PFO闭合可能使复发性隐发性中风与偏头痛患者受益

PFO Closure May Benefit Patients with Recurrent Cryptogenic Stroke, Migraine

关键点:随机的临床试验数据和证据依然不足

      尽管历来已有旁证说明卵圆孔未闭常常与中风、偏头痛的发生相关联，但是近来一些研究还试图在描述PFO的存在与复发性中风隐发性中风以及偏头痛之间的关系。

       英国伦敦圣乔治医院心导管实验室主任Stephen J. Brecker博士强调目前还没有随机的临床试验以评估PFO封堵与中风之间的关系，而且仅有一个研究评估了PFO与偏头痛之间的关系。除了上述不足外，已有几项研究提到了在几方面上，PFO封堵与中风（图1）以及偏头痛（图2）之间的关系。

 PFO研究
     

       在2000年刊登的一项针对22个对照病例的系统回顾与荟萃分析的结果显示了PFO为中风的危险因子的比数比是1.83，在55岁以下患者当中呈上升趋势。如果患者有房间隔瘤，比数比是23.26。Brecker还引用了2007年的一个研究，其中隐源性中风与原因明确的中风之间的比数比在小于55岁的患者中为0.47 (43.9% 对 14.3%; P<0.001)，而在55岁以上患者当中为2.9(28.3% 对11.9%; P<0.001)。

      当前的美国心脏学会/美国中风学会PFO封堵与中风评论理事会声明说没有足够的数据来为初次中风患者的PFO封堵提供建议。然而，他们还声明了在复发性隐发性中风患者当中除非在没有更加理想的药物治疗的情况下才可以考虑行PFO封堵。Brecker讲到，风险与收益比说明在某些亚型的患者当中应当考虑PFO封堵。

      应用STARFlex 技术进行偏头痛的介入治疗（MIST）研究的研究人员评估了PFO封堵以降低或消除偏头痛发生的隐患。2006年，研究人员报道了头痛天数减少50%的患者在PFO封堵组当中要高于对照组(42% 对 23%; P=0.038)，头痛负担的减轻方面也有同样的结果（37% 对 17%; P=0.033）。然而，据Becker提到，由于MIST在患者选择以及在对公众与在出版物中数据的差别，引发了人们对于其主要终点的顾虑。

    “与中风，有很强的旁证证明二者之间的联系，我们需要更好地特征描述我们正在处理的PFO类型，”他说到，“就偏头痛而言，我们有旁证——在出现视觉先兆和巨大分流的患者当中，确实存在联系，并且在治疗效果上也有观察性的证据。”“正在进行的研究PFO封堵与中风和偏头痛关系的关联试验，包括PRIMA和PREMIUM，对于推进我们对这一事件的理解非常重要。”Brecker博士这样说到。

（医心评论：孟祥飞 译  陆卫 校）

PFO Closure May Benefit Patients with Recurrent Cryptogenic Stroke, Migraine

Key Points:

• Randomized clinical trial data and evidence still lacking.

By TCT Daily Staff

Even though the association between patent foramen ovale, stroke, and migraine traditionally has been circumstantial, a number of recent studies have attempted to characterize the association between the presence of PFO and recurrent stroke, cryptogenic stroke, and migraine headaches.

Stephen J. Brecker, MD (right), director of the cardiac cath lab at St. George’s Hospital in London, noted that there have been no randomized clinical trials evaluating the association between PFO closure and stroke, and only one evaluating its association with migraines. Despite this shortcoming, there have been studies addressing various aspects of the relationship between PFO closure and stroke (Figure 1) and migraines (Figure 2).

PFO studies

A systematic review and meta-analysis of 22 case-control studies published in 2000 demonstrated a 1.83 odds ratio for PFO as a stroke risk factor, which increased in patients younger than 55.

The odds ratio was 23.26 if there was an atrial-septal aneurysm present. Brecker also cited a 2007 study in which the odd ratio of cryptogenic stroke vs. known stroke was 0.47 in patients younger than 55 (43.9% vs. 14.3%; P<.001) and 2.9 in those older than 55 (28.3% vs. 11.9%; P<.001).

The current American Heart Association/American Stroke Association Council on Stroke recommendations for PFO closure for stroke state that there are "insufficient data to make a recommendation about PFO closure in patients with first stroke."

However, they also state that "PFO closure in patients may be considered in patients with recurrent cryptogenic stroke despite optimal medical therapy." Brecker said risk-to-benefit ratio should dictate PFO closure in certain subsets of patients.

Researchers for the Migraine Intervention with STARFlex Technology (MIST) trial evaluated the potential for PFO closure to reduce or eliminate the occurrence of migraines. The researchers reported in 2006 that reduction in the number of headache days by 50% was greater in the PFO closure cohort of the study than in the control group (42% vs. 23%; P=.038), as was reduction in headache burden (37% vs. 17%; P=.033).

However, concerns over the primary endpoint, patient selection and differing datasets presented in public and in print have been raised about MIST, according to Brecker.

"With stroke, there is strong circumstantial evidence of a link, and we need better characterization of the types of PFO that we are dealing with," he said. "With respect to migraine, there is circumstantial evidence of a link in patients with migraine and visual aura and large shunts, and there is strong anecdotal evidence of a therapeutic effect." Ongoing trials investigating PFO closure for stroke and migraine, including PRIMA and PREMIUM, are essential to furthering our understanding of this issue, Brecker said.

Disclosures:

（source：www.tctmd.com）