Patent foramen ovale closure and medical treatments for secondary stroke prevention: a systematic review of observational and randomized evidence.
Patent foramen ovale closure and medical treatments for secondary stroke prevention: a systematic review of observational and randomized evidence.
复制标题
DOI：
10.1161/strokeaha.111.631648
复制
发表时间：
2012-02
期刊：
影响因子：
8.3
通讯作者：
Kent DM
中科院分区：
文献类型：
--
作者：
Kitsios GD;Dahabreh IJ;Abu Dabrh AM;Thaler DE;Kent DM
在隐源性卒中背景下发现卵圆孔未闭的患者可采用经皮闭合术、抗血小板治疗或抗凝剂治疗。最近的一项随机试验（CLOSURE I）未发现闭合术优于单纯药物治疗;最佳药物治疗也未知。我们综合了卵圆孔未闭和隐源性卒中患者卒中二级预防的现有证据。进行MEDLINE检索，以查找调查药物治疗或闭合的纵向研究、复发性脑血管事件发生率（IR）和IR比率的荟萃分析。回顾了52项单组研究和7项比较性非随机研究以及CLOSURE I试验。复发性卒中的总体IR为0.36起事件（95% CI，0.24-0.56）/100人-年（闭合组）和2.53起事件（95% CI，1.91-3.35）/100人-年（药物治疗组）。在比较观察性研究中，闭合上级优于药物治疗（IR比=0.19; 95% CI，0.07-0.54）。CLOSURE I试验闭合组的IR高于观察性研究的总结估计值;闭合相对于药物治疗无显著获益（比较观察性研究和试验之间的疗效估计值，P=0.002）。比较药物治疗的观察性和随机化数据（9项研究）是一致的，表明抗凝剂在预防卒中复发方面上级抗血小板药物（IR比= 0. 42; 95% CI，0. 18 - 0. 98）。虽然需要进一步的随机试验数据来精确确定闭合对卒中复发的影响，但CLOSURE I的结果对大量观察证据的可信度提出了挑战，这些证据强烈支持机械闭合而不是药物治疗。
Patients discovered to have a patent foramen ovale in the setting of a cryptogenic stroke may be treated with percutaneous closure, antiplatelet therapy, or anticoagulants. A recent randomized trial (CLOSURE I) did not detect any benefit of closure over medical treatment alone; the optimal medical therapy is also unknown. We synthesized the available evidence on secondary stroke prevention in patients with patent foramen ovale and cryptogenic stroke. A MEDLINE search was performed for finding longitudinal studies investigating medical treatment or closure, meta-analysis of incidence rates (IR), and IR ratios of recurrent cerebrovascular events. Fifty-two single-arm studies and 7 comparative nonrandomized studies and the CLOSURE I trial were reviewed. The summary IR of recurrent stroke was 0.36 events (95% CI, 0.24–0.56) per 100 person-years with closure versus 2.53 events (95% CI, 1.91–3.35) per 100 person-years with medical therapy. In comparative observational studies, closure was superior to medical therapy (IR ratio=0.19; 95% CI, 0.07–0.54). The IR for the closure arm of the CLOSURE I trial was higher than the summary estimate from observational studies; there was no significant benefit of closure over medical treatment (P=0.002 comparing efficacy estimates between observational studies and the trial). Observational and randomized data (9 studies) comparing medical therapies were consistent and suggested that anticoagulants are superior to antiplatelets for preventing stroke recurrence (IR ratio=0.42; 95% CI, 0.18–0.98). Although further randomized trial data are needed to precisely determine the effects of closure on stroke recurrence, the results of CLOSURE I challenge the credibility of a substantial body of observational evidence strongly favoring mechanical closure over medical therapy.