老年人颈动脉内膜切除术的长期结果-猫眼课题宝

老年人颈动脉内膜切除术的长期结果

批准号：

7264930

负责人：

Ethan A Halm

金额：

$49.86万

依托单位：

ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI

依托单位国家：

美国

项目类别：

财政年份：

2007

资助国家：

美国

项目状态：

已结题

起止时间：

2007-07-01 至 2012-03-31

来源：

https://reporter.nih.gov/project-details/7264930

关键词：

Acute Admission activity Adult Age Algorithms Cardiovascular system Caring Carotid Arteries Carotid Endarterectomy Carotid Stenosis Carotid stent Cerebrovascular Disorders Cessation of life Characteristics Clinical Closure Cohort Studies Communities Community Practice Comorbidity Control Groups Coronary Data Data Set Databases Death Rate Disease Disease regression Effectiveness Elderly Eligibility Determination Endarterectomy Epidemiologic Studies Ethnic Origin Foundations Funding Gender 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 Population Positioning Attribute Procedures Process Publishing Race Randomized Controlled Trials Rate Relative (related person)Reporting Research Research Personnel Research Training Risk Risk Factors Score Scoring Method 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 day experience follow-up human old age (65+)indexing male medical specialties older patient programs prospective trial comparing

中文摘要

翻译

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，很常见，但存在潜在风险。随机对照试验 (RCT) 表明，在精心挑选的患者 (Pts) 和外科医生中，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（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，而无症状的患者需要生存 5 年才能受益。由于在社区实践中接受 CEA 的患者比随机对照试验中的患者年龄更大、病情更重，并且预期寿命更短，因此 CEA 对这些患者的益处可能更加有限。 CEA 潜在益处的减少在无症状患者中最为明显，他们占接受该手术患者的四分之三。尽管广泛使用，但 CEA 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益处尚不清楚。本申请的具体目的是： 1) 通过将使用基于人群的纽约颈动脉手术 (NYCAS) 医疗保险队列研究在社区实践中进行的 CEA 的长期结果与 RCT 中报告的结果进行比较，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的手术 (CEA) 与医疗管理的有效性： 2A) 将在 NYCAS 接受 CEA 的医疗保险患者与在基于人群的心血管健康研究 (CHS) 中未接受手术的类似颈动脉疾病患者的长期结果进行比较； 2B) 比较患有 CHS 颈动脉疾病的老年人接受手术 (CEA) 与使用倾向评分方法进行药物治疗的长期结果； 3) 根据年龄、合并症、RCT 资格、性别、种族/族裔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来预测结果； 4) 确定影响风险调整后的中风特定生存率的护理、外科医生和医院因素的独立过程，为最佳实践和政策提供信息。 NYCAS 拥有详细的患者、临床、流程、外科医生和医院数据。将使用国家死亡指数并对 Medicare A 部分索赔确定的中风入院情况进行图表审查，对 4000 名 NYCAS 患者在 CEA 后 5 年和 10 年的死亡和中风进行评估。 CHS 拥有详细的临床基线和长期结果数据。 NYCAS 的结果将与 RCT 进行比较。将通过匹配分析 (1:4) 将 418 名患有颈动脉疾病的 CHS 患者的长期结果与 1672 名类似的 NYCAS CEA 患者进行比较（“研究之间”分析）。在“研究内”分析中，将使用倾向评分将 69 名患有 CEA 的 CHS 患者与 418 名接受医疗管理的患者进行比较。多元回归将用于确定 NYCAS (N=4000) 长期结果的 Pt、护理过程、外科医生和医院预测因素。

英文摘要

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).

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