Carotid Revascularization Endarterectomy vs Stenting Trial

描述(申请人提供)：颈动脉支架置入术(CAS)是近年来越来越多地使用的一种新兴手术。它的增长至少在一定程度上是由于对颅外颈动脉闭塞性疾病进行侵入性较小的治疗所带来的优势。然而，除了在受限人群中，没有对比CAS和颈动脉内膜切除术(CEA)疗效的随机临床试验数据，CEA是颈动脉粥样硬化的黄金标准治疗方法。颈动脉再血管化内膜切除术与支架植入试验(CREST)是一项持续的努力，旨在比较CAS和CEA在有症状和无症状的严重颈动脉闭塞症患者30天围手术期内预防中风、心肌梗死或死亡或此后同侧中风方面的相对有效性。随访期最长可达四年。次要结果是：(1)描述CAS和CEA在男性和女性中的不同疗效，(2)对比围手术期(30天)和术后(30天后)的发病率和死亡率(3)估计和对比两种手术的再狭窄率，(4)评估与健康相关的生活质量和成本效益指标的差异，(5)确定CAS和CEA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(对于有症状的短暂性脑缺血发作或同侧非致残性中风患者，血管造影术为50%，超声为70%；对于无症状疾病，血管造影术为60%或超声为70%)。有可能限制他们在随访期间参与或干扰结果评估的医疗条件的患者被排除在外。认证和培训阶段在每个临床中心随机化之前进行，在该阶段，围术期发病率和死亡率与有症状的受试者的NASCET相同。2500名参与者将在120个中心随机进行调查。主要结果的统计分析将使用标准的生存技术，旨在提供90%的能力来检测主要结果的年度差异？1.2%。随机化率已经加快，以达到并超过NIH去年设定的登记目标，CREST的随机部分现在包括962例。随着CAS的使用越来越多，CREST可能是客观评估CEA与CAS的最后机会，这使得它的重要性变得更加重要。在其以前资助的几年中获得的经验的基础上，CREST调查人员拥有专门的调查团队、基础设施和程序，启动了120个临床站点中的108个，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.