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A randomized trial of therapies for type 2 diabetes and coronary artery disease
New England Journal of Medicine, 06/10/09

BARI 2D Study Group et al. – Findings show no significant difference overall in rates of death and major cardiovascular events between pts undergoing prompt revascularization and those undergoing medical therapy or between strategies of insulin sensitization and insulin provision.

Methods

Randomization of 2368 pts with both type 2 diabetes and heart disease to either prompt revascularization with intensive medical therapy or intensive medical therapy alone and to undergo either insulin-sensitization or insulin-provision therapy
Primary endpoints: rate of death and composite of death, myocardial infarction, or stroke (major cardiovascular events)
Randomization stratified by choice of percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) as the more appropriate intervention

Results

At 5 yrs, rates of survival did not differ significantly between revascularization (88.3%) and medical-therapy group (87.8%) or between insulin-sensitization (88.2%) and insulin-provision group (87.9%)
Rates of freedom from major cardiovascular events did not differ significantly among groups: 77.2% in revascularization vs 75.9% in medical-treatment group and 77.7% in insulin-sensitization vs 75.4% in insulin-provision group
In PCI stratum, no significant difference in primary endpoints between revascularization vs medical-therapy group
In CABG stratum, significantly lower rate of major cardiovascular events in revascularization (22.4%) vs medical-therapy group (30.5%) for interaction between stratum and study group
Adverse events and serious adverse events generally similar among the groups
Severe hypoglycemia more frequent in insulin-provision (9.2%) vs insulin-sensitization group (5.9%)

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