Long Term Outcomes of Carotid Endarterectomy in the Elderly

老年人颈动脉内膜切除术的长期结果

• 批准号: 7910504
• 负责人: Ethan A Halm
• 金额: $ 66.85万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7910504
• 关键词: Acute; Admission activity; Age; Algorithms; Cardiovascular system; Caring; Carotid Arteries; Carotid Endarterectomy; Carotid Stenosis; Cerebrovascular Disorders; Cessation of life; Characteristics; Clinical; Cohort Studies; Communities; Community Practice; Comorbidity; Control Groups; Coronary; Data; Databases; Death Rate; Disease; Effectiveness; Elderly; Eligibility Determination; Ethnic Origin; FDA approved; Foundations; Funding; Gender; Guidelines; Health; Hospitalization; Hospitals; ICD-9; Inpatients; Life Expectancy; Literature; Medical; Medical Records; Medicare; Medicare Part A; Methods; Modeling; New York; Nursing Research; Operative Surgical Procedures; Outcome; Parents; Patients; Perioperative; Perioperative complication; Phase; Policies; Positioning Attribute; Procedures; Process; Publishing; Race; Randomized Controlled Trials; Relative (related person); Reporting; Research; Research Training; Risk; Risk Factors; Sampling; Scoring Method; Stents; Stroke; Stroke prevention; Subgroup; Surgeon; Survival Analysis; Symptoms; Techniques; Transient Ischemic Attack; United States Agency for Healthcare Research and Quality; United States Centers for Medicare and Medicaid Services; Wood material; abstracting; arm; base; beneficiary; experience; follow-up; high risk; indexing; male; medical specialties; older patient; population based; prospective; trial comparing

DESCRIPTION (provided by applicant): Carotid endarterectomy (CEA), surgery to prevent stroke, is common but potentially risky. Randomized controlled trials (RCTs) showed that among carefully selected patients (Pts) and surgeons, CEA reduced the risk of death and stroke compared to medical therapy. However, symptomatic Pts (with strokes or transient ischemic attacks) needed to survive for 2-3 years to realize the benefits of CEA, and asymptomatic patients needed to survive for 5 years to benefit. Because Pts undergoing CEA in community practice are older and sicker than those in the RCTs and have shorter life expectancy, the benefits of CEA for these Pts may be more limited. The potentially reduced benefit of CEA would be most marked among asymptomatic Pts who comprise three-quarters of those having the procedure. Despite its, widespread use, the long term outcomes of CEA in community practice and the relative benefits of CEA v. medical therapy in the elderly is unknown. The specific aims of this application are to: 1) Determine the generalizability of the CEA RCTs by comparing the long term outcomes of CEA performed in community practice using the population-based, New York Carotid Artery Surgery (NYCAS) Medicare cohort study to those reported in the RCTs; 2) Assess the effectiveness of surgical (CEA) v. medical management of carotid disease among the elderly in community practice using 2 methods: 2A) Comparing long term outcomes of Medicare Pts who underwent CEA in NYCAS to similar Pts with carotid disease in the population-based Cardiovascular Health Study (CHS) who did not have surgery; and 2B) Comparing long term outcomes of elders with carotid disease in CHS who were surgically (CEA) v. medically managed using propensity score methods; 3) Examine differences in long term outcomes of CEA in the elderly according to: age, comorbidities, RCT eligibility, gender, race/ethnicity, and symptom status, and develop and validate a multivariate clinical model to predict outcomes; and 4) Identify the independent process of care, surgeon, and hospital factors that influence risk-adjusted, stroke- specific survival to inform best practices and policies. NYCAS has detailed Pt, clinical, process, surgeon, and hospital data. Deaths and strokes 5 and 10 years after CEA for 4000 NYCAS Pts will be assessed using the National Death Index and performing chart review of stroke admissions identified by Medicare Part A claims. CHS has detailed clinical baseline and long term outcomes data. Outcomes in NYCAS will be compared to the RCTs. Long term outcomes of 418 CHS Pts with carotid disease who were medically managed will be compared(1:4) in matched analysis to 1672 similar NYCAS CEA Pts ('Between Study' analysis). In a 'Within Study' analysis, 69 CHS Pts who had CEA will be compared to 418 who were medically managed using propensity scores. Multivariate regression will be used to identify Pt, process of care, surgeon, and hospital predictors of long term outcomes in NYCAS (N=4000).

描述（由申请人提供）：颈动脉内膜切除术（CEA）是一种常见的预防中风的手术，但具有潜在风险。随机对照试验（RCT）表明，在精心挑选的患者（Pts）和外科医生中，CEA与药物治疗相比降低了死亡和中风的风险。然而，有症状的患者（中风或短暂性脑缺血发作）需要生存2-3年才能实现CEA的益处，无症状患者需要生存5年才能受益。由于在社区实践中接受CEA的患者比RCT中的患者年龄更大，病情更重，预期寿命更短，因此CEA对这些患者的益处可能更有限。CEA的潜在获益减少在无症状患者中最为明显，这些患者占接受该手术患者的四分之三。尽管CEA广泛使用，但其在社区实践中的长期结果以及CEA与药物治疗在老年人中的相对获益尚不清楚。本申请的具体目的是：1）通过比较社区实践中使用基于人群的纽约颈动脉手术（NYCAS）Medicare队列研究进行的CEA的长期结局与RCT中报告的结局，确定CEA RCT的普遍性; 2）使用2种方法评估社区实践中老年人颈动脉疾病手术（CEA）与药物管理的有效性：2A）将在NYCAS中接受CEA的Medicare患者的长期结果与在基于人群的心血管健康研究（CHS）中患有颈动脉疾病但未进行手术的类似患者的长期结果进行比较;以及2B）将在CHS中患有颈动脉疾病的老年人的长期结果进行比较，这些老年人使用倾向评分方法进行手术（CEA）与药物管理; 3）根据年龄、合并症、RCT资格、性别、种族/民族和症状状态检查老年人CEA长期结果的差异，并开发和验证多变量临床模型以预测结果;和4）识别影响风险调整的独立护理过程、外科医生和医院因素，中风特异性存活率，以告知最佳实践和政策。NYCAS有详细的患者、临床、过程、外科医生和医院数据。将使用国家死亡指数评估4000名NYCAS患者CEA后5年和10年的死亡和卒中，并对Medicare A部分索赔确定的卒中入院进行图表审查。CHS有详细的临床基线和长期结局数据。NYCAS的结局将与RCT进行比较。将在匹配分析中比较（1：4）418例接受药物治疗的患有颈动脉疾病的CHS患者与1672例相似NYCAS CEA患者的长期结局（“研究间”分析）。在“研究内”分析中，将69名患有CEA的CHS患者与418名使用倾向评分进行医学管理的患者进行比较。将使用多变量回归确定NYCAS中患者、护理过程、外科医生和医院长期结局的预测因素（N=4000）。