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

描述（由申请人提供）：这是一项颈动脉血运重建、动脉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。在最初的资助期间，我们成功地完成了我们预先指定的2522名参与者的入组。预计平均随访2.8年的围手术期和中期结局将于2010年2月或更早报告。CREST的主要结果、ICSS的主要结果的发布以及其他血运重建试验（包括SAPPHIRE、伊娃-3S和SPACE）的结果将提供可靠的“1A级”证据，以指导2至4年内的颈动脉治疗。这与CEA和CAS后数十年的患者形成鲜明对比。研究的时间范围和患者可能受益的持续时间之间的不一致造成了一个缺乏证据的知识空白。在这次竞争性更新中，我们寻求资金继续监测这些参与者额外的5年，并有可能随访长达10年。 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在术后6 - 10年内预防同侧卒中的相对有效性。次要目的是：1）评估两种手术的长期耐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有效性是否存在时间变化或模式，3）评估再狭窄或血运重建率的组间差异，4）将符合Medicare资格的CREST参与者与住院和门诊CMS数据文件联系起来，以评估患者结局和医疗保健服务的利用率，5）收集可用随机受试者的DNA，用于未来研究血运重建反应的遗传决定因素。 我们计划对现有的2522例入组患者进行随访，这些患者每年进行一次门诊访视，中间穿插电话联系，从主要结局报告时的平均2.8年延长至平均7.5年，最长随访时间为10年。通过延长随访，主要目的的统计分析将评估从第31天到10年随访的术后治疗差异，旨在提供90%的把握度检测风险比1.67。由于长期随访的重点是临床结局，简化随访方案将减少患者/诊所的负担，降低成本，提高数据质量。预计CREST的长期结果将对管理症状性和无症状性颈动脉狭窄的护理标准产生实践改变的影响。

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.