Department of Neurology, Bern University Hospital, Bern 3010, Switzerland
University Hospital of Münster, Münster, Germany.
Eur Heart J. 2016 Jul 7;37(26):2029-36. doi: 10.1093/eurheartj/ehw027. Epub 2016 Feb 22.
Migraine with aura and patent foramen ovale (PFO) are associated. The Percutaneous Closure of PFO in Migraine with Aura (PRIMA) trial is a multicentre, randomized trial to investigate the effect of percutaneous PFO closure in patients refractory to medical treatment.
Migraine with aura patients and PFO who were unresponsive to preventive medications were randomized to PFO closure or medical treatment. Both groups were given acetylsalicylic acid 75-100 mg/day for 6 months and clopidogrel 75 mg/day for 3 months. The primary endpoint was reduction in monthly migraine days during months 9-12 after randomization compared with a 3-month baseline phase before randomization. The committee reviewing the headache diaries were blinded to treatment assignment.
One hundred and seven patients were randomly allocated to treatment with an Amplatzer PFO Occluder (N = 53) or control with medical management (N = 54). The trial was terminated prematurely because of slow enrolment. Eighty-three patients (40 occluder, 43 control) completed 12-month follow-up. Mean migraine days at baseline were 8 (±4.7 SD) in the closure group and 8.3 (±2.4) in controls. The primary endpoint was negative with -2.9 days after PFO closure vs. -1.7 days in control group (P = 0.17). Patent foramen ovale closure caused five adverse events without permanent sequelae.
In patients with refractory migraine with aura and PFO, PFO closure did not reduce overall monthly migraine days.
偏头痛伴先兆和卵圆孔未闭（PFO）相关。经皮卵圆孔未闭封堵术治疗偏头痛伴先兆（PRIMA）试验是一项多中心、随机试验，旨在研究经皮 PFO 封堵术对药物治疗无效的患者的疗效。
偏头痛伴先兆患者和对预防药物无反应的 PFO 患者被随机分为 PFO 封堵或药物治疗。两组患者均接受阿司匹林 75-100mg/天治疗 6 个月，氯吡格雷 75mg/天治疗 3 个月。主要终点是与随机分组前 3 个月的基线期相比，随机分组后 9-12 个月每月偏头痛天数的减少。审查头痛日记的委员会对治疗分配情况不知情。
107 例患者被随机分配接受 Amplatzer PFO 封堵器治疗（N=53）或药物治疗对照组（N=54）。由于入组缓慢，试验提前终止。83 例患者（40 例封堵器，43 例对照组）完成了 12 个月的随访。封堵组基线时偏头痛天数的平均值为 8（±4.7 标准差），对照组为 8.3（±2.4）。主要终点为封堵组为-2.9 天，对照组为-1.7 天（P=0.17）。PFO 封堵引起 5 例不良事件，但无永久性后遗症。
在药物治疗无效的偏头痛伴先兆和 PFO 患者中，PFO 封堵并不能减少总体每月偏头痛天数。
