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: 8590191
• 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 2015-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8590191
• 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）： 我们建议评估退伍军人接受冠状动脉支架置入术后经皮冠状动脉介入治疗 (PCI) 后延长氯吡格雷治疗（>12 个月）与 <12 个月的风险和益处。我们的主要目的是根据冠状动脉支架类型（裸金属支架、第一代药物洗脱支架和第二代药物洗脱支架）评估死亡或心肌梗塞的风险。我们将使用 VA 管理和临床数据库创建两组 2002 年至 2007 年间接受裸金属支架和第一代药物洗脱支架的患者，以及第二组更现代的接受裸金属支架和第一代药物洗脱支架的患者。 2008-2010 年间的第二代药物洗脱支架。我们的数据将源自 VA 国家患者护理数据库，其中包含患者治疗文件 (PTF) 和门诊诊所 (OPC) 文件中的住院和门诊详细信息。人口统计数据将从 VHA 生命状态文件中获取。药房数据将从药房福利管理系统文件中获取，包括用于估计用药持续时间的药物处方。 治疗。在 2008-2010 年队列中，我们还将从 VA 心血管评估报告和跟踪 (CART) 数据库中获取程序特征数据（例如支架长度、直径、支架数量、动脉支架）作为协变量。对于每种支架类型，我们将使用标志性分析策略和 Cox 比例风险回归来评估接受支架治疗的患者死亡或心肌梗塞的风险 延长氯吡格雷> 12个月与< 12个月的治疗。我们还将评估长期氯吡格雷治疗对心源性死亡、缺血性卒中、PCI或冠状动脉搭桥手术的冠状动脉血运重建以及大出血等次要终点的风险。作为次要目标，我们将评估延长氯吡格雷与药物洗脱支架类型（第一或第二）的相互作用 第二代）通过结合两个队列。使用相同的方法，我们将评估长期抗凝治疗其他适应症（例如心房颤动）的患者亚组中长期服用氯吡格雷的风险。为了评估潜在的数据限制，我们将对队列的子样本进行图表审查，以验证几个关键的协变量，例如阿司匹林的依从性。我们还将评估混淆和的潜在影响 通过三种方法根据适应症进行混杂：1.传统的多变量调整，2.倾向评分调整和匹配分析，3.将队列限制为具有低风险特征的患者。我们还将进行敏感性分析，以评估缺失协变量数据的影响。探索性分析将评估 PCI 术后 18 个月、24 个月和 36 个月这一里程碑之后更长时间氯吡格雷治疗的风险和益处。的 拟议的研究将提供有价值的信息，以弥合心脏病学界当前关于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益处的信息差距。这些数据也可能为未来的随机试验提供信息，以探讨长期氯吡格雷治疗的价值。

项目成果

Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights From the Excellence in Peripheral Artery Disease (XLPAD) Registry.

腹股沟下外周动脉疾病支架和非支架干预的临床结果和成本比较：来自卓越外周动脉疾病 (XLPAD) 登记的见解。

• 发表时间: 2019
• 期刊: The Journal of invasive cardiology
• 作者: Banerjee,Subhash;Jeon-Slaughter,Haekyung;Armstrong,EhrinJ;Bajzer,Christopher;Abu-Fadel,Mazen;Khalili,Houman;Prasad,Anand;BouDargham,Bassel;Kamath,Preeti;Addo,Tayo;Luna,Michael;Gigliotti,Osvaldo;Foteh,Mazin;Cawich,Ian;Kinlay,
• 通讯作者: Kinlay,

Premature Discontinuation of Dual Antiplatelet Therapy After Coronary Stenting in Veterans: Characteristics and Long-Term Outcomes.

退伍军人冠状动脉支架置入术后过早停止双联抗血小板治疗：特征和长期结果。

• DOI: 10.1161/jaha.120.018481
• 发表时间: 2021-05-04
• 期刊: Journal of the American Heart Association
• 影响因子: 5.4
• 作者: Kinlay S;Quach L;Cormack J;Morgenstern N;Hou Y;Young M;Sherrod R;Cho K;Faxon DP;Ramadan R;Gaziano M;Gagnon D
• 通讯作者: Gagnon D

The Future of Vascular Biology and Medicine.

• DOI: 10.1161/circulationaha.116.023513
• 发表时间: 2016-06-21
• 期刊: Circulation
• 影响因子: 37.8
• 作者: Kinlay S;Michel T;Leopold JA
• 通讯作者: Leopold JA

Prospects for multimodality imaging in peripheral artery disease.

外周动脉疾病多模态成像的前景。

• DOI: 10.1161/circimaging.113.001434
• 发表时间: 2014
• 期刊: Circulation. Cardiovascular imaging
• 作者: Kinlay,Scott

2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

• DOI: 10.1161/cir.0000000000000471
• 发表时间: 2017-03-21
• 期刊: Circulation
• 影响因子: 37.8
• 作者: Gerhard-Herman MD;Gornik HL;Barrett C;Barshes NR;Corriere MA;Drachman DE;Fleisher LA;Fowkes FG;Hamburg NM;Kinlay S;Lookstein R;Misra S;Mureebe L;Olin JW;Patel RA;Regensteiner JG;Schanzer A;Shishehbor MH;Stewart KJ;Treat-Jacobson D;Walsh ME
• 通讯作者: Walsh ME