Jacobs School of Medicine and Biomedical Sciences, The State University of New York at Buffalo, Buffalo, NY, USA.
Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Curr Neurol Neurosci Rep. 2017 Mar;17(3):20. doi: 10.1007/s11910-017-0730-5.
Observational studies suggest that closure of a patent foramen ovale for other indications may reduce or even eliminate migraine attacks, particularly migraine with aura. The first randomized clinical trial of patent foramen ovale (PFO) closure for prevention of migraine, the MIST trial, showed negative results. The results of the other two completed studies in this area have recently been published in the last year. PRIMA and PREMIUM were also both negative for their primary endpoints. The PREMIUM trial did show a reduction in headache days in the migraine with aura subgroup but the final results of this subset analysis have not been published. There may be an as yet undetermined subgroup of patients with migraine who would benefit from closure, but slow recruitment has been a barrier to further study. Several potentially life-threatening procedure-related adverse events occurred in the clinical trials. At this time, we recommend against offering PFO closure as a preventive treatment for migraine. Based on available observational data, patients for whom PFO closure is indicated for other reasons may see some improvement in their migraines.
观察性研究表明，对于其他适应证，卵圆孔未闭（PFO）封堵术可能会减少甚至消除偏头痛发作，尤其是有先兆的偏头痛。第一项针对卵圆孔未闭封堵术（PFO）预防偏头痛的随机临床试验（MIST 试验）结果为阴性。该领域另外两项已完成研究的结果最近在过去一年中发表。PRIMA 和 PREMIUM 也都未达到其主要终点。PREMIUM 试验确实显示出有先兆的偏头痛亚组头痛天数减少，但该亚组分析的最终结果尚未公布。可能存在一个尚未确定的偏头痛患者亚组，他们可能会从封堵中获益，但招募缓慢一直是进一步研究的障碍。临床试验中发生了几起与治疗相关的潜在危及生命的不良事件。目前，我们不建议将 PFO 封堵作为偏头痛的预防治疗。基于现有的观察性数据，对于因其他原因需要进行 PFO 封堵的患者，其偏头痛可能会有所改善。
