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Cited by 1,939Diabetes Treatment and ManagementCoronary Interventions and DiagnosticsDiabetes, Cardiovascular Risks, and Lipoproteins

A Randomized Trial of Therapies for Type 2 Diabetes and Coronary Artery Disease

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The BARI 2D Study Group·2009·New England Journal of Medicine
DOI 10.1056/nejmoa0805796PMC PMC2863990
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Abstract

BACKGROUND: Optimal treatment for patients with both type 2 diabetes mellitus and stable ischemic heart disease has not been established. METHODS: We randomly assigned 2368 patients with both type 2 diabetes and heart disease to undergo either prompt revascularization with intensive medical therapy or intensive medical therapy alone and to undergo either insulin-sensitization or insulin-provision therapy. Primary end points were the rate of death and a composite of death, myocardial infarction, or stroke (major cardiovascular events). Randomization was stratified according to the choice of percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) as the more appropriate intervention. RESULTS: At 5 years, rates of survival did not differ significantly between the revascularization group (88.3%) and the medical-therapy group (87.8%, P=0.97) or between the insulin-sensitization group (88.2%) and the insulin-provision group (87.9%, P=0.89). The rates of freedom from major cardiovascular events also did not differ significantly among the groups: 77.2% in the revascularization group and 75.9% in the medical-treatment group (P=0.70) and 77.7% in the insulin-sensitization group and 75.4% in the insulin-provision group (P=0.13). In the PCI stratum, there was no significant difference in primary end points between the revascularization group and the medical-therapy group. In the CABG stratum, the rate of major cardiovascular events was significantly lower in the revascularization group (22.4%) than in the medical-therapy group (30.5%, P=0.01; P=0.002 for interaction between stratum and study group). Adverse events and serious adverse events were generally similar among the groups, although severe hypoglycemia was more frequent in the insulin-provision group (9.2%) than in the insulin-sensitization group (5.9%, P=0.003). CONCLUSIONS: Overall, there was no significant difference in the rates of death and major cardiovascular events between patients undergoing prompt revascularization and those undergoing medical therapy or between strategies of insulin sensitization and insulin provision. (ClinicalTrials.gov number, NCT00006305.)

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  • In the BARI-2D trial, the primary outcome of death, stroke, or MI was not significantly lower with rosiglitazone and metformin than with insulin and sulfonylurea.

    “In the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI-2D) trial,31 the rate of primary outcome of death, stroke, or myocardial infarction was not significantly lower among patients receiving rosiglitazone and metformin (insulin-sparing strategy) than among those receiving insulin and sulfonylurea therapy (insulin-providing strategy).”

    From Pioglitazone after Ischemic Stroke or Transient Ischemic Attack (2016) · cites this paper as [31]

    The Results (Primary and Principal Secondary Outcomes; page unavailable) report no significant difference in major cardiovascular events between the insulin-sensitization and insulin-provision groups (P=0.13). But the Methods (Evaluation of Outcomes; page unavailable) define death, myocardial infarction, or stroke as the principal secondary end point, not the primary end point, which was death from any cause. The Methods (Treatment Strategies; page unavailable) also describe randomized treatment strategies that allowed drugs from the other strategy, rather than a direct comparison of the named drug combinations. (LLM, conf=0.92)

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  • Screening of asymptomatic individuals with high ASCVD risk is not recommended, in part because these high-risk people should already be receiving intensive medical therapy-an approach that provides benefits similar to those of invasive revascularization.

    “The screening of asymptomatic individuals with high ASCVD risk is not recommended (Fig. 10.5), in part because these high-risk people should already be receiving intensive medical therapy-an approach that provides benefits similar to those of invasive revascularization (208,209).”

    From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [209]

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  • Intensive medical therapy provides benefits similar to those of invasive revascularization in high-risk asymptomatic individuals.

    “The screening of asymptomatic individuals with high ASCVD risk is not recommended, in part because these high-risk people should already be receiving intensive medical therapy—an approach that provides benefits similar to those of invasive revascularization (197,198).”

    From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [198]

    The Discussion reports similar overall outcomes with intensive medical therapy and prompt revascularization in patients with type 2 diabetes and stable ischemic heart disease. It does not establish the same result for high-risk asymptomatic individuals generally: the Results (Patients; page not provided) say 82.1% had symptomatic ischemia, and the Discussion reports fewer major cardiovascular events with prompt revascularization in patients selected for CABG. (LLM, conf=0.89)

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  • In the BARI 2D trial, typical angina, anginal equivalent, or a combination of both were observed in 19%, 21%, and 42% of patients, respectively, whereas 18% remained asymptomatic.

    “In the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial in patients with angiographically confirmed CAD and a mean diabetes duration of 10.4 years, typical angina, anginal equivalent, or a combination of both were observed in 19%, 21%, and 42% of patients, respectively, whereas 18% remained asymptomatic.382,383”

    From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [383]

  • Optimized medical therapy plus risk-factor modification is the cornerstone of care for patients with type 2 diabetes and coronary artery disease.

    “OMT with risk modification remains the foundation of management in patients with T2DM and CAD.263,264”

    From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [263]

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Authors
The BARI 2D Study Group
Affiliations
University of Pittsburgh (US)
Corresponding author
The BARI 2D Study Group
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2009-06-11
Volume
360
Issue
24
Pages
2503-2515
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa0805796
PMC
PMC2863990
OpenAlex
W2169226612
Cited by
1,939
References
39
Citations by year
2026: 33 · 2025: 50 · 2024: 61 · 2023: 69 · 2022: 77 · 2021: 136 · 2020: 121 · 2019: 115 · 2018: 103 · 2017: 108 · 2016: 147 · 2015: 146 · 2014: 119 · 2013: 156 · 2012: 148
FWCI
119.47
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institutes of Health (UL1TR000454)
  • National Heart, Lung, and Blood Institute (U01HL063804, U01HL061748, U01HL061744, U01HL061746)
  • National Center for Advancing Translational Sciences
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
type 2 diabetes, coronary artery disease, stable coronary artery disease, revascularization, percutaneous coronary intervention, coronary artery bypass grafting, intensive medical therapy, insulin sensitizers, insulin therapy, major adverse cardiovascular events, mortality, hypoglycemia
MeSH terms
Coronary Artery Bypass, Combined Modality Therapy, Coronary Disease, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Metformin, Middle Aged, Myocardial Infarction, Sulfonylurea Compounds, Angioplasty, Balloon, Coronary, Coronary Angiography, Stroke, Thiazolidinediones, Kaplan-Meier Estimate

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