CAROTID OCCLUSION SURGERY STUDY (COSS)

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 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）增加是症状性颈动脉闭塞患者随后卒中的一个强大的独立风险因素。校正17例基线患者特征和间隔期药物治疗后，II期血流动力学衰竭导致同侧缺血性卒中的相对风险为7.3（95% CI 1.6 - 33.4），对应于42例OEF正常患者和39例OEF升高患者的同侧卒中两年发生率分别为5.3%和26.5%（p= 0.004）。在120天内出现半球症状的患者中，27例OEF正常患者的2年同侧卒中发生率为12%，18例OEF升高患者的2年同侧卒中发生率为50%。既往PET研究表明，颞浅动脉与大脑中动脉（STA-MCA）的手术吻合可使OEF恢复正常。 我们将检验以下假设：在最近（> 120天）有症状的颈内动脉闭塞和II期血流动力学衰竭患者中，将STA-MCA手术吻合术添加到最佳药物治疗中，尽管围手术期卒中和死亡，但术后2年同侧缺血性卒中（致死性和非致死性）的发生率可降低40%。如果PET显示OEF增加，则将要求经血管成像证实单侧颈动脉闭塞的临床合格患者同意接受PET和治疗随机化。同意并符合标准的患者将以1：1的比例随机接受STA-MCA旁路手术，然后进行药物治疗或仅进行药物治疗。所有随机化患者将每3个月随访一次。主要终点将是从随机化至术后30天（非手术组的相同时间段）的所有卒中和死亡，以及随后两年内的同侧缺血性卒中。

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.