Background Optimal treatment for patients with both type 2 diabetesmellitus and stable ischemic heart disease has not been established.
Methods We randomly assigned 2368 patients with both type 2diabetes and heart disease to undergo either prompt revascularizationwith intensive medical therapy or intensive medical therapyalone and to undergo either insulin-sensitization or insulin-provisiontherapy. Primary end points were the rate of death and a compositeof death, myocardial infarction, or stroke (major cardiovascularevents). Randomization was stratified according to the choiceof percutaneous coronary intervention (PCI) or coronary-arterybypass grafting (CABG) as the more appropriate intervention.
Results At 5 years, rates of survival did not differ significantlybetween the revascularization group (88.3%) and the medical-therapygroup (87.8%, P=0.97) or between the insulin-sensitization group(88.2%) and the insulin-provision group (87.9%, P=0.89). Therates of freedom from major cardiovascular events also did notdiffer significantly among the groups: 77.2% in the revascularizationgroup and 75.9% in the medical-treatment group (P=0.70) and77.7% in the insulin-sensitization group and 75.4% in the insulin-provisiongroup (P=0.13). In the PCI stratum, there was no significantdifference in primary end points between the revascularizationgroup and the medical-therapy group. In the CABG stratum, therate of major cardiovascular events was significantly lowerin the revascularization group (22.4%) than in the medical-therapygroup (30.5%, P=0.01; P=0.002 for interaction between stratumand study group). Adverse events and serious adverse eventswere generally similar among the groups, although severe hypoglycemiawas more frequent in the insulin-provision group (9.2%) thanin the insulin-sensitization group (5.9%, P=0.003).
Conclusions Overall, there was no significant difference inthe rates of death and major cardiovascular events between patientsundergoing prompt revascularization and those undergoing medicaltherapy or between strategies of insulin sensitization and insulinprovision. (ClinicalTrials.gov number, NCT00006305
[ClinicalTrials.gov]
.)
Source Information
The members of the writing group (Robert L. Frye, M.D., Mayo Clinic, Rochester, MN; Phyllis August, M.D., M.P.H., New York Hospital Queens, Queens, NY; Maria Mori Brooks, Ph.D., Regina M. Hardison, M.S., Sheryl F. Kelsey, Ph.D., Joan M. MacGregor, M.S., and Trevor J. Orchard, M.B., B.Ch., University of Pittsburgh, Pittsburgh; Bernard R. Chaitman, M.D., Saint Louis University, St. Louis; Saul M. Genuth, M.D., Case Western Reserve University, Cleveland; Suzanne H. Goldberg, R.N., M.S.N., National Heart, Lung, and Blood Institute, Bethesda, MD; Mark A. Hlatky, M.D., Stanford University, Palo Alto, CA; Teresa L.Z. Jones, M.D., National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD; Mark E. Molitch, M.D., Feinberg School of Medicine, Northwestern University, Chicago; Richard W. Nesto, M.D., Lahey Clinic Medical Center, Burlington, MA; Edward Y. Sako, M.D., Ph.D., University of Texas Health Science Center, San Antonio; and Burton E. Sobel, M.D., University of Vermont, Burlington) assume responsibility for the overall content and integrity of the article. This article (10.1056/NEJMoa0805796) was published on June 7, 2009, at NEJM.org.
Address reprint requests to Dr. Brooks at the Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, 130 DeSoto St., Pittsburgh, PA 15261, or at mbrooks{at}pitt.edu.
Therapies for Type 2 Diabetes and Coronary Artery Disease
Pfisterer M. E., Zellweger M. J., Garratt K. N., Bailey S. R., Bertoldi E. G., Weinert L. S., Polanczyk C. A., DeVries J. H., Brooks M. M., Chaitman B. R., Molitch M. E., the BARI 2D Study Group , Boden W. E., Taggart D. P.
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N Engl J Med 2009;
361:1407-1410, Oct 1, 2009.
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