Carotid Revascularization Endarterectomy vs Stenting Trial

描述（由申请人提供）：颈动脉支架植入术（CAS）是近年来使用越来越多的新兴手术。它的增长是由于，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，没有对比CAS和颈动脉内膜切除术（CEA）（颈动脉粥样硬化的金标准治疗）疗效的随机临床试验数据。颈动脉血运重建内膜切除术与支架植入术试验（CREST）是一项持续的努力，旨在对比CAS与CEA在预防有症状和无症状的重度颈动脉闭塞性疾病患者在30天围手术期卒中、心肌梗死或死亡或此后同侧卒中方面的相对有效性。随访期将延长至四年。次要结局为：（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）发病率和术后（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）评价健康相关生活质量和成本效益指标的差异，和（5）确定CAS和CEA风险不同的参与者亚组。CREST的主要合格标准是颈动脉的高度狭窄（对于患有短暂性脑缺血发作或同侧非致残性卒中的患者中的症状性疾病，通过血管造影片>50%或通过超声>70%;对于无症状性疾病，通过血管造影片>60%或通过超声>70%）。排除了可能限制其参与随访或干扰结局评价的疾病患者。在每个临床中心随机化之前进行资格认证和培训阶段，其中该阶段的手术发病率和死亡率与有症状受试者的NASCET相当。2,500名受试者将在120个中心随机分配。主要结局的统计分析将采用标准的生存技术，旨在提供90%的把握度来检测年度差异。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去年设定的招募目标，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可能是客观评估CEA与CAS的最后机会，使其重要性变得更加重要。在其先前资助的几年中获得的经验的基础上，CREST研究者拥有专门的研究团队，基础设施和程序，120个临床研究中心中的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.