Elsevier

American Heart Journal

Volume 156, Issue 3, September 2008, Pages 528-536.e5
American Heart Journal

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

https://doi.org/10.1016/j.ahj.2008.05.015Get rights and content

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.

Section snippets

Trial design

The BARI 2D trial was designed to compare treatment strategies for diabetes and established CAD in the setting of standardized glycemic control and intensive management of dyslipidemia, hypertension, smoking, and obesity. The trial protocol and rationale have been described in detail.7, 8, 9, 10 Using a 2 × 2 factorial design, patients were assigned at random to a diabetes treatment and to a cardiovascular treatment. The diabetes component compares an insulin-sensitizing strategy of glycemic

Patient origin

A total of 4,623 patients consented to be screened for the BARI 2D trial. Most were identified in the cardiac catheterization laboratory or cardiology clinic (Figure 1) and generally consented before the qualifying angiogram. Approximately half of screened patients were eligible for enrollment (n = 2,436), and 97% consented to randomization. The reason for ineligibility was not collected before July 15, 2002. Among 1,545 ineligible patients with reason for exclusion available, 51% were excluded

Discussion

The patients enrolled in the BARI 2D clinical trial represent a large segment of the population of patients with diabetes and coronary disease. Evidence-based guidelines for the optimal treatment of both of these conditions are lacking. The BARI 2D trial has the potential to address the impact of alternative diabetes and CAD treatments on cardiovascular outcomes, the major causes of mortality in this population.

Conclusion

The baseline data presented in this article confirm that the BARI 2D clinical trial participants comprise an appropriate patient population for assessing the risks and benefits of the selected interventions. With systematic monitoring of glycemic control, blood pressure, and lipids to ensure proper control of cardiovascular risk factors, the BARI 2D study is in an excellent position to evaluate alternative modes of treatment of CAD and to determine whether the mode of diabetes treatment

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      Citation Excerpt :

      Although regional and institutional differences were present, overall, the ratio of PCI to CABG procedures of 2:1 was close to most centers' experience. The higher number of lesions and increased myocardium at risk for the CABG strata also reflected the design of the trial.4,5 Although BARI 2D was a negative trial when analyzing the entire cohort in terms of both any advantage of early revascularization and the control of glycemia by insulin sensitization, the analysis by predefined strata showed an advantage for CABG relative to medical therapy in reducing the combined outcome of death, MI, and stroke (22.4% CABG vs 30.5% medical therapy, P < .001) and MI, in particular.

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    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.

    Email: [email protected]

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