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A Randomized Trial of Therapies for Type 2 Diabetes and Coronary Artery Disease
Open accessAbstract
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 citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredIn the citing paper
“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]
In the citing paper
“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]
In the citing paper
“However, as coronary anatomic burden and complexity increase, particularly among those with large ischemic burden or frequent angina, the benefit of revascularization combined with OMT becomes manifest.263,265–267”
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]
In the citing paper
“these high-risk patients should already be receiving intensive medical therapy -an approach that provides benefi t similar to invasive revascularization (172,173).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2023 (2023) · cites this paper as [173]
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Metadata
- 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
- 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
- bronze
- doi.org
- 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 › Cardiology and Cardiovascular Medicine › 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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