Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes

NCT00006305 | Completed Phase 3 Results DMC

• 5 other identifiers: 133U01HL061744U01HL061746U01HL061748U01HL063804
• Study Type: interventional
• Target: 2,368
• Locations: 0 countries
• Sites: N/A

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:

1. 1.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;
2. 2.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.

Conditions

Coronary Disease; Cardiovascular Diseases; Heart Diseases; Insulin Resistance; Diabetes Mellitus; Diabetes Mellitus, Non-Insulin-Dependent

Outcome Measures

Primary Outcomes (1)

• Number of Participants With All-Cause Mortality

  five years

Secondary Outcomes (1)

• Number of Participants With Death, Myocardial Infarction, or Stroke

  five years

Study Arms (4)

Revascularization and Insulin Providing (IP)

ACTIVE COMPARATOR

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

Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions; Procedure: Coronary Artery Bypass; Drug: Insulin, sulfonylurea; Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers

Revascularization and Insulin Sensitizing (IS)

ACTIVE COMPARATOR

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

Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions; Procedure: Coronary Artery Bypass; Drug: Biguanides, thiazolidinediones; Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers

Medical Therapy and Insulin Providing (IP)

ACTIVE COMPARATOR

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

Drug: Insulin, sulfonylurea; Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers

Medical Therapy and Insulin Sensitizing (IS)

ACTIVE COMPARATOR

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

Drug: Biguanides, thiazolidinediones; Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers

Interventions

Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions PROCEDURE

Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions

Revascularization and Insulin Providing (IP); Revascularization and Insulin Sensitizing (IS)

Coronary Artery Bypass PROCEDURE

Coronary Artery Bypass

Revascularization and Insulin Providing (IP); Revascularization and Insulin Sensitizing (IS)

Biguanides, thiazolidinediones DRUG

Biguanides, thiazolidinediones

Medical Therapy and Insulin Sensitizing (IS); Revascularization and Insulin Sensitizing (IS)

Insulin, sulfonylurea DRUG

Insulin, sulfonylurea

Medical Therapy and Insulin Providing (IP); Revascularization and Insulin Providing (IP)

ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers DRUG

ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers

Medical Therapy and Insulin Providing (IP); Medical Therapy and Insulin Sensitizing (IS); Revascularization and Insulin Providing (IP); Revascularization and Insulin Sensitizing (IS)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Related Publications (52)

• 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.

  PMID: 12566379 BACKGROUND

• 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.

  PMID: 16813734 BACKGROUND

• 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.

  PMID: 18760137 BACKGROUND

• 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.

  PMID: 19502645 BACKGROUND

• 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.

  PMID: 20937978 BACKGROUND

• 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.

  PMID: 20584997 BACKGROUND

• 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.

  PMID: 20375690 BACKGROUND

• 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.

  PMID: 20626665 BACKGROUND

• 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.

  PMID: 20147671 BACKGROUND

• 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.

  PMID: 20152229 BACKGROUND

• 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.

  PMID: 19875998 BACKGROUND

• 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.

  PMID: 19920002 BACKGROUND

• 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.

  PMID: 19920001 BACKGROUND

• 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.

  PMID: 19463459 BACKGROUND

• 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.

  PMID: 19231325 BACKGROUND

• 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.

  PMID: 16464721 BACKGROUND

• 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.

  PMID: 16813735 BACKGROUND

• 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.

  PMID: 16813736 BACKGROUND

• 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.

  PMID: 16813738 BACKGROUND

• 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.

  PMID: 16813739 BACKGROUND

• 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.

  PMID: 20042560 BACKGROUND

• 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.

  PMID: 20102884 BACKGROUND

• 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.

  PMID: 19576321 BACKGROUND

• 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.

  PMID: 19228864 BACKGROUND

• 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.

  PMID: 19335534 BACKGROUND

• Pambianco G, Lombardero M, Bittner V, Forker A, Kennedy F, Krishnaswami A, Mooradian AD, Pop-Busui R, Rana JS, Rodriguez A, Steffes M, Orchard TJ. Control of lipids at baseline in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Prev Cardiol. 2009 Winter;12(1):9-18. doi: 10.1111/j.1751-7141.2008.00014.x.

  PMID: 19301686 BACKGROUND

• 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.

  PMID: 16813733 BACKGROUND

• 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.

  PMID: 16813737 BACKGROUND

• 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.

  PMID: 31590967 DERIVED

• 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.

  PMID: 30286920 DERIVED

• 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.

  PMID: 28903941 DERIVED

• 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.

  PMID: 28126156 DERIVED

• 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.

  PMID: 27289411 DERIVED

• 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.

  PMID: 26853953 DERIVED

• 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.

  PMID: 26271057 DERIVED

• 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.

  PMID: 26267622 DERIVED

• 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.

  PMID: 24178969 DERIVED

• 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.

  PMID: 23910429 DERIVED

• 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.

  PMID: 23857320 DERIVED

• 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.

  PMID: 23757426 DERIVED

• 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.

  PMID: 23735723 DERIVED

• 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.

  PMID: 23500281 DERIVED

• 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.

  PMID: 23500245 DERIVED

• 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.

  PMID: 23410541 DERIVED

• 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.

  PMID: 23008442 DERIVED

• 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.

  PMID: 22496082 DERIVED

• 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.

  PMID: 21911782 DERIVED

• 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.

  PMID: 21835316 DERIVED

• 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.

  PMID: 21768545 DERIVED

• 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.

  PMID: 21742107 DERIVED

• 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.

  PMID: 21473976 DERIVED

• 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.

  PMID: 21444887 DERIVED

Related Links

• Click here for the BARI 2D Study Web site

MeSH Terms

Conditions

Coronary Disease; Cardiovascular Diseases; Heart Diseases; Insulin Resistance; Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Angioplasty; Coronary Artery Bypass; Biguanides; Thiazolidinediones; Insulin; Sulfonylurea Compounds; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists; Adrenergic beta-Antagonists; Calcium Channel Blockers

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Myocardial Revascularization; Cardiac Surgical Procedures; Vascular Grafting; Thoracic Surgical Procedures; Guanidines; Amidines; Organic Chemicals; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Urea; Amides; Sulfones; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Cardiovascular Agents; Therapeutic Uses

Results Point of Contact

• Title: Dr. Maria Brooks
• Organization: University of Pittsburgh

brooks@edc.pitt.edu

4126241618

Study Officials

• Bernard Chaitman, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

• Robert L Frye, MD

  Mayo Clinic

  STUDY CHAIR

• Mark Hlatky

  Stanford University

  PRINCIPAL INVESTIGATOR

• Burton Sobel

  University of Vermont & State Agricultural College

  PRINCIPAL INVESTIGATOR

• Sheryl F. Kelsey, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Epidemiology

Study Record Dates

• First Submitted: September 28, 2000
• First Posted: September 29, 2000
• Study Start: September 1, 2000
• Primary Completion: November 1, 2008
• Study Completion: March 1, 2009
• Last Updated: February 8, 2016
• Results First Posted: May 12, 2011

Record last verified: 2016-01