Dowson Andrew, Mullen Michael J, Peatfield Richard, Muir Keith, Khan Arif Anis, Wells Christopher, Lipscombe Susan L, Rees Trevor, De Giovanni Joseph V, Morrison W Lindsay, Hildick-Smith David, Elrington Giles, Hillis W Stewart, Malik Iqbal S, Rickards Anthony
The King's Headache Service, King's College Hospital, Denmark Hill, London SE5 9RS, UK.
Circulation. 2008 Mar 18;117(11):1397-404. doi: 10.1161/CIRCULATIONAHA.107.727271. Epub 2008 Mar 3.
Patent foramen ovale (PFO) is prevalent in patients with migraine with aura. Observational studies show that PFO closure resulted in migraine cessation or improvement in approximately 80% of such patients. We investigated the effects of PFO closure for migraine in a randomized, double-blind, sham-controlled trial.
Patients who suffered from migraine with aura, experienced frequent migraine attacks, had previously failed > or = 2 classes of prophylactic treatments, and had moderate or large right-to-left shunts consistent with the presence of a PFO were randomized to transcatheter PFO closure with the STARFlex implant or to a sham procedure. Patients were followed up for 6 months. The primary efficacy end point was cessation of migraine headache 91 to 180 days after the procedure. In total, 163 of 432 patients (38%) had right-to-left shunts consistent with a moderate or large PFO. One hundred forty-seven patients were randomized. No significant difference was observed in the primary end point of migraine headache cessation between implant and sham groups (3 of 74 versus 3 of 73, respectively; P=0.51). Secondary end points also were not achieved. On exploratory analysis, excluding 2 outliers, the implant group demonstrated a greater reduction in total migraine headache days (P=0.027). As expected, the implant arm experienced more procedural serious adverse events. All events were transient.
This trial confirmed the high prevalence of right-to-left shunts in patients with migraine with aura. Although no significant effect was found for primary or secondary end points, the exploratory analysis supports further investigation. The robust design of this study has served as the model for larger trials that are currently underway in the United States and Europe.
卵圆孔未闭（PFO）在伴先兆偏头痛患者中很常见。观察性研究表明，卵圆孔未闭封堵术可使约80%的此类患者偏头痛停止或改善。我们在一项随机、双盲、假手术对照试验中研究了卵圆孔未闭封堵术对偏头痛的影响。
患有伴先兆偏头痛、偏头痛发作频繁、先前至少两种预防性治疗失败且存在与卵圆孔未闭一致的中至大量右向左分流的患者，被随机分配接受使用STARFlex植入物的经导管卵圆孔未闭封堵术或假手术。对患者进行6个月的随访。主要疗效终点是术后91至180天偏头痛头痛停止。总共432例患者中有163例（38%）存在与中至大量卵圆孔未闭一致的右向左分流。147例患者被随机分组。植入组和假手术组在偏头痛头痛停止的主要终点上未观察到显著差异（分别为74例中的3例和73例中的3例；P = 0.51）。次要终点也未达到。在探索性分析中，排除2例异常值后，植入组的偏头痛总天数减少更多（P = 0.027）。正如预期的那样，植入组经历了更多的手术严重不良事件。所有事件均为短暂性。
本试验证实了伴先兆偏头痛患者中右向左分流的高患病率。尽管在主要或次要终点上未发现显著效果，但探索性分析支持进一步研究。本研究的稳健设计已成为美国和欧洲目前正在进行的更大规模试验的模型。
