Predictors of Recurrent Events in Patients With Cryptogenic Stroke and Patent Foramen Ovale Within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) Trial
Predictors of Recurrent Events in Patients With Cryptogenic Stroke and Patent Foramen Ovale Within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) Trial
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DOI：
10.1016/j.jcin.2014.01.170
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发表时间：
2014-08-01
影响因子：
11.3
通讯作者：
Mauri, Laura
中科院分区：
文献类型：
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作者：
Elmariah, Sammy;Furlan, Anthony J.;Mauri, Laura
目的本研究旨在确定CLOSE I试验(STARFlex间隔关闭系统在卒中和/或短暂性脑缺血发作患者中的评估)试验中复发缺血性神经事件的预测因素。背景：CLOSE I试验发现，在隐源性卒中或短暂性脑缺血发作(TIA)和短暂性脑缺血发作(PFO)患者中，使用STARFlex装置的经导管卵圆孔未闭(PFO)封堵术并不优于药物治疗。结果909例患者中，复发事件发生率为5.7%，其中25例复发卒中，30例短暂性脑缺血发作。有复发事件的患者有更高的体重指数(30.2vs.28.3vs.28.3+/-5.8%；p=0.03)，更常见的是糖尿病(19.2%vs.7.1%；p=0.0016)、高血压(46.2%vs.30.1%；p=0.015)和缺血性心脏病(3.8%vs.0.9%；p=0.015)。糖尿病(危险比：3.39；95%可信区间：1.69至6.84；p=0.0007)、短暂性脑缺血指数(心率与中风：2.13；95%可信区间：1.2至3.8；p=0.01)，以及研究登记后检测到心房颤动(心率：4.85；95%可信区间：2.05至11.47；p=0.0003)独立预测复发的缺血性神经事件。复发的神经系统事件在ROPE评分为5分的受试者中更为常见(14.5%vs.4.2%；p<；0.0001)。结论这些发现提示在CLOSE I试验中，悖论栓塞的另一种病因经常导致复发事件。(C)2014年，由美国心脏病学会基金会提供。
OBJECTIVES This study sought to identify predictors of recurrent ischemic neurologic events within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) trial.BACKGROUND The CLOSURE I trial found that transcatheter patent foramen ovale (PFO) closure using the STARFlex device was not superior to medical therapy in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO.METHODS The CLOSURE I trial is a multicenter, randomized trial of transcatheter PFO closure compared with medical therapy in patients who presented with cryptogenic stroke or TIA and had a PFO. We identified clinical predictors of recurrent ischemic stroke or TIA during 2 years of follow-up using Cox proportional hazards regression within the pooled intention-to-treat cohort.RESULTS In 909 patients, the incidence of recurrent events was 5.7% with 25 patients suffering a recurrent stroke and 30 a TIA. Patients who had a recurrent event had higher body mass index (30.2 +/- 6.2 vs. 28.3 +/- 5.8%; p = 0.03) and more frequently had diabetes (19.2% vs. 7.1%; p = 0.0016), hypertension (46.2% vs. 30.1%; p = 0.015), and ischemic heart disease (3.8% vs. 0.9%; p = 0.05). Diabetes (hazard ratio [HR]: 3.39; 95% confidence interval [CI]: 1.69 to 6.84; p = 0.0007), index TIA (HR vs. stroke: 2.13; 95% CI: 1.20 to 3.80; p = 0.01), and the detection of atrial fibrillation after study enrollment (HR: 4.85; 95% CI: 2.05 to 11.47; p = 0.0003) independently predicted recurrent ischemic neurologic events. Recurrent neurologic events were more frequent in subjects with RoPE (Risk of Paradoxical Embolism) score 5 (14.5% vs. 4.2%; p < 0.0001).CONCLUSIONS These findings suggest an alternative etiology to paradoxical embolism was frequently responsible for recurrent events within the CLOSURE I trial. (C) 2014 by the American College of Cardiology Foundation.