The revised Bypass Angioplasty Revascularization Investigation (BARI) II study proposes to evaluate treatments for Type 2 diabetic patients with angiographically proven coronary artery disease and stable angina or ischemia. For this rapidly growing patient population with very poor prognosis and quality of life, revascularization has been less beneficial than in nondiabetics. Using a factorial design, BARI II will compare revascularization combined with aggressive medical anti-ischemia treatment to aggressive medical anti-ischemia treatment alone; simultaneously, BARI II will compare two glycemic control strategies, insulin sensitization versus insulin provision. All patients will have target HbA1c values < 7.5%, and uniform control of hypertension, dyslipidemia and obesity following recommended guidelines. A total of 2,600 patients will be recruited, randomized, treated, and followed at 30 clinical centers. Five-year mortality will be the primary endpoint analyzed by intention-to-treat. The Coordinating Center (CC) will assume responsibility for overall trial operations including clinical site selection, data management using an Internet system, and statistical analysis. Within the CC will be operational units for the management of diabetes control, lipids and hypertension. Detailed data on potential mechanisms of macrovascular events will be collected with centralized evaluations of ECGs, lipids and HbA1c levels. A fibrinolysis core laboratory will explore the effect of glycemic control strategy on the progression and mechanism of vasculopathy, including changes in PAI-1 activity and gene expression. The investigators will evaluate the relative economic costs associated with revascularization approaches and diabetes control (Separate application for the ECG Core, the Fibrinolysis Core and the Economics Core complement this lead application). This 7-year application includes a 6-month protocol finalization phase, 2 years of patient recruitment and an additional 4.5 years of follow-up. BARI II aims to answer critical scientific questions regarding treatment efficacy in Type 2 diabetic patients with stable CAD. The investigators further expect that this collaborative effort will translate into a new practical clinical paradigm that will be used for treatment of Type II diabetic patients.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL061744-05
Application #
6800417
Study Section
Special Emphasis Panel (ZHL1-CSR-R (O2))
Program Officer
Hoke, Tracey R
Project Start
2000-09-15
Project End
2007-05-31
Budget Start
2004-06-01
Budget End
2005-05-31
Support Year
5
Fiscal Year
2004
Total Cost
$7,771,898
Indirect Cost
Name
University of Pittsburgh
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Everett, Brendan M; Brooks, Maria Mori; Vlachos, Helen E A et al. (2016) Sex Differences in Cardiac Troponin and the Risk of Death or Major Cardiovascular Events. J Am Coll Cardiol 68:978-80
Bertolet, Marnie; Brooks, Maria M; Bittner, Vera (2016) Tree-based identification of subgroups for time-varying covariate survival data. Stat Methods Med Res 25:488-501
Wolk, Robert; Bertolet, Marnie; Singh, Prachi et al. (2016) Prognostic Value of Adipokines in Predicting Cardiovascular Outcome: Explaining the Obesity Paradox. Mayo Clin Proc 91:858-66
Singh, Ashima; Schaff, Hartzell V; Mori Brooks, Maria et al. (2016) On-pump versus off-pump coronary artery bypass graft surgery among patients with type 2 diabetes in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial. Eur J Cardiothorac Surg 49:406-16
Wolk, Robert; Bertolet, Marnie; Brooks, Maria M et al. (2016) Differential effects of insulin sensitization and insulin provision treatment strategies on concentrations of circulating adipokines in patients with diabetes and coronary artery disease in the BARI 2D trial. Eur J Prev Cardiol 23:50-8
Everett, Brendan M; Brooks, Maria Mori; Vlachos, Helen E A et al. (2015) Troponin and Cardiac Events in Stable Ischemic Heart Disease and Diabetes. N Engl J Med 373:610-20
Magee, Michelle F; Tamis-Holland, Jacqueline E; Lu, Jiang et al. (2015) Sex, Prescribing Practices and Guideline Recommended, Blood Pressure, and LDL Cholesterol Targets at Baseline in the BARI 2D Trial. Int J Endocrinol 2015:610239
Zonszein, Joel; Lombardero, Manuel; Ismail-Beigi, Faramarz et al. (2015) Triglyceride High-Density Lipoprotein Ratios Predict Glycemia-Lowering in Response to Insulin Sensitizing Drugs in Type 2 Diabetes: A Post Hoc Analysis of the BARI 2D. J Diabetes Res 2015:129891
Bittner, Vera; Bertolet, Marnie; Barraza Felix, Rafael et al. (2015) Comprehensive Cardiovascular Risk Factor Control Improves Survival: The BARI 2D Trial. J Am Coll Cardiol 66:765-773
Sako, Edward Y; Brooks, Maria Mori; Hardison, Regina M et al. (2014) Coronary artery bypass in patients with type 2 diabetes: experience from the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial. J Thorac Cardiovasc Surg 148:1268-72

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