Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.
Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.
复制标题
参加旁路血管成形术血运重建调查 2 糖尿病 (BARI 2D) 试验的糖尿病合并冠状动脉疾病患者的基线特征。
DOI：
10.1016/j.ahj.2008.05.015
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发表时间：
2008
影响因子：
4.8
通讯作者：
BypassAngioplastyRevascularizationInvestigation2DiabetesStudyGroup
中科院分区：
文献类型：
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作者：
BypassAngioplastyRevascularizationInvestigation2DiabetesStudyGroup
背景：在2型糖尿病合并稳定型冠状动脉疾病（CAD）患者中，为了确定在积极药物治疗的情况下，早期血运重建干预是否优于延期干预，以及针对胰岛素敏感性的降糖方案在减少心血管事件方面是否比针对胰岛素供应的降糖方案更有效。方法BARI 2D是美国国立卫生研究院（nih）赞助的随机临床试验，采用2×2析因设计。2001年至2005年间，北美、南美和欧洲的49个临床地点随机抽取了2368名患者。在基线时，试验收集了临床病史、症状和药物的数据，以及血管造影、心电图、血液和尿液标本的集中评估。结果绝大多数BARI 2D患者来自心导管实验室（54%）或心脏科诊所（27%）。在随机参与者中，30%为女性，34%为少数民族，61%患有心绞痛，67%患有多地区冠心病。此外，29%接受胰岛素治疗，58%的HbA1c为7.0%，41%的LDL胆固醇≥100 mg/dl， 52%的血压为> 130/80 mmHg， 56%的BMI≥30 kg/m2。结论：BARI 2D的基线特征在随机治疗组之间很好地平衡，研究队列的临床概况代表了目标人群。因此，BARI 2D临床试验在评估糖尿病和CAD的替代治疗方法方面处于很好的地位。
Background The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) was undertaken to determine whether early revascularization intervention is superior to deferred intervention in the presence of aggressive medical therapy and whether antidiabetes regimens targeting insulin sensitivity are more or less effective than regimens targeting insulin provision in reducing cardiovascular events among patients with type 2 diabetes mellitus and stable coronary artery disease (CAD). Methods BARI 2D is an NIH-sponsored randomized clinical trial with a 2×2 factorial design. Between 2001 and 2005, 49 clinical sites in North America, South America and Europe randomized 2,368 patients. At baseline, the trial collected data on clinical history, symptoms and medications along with centralized evaluations of angiograms, electrocardiograms, and blood and urine specimens. Results The majority of BARI 2D patients were referred from the cardiac catheterization laboratory (54%) or cardiology clinic (27%). Of the randomized participants, 30% were women, 34% were minorities, 61% had angina, and 67% had multi-region CAD. Moreover, 29% had been treated with insulin, 58% had HbA1c > 7.0%, 41% LDL cholesterol ≥ 100 mg/dl, 52% blood pressure > 130/80 mmHg, and 56% BMI ≥ 30 kg/m2. Conclusions Baseline characteristics in BARI 2D are well-balanced between the randomized treatment groups, and the clinical profile of the study cohort is representative of the target population. As a result, the BARI 2D clinical trial is in an excellent position to evaluate alternative treatment approaches for diabetes and CAD.