BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIG 2 DIABETES STUDY (BARI2D)

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。尽管有冠状动脉疾病记录的糖尿病患者预后不良是众所周知的，但对这一群体的最佳治疗策略尚未确定。冠状动脉血运重建术虽然越来越多地被使用，但除了管理高血糖、高血压、血脂异常和其他危险因素外，并没有直接被证明对同时加强冠状动脉疾病的药物治疗有额外的好处。此外，最佳的高血糖治疗策略及其与冠状动脉疾病表现的关系尚不清楚。BARI 2D是一项多中心随机试验，旨在确定在冠心病稳定的2型糖尿病患者中，初始选择性冠状动脉血运重建术结合积极药物治疗的疗效，与最初的积极药物治疗策略进行比较。该试验的第二个主要目标是检查提供更多胰岛素的策略与增加对胰岛素敏感性的策略在控制高血糖方面的有效性。这项试验的主要终点将是全死因死亡。要评估的二次研究终点包括仅限心脏的死亡率、心肌梗死、复合临床终点、心绞痛和生活质量。除临床终点外，还将分析累计医疗成本。糖尿病特有的并发症，包括视网膜病变、肾病、神经病变和外周血管疾病，将被定期监测。将从随机开始对患者进行为期5年的密切跟踪调查，以确定糖尿病合并冠心病患者的理想治疗模式。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Despite the well known poor prognosis of diabetic patients who have documented coronary artery disease, the best treatment strategy for this group has not been determined. Coronary revascularization, while increasingly used, has not been directly shown to be of additional benefit to simultaneous intensive medical management of coronary artery disease in addition to management of hyperglycemia, hypertension, dyslipidemia, and other risk factors. Furthermore, the optimal hyperglycemia management strategy and its relation to the manifestations of coronary artery disease is not known. BARI 2D, a multi center randomized trial is designed to determine the efficacy of initial elective coronary revascularization combined with aggressive medical therapy, compared to an initial strategy of aggressive medical therapy alone in Type 2 diabetic patients with stable CAD. The second primary objective of the trial is to examine the efficacy of a strategy of providing more insulin versus a strategy of increasing sensitivity to insulin in the management of hyperglycemia. The primary endpoint of this trial will be all cause mortality. Secondary study endpoints to be evaluated include cardiac-only mortality, myocardial infarction, composite clinical endpoints, angina, and quality of life. In addition to clinical endpoints, cumulative medical costs will be analyzed. "Diabetes-specific" complications including retinopathy, nephropathy, neuropathy and peripheral vascular disease will be monitored regularly. Patients will be followed closely for a period of 5 years from randomization to determine the ideal treatment pattern for diabetics with CAD.