- Question
- In patients with type 2 diabetes and stable ischemic heart disease, which is the better approach: prompt revascularization plus intensive medical therapy versus intensive medical therapy alone, and glycemic control by insulin sensitization versus insulin provision?
- Design
- Randomized, open-label (unmasked) trial with a 2x2 factorial design enrolling 2368 patients. Randomization was stratified by whether PCI or coronary artery bypass grafting (CABG) was judged the more appropriate revascularization.
- Population
- Patients with type 2 diabetes mellitus and coronary artery disease (stable ischemic heart disease).
- Intervention
- Prompt revascularization (PCI or CABG) together with intensive medical therapy; for the second factor, an insulin-sensitization strategy.
- Control
- Intensive medical therapy alone, with delayed revascularization if clinically indicated; for the second factor, an insulin-provision strategy.
- Primary outcome
- All-cause mortality and a composite of death, myocardial infarction, or stroke (major cardiovascular events) at 5 years.
- Results
- At 5 years, survival was 88.3% with revascularization versus 87.8% with medical therapy (P=0.97), and 88.2% with insulin sensitization versus 87.9% with insulin provision (P=0.89). Freedom from major cardiovascular events was 77.2% versus 75.9% (P=0.70) for revascularization versus medical therapy, and 77.7% versus 75.4% (P=0.13) for sensitization versus provision. In the CABG stratum, major cardiovascular events were less frequent with revascularization (22.4%) than with medical therapy (30.5%, P=0.01; P=0.002 for interaction).
- Safety
- Adverse and serious adverse events were generally similar across groups, except that severe hypoglycemia was more frequent with insulin provision (9.2%) than with insulin sensitization (5.9%, P=0.003).
- Conclusion
- Overall there was no significant difference in death or major cardiovascular events between prompt revascularization and medical therapy, or between insulin-sensitization and insulin-provision strategies.
- Why it matters
- It showed that routine revascularization is not superior to intensive medical therapy in diabetic patients with stable ischemic heart disease, and suggested that any benefit of revascularization may be concentrated in patients suited to bypass surgery, supporting individualized selection of strategy.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 10, 2026