CAROTID OCCLUSION SURGERY STUDY

颈动脉闭塞手术研究

• 批准号: 7696299
• 负责人: WILLIAM J POWERS
• 金额: $ 424.48万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-03-07 至 2012-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7696299
• 关键词: Arteriogram; Blood Vessels; Bypass; Carotid Arteries; Cessation of life; Consent; End Point; Enrollment; Failure; Goals; Image; Ipsilateral; Ischemic Stroke; Measures; Medical; Operative Surgical Procedures; Oxygen; Patients; Perioperative; Positron-Emission Tomography; Postoperative Period; Randomized; Rate; Relative Risks; Risk Factors; Staging; Stroke; Surgical Anastomosis; Symptoms; Temporal Arteries; Testing; artery occlusion; day; hemodynamics; middle cerebral artery; mortality

Ipsilateral increased oxygen extraction fraction (OEF) measured by PET is a powerful independent risk factor for subsequent stroke in patients with symptomatic carotid occlusion. The St. Louis Carotid Occlusion Study found that the relative risk conferred by increases OEF was 7.3 (95% Cl 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 patients with hemispheric symptoms within 120 days, the two year ipsilateral stroke rates were 12% in patients with normal OEF and 40% in 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. The Carotid Occlusion Surgery Study (COSS) 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 recent (<120 days) symptomatic internal carotid artery occlusion and increased OEF. Clinically eligible patients with unilateral carotid artery occlusion demonstrated by any vascular imaging will be asked to consent to PET and treatment randomization if PET shows increased OEF. If necessary, consent for a supplemental arteriogram to confirm occlusion or demonstrate that extracranial and intracranial vessels will be sought as well. Those who agree and meet both arteriographic and PET 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 for two years. The primary endpoint in the surgical group is the combination of the following: (1) 30 day post-operative (surgical group) or post-randomization (non-surgical group) occurrence of all stroke and death and (2) the occurrence of ipsilateral ischemic stroke within two years of randomization. Adjusting for anticipated 2 year mortality, 372 patients (186 in each group) will provide 90% power to detect the anticipated difference (40% vs. 24.2%). 91 have been randomized. Assuming 25-30% of PET scans will demonstrate increased OEF, this will require enrolling a total of 1400 clinically eligible subjects for PET. This proposal covers the second 5 years of this trial.

PET测量的同侧增加的氧摄取分数(OEF)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。圣路易斯颈动脉闭塞研究发现，OEF升高对同侧缺血性中风的相对风险为7.3(95%可信区间1.6-33.4)，而在42名OEF正常的患者中，同侧中风的两年发生率为5.3%，在39名OEF升高的患者中为26.5%(p=0.004)。在大脑半球症状在120天内的患者中，OEF正常的患者2年同侧卒中的发生率为12%，OEF升高的患者的2年同侧卒中发生率为40%。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。颈动脉闭塞手术研究(COSS)将测试这样一个假设，即在最佳药物治疗的基础上，STA-MCA手术吻合术可以减少40%，尽管在最近(120天)有症状的颈内动脉闭塞和OEF增加的患者中，围术期中风和死亡、随后的同侧缺血性中风(致命和非致命)在两年内都可以减少。临床上符合条件的单侧颈动脉闭塞患者，如果PET显示OEF增加，将被要求同意接受PET和治疗随机。如有必要，还需征得补充动脉造影的同意，以确认闭塞或显示颅内外血管。同意并同时符合动脉造影和PET标准的患者将被随机1：1接受STA-MCA搭桥手术，然后接受内科治疗或仅接受内科治疗。所有随机分组的患者将每隔三个月接受一次为期两年的随访。手术组的主要终点是以下各项的组合：(1)术后30天(手术组)或随机化后(非手术组)发生的所有卒中和死亡；(2)随机化两年内发生的同侧缺血性卒中。调整预期的两年死亡率，372名患者(每组186人)将提供90%的能力来检测预期的差异(40%对24.2%)。91人已被随机分配。假设25%-30%的PET扫描将显示OEF增加，这将需要总共1400名符合临床条件的受试者参加PET。这项提案涵盖了试验的第二个5年。