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: 7587373
• 负责人: Ethan A Halm
• 金额: $ 52.02万
• 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/7587373
• 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; Upper arm; Wood material; abstracting; 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）是一种预防中风的手术，常见但有潜在风险。随机对照试验（RCTs）显示，在精心挑选的患者（Pts）和外科医生中，与药物治疗相比，CEA降低了死亡和中风的风险。然而，有症状的患者（卒中或短暂性脑缺血发作）需要生存2-3年才能实现CEA的获益，无症状患者需要生存5年才能获益。由于在社区实践中接受CEA的患者比随机对照试验中的患者年龄更大，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潜在降低的益处在无症状患者中最为明显，他们占接受该手术的患者的四分之三。尽管CEA被广泛使用，但其在社区实践中的长期结果以及在老年人中CEA与药物治疗的相对益处尚不清楚。本应用程序的具体目的是：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）医疗保险队列研究的CEA的长期结果，确定CEA随机对照试验的普遍性；2)在社区实践中，采用两种方法评估手术（CEA）与内科治疗老年颈动脉疾病的有效性：2A)比较在NYCAS接受CEA的Medicare患者与在基于人群的心血管健康研究（CHS）中未接受手术的颈动脉疾病相似患者的长期预后；和2B)比较手术（CEA）和使用倾向评分方法进行医学管理的老年CHS颈动脉疾病的长期结局；3)根据年龄、合并症、RCT资格、性别、种族/民族、症状状态等因素，研究老年人CEA长期预后的差异，建立并验证多因素临床模型预测预后；4)确定独立的护理过程、外科医生和医院因素，这些因素会影响风险调整后的卒中特异性生存，从而为最佳实践和政策提供信息。NYCAS拥有详细的Pt、临床、过程、外科医生和医院数据。4000名NYCAS患者在CEA后5年和10年的死亡和中风将使用国家死亡指数进行评估，并对医疗保险A部分索赔确定的中风入院进行图表审查。CHS有详细的临床基线和长期结果数据。NYCAS的结果将与随机对照试验进行比较。418例经医学治疗的颈动脉疾病CHS患者的长期预后将在匹配分析中与1672例相似的NYCAS CEA患者（“研究间”分析）进行比较（1:4）。在一项“研究内”分析中，69名患有CEA的CHS患者将与418名使用倾向评分进行医学管理的患者进行比较。多元回归将用于确定NYCAS患者的Pt、护理过程、外科医生和医院的长期预后预测因素（N=4000）。