Treatment and Risk Factor Determinants of Cardiovascular Outcomes in BARI 2D

BARI 2D 心血管结局的治疗和危险因素决定因素

• 批准号: 8625130
• 负责人: Maria Mori Brooks
• 金额: $ 10.91万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-19 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8625130
• 关键词: Anatomy; Angioplasty; Atherosclerosis; Biochemical; Biological Markers; Blood Glucose; Bypass; C-reactive protein; Cardiac; Cardiovascular system; Cessation of life; Characteristics; Clinical; Coagulation Process; Complex; Coronary; Coronary Arteriosclerosis; Coronary Artery Bypass; Coronary heart disease; Data; Data Analyses; Diabetes Mellitus; Early Intervention; Event; Fibrin fragment D; Fibrinogen; Fibrinolysis; Glycosylated hemoglobin A; Hyperglycemia; Individual; Inflammation; Insulin; Investigation; Laboratory Study; Lipids; Measures; Medical; Metabolic; Methods; Mission; Multi-Institutional Clinical Trial; Myocardial Infarction; Myocardial Ischemia; National Heart, Lung, and Blood Institute; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Patients; Persons; Pharmaceutical Preparations; Plasminogen Activator Inhibitor 1; Procedures; Prognostic Marker; Randomized; Randomized Clinical Trials; Recording of previous events; Risk; Risk Factors; Severities; Specific qualifier value; Stroke; Surgical Management; Symptoms; Testing; Thrombosis; Time; Treatment Factor; Treatment Protocols; Work; adipokines; base; cardiovascular risk factor; clinical practice; design; diabetes risk; follow-up; glycemic control; high risk; improved; mortality; patient population; percutaneous coronary intervention; prognostic; public health relevance; treatment strategy

PROJECT SUMMARY ABSTRACT Patients with coronary artery disease and type 2 diabetes mellitus are at higher risk for cardiac events than those with coronary disease but no history of diabetes. Interactions among hyperglycemia, treatment to lower blood glucose, cardiac risk factors and coronary revascularization are complex and not well delineated. The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial is a multi- center randomized clinical trial that treated and followed 2368 patients with type 2 diabetes and documented coronary artery disease. The 2x2 factorial design simultaneously compared cardiac and diabetes treatment strategies: 1) prompt revascularization with intensive medical therapy versus intensive medical therapy with revascularization only when clinically indicated, and 2) an insulin sensitization versus an insulin provision approach to glycemic control, both on clinical cardiovascular outcomes. During the five- year follow-up, plasminogen activator inhibitor-1 (PAI-1), C-reactive protein (CRP), fibrinogen, and D-dimer were lower in the insulin sensitization group compared with the insulin provision group, indicating a lower risk of coagulation, inflammation, and thrombosis. However, neither all-cause mortality nor major cardiovascular events (composite of death, myocardial infarction and stroke) differed significantly among the randomized treatment strategy groups in the overall trial. When coronary artery bypass surgery (CABG) was pre-specified as the intended method of revascularization, prompt revascularization significantly reduced major cardiovascular events compared with initial medical therapy, and, the rate of major cardiovascular events was lowest among patients assigned to the combination of prompt revascularization and insulin sensitization. New data from core laboratory studies of adipokines are available to be analyzed with metabolic variables including HbA1c and lipids. The purpose of this application is to determine the risk of major cardiovascular events for patients with type 2 diabetes and coronary artery disease based on their multifactorial risk factor profile and treatment regimens over the course of five years of follow-up. We will create a BARI 2D Risk Score from baseline demographic, clinical, angiographic, and biochemical risk factors, obtaining a prognostic indicator of long-term risk of cardiovascular clinical outcomes. Moreover, we will evaluate how follow-up measures of the aforementioned risk factors predict death and cardiovascular events. We will test if the relationship between these risk factors and clinical outcomes depends on the randomized glycemic and cardiac treatment approaches. We hypothesize that biomarkers measured in BARI 2D, along with HbA1c level and severity of coronary disease can identify subsets of patients who will benefit from specified glycemic and cardiac treatment strategies. Such results would have important clinical implications for the treatment of the large and growing population of patients with type 2 diabetes and stable ischemic heart disease.

项目概要 摘要 患有冠状动脉疾病和 2 型糖尿病的患者发生心脏事件的风险高于普通患者 患有冠心病但无糖尿病史的人。高血糖、治疗之间的相互作用 降低血糖、心脏病危险因素和冠状动脉血运重建是复杂且效果不佳的 划定。糖尿病旁路血管成形术血运重建调查 2 (BARI 2D) 试验是一项多方 中心随机临床试验，治疗并随访了 2368 名 2 型糖尿病患者 记录了冠状动脉疾病。 2x2 因子设计同时比较心脏和 糖尿病治疗策略：1）通过强化药物治疗与强化治疗进行及时血运重建 仅在有临床指征时才进行血运重建药物治疗，以及 2) 胰岛素增敏与 一种用于血糖控制的胰岛素提供方法，两者都影响临床心血管结果。五期间—— 年随访，纤溶酶原激活剂抑制剂-1 (PAI-1)、C 反应蛋白 (CRP)、纤维蛋白原和 D-二聚体 与胰岛素提供组相比，胰岛素增敏组的胰岛素敏感性较低，表明胰岛素敏感性较低。 凝血、炎症和血栓形成的风险。然而，无论是全因死亡率还是重大死亡率 心血管事件（死亡、心肌梗塞和中风的综合）在不同人群之间存在显着差异 整个试验中的随机治疗策略组。当冠状动脉搭桥手术（CABG）时 被预先指定为血运重建的预期方法，显着促进血运重建 与初始药物治疗相比，主要心血管事件减少，并且主要心血管事件发生率 接受立即血运重建联合治疗的患者心血管事件发生率最低 和胰岛素增敏。脂肪因子核心实验室研究的新数据可供分析 代谢变量包括 HbA1c 和脂质。此应用程序的目的是确定风险 2 型糖尿病合并冠状动脉疾病患者主要心血管事件的发生率 五年随访期间的多因素危险因素概况和治疗方案。我们将 根据基线人口统计、临床、血管造影和生化风险创建 BARI 2D 风险评分 因素，获得心血管临床结果长期风险的预后指标。此外，我们 将评估上述危险因素的后续措施如何预测死亡和心血管疾病 事件。我们将测试这些风险因素与临床结果之间的关系是否取决于 随机血糖和心脏治疗方法。我们假设测量的生物标志物 BARI 2D 与 HbA1c 水平和冠状动脉疾病的严重程度一起可以识别出哪些患者的子集 受益于特定的血糖和心脏治疗策略。这样的结果将具有重要的临床意义 对大量且不断增长的 2 型糖尿病患者和病情稳定的患者的治疗的影响 缺血性心脏病。