Carotid Revascularization Endarterectomy vs Stenting Trial

描述（由申请人提供）：颈动脉支架植入术（CAS）是近年来越来越多地使用的一种新兴手术。其增长至少部分是由于颅外颈动脉闭塞性疾病的微创治疗的优势。然而，除了在有限的人群中，没有比较CAS和颈动脉内膜切除术（颈动脉粥样硬化的金标准治疗）疗效的随机临床试验数据。颈动脉血管重建术内膜切除术与支架置入试验（CREST）是一项持续的研究，旨在比较CAS与CEA在有症状和无症状的严重颈动脉闭塞疾病患者在30天围手术期预防卒中、心肌梗死或死亡或随后同侧卒中的相对疗效。后续期将延长至四年。次要结局是：(1)描述CAS和CEA在男性和女性中的不同疗效，(2)对比手术期间（30天）发病率和手术后（30天后）发病率和死亡率，(3)估计和对比两种手术的再狭窄率，(4)评估健康相关生活质量和成本效益测量的差异，(5)确定CAS和CEA有不同风险的参与者亚组。CREST的主要资格标准是颈动脉高度狭窄（短暂性脑缺血发作或同侧非致残性卒中的症状性疾病患者，血管造影显示bbb50 %，超声显示>70%；无症状疾病患者，血管造影显示>60%，超声显示>70%）。排除有可能限制其参与随访或干扰结果评估的医疗状况的患者。在每个临床中心进行随机分组之前，都要进行认证和培训阶段，该阶段的围手术期发病率和死亡率与有症状受试者的NASCET相当。2500名参与者将被随机分配到120个中心。主要结局的统计分析将采用标准生存技术，并设计为提供90%的能力来检测年差异。主要结局的事件发生率为1.2%。随机化率已经加速达到并超过了NIH去年设定的入学目标，CREST的随机化部分现在包括962例病例。随着CAS的使用越来越多，CREST可能是对CEA和CAS进行客观评估的最后机会，使其更加重要。基于之前获得资助的经验，CREST研究人员拥有专门的调查团队、基础设施和程序，120个临床站点中的108个已启动，以成功完成这项研究。

DESCRIPTION (provided by applicant): Carotid artery stenting (CAS) is an emerging procedure that has been used increasingly in recent years. Its growth is due, at least in part, to the perceived advantages of a less invasive treatment for extracranial carotid occlusive disease. However, randomized clinical trial data contrasting the efficacy of CAS and carotid endarterectomy (CEA), the gold standard treatment for carotid atherosclerosis, are not available except in restricted populations. The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is a continuing effort to contrast the relative efficacy of CAS with CEA in preventing stroke, myocardial infarction or death during a 30-day peri-procedural period, or ipsilateral stroke thereafter in symptomatic and asymptomatic patients with severe carotid occlusive disease. The follow-up period will extend up to four years. Secondary outcomes are to: (1) describe differential efficacy of CAS and CEA in men and women, (2) contrast peri-procedural (30- day) morbidity and post-procedural (after 30-days) morbidity and mortality (3) estimate and contrast the restenosis rates of the two procedures, (4) evaluate differences in measures of health-related quality of life and cost effectiveness, and (5) identify subgroups of participants at differential risk for CAS and CEA. The primary eligibility criterion for CREST is a high-grade stenosis of the carotid artery (>50% by angiogram or >70% by ultrasound for symptomatic disease in patients with transient ischemic attack or ipsilateral non- disabling stroke; >60% by angiogram or >70% by ultrasound for asymptomatic disease). Patients with medical conditions likely to limit their participation during the follow-up or to interfere with outcome evaluation are excluded. A credentialing and training phase precedes randomization at each clinical center where peri- operative morbidity and mortality in this phase has been equivalent to NASCET for symptomatic subjects. 2,500 participants will be randomized at 120 centers. Statistical analysis of the primary outcome will employ standard survival techniques and is designed to provide 90% power to detect an annual difference ? 1.2% in event rates of the primary outcomes. Randomization rates have accelerated to meet and exceed the enrollment goal set by NIH last year and the randomized portion of CREST now includes 962 cases. With the growing use of CAS, CREST may be the last opportunity for an objective evaluation of CEA vs CAS, making its importance even greater. Building on the experience gained in its previously funded years, the CREST investigators have the dedicated investigative team, infrastructure and procedures in place with 108 of the120 clinical sites activated to successfully complete this study.