Carotid Revascularization Endarterectomy vs. Stenting Trial: Long Term Follow-up

描述（由申请人提供）：这是颈动脉血管重建术内膜切除术与支架植入术试验（CREST）的竞争性更新，旨在确定颈动脉内膜切除术（CEA）与颈动脉支架植入术（CAS）的相对疗效。在最初的资助期内，我们已经成功地完成了预先指定的2522名参与者的登记。预计平均随访2.8年，将于2010年2月或更早报告手术期间和中期结果。CREST的主要结果、ICSS的主要结果的发表，以及SAPPHIRE、EVA-3S和SPACE等其他血血重建试验的结果，将为指导2至4年的颈动脉治疗提供坚实的“1A级”证据。这与CEA和CAS术后存活数十年的患者形成对比。研究的时间范围与患者可能受益的持续时间之间的不一致造成了证据真正缺乏的知识差距。在这一竞争性更新中，我们寻求资金，继续对这些参与者进行额外5年的监测，并有可能进行长达10年的后续工作。我们的主要目的是将CREST队列的随访时间延长至4年以上，并评估CEA与CAS在手术后6至10年内预防同侧卒中的相对疗效。次要目的是1)评估两种手术的长期持久性是否存在影响因素，如年龄、性别、术前狭窄程度和症状状态；2)评估两种手术的相对疗效是否存在时间变化或模式；3)评估两组再狭窄或血运重建率的差异。4)将符合医疗保险条件的CREST参与者与住院和门诊CMS数据文件联系起来，以评估患者的结果和医疗保健服务的利用情况；5)收集可用随机受试者的DNA，用于未来研究对血管重建反应的遗传决定因素。我们计划将现有的2522名入组患者的随访时间延长，包括每年的诊所访问和中间的电话联系，从主要结果报告时的平均2.8年延长到平均7.5年，最长随访时间为10年。随着随访时间的延长，主要目的的统计分析将评估从第31天到随访10年的术后治疗差异，并设计为提供90%的检测风险比为1.67的能力。随着长期随访的重点是临床结果，简化随访方案将减轻患者/诊所负担，降低成本，提高数据质量。预计CREST的长期结果将对治疗有症状和无症状颈动脉狭窄的护理标准具有实践改变意义。

DESCRIPTION (provided by applicant): This is a competitive renewal for the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) that is designed to establish the relative efficacy of carotid endarterectomy (CEA) versus carotid artery stenting (CAS). During the initial funding period we have successfully completed enrollment of our pre-specified cohort of 2522 participants. Peri-procedural and mid-term outcomes, over a projected mean follow-up of 2.8 years, will be reported in February of 2010 or earlier. The primary results from CREST, publication of the primary results from ICSS, and the results of other revascularization trials including SAPPHIRE, EVA-3S, and SPACE will provide solid "Level 1A" evidence to guide carotid treatment over a 2 to 4 year time horizon. This is in contrast to patients living decades after CEA and CAS have been performed. The discordance between the time horizons of studies and the duration that patients may benefit creates a knowledge gap where there is a true dearth of evidence. In this competitive renewal we seek funding to continue to monitor these participants for an additional 5 years, with the potential for follow-up of up to 10 years. Our Primary Aim is to extend follow-up of the CREST cohort beyond 4 years and to assess the relative efficacy of CEA versus CAS over the 6 to 10 year post-procedural period in the prevention of ipsilateral stroke. Secondary aims will 1) assess if there are effect modifiers of the long-term durability of the two procedures, such as age, sex, pre-operative degree of stenosis and symptomatic status, 2) assess if there is a temporal change or pattern in the relative efficacy of the two procedures, 3) assess differences between groups in the rates of restenosis or revascularization, 4) link Medicare-eligible CREST participants with inpatient and outpatient CMS data files to assess patient outcomes and utilization of healthcare services, 5) collect DNA on available randomized subjects for future studies of genetic determinants of response to revascularization. We plan to extend follow-up of the existing 2522 enrolled with annual clinic visits interspersed with midpoint telephone contacts, from an average 2.8 years at the time of primary outcome reporting to an average 7.5 years, with a maximum follow-up of 10 years. With extended follow-up, statistical analysis of the primary aim will assess post-procedural treatment differences from Day 31 for up to 10 years of follow-up and is designed to provide 90% power to detect a hazard ratio of 1.67. With the focus of long-term follow-up on clinical outcomes, simplification of the follow-up protocol will result in reduced patient/clinic burden, reduced cost, and improved data quality. It is anticipated that CREST long-term results will have practice-changing implications regarding the standard of care for managing symptomatic and asymptomatic carotid arterial stenosis. PUBLIC HEALTH RELEVANCE: CREST will provide data regarding the long-term durability of CEA versus CAS for the medical community, CMS and other healthcare agencies to empower decision-making for the optimum management of carotid disease with a corresponding reduction in the number and cost of strokes annually. Linkage to CMS in- and out-patient data files will provide a model for resource utilization and cost of care for the elderly and future studies.