who experienced complete cessation of migraine. The safety endpoint was major procedure- and device-related adverse events.
Among 337 subjects, 176 were randomized by blocks to device closure and 161 to medical treatment only. At 12-month follow-up, the analysis met 3 of the 4 efficacy endpoints: mean reduction of monthly migraine days (-3.1 days vs. -1.9 days; p = 0.02), mean reduction of monthly migraine attacks (-2.0 vs. -1.4; p = 0.01), and number of subjects who experienced complete cessation of migraine (14 [9%] vs. 1 [0.7%]; p < 0.001). For the safety analysis, 9 procedure-related and 4 device-related adverse events occurred in 245 subjects who eventually received devices. All events were transient and resolved.
This pooled analysis of patient-level data demonstrates that PFO closure was safe and significantly reduced the mean number of monthly migraine days and monthly migraine attacks, and resulted in a greater number of subjects who experienced complete migraine cessation.
虽然观察性研究表明，经皮卵圆孔未闭（PFO）封堵术是减少偏头痛发作频率和持续时间的安全方法，但随机临床试验并未达到其主要疗效终点。
作者报告了使用 Amplatzer PFO 封堵器进行的 2 项随机试验的个体参与者数据汇总分析结果，以评估经皮装置封堵作为有或无先兆偏头痛发作的治疗方法的疗效和安全性。
作者分析了 2 项随机偏头痛试验（PRIMA[有先兆偏头痛患者经皮卵圆孔未闭封堵术]和 PREMIUM[前瞻性随机研究，评估使用 Amplatzer PFO 封堵器与药物治疗相比偏头痛和 PFO 患者头痛减少发生率]）的个体患者水平数据。疗效终点为每月偏头痛天数的平均减少、应答率（定义为每月偏头痛发作减少≥50%）、每月偏头痛发作的平均减少和经历偏头痛完全停止的患者比例。安全性终点为主要手术和器械相关不良事件。
在 337 名患者中，176 名按块随机分配至器械封堵组，161 名仅接受药物治疗。在 12 个月的随访中，分析达到了 4 个疗效终点中的 3 个：每月偏头痛天数的平均减少（-3.1 天比-1.9 天；p=0.02）、每月偏头痛发作的平均减少（-2.0 比-1.4；p=0.01）以及经历偏头痛完全停止的患者比例（14 [9%]比 1 [0.7%]；p<0.001）。对于安全性分析，245 名最终接受器械治疗的患者中有 9 例与手术相关和 4 例与器械相关的不良事件。所有事件均为短暂性，且已解决。
这项基于患者水平数据的汇总分析表明，PFO 封堵术是安全的，可显著减少每月偏头痛天数和每月偏头痛发作次数，并使更多患者经历偏头痛完全停止。
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