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: 8391096
• 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/8391096
• 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）：