Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial

Abstract

Background: The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial 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: The BARI 2D trial is a National Institutes of Health-sponsored randomized clinical trial with a 2 x 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: Most of the 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 multiregion CAD. Moreover, 29% had been treated with insulin, 58% had hemoglobin A(1c) >7.0%, 41% had low-density lipoprotein cholesterol >or=100 mg/dL, 52% had blood pressure >130/80 mm Hg, and 56% had body mass index >or=30 kg/m(2).

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.

Figure 1

Flow chart of the enrollment process in the BARI 2D clinical trial.

Figure 2

The BARI 2D population categorized by race/ethnicity overall and stratified by region.

Figure 3

Observed combinations of cardiac risk factors and clinical history in the BARI 2D population.

Figure 4

Distribution of myocardial jeopardy index in the PCI stratum (yellow bars) and CABG stratum (green bars).

Figure 5

Frequency of total cholesterol ≥ 200 mg/dl, blood pressure ≥ 140/90 mmHg and current smoking in BARI 2D at baseline and in the NHANES 1999-2000 cohort.