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Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI2D)

Primary Purpose

Coronary Disease, Cardiovascular Diseases, Heart Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions
Coronary Artery Bypass
Biguanides, thiazolidinediones
Insulin, sulfonylurea
ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of Type 2 diabetes mellitus Coronary arteriogram showing one or more vessels amenable to revascularization (greater than or equal to 50% stenosis) Objective documentation of ischemia OR subjectively documented typical angina with greater than or equal to 70% stenosis in at least one artery Suitability for coronary revascularization by at least one of the available methods (does not require the ability to achieve complete revascularization) Ability to perform all tasks related to glycemic control and risk factor management Exclusion Criteria: Definite need for invasive intervention as determined by the attending cardiologist Prior bypass surgery (CABG) or prior catheter-based intervention within the 12 months before study entry Planned intervention for disease in bypass graft(s) if the patient is randomly assigned to a strategy of initial revascularization Class III or IV CHF Creatinine greater than 2.0 mg/dL HbA1c greater than 13% Need for major vascular surgery concomitant with revascularization (e.g., carotid endarterectomy) Left main stenosis greater than or equal to 50% Non-cardiac illness expected to limit survival Hepatic disease (ALT greater than 2 times the ULN) Fasting triglycerides greater than 1000 mg/dL in the presence of moderate glycemic control (HbA1c less than 9.0%) Current alcohol abuse Chronic steroid use judged to interfere with the control of diabetes, exceeding 10 mg of Prednisone per day or the equivalent Pregnancy, known, suspected, or planned in 5 years after study entry Geographically inaccessible or unable to return for follow-up Enrolled in a competing randomized trial or clinical study Unable to understand or cooperate with protocol requirements Patients with Type 2 diabetes mellitus and CAD documented by coronary arteriography will be eligible for the trial if revascularization is not required for prompt control of severe or unstable angina. Diabetic patients who are being treated with insulin or oral hypoglycemic drugs will be eligible as well as diabetic patients treated with diet and exercise alone provided that a diagnosis of diabetes can be confirmed by record review or that a fasting plasma glucose (FPG) greater than 125/mg/dL (7.0 mmol/L) can be obtained. The determination of suitability for BARI 2D will be made by a physician-investigator at each participating institution on clinical grounds at the time of coronary angiography. Significant CAD will be defined as at least one stenosis greater than 50%. Angina and ischemia will be assessed by use of patient self-report, physician examination, and appropriate diagnostic measures including exercise myocardial perfusion imaging, exercise echocardiography, exercise electrocardiography, and IV dipyridamole or adenosine myocardial perfusion imaging or invasively by doppler or pressure wire. Objective documentation of myocardial ischemia includes any of the following: Exercise or pharmacologically-induced: Greater than or equal to 1 mm of horizontal or downsloping ST depression or elevation for greater than or equal to 60-80 milliseconds after the end of the QRS complex Myocardial perfusion defect Myocardial wall motion abnormality Stabilized, prior acute coronary syndrome with CK-MB or troponin elevation or with new, greater than or equal to 0.5 mm ST depression or elevation, or T wave inversion of greater than or equal to 3 mm in 2 contiguous ECG leads Doppler or pressure wire showing coronary flow reserve (CFR) less than 2.0 or fractional flow reserve (FFR) less than 0.75 Among patients without documented ischemia, only patients with stenosis greater than or equal to 70% presenting with classic anginal symptoms will be eligible for randomization.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Revascularization and Insulin Providing (IP)

    Revascularization and Insulin Sensitizing (IS)

    Medical Therapy and Insulin Providing (IP)

    Medical Therapy and Insulin Sensitizing (IS)

    Arm Description

    Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy

    Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy

    Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy

    Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy

    Outcomes

    Primary Outcome Measures

    Number of Participants With All-Cause Mortality

    Secondary Outcome Measures

    Number of Participants With Death, Myocardial Infarction, or Stroke

    Full Information

    First Posted
    September 28, 2000
    Last Updated
    January 12, 2016
    Sponsor
    University of Pittsburgh
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006305
    Brief Title
    Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
    Acronym
    BARI2D
    Official Title
    Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2000 (undefined)
    Primary Completion Date
    November 2008 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pittsburgh
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients being assigned at random to initial elective revascularization with aggressive medical therapy or aggressive medical therapy alone with equal probability, and simultaneously being assigned at random to an insulin providing or insulin sensitizing strategy of glycemic control (with a target value for HbA1c of less than 7.0% for all patients). SPECIFIC AIMS A. Primary Aim The primary aim of the BARI 2D trial is to test the following two hypotheses of treatment efficacy in 2400 patients with Type 2 diabetes mellitus and documented stable CAD, in the setting of uniform glycemic control and intensive management of all other risk factors including dyslipidemia, hypertension, smoking, and obesity: Coronary Revascularization Hypothesis: a strategy of initial elective revascularization of choice (surgical or catheter-based) combined with aggressive medical therapy results in lower 5-year mortality compared to a strategy of aggressive medical therapy alone; Method of Glycemic Control Hypothesis: with a target HbA1c level of less than 7.0%, a strategy of hyperglycemia management directed at insulin sensitization results in lower 5-year mortality compared to a strategy of insulin provision. B. Secondary Aims The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial infarction or stroke combined endpoint event rate between the revascularization versus medical therapy groups and between the insulin sensitization versus insulin provision groups; b) comparing rates of myocardial infarction, other ischemic events, angina and quality of life associated with each revascularization and hyperglycemia management strategy; c) evaluating the relative economic costs associated with the trial treatment strategies, d) exploring the effect of glycemic control strategy on the progression and mechanism of vasculopathy including changes in PAI-1 gene expression.
    Detailed Description
    BACKGROUND: Type 2 diabetes mellitus, which is becoming more prevalent in our society as the population ages, is one of the strongest risk factors for coronary artery disease (CAD) and consequent mortality. In addition to generating an enormous toll in human suffering, diabetes places an economic burden approaching 100 billion dollars annually on the U.S. health care system. Despite the well known dismal prognosis of diabetes complicated by angiographically documented CAD, the optimal treatment paradigm for this large group of patients has not been studied. Coronary revascularization, while increasingly used, has not been directly shown to be of additional benefit to simultaneous intensive medical management of CAD along with management of hyperglycemia, hypertension, dyslipidemia, and other risk factors. Moreover, while intensive efforts to lower HbA1c have been demonstrated to favorably affect the clinical course of Type 2 diabetes mellitus in terms of microvascular complications, the optimal hyperglycemia management strategy with regard to macrovascular outcome is not known. These critical treatment dilemmas have motivated the development of BARI 2D, a multicenter randomized trial designed to determine in patients with Type 2 diabetes and stable CAD: 1) the efficacy of initial elective coronary revascularization combined with aggressive medical therapy, compared to an initial strategy of aggressive medical therapy alone; and 2) the efficacy of a strategy of providing more insulin (endogenous or exogenous), versus a strategy of increasing sensitivity to insulin (reducing insulin resistance), in the management of hyperglycemia, with a target HbA1c level of less than 7.0% for each strategy. DESIGN NARRATIVE: The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients being assigned at random to initial elective revascularization with aggressive medical therapy or aggressive medical therapy alone with equal probability, and simultaneously being assigned at random to an insulin providing or insulin sensitizing strategy of glycemic control (with a target value for HbA1c of less than 7.0% for all patients). Following confirmation of patient eligibility and provision of written consent, patients were randomized as shown below: Number of Patients Per Treatment Assignment (N=2400 patients in total) Stable Ischemic Heart Disease Treatment Strategy and Glycemic Control Strategy: Revascularization and Insulin Providing (IP) N=600; Revascularization and Insulin Sensitizing (IS) N=600; Medical and Insulin Providing (IP) N=600; Medical and and Insulin Sensitizing (IS) N=600.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Disease, Cardiovascular Diseases, Heart Diseases, Insulin Resistance, Diabetes Mellitus, Diabetes Mellitus, Non-Insulin-Dependent

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2368 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Revascularization and Insulin Providing (IP)
    Arm Type
    Active Comparator
    Arm Description
    Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
    Arm Title
    Revascularization and Insulin Sensitizing (IS)
    Arm Type
    Active Comparator
    Arm Description
    Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
    Arm Title
    Medical Therapy and Insulin Providing (IP)
    Arm Type
    Active Comparator
    Arm Description
    Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
    Arm Title
    Medical Therapy and Insulin Sensitizing (IS)
    Arm Type
    Active Comparator
    Arm Description
    Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
    Intervention Type
    Procedure
    Intervention Name(s)
    Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions
    Intervention Description
    Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions
    Intervention Type
    Procedure
    Intervention Name(s)
    Coronary Artery Bypass
    Intervention Description
    Coronary Artery Bypass
    Intervention Type
    Drug
    Intervention Name(s)
    Biguanides, thiazolidinediones
    Intervention Description
    Biguanides, thiazolidinediones
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin, sulfonylurea
    Intervention Description
    Insulin, sulfonylurea
    Intervention Type
    Drug
    Intervention Name(s)
    ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers
    Intervention Description
    ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers
    Primary Outcome Measure Information:
    Title
    Number of Participants With All-Cause Mortality
    Time Frame
    five years
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Death, Myocardial Infarction, or Stroke
    Time Frame
    five years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of Type 2 diabetes mellitus Coronary arteriogram showing one or more vessels amenable to revascularization (greater than or equal to 50% stenosis) Objective documentation of ischemia OR subjectively documented typical angina with greater than or equal to 70% stenosis in at least one artery Suitability for coronary revascularization by at least one of the available methods (does not require the ability to achieve complete revascularization) Ability to perform all tasks related to glycemic control and risk factor management Exclusion Criteria: Definite need for invasive intervention as determined by the attending cardiologist Prior bypass surgery (CABG) or prior catheter-based intervention within the 12 months before study entry Planned intervention for disease in bypass graft(s) if the patient is randomly assigned to a strategy of initial revascularization Class III or IV CHF Creatinine greater than 2.0 mg/dL HbA1c greater than 13% Need for major vascular surgery concomitant with revascularization (e.g., carotid endarterectomy) Left main stenosis greater than or equal to 50% Non-cardiac illness expected to limit survival Hepatic disease (ALT greater than 2 times the ULN) Fasting triglycerides greater than 1000 mg/dL in the presence of moderate glycemic control (HbA1c less than 9.0%) Current alcohol abuse Chronic steroid use judged to interfere with the control of diabetes, exceeding 10 mg of Prednisone per day or the equivalent Pregnancy, known, suspected, or planned in 5 years after study entry Geographically inaccessible or unable to return for follow-up Enrolled in a competing randomized trial or clinical study Unable to understand or cooperate with protocol requirements Patients with Type 2 diabetes mellitus and CAD documented by coronary arteriography will be eligible for the trial if revascularization is not required for prompt control of severe or unstable angina. Diabetic patients who are being treated with insulin or oral hypoglycemic drugs will be eligible as well as diabetic patients treated with diet and exercise alone provided that a diagnosis of diabetes can be confirmed by record review or that a fasting plasma glucose (FPG) greater than 125/mg/dL (7.0 mmol/L) can be obtained. The determination of suitability for BARI 2D will be made by a physician-investigator at each participating institution on clinical grounds at the time of coronary angiography. Significant CAD will be defined as at least one stenosis greater than 50%. Angina and ischemia will be assessed by use of patient self-report, physician examination, and appropriate diagnostic measures including exercise myocardial perfusion imaging, exercise echocardiography, exercise electrocardiography, and IV dipyridamole or adenosine myocardial perfusion imaging or invasively by doppler or pressure wire. Objective documentation of myocardial ischemia includes any of the following: Exercise or pharmacologically-induced: Greater than or equal to 1 mm of horizontal or downsloping ST depression or elevation for greater than or equal to 60-80 milliseconds after the end of the QRS complex Myocardial perfusion defect Myocardial wall motion abnormality Stabilized, prior acute coronary syndrome with CK-MB or troponin elevation or with new, greater than or equal to 0.5 mm ST depression or elevation, or T wave inversion of greater than or equal to 3 mm in 2 contiguous ECG leads Doppler or pressure wire showing coronary flow reserve (CFR) less than 2.0 or fractional flow reserve (FFR) less than 0.75 Among patients without documented ischemia, only patients with stenosis greater than or equal to 70% presenting with classic anginal symptoms will be eligible for randomization.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bernard Chaitman, MD
    Organizational Affiliation
    St. Louis University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Robert L Frye, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mark Hlatky
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Burton Sobel
    Organizational Affiliation
    University of Vermont & State Agricultural College
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sheryl F. Kelsey, PhD
    Organizational Affiliation
    University of Pittsburgh
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12566379
    Citation
    Sobel BE, Frye R, Detre KM; Bypass Angioplasty Revascularization Investigation 2 Diabetes Trial. Burgeoning dilemmas in the management of diabetes and cardiovascular disease: rationale for the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial. Circulation. 2003 Feb 4;107(4):636-42. doi: 10.1161/01.cir.0000048897.03553.e4. Erratum In: Circulation. 2003 Jul 29;108(4):500.
    Results Reference
    background
    PubMed Identifier
    16813734
    Citation
    Brooks MM, Frye RL, Genuth S, Detre KM, Nesto R, Sobel BE, Kelsey SF, Orchard TJ; Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial Investigators. Hypotheses, design, and methods for the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial. Am J Cardiol. 2006 Jun 19;97(12A):9G-19G. doi: 10.1016/j.amjcard.2006.02.023. Epub 2006 Apr 17.
    Results Reference
    background
    PubMed Identifier
    18760137
    Citation
    Bypass Angioplasty Revascularization Investigation 2 Diabetes Study Group. Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Am Heart J. 2008 Sep;156(3):528-536, 536.e1-5. doi: 10.1016/j.ahj.2008.05.015. Epub 2008 Jul 31.
    Results Reference
    background
    PubMed Identifier
    19502645
    Citation
    BARI 2D Study Group; Frye RL, August P, Brooks MM, Hardison RM, Kelsey SF, MacGregor JM, Orchard TJ, Chaitman BR, Genuth SM, Goldberg SH, Hlatky MA, Jones TL, Molitch ME, Nesto RW, Sako EY, Sobel BE. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009 Jun 11;360(24):2503-15. doi: 10.1056/NEJMoa0805796. Epub 2009 Jun 7.
    Results Reference
    background
    PubMed Identifier
    20937978
    Citation
    Brooks MM, Chung SC, Helmy T, Hillegass WB, Escobedo J, Melsop KA, Massaro EM, McBane RD, Hyde P, Hlatky MA; Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Study Group. Health status after treatment for coronary artery disease and type 2 diabetes mellitus in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial. Circulation. 2010 Oct 26;122(17):1690-9. doi: 10.1161/CIRCULATIONAHA.109.912642. Epub 2010 Oct 11.
    Results Reference
    background
    PubMed Identifier
    20584997
    Citation
    Grogan M, Jenkins M, Sansing VV, MacGregor J, Brooks MM, Julien-Williams P, Amendola A, Abbott JD; BARI 2D Study Group. Health insurance status and control of diabetes and coronary artery disease risk factors on enrollment into the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Diabetes Educ. 2010 Sep-Oct;36(5):774-83. doi: 10.1177/0145721710374653. Epub 2010 Jun 28.
    Results Reference
    background
    PubMed Identifier
    20375690
    Citation
    Wall BM, Hardison RM, Molitch ME, Marroquin OC, McGill JB, August PA; BARI 2D Study Group. High prevalence and diversity of kidney dysfunction in patients with type 2 diabetes mellitus and coronary artery disease: the BARI 2D baseline data. Am J Med Sci. 2010 May;339(5):401-10. doi: 10.1097/MAJ.0b013e3181d430ad.
    Results Reference
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    PubMed Identifier
    20626665
    Citation
    Rana JS, Hardison RM, Pop-Busui R, Brooks MM, Jones TL, Nesto RW, Bourassa MG; BARI 2D Investigators. Resting heart rate and metabolic syndrome in patients with diabetes and coronary artery disease in bypass angioplasty revascularization investigation 2 diabetes (BARI 2D) trial. Prev Cardiol. 2010 Summer;13(3):112-6. doi: 10.1111/j.1751-7141.2010.00067.x.
    Results Reference
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    PubMed Identifier
    20147671
    Citation
    Thomas SB, Sansing VV, Davis A, Magee M, Massaro E, Srinivas VS, Helmy T, Desvigne-Nickens P, Brooks MM; BARI 2D Study Group. Racial differences in the association between self-rated health status and objective clinical measures among participants in the BARI 2D trial. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S269-76. doi: 10.2105/AJPH.2009.176180. Epub 2010 Feb 10.
    Results Reference
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    PubMed Identifier
    20152229
    Citation
    Hlatky MA, Chung SC, Escobedo J, Hillegass WB, Melsop K, Rogers W, Brooks MM; BARI 2D Study Group. The effect of obesity on quality of life in patients with diabetes and coronary artery disease. Am Heart J. 2010 Feb;159(2):292-300. doi: 10.1016/j.ahj.2009.11.004.
    Results Reference
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    PubMed Identifier
    19875998
    Citation
    Albu JB, Lu J, Mooradian AD, Krone RJ, Nesto RW, Porter MH, Rana JS, Rogers WJ, Sobel BE, Gottlieb SH; BARI 2D Study Group. Relationships of obesity and fat distribution with atherothrombotic risk factors: baseline results from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Obesity (Silver Spring). 2010 May;18(5):1046-54. doi: 10.1038/oby.2009.339. Epub 2009 Oct 29.
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    PubMed Identifier
    19920002
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    Hlatky MA, Boothroyd DB, Melsop KA, Kennedy L, Rihal C, Rogers WJ, Venkitachalam L, Brooks MM; Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Study Group. Economic outcomes of treatment strategies for type 2 diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial. Circulation. 2009 Dec 22;120(25):2550-8. doi: 10.1161/CIRCULATIONAHA.109.912709. Epub 2009 Nov 17.
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    19920001
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    Chaitman BR, Hardison RM, Adler D, Gebhart S, Grogan M, Ocampo S, Sopko G, Ramires JA, Schneider D, Frye RL; Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Study Group. The Bypass Angioplasty Revascularization Investigation 2 Diabetes randomized trial of different treatment strategies in type 2 diabetes mellitus with stable ischemic heart disease: impact of treatment strategy on cardiac mortality and myocardial infarction. Circulation. 2009 Dec 22;120(25):2529-40. doi: 10.1161/CIRCULATIONAHA.109.913111. Epub 2009 Nov 17. Erratum In: Circulation. 2010 Mar 30;121(12):e254.
    Results Reference
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    PubMed Identifier
    19463459
    Citation
    Kim LJ, King SB 3rd, Kent K, Brooks MM, Kip KE, Abbott JD, Jacobs AK, Rihal C, Hueb WA, Alderman E, Sing IR, Attubato MJ, Feit F; BARI 2D (Bypass Angioplasty Revascularization Investigation Type 2 Diabetes) Study Group. Factors related to the selection of surgical versus percutaneous revascularization in diabetic patients with multivessel coronary artery disease in the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) trial. JACC Cardiovasc Interv. 2009 May;2(5):384-92. doi: 10.1016/j.jcin.2009.01.009.
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    Schwartz L, Kip KE, Alderman E, Lu J, Bates ER, Srinivas V, Bach RG, Mighton LD, Feit F, King S 3rd, Frye RL; BARI 2D Study Group. Baseline coronary angiographic findings in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial (BARI 2D). Am J Cardiol. 2009 Mar 1;103(5):632-8. doi: 10.1016/j.amjcard.2008.11.024. Epub 2009 Jan 12.
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    Iskandrian AE, Heo J, Mehta D, Tauxe EL, Yester M, Hall MB, MacGregor JM. Gated SPECT perfusion imaging for the simultaneous assessment of myocardial perfusion and ventricular function in the BARI 2D trial: an initial report from the Nuclear Core Laboratory. J Nucl Cardiol. 2006 Jan-Feb;13(1):83-90. doi: 10.1016/j.nuclcard.2005.10.002.
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    Magee MF, Isley WL; BARI 2D Trial Investigators. Rationale, design, and methods for glycemic control in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial. Am J Cardiol. 2006 Jun 19;97(12A):20G-30G. doi: 10.1016/j.amjcard.2006.02.024. Epub 2006 Apr 19.
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    Barsness GW, Gersh BJ, Brooks MM, Frye RL; BARI 2D Trial Investigators. Rationale for the revascularization arm of the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial. Am J Cardiol. 2006 Jun 19;97(12A):31G-40G. doi: 10.1016/j.amjcard.2006.03.011. Epub 2006 Apr 17.
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    Sobel BE; BARI 2D Trial Investigators. Ancillary studies in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial: Synergies and opportunities. Am J Cardiol. 2006 Jun 19;97(12A):53G-58G. doi: 10.1016/j.amjcard.2006.03.013. Epub 2006 Apr 17.
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    Hlatky MA, Melsop KA, Boothroyd DB; Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial Investigators. Economic evaluation of alternative strategies to treat patients with diabetes mellitus and coronary artery disease. Am J Cardiol. 2006 Jun 19;97(12A):59G-65G. doi: 10.1016/j.amjcard.2006.03.014. Epub 2006 Apr 7.
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    Escobedo J, Rana JS, Lombardero MS, Albert SG, Davis AM, Kennedy FP, Mooradian AD, Robertson DG, Srinivas VS, Gebhart SS; BARI 2D Study Group. Association between albuminuria and duration of diabetes and myocardial dysfunction and peripheral arterial disease among patients with stable coronary artery disease in the BARI 2D study. Mayo Clin Proc. 2010 Jan;85(1):41-6. doi: 10.4065/mcp.2009.0265.
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    McBane RD 2nd, Hardison RM, Sobel BE; BARI 2D Study Group. Comparison of plasminogen activator inhibitor-1, tissue type plasminogen activator antigen, fibrinogen, and D-dimer levels in various age decades in patients with type 2 diabetes mellitus and stable coronary artery disease (from the BARI 2D trial). Am J Cardiol. 2010 Jan 1;105(1):17-24. doi: 10.1016/j.amjcard.2009.08.643. Epub 2009 Nov 14.
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    Pop-Busui R, Lombardero M, Lavis V, Forker A, Green J, Korytkowski M, Sobel BE, Jones TL; BARI 2D Study Group. Relation of severe coronary artery narrowing to insulin or thiazolidinedione use in patients with type 2 diabetes mellitus (from the Bypass Angioplasty Revascularization Investigation 2 Diabetes Study). Am J Cardiol. 2009 Jul 1;104(1):52-8. doi: 10.1016/j.amjcard.2009.02.046. Epub 2009 May 13.
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    Schneider DJ, Hardison RM, Lopes N, Sobel BE, Brooks MM; Pro-Thrombosis Ancillary Study Group. Association between increased platelet P-selectin expression and obesity in patients with type 2 diabetes: a BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) substudy. Diabetes Care. 2009 May;32(5):944-9. doi: 10.2337/dc08-1308. Epub 2009 Feb 19.
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    Pop-Busui R, Lu J, Lopes N, Jones TL; BARI 2D Investigators. Prevalence of diabetic peripheral neuropathy and relation to glycemic control therapies at baseline in the BARI 2D cohort. J Peripher Nerv Syst. 2009 Mar;14(1):1-13. doi: 10.1111/j.1529-8027.2009.00200.x.
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    Steiner G; Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial Investigators. Statement of the problem. Am J Cardiol. 2006 Jun 19;97(12A):3G-8G. doi: 10.1016/j.amjcard.2006.02.022. Epub 2006 Apr 7.
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    Albu J, Gottlieb SH, August P, Nesto RW, Orchard TJ; Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial Investigators. Modifications of coronary risk factors. Am J Cardiol. 2006 Jun 19;97(12A):41G-52G. doi: 10.1016/j.amjcard.2006.03.012. Epub 2006 Apr 19.
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    31590967
    Citation
    Genuth SM, Vlachos H, Brooks MM, Bantle JP, Chaitman BR, Green J, Kelsey SF, King SB 3rd, McBane R, Sako EY, Schneider DJ, Steffes M, Frye RL; BARI 2D Study Group. BARI 2D: A Reanalysis Focusing on Cardiovascular Events. Mayo Clin Proc. 2019 Nov;94(11):2249-2262. doi: 10.1016/j.mayocp.2019.04.015. Epub 2019 Oct 4.
    Results Reference
    derived
    PubMed Identifier
    30286920
    Citation
    Rezende PC, Everett BM, Brooks MM, Vlachos H, Orchard TJ, Frye RL, Bhatt DL, Hlatky MA. Hypoglycemia and Elevated Troponin in Patients With Diabetes and Coronary Artery Disease. J Am Coll Cardiol. 2018 Oct 9;72(15):1778-1786. doi: 10.1016/j.jacc.2018.07.067.
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    derived
    PubMed Identifier
    28903941
    Citation
    Khan AA, Chung MJ, Novak E, Brown DL. Increased Hazard of Myocardial Infarction With Insulin-Provision Therapy in Actively Smoking Patients With Diabetes Mellitus and Stable Ischemic Heart Disease: The BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) Trial. J Am Heart Assoc. 2017 Sep 13;6(9):e005946. doi: 10.1161/JAHA.117.005946.
    Results Reference
    derived
    PubMed Identifier
    28126156
    Citation
    Ikeno F, Brooks MM, Nakagawa K, Kim MK, Kaneda H, Mitsutake Y, Vlachos HA, Schwartz L, Frye RL, Kelsey SF, Waseda K, Hlatky MA; BARI-2D Study Group. SYNTAX Score and Long-Term Outcomes: The BARI-2D Trial. J Am Coll Cardiol. 2017 Jan 31;69(4):395-403. doi: 10.1016/j.jacc.2016.10.067.
    Results Reference
    derived
    PubMed Identifier
    27289411
    Citation
    Wolk R, Bertolet M, Singh P, Brooks MM, Pratley RE, Frye RL, Mooradian AD, Rutter MK, Calvin AD, Chaitman BR, Somers VK; BARI 2D Study Group. Prognostic Value of Adipokines in Predicting Cardiovascular Outcome: Explaining the Obesity Paradox. Mayo Clin Proc. 2016 Jul;91(7):858-66. doi: 10.1016/j.mayocp.2016.03.020. Epub 2016 Jun 9.
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    PubMed Identifier
    26853953
    Citation
    Damluji AA, Pomenti SF, Ramireddy A, Al-Damluji MS, Alfonso CE, Schob AH, Marso SP, Gilchrist IC, Moscucci M, Kandzari DE, Cohen MG. Influence of Total Coronary Occlusion on Clinical Outcomes (from the Bypass Angioplasty Revascularization Investigation 2 DiabetesTrial). Am J Cardiol. 2016 Apr 1;117(7):1031-8. doi: 10.1016/j.amjcard.2015.12.047. Epub 2016 Jan 14.
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    PubMed Identifier
    26271057
    Citation
    Bittner V, Bertolet M, Barraza Felix R, Farkouh ME, Goldberg S, Ramanathan KB, Redmon JB, Sperling L, Rutter MK; BARI 2D Study Group. Comprehensive Cardiovascular Risk Factor Control Improves Survival: The BARI 2D Trial. J Am Coll Cardiol. 2015 Aug 18;66(7):765-773. doi: 10.1016/j.jacc.2015.06.019.
    Results Reference
    derived
    PubMed Identifier
    26267622
    Citation
    Everett BM, Brooks MM, Vlachos HE, Chaitman BR, Frye RL, Bhatt DL; BARI 2D Study Group. Troponin and Cardiac Events in Stable Ischemic Heart Disease and Diabetes. N Engl J Med. 2015 Aug 13;373(7):610-20. doi: 10.1056/NEJMoa1415921.
    Results Reference
    derived
    PubMed Identifier
    24178969
    Citation
    August P, Hardison RM, Hage FG, Marroquin OC, McGill JB, Rosenberg Y, Steffes M, Wall BM, Molitch M; BARI 2D Study Group. Change in albuminuria and eGFR following insulin sensitization therapy versus insulin provision therapy in the BARI 2D study. Clin J Am Soc Nephrol. 2014 Jan;9(1):64-71. doi: 10.2215/CJN.12281211. Epub 2013 Oct 31.
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    derived
    PubMed Identifier
    23910429
    Citation
    Beohar N, Sansing VV, Davis AM, Srinivas VS, Helmy T, Althouse AD, Thomas SB, Brooks MM; BARI 2D Study Group. Race/ethnic disparities in risk factor control and survival in the bypass angioplasty revascularization investigation 2 diabetes (BARI 2D) trial. Am J Cardiol. 2013 Nov 1;112(9):1298-305. doi: 10.1016/j.amjcard.2013.05.071. Epub 2013 Aug 1.
    Results Reference
    derived
    PubMed Identifier
    23857320
    Citation
    Bach RG, Brooks MM, Lombardero M, Genuth S, Donner TW, Garber A, Kennedy L, Monrad ES, Pop-Busui R, Kelsey SF, Frye RL; BARI 2D Investigators. Rosiglitazone and outcomes for patients with diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Circulation. 2013 Aug 20;128(8):785-94. doi: 10.1161/CIRCULATIONAHA.112.000678. Epub 2013 Jul 15.
    Results Reference
    derived
    PubMed Identifier
    23757426
    Citation
    Pop-Busui R, Lu J, Brooks MM, Albert S, Althouse AD, Escobedo J, Green J, Palumbo P, Perkins BA, Whitehouse F, Jones TL; BARI 2D Study Group. Impact of glycemic control strategies on the progression of diabetic peripheral neuropathy in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Cohort. Diabetes Care. 2013 Oct;36(10):3208-15. doi: 10.2337/dc13-0012. Epub 2013 Jun 11.
    Results Reference
    derived
    PubMed Identifier
    23735723
    Citation
    Althouse AD, Abbott JD, Sutton-Tyrrell K, Forker AD, Lombardero MS, Buitron LV, Pena-Sing I, Tardif JC, Brooks MM; BARI 2D Study Group. Favorable effects of insulin sensitizers pertinent to peripheral arterial disease in type 2 diabetes: results from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Diabetes Care. 2013 Oct;36(10):3269-75. doi: 10.2337/dc12-2265. Epub 2013 Jun 4.
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    derived
    PubMed Identifier
    23500281
    Citation
    Farkouh ME, Boden WE, Bittner V, Muratov V, Hartigan P, Ogdie M, Bertolet M, Mathewkutty S, Teo K, Maron DJ, Sethi SS, Domanski M, Frye RL, Fuster V. Risk factor control for coronary artery disease secondary prevention in large randomized trials. J Am Coll Cardiol. 2013 Apr 16;61(15):1607-15. doi: 10.1016/j.jacc.2013.01.044.
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    PubMed Identifier
    23500245
    Citation
    Tamis-Holland JE, Lu J, Korytkowski M, Magee M, Rogers WJ, Lopes N, Mighton L, Jacobs AK; BARI 2D Study Group. Sex differences in presentation and outcome among patients with type 2 diabetes and coronary artery disease treated with contemporary medical therapy with or without prompt revascularization: a report from the BARI 2D Trial (Bypass Angioplasty Revascularization Investigation 2 Diabetes). J Am Coll Cardiol. 2013 Apr 30;61(17):1767-76. doi: 10.1016/j.jacc.2013.01.062. Epub 2013 Feb 28.
    Results Reference
    derived
    PubMed Identifier
    23410541
    Citation
    Dagenais GR, Lu J, Faxon DP, Bogaty P, Adler D, Fuentes F, Escobedo J, Krishnaswami A, Slater J, Frye RL; BARI 2D Study Group. Prognostic impact of the presence and absence of angina on mortality and cardiovascular outcomes in patients with type 2 diabetes and stable coronary artery disease: results from the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial. J Am Coll Cardiol. 2013 Feb 19;61(7):702-11. doi: 10.1016/j.jacc.2012.11.036.
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    PubMed Identifier
    23008442
    Citation
    Brooks MM, Chaitman BR, Nesto RW, Hardison RM, Feit F, Gersh BJ, Krone RJ, Sako EY, Rogers WJ, Garber AJ, King SB 3rd, Davidson CJ, Ikeno F, Frye RL; BARI 2D Study Group. Clinical and angiographic risk stratification and differential impact on treatment outcomes in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Circulation. 2012 Oct 23;126(17):2115-24. doi: 10.1161/CIRCULATIONAHA.112.092973. Epub 2012 Sep 24.
    Results Reference
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    PubMed Identifier
    22496082
    Citation
    Schwartz L, Bertolet M, Feit F, Fuentes F, Sako EY, Toosi MS, Davidson CJ, Ikeno F, King SB 3rd. Impact of completeness of revascularization on long-term cardiovascular outcomes in patients with type 2 diabetes mellitus: results from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D). Circ Cardiovasc Interv. 2012 Apr;5(2):166-73. doi: 10.1161/CIRCINTERVENTIONS.111.963512. Epub 2012 Apr 10.
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    PubMed Identifier
    21911782
    Citation
    Cresci S, Wu J, Province MA, Spertus JA, Steffes M, McGill JB, Alderman EL, Brooks MM, Kelsey SF, Frye RL, Bach RG; BARI 2D Study Group. Peroxisome proliferator-activated receptor pathway gene polymorphism associated with extent of coronary artery disease in patients with type 2 diabetes in the bypass angioplasty revascularization investigation 2 diabetes trial. Circulation. 2011 Sep 27;124(13):1426-34. doi: 10.1161/CIRCULATIONAHA.111.029173. Epub 2011 Sep 12.
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    PubMed Identifier
    21835316
    Citation
    Chung SC, Hlatky MA, Faxon D, Ramanathan K, Adler D, Mooradian A, Rihal C, Stone RA, Bromberger JT, Kelsey SF, Brooks MM; BARI 2D Study Group. The effect of age on clinical outcomes and health status BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes). J Am Coll Cardiol. 2011 Aug 16;58(8):810-9. doi: 10.1016/j.jacc.2011.05.020.
    Results Reference
    derived
    PubMed Identifier
    21768545
    Citation
    Sobel BE, Hardison RM, Genuth S, Brooks MM, McBane RD 3rd, Schneider DJ, Pratley RE, Huber K, Wolk R, Krishnaswami A, Frye RL; BARI 2D Investigators. Profibrinolytic, antithrombotic, and antiinflammatory effects of an insulin-sensitizing strategy in patients in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Circulation. 2011 Aug 9;124(6):695-703. doi: 10.1161/CIRCULATIONAHA.110.014860. Epub 2011 Jul 18.
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    derived
    PubMed Identifier
    21742107
    Citation
    Chung SC, Hlatky MA, Stone RA, Rana JS, Escobedo J, Rogers WJ, Bromberger JT, Kelsey SF, Brooks MM. Body mass index and health status in the Bypass Angioplasty Revascularization Investigation 2 Diabetes Trial (BARI 2D). Am Heart J. 2011 Jul;162(1):184-92.e3. doi: 10.1016/j.ahj.2011.03.019.
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    derived
    PubMed Identifier
    21473976
    Citation
    Beohar N, Davidson CJ, Massaro EM, Srinivas VS, Sansing VV, Zonszein J, Davis AM, Helmy T, Lopes NH, Thomas SB, Brooks MM. The impact of race/ethnicity on baseline characteristics and the burden of coronary atherosclerosis in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial. Am Heart J. 2011 Apr;161(4):755-63. doi: 10.1016/j.ahj.2010.12.013.
    Results Reference
    derived
    PubMed Identifier
    21444887
    Citation
    Dagenais GR, Lu J, Faxon DP, Kent K, Lago RM, Lezama C, Hueb W, Weiss M, Slater J, Frye RL; Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Study Group. Effects of optimal medical treatment with or without coronary revascularization on angina and subsequent revascularizations in patients with type 2 diabetes mellitus and stable ischemic heart disease. Circulation. 2011 Apr 12;123(14):1492-500. doi: 10.1161/CIRCULATIONAHA.110.978247. Epub 2011 Mar 28.
    Results Reference
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    Links:
    URL
    http://www.bari2d.org/
    Description
    Click here for the BARI 2D Study Web site

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    Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes

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