Prolonged Clopidogrel Use After Drug-Eluting and Bare-Metal Coronary Stenting

药物洗脱和裸金属冠状动脉支架术后长期使用氯吡格雷

• 批准号: 8244612
• 负责人: Scott Kinlay
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-10-01 至 2014-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8244612
• 关键词: Acute myocardial infarction; Address; Adherence; Ambulatory Care Facilities; Anticoagulation; Arteries; Aspirin; Atrial Fibrillation; Benefits and Risks; Blood Platelets; Brain hemorrhage; Bypass; Caliber; Cardiac; Cardiac Death; Cardiology; Cardiovascular system; Cessation of life; Characteristics; Chronic; Clinical; Communities; Comorbidity; Coronary; Coronary Arteriosclerosis; Coronary Artery Bypass; Coronary heart disease; Data; Databases; Disease; Event; Future; Generations; Goals; Heart Valve Prosthesis; Hemorrhage; Infarction; Inpatients; Ischemic Stroke; Length; Metals; Methods; Myocardial Infarction; Operative Surgical Procedures; Outpatients; Patient Care; Patients; Pharmaceutical Preparations; Pharmacy facility; Procedures; Randomized Controlled Trials; Recurrence; Reporting; Research; Risk; Stents; Subgroup; System; Thromboembolism; Thrombosis; Venous; Veterans; Vital Status; clopidogrel; cohort; design; hazard; percutaneous coronary intervention; pharmacy benefit; prevent; randomized trial; restenosis; sudden cardiac death; therapy duration

DESCRIPTION (provided by applicant): We proposed to assess the risks and benefits of prolonged clopidogrel therapy (>12 months) versus <12 months among Veterans following percutaneous coronary interventions (PCI) with coronary stenting. Our primary aim is to assess the risk of death or myocardial infarction by type of coronary stent (bare-metal stents, 1st generation drug-eluting stents, and 2nd generation drug-eluting stents. We will use VA administrative and clinical databases to create two cohorts of patients receiving bare-metal and 1st generation drug-eluting stents between 2002-2007, and a second more contemporary cohort of patients receiving 2nd generation drug-eluting stents between 2008- 2010. Our data will be derived from the VA National Patient Care Database, which contains information on inpatient and outpatient details from the Patient Treatment Files (PTF) and Outpatient Clinic (OPC) files. Demographic data will be obtained from the VHA Vital Status file. Pharmacy data will be obtained from the Pharmacy Benefits Management system files, including medication prescriptions to estimate duration of therapy. In the 2008-2010 cohort we will also obtain data on procedural characteristics (e.g. stent length, diameter, number of stents, artery stented) as covariables from the VA Cardiovascular Assessment Reporting and Tracking (CART) database. For each stent type, we will use a landmark analysis strategy and Cox's proportional hazards regression to assess the risk of death or myocardial infarction in patients receiving prolonged clopidogrel > 12 months versus <12 months treatment. We will also evaluate the risk of prolonged clopidogrel therapy on the secondary endpoints of cardiac death, ischemic stroke, coronary revascularization with PCI or coronary artery bypass surgery, and major bleeding. As secondary aims, we will evaluate the interaction of prolonged clopidogrel and type of drug-eluting stent (1st or 2nd generation) by combining both cohorts. Using the same method, we will assess the risk of prolonged clopidogrel in subgroups of patients on chronic anticoagulation for other indications (e.g. atrial fibrillation). To evaluate potential data limitations we will perform chart reviews in a subsample of the cohorts to validate several key covariates, such as aspirin adherence. We will also evaluate the potential impact of confounding and confounding by indication by three methods: 1. Traditional multivariable adjustment, 2. Propensity score adjusted and matched analysis, 3. Restriction of the cohorts to patients with low risk characteristics. We will also conduct sensitivity analyses to assess the impact of missing covariate data. Exploratory analyses will evaluate the risks and benefits of more prolonged clopidogrel therapy beyond the landmarks of 18 months, 24 months and 36 months after PCI. The proposed research will provide valuable information to bridge the current information gap in the cardiology community regarding the risks and benefits of prolonged clopidogrel therapy in Veterans receiving coronary stents. These data may also inform future randomized trials to address the value of prolonged clopidogrel therapy.

描述（由申请人提供）： 我们提议评估经皮冠状动脉干预（PCI）和冠状动脉支架后的退伍军人中长时间氯吡格雷治疗（> 12个月）的风险和益处。我们的主要目的是通过冠状动脉支架（裸机支架，第一代药物洗脱支架以及第二代药物洗脱支架）来评估死亡或心肌梗塞的风险。我们将使用VA行政和临床数据库来创建两个患者的裸露和1代药物的患者，并使用VA行政和临床数据库进行更多的患者，并在2007年之间进行了众多群体，并进行了20072-002-0072-0072-007777777777777777777777.在2008年至2010年之间，我们的数据将源自VA国家患者护理数据库，其中包含有关患者治疗档案（PTF）的门诊细节（PTF）的信息，将从vha clinice for expercript for va clientation。在2008-2010同类中，我们还将获得有关VA心血管评估报告和跟踪（CART）数据库的过程特征的数据（例如支架长度，直径，支架数，支架支架数）。对于每种支架类型，我们将使用具有里程碑意义的分析策略和Cox的比例危害回归来评估接受长期氯吡格雷> 12个月的患者的死亡或心肌梗塞的风险，而<12个月的治疗。我们还将评估长期氯吡格雷治疗在心脏死亡，缺血性中风，PCI或冠状动脉搭桥手术外科手术以及重度出血的次要终点上的风险。作为次要目的，我们将通过组合两个队列来评估长时间氯吡格雷和药物洗脱支架的类型（第一代或第二代）的相互作用。使用相同的方法，我们将评估患者在慢性抗凝治疗的患者亚组中长期氯吡格雷的风险（例如心房颤动）。为了评估潜在的数据限制，我们将在队列的子样本中进行图表审查，以验证几种关键协变量，例如阿司匹林依从性。我们还将通过三种方法来评估混淆和混淆的潜在影响：1。传统的多变量调整，2。倾向评分调整和匹配分析，3。限制了对低风险特征患者的同伙。我们还将进行灵敏度分析，以评估缺失的协变量数据的影响。探索性分析将评估超过18个月，24个月零36个月的地标的更长时间的氯吡格雷治疗的风险和益处。拟议的研究将提供有价值的信息，以弥合心脏病学界当前的信息差距，内容涉及接受冠状动脉支架的退伍军人长期氯吡格雷治疗的风险和好处。这些数据还可能为未来的随机试验提供信息，以解决延长氯吡格雷治疗的价值。