CAROTID OCCLUSION SURGERY STUDY (COSS)

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 圣路易斯颈动脉闭塞研究表明，PET测量的同侧氧摄取分数(OEF)增加是有症状的颈动脉闭塞患者继发卒中的一个强大的独立危险因素。在调整了17个基线患者特征和间隔治疗后，血流动力学II期衰竭对同侧缺血性卒中的相对危险度为7.3(95%可信区间1.6~33.4)，相应于同侧卒中的两年发生率在42例OEF正常的患者中为5.3%，在39例OEF升高的患者中为26.5%(p=0.004)。在120天内有半球症状的患者中，27例OEF正常的患者2年同侧卒中发生率为12%，18例OEF升高的患者2年同侧卒中发生率为50%。以往的PET研究表明，手术吻合颞浅动脉和大脑中动脉(STA-MCA)可以使OEF恢复正常。我们将测试这样一种假设，即在最佳药物治疗的基础上，STA-MCA手术吻合术可以减少40%，尽管最近(120天)有症状的颈内动脉闭塞和II期血流动力学衰竭的患者在两年内发生了围术期中风和死亡，随后的同侧缺血性中风(致命和非致命)。临床上符合条件的单侧颈动脉闭塞患者经血管成像证实，如果PET显示OEF增加，将被要求同意接受PET和治疗随机。同意并符合标准的患者将以1：1的随机比例接受STA-MCA搭桥手术，然后接受内科治疗或单纯内科治疗。所有随机分组的患者将每隔三个月接受一次随访。主要终点将是术后30天(非手术组中相同的时间段)之前的所有中风和随机死亡，加上两年内继发的同侧缺血性中风。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The St. Louis Carotid Occlusion Study has demonstrated that ipsilateral increased oxygen extraction fraction (OEF) measured by PET is a powerful independent risk factor for subsequent stroke in patients with symptomatic carotid occlusion. After adjustment for 17 baseline patient characteristics and interval medical treatment, the relative risk conferred by Stage II hemodynamic failure was 7.3 (95% CI 1.6 - 33.4) for ipsilateral ischemic stroke corresponding to two year rates for ipsilateral stroke of 5.3% in 42 patients with normal OEF and 26.5% in 39 patients with increased OEF (p=.004). In those patients with hemispheric symptoms within 120 days, the two year ipsilateral stroke rates were 12% in 27 patients with normal OEF and 50% in 18 patients with increased OEF. Previous PET studies have demonstrated that surgical anastomosis of the superficial temporal artery to the middle cerebral artery (STA-MCA) can restore OEF to normal. We will test the hypothesis that STA-MCA surgical anastomosis when added to best medical therapy can reduce by 40%, despite perioperative stroke and death, subsequent ipsilateral ischemic stroke (fatal and non-fatal) at two years in patients with recently (120 days) symptomatic internal carotid artery occlusion and Stage II hemodynamic failure. Clinically eligible patients with unilateral carotid artery occlusion demonstrated by vascular imaging will be asked to consent to PET and treatment randomization if PET shows increased OEF. Those who agree and meet criteria will be randomized 1:1 to undergo STA-MCA bypass surgery followed by medical management or medical management alone. All randomized patients will be followed at three month intervals. The primary endpoint will be all stroke and death from randomization until 30 days post-operatively (an equivalent period in the non-surgical group) plus subsequent ipsilateral ischemic stroke within two years.