CLINICAL TRIAL: BYPASS ANGIOPLASTY REVASCULARIZATION 2 DIABETES (BARI 2D)

临床试验：旁路血管成形术血运重建 2 型糖尿病 (BARI 2D)

• 批准号: 7718389
• 负责人: FRED FEIT
• 金额: $ 2.03万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718389
• 关键词: Affect; Angioplasty; Bypass; Cardiac; Cardiovascular system; Caring; Cholesterol; Clinical; Clinical Trials; Communities; Computer Retrieval of Information on Scientific Projects Database; Coronary; Coronary Arteriosclerosis; Coronary Artery Bypass; Coronary heart disease; Diabetes Mellitus; End Point; Event; Funding; Glycosylated Hemoglobin; Glycosylated hemoglobin A; Goals; Grant; Incidence; Institution; Insulin; Ischemia; Lipids; Medical; Morbidity - disease rate; Myocardial Infarction; Non-Insulin-Dependent Diabetes Mellitus; Numbers; Outcome; Patients; Percutaneous Transluminal Coronary Angioplasty; Population; Quality of life; Randomized; Randomized Clinical Trials; Recruitment Activity; Registries; Research; Research Personnel; Resources; Risk Factors; Source; Syndrome; United States National Institutes of Health; blood glucose regulation; design; diabetic; glycemic control; internal thoracic artery; mortality; outcome forecast

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. There is ample evidence that patients with Type II diabetes mellitus have increased cardiovascular mortality and morbidity. The BARI I trial found that patients with treated diabetes mellitus had a significantly better outcome when treated with coronary artery bypass graft (CABG) (involving internal mammary artery graft) than if treated initially with percutaneous transluminal coronary angioplasty (PTCA). The BARI I trial studied patients with unstable coronary syndrome. However, the marked difference in results between the randomized BARI I trial results and the BARI I registry that showed no difference in outcome between diabetic patients receiving CABG vs. PTCA has raised questions. There are many plausible explanations for the difference in the results. One of these is that the patients in the Registry had potentially less severe CAD. This is the population to be recruited for BARI II. BARI II extends the question of optimum therapy to the large number who have documented coronary disease but non-urgent symptomatology. This study will provide information useful to the medical community on the optimum choice of treatment strategy for these patients. The recent AVERT trial showing a similar incidence of ischemic events in patients with stable coronary artery disease treated with aggressive lipid lowering compared to angioplasty and usual care. This increases the importance of determining the optimum strategy for management of diabetic patients with stable coronary artery disease. Although the AVERT trial was not specifically in diabetic patients, the benefit of reduced cardiovascular morbidity as a result of aggressive cholesterol lowering has been seen in the diabetic subsets of other lipid lowering trials. This is a multicenter, randomized, clinical trial with a 2 x 2 factorial design. The effect of initial elective coronary revascularization with aggressive medical therapy is compared to aggressive medical therapy of ischemia alone in reducing mortality in patients with CAD and Type 2 diabetes mellitus (DM). Whether the strategy of glucose control affects the prognosis of these patients will also be determined. The strategies of insulin sensitization will be compared with a strategy of augmenting insulin. A total of 2,600 patients will be entered from 30 clinical centers. Subjects will be randomized between medical therapy versus revascularization and simultaneously be assigned at random to an insulin providing or insulin sensitizing strategy of glycemic control. Aggressive management of risk factors and a goal of HbA1C (glycosylated hemoglobin) of 7.5 will be followed in both groups. Patients will be followed for 5 years and the primary outcome will be total mortality analyzed by intention-to-treat with secondary endpoints of cardiac mortality, myocardial infarction, composite clinical endpoint, angina, and quality of life.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 有充分的证据表明，II型糖尿病患者的心血管死亡率和发病率增加。巴里I试验发现，接受冠状动脉旁路移植术（CABG）（包括乳内动脉移植）治疗的糖尿病患者的结局明显优于最初接受经皮腔内冠状动脉成形术（PTCA）治疗的患者。巴里I试验研究了不稳定冠状动脉综合征患者。然而，随机巴里I试验结果与巴里I登记研究结果之间的显著差异（显示接受CABG与PTCA的糖尿病患者的结局无差异）引起了质疑。对于结果的差异，有许多似是而非的解释。其中之一是登记研究中的患者可能患有不太严重的CAD。这是巴里第二阶段将招募的人口。巴里II将最佳治疗的问题扩展到大量有记录的冠心病但非紧急冠状动脉病变的患者。这项研究将提供有用的信息，医学界对这些患者的治疗策略的最佳选择。最近的AVERT试验显示，与血管成形术和常规护理相比，接受积极降脂治疗的稳定型冠状动脉疾病患者的缺血事件发生率相似。这增加了确定糖尿病合并稳定性冠状动脉疾病患者管理的最佳策略的重要性。尽管AVERT试验并非专门针对糖尿病患者，但在其他降脂试验的糖尿病亚组中已观察到积极降胆固醇导致心血管发病率降低的获益。 这是一项多中心、随机、临床试验，采用2 x 2析因设计。在CAD和2型糖尿病（DM）患者中，比较了初始选择性冠状动脉血运重建联合积极药物治疗与单纯缺血积极药物治疗在降低死亡率方面的效果。血糖控制策略是否影响这些患者的预后也将被确定。胰岛素增敏策略将与增加胰岛素的策略进行比较。共有2,600名患者将从30个临床中心进入。受试者将在药物治疗与血运重建之间随机分配，同时随机分配至胰岛素提供或胰岛素增敏血糖控制策略。两组均将遵循积极的风险因素管理和HbA 1C（糖化血红蛋白）7.5的目标。将对患者进行5年随访，主要结局将是按意向治疗分析的总死亡率，次要终点为心源性死亡率、心肌梗死、复合临床终点、心绞痛和生活质量。