Clinical InvestigationDiabetes and MetabolismBaseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial
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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Cited by (51)
Coronary surgery and scientific evidence?
2023, Cirugia CardiovascularAn overview on medicinal perspective of thiazolidine-2,4-dione: A remarkable scaffold in the treatment of type 2 diabetes
2020, Journal of Advanced ResearchCoronary artery disease in black African patients with diabetes: Insights from an Ivorian cardiac catheterization centre
2019, Archives of Cardiovascular DiseasesInsulin Sensitivity and Diabetic Kidney Disease in Children and Adolescents With Type 2 Diabetes: An Observational Analysis of Data From the TODAY Clinical Trial
2018, American Journal of Kidney DiseasesSYNTAX Score and Long-Term Outcomes: The BARI-2D Trial
2017, Journal of the American College of CardiologyCoronary artery bypass in patients with type 2 diabetes: Experience from the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial
2014, Journal of Thoracic and Cardiovascular SurgeryCitation 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.
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).
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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]