A Randomized Trial of Therapies for Type 2 Diabetes and Coronary Artery Disease
By R. Frye, P. August, M. Brooks, Regina M. Hardison, S. Kelsey, Joan M. MacGregor, T. Orchard, Bernard R. Chaitman, S. Genuth, S. Goldberg and 6 more. New England Journal of Medicine, 2009
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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.)
Subfields: Endocrinology, Diabetes and Metabolism
View Paper: https://www.semanticscholar.org/paper/759981c8ae52a09e425c8ad902e633869a79c829
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Citations in the corpus
- Atherosclerotic Cardiovascular Disease and Heart Failure in Type 2 Diabetes – Mechanisms, Management, and Clinical Considerations (2016, neutral): “Structural Changes Cardiomyocyte hypertrophy is common in diabetic cardiomyopathy and may result from insulin resistance and cell growth in response to hyperinsulinemia, as occurs in type 2 diabetes mellitus.(104,347,431) This observation has led to concern about the use of insulin but has not been ”
- 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesi (2011, methodology): “tion) (370) nor BARI 2D (404), which treated all patients”
- Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: part II. (2013, methodology): “with type 2 diabetes and heart disease were given intensive medical therapy and randomized to prompt revascularization or expected management.(153) In the revascularization arm, the responsible physician determined the appropriate strategy.”
- Guidelines on myocardial revascularization. (2010, methodology): “I A [111]”