Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial
Received 11 February 2008; accepted 16 May 2008. published online 01 August 2008.
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 × 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 A1c >7.0%, 41% had low-density lipoprotein cholesterol ≥100 mg/dL, 52% had blood pressure >130/80 mm Hg, and 56% had body mass index ≥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.
Writing group: Maria Mori Brooks, Gregory Barsness, Bernard Chaitman, Sheng-Chia Chung, David Faxon, Frederick Feit, Robert Frye, Saul Genuth, Jennifer Green, Mark Hlatky, Sheryl Kelsey, Frank Kennedy, Ronald Krone, Richard Nesto, Trevor Orchard, Robert O'Rourke, Charanjit Rihal, Jean-Claude Tardif.
BARI 2D is funded by the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases (U01 HL061744, U01 HL061746, U01 HL061748, U01 HL063804).
BARI 2D receives significant supplemental funding from GlazoSmithKline (Collegeville, PA); Bristol-Myers Squibb Medical Imaging, Inc. (North Billerica, MA); Astellas Pharma US, Inc. (Deerfield, IL); Merck & Co., Inc. (Whitehouse Station, NJ); Abbott Laboratories, Inc. (Abbott Park, IL); and Pfizer, Inc (New York, NY), and generous support from Abbott Laboratories Ltd.; MediSense Products (Mississauga, Ontario, Canada); Bayer Diagnostics (Tarrytown, NY); Becton, Dickinson and Company (Franklin Lakes, NJ); J. R. Carlson Labs (Arlington Heights, IL); Centocor, Inc. (Malvern, PA); Eli Lilly and Company (Indianapolis, IN); LipoScience, Inc. (Raleigh, NC); Merck Sante (Lyon, France); Novartis Pharmaceuticals Corporation (East Hanover, NJ); and Novo Nordisk, Inc. (Princeton, NJ).
a BARI 2D sites and Study Group are listed in the
Appendix A
available online.
Reprint requests: Maria Mori Brooks, PhD, University of Pittsburgh, GSPH, A530 Crabtree Hall, Pittsburgh, PA 15261.
ABSTRACT