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BARI-2D TRIAL |
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|---|---|
| Problem | T2DM & IHD |
| Format | Multi-center RCT |
| Treatment | PCI or CABG |
| Control | Medical therapy |
| Population | 2368 patients |
| Inclusion criteria | Diagnosis of both type 2 diabetes and coronary artery disease. The diagnosis of type 2 diabetes was based on the need for treatment with insulin or oral hypoglycemic drugs or a confirmed elevated blood glucose level. The diagnosis of coronary artery disease was documented on angiography (>50% stenosis of a major epicardial coronary artery associated with a positive stress test or >70% stenosis of a major epicardial coronary artery and classic angina). All patients had to be candidates for elective percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG). |
| Exclusion criteria | Patients were excluded if they required immediate revascularization or had left main coronary disease, a creatinine level of more than 2.0 mg per deciliter (177 mmol per liter), a glycated hemoglobin level of more than 13.0%, class III or IV heart failure, or hepatic dysfunction or if they had undergone PCI or CABG within the previous 12 months. |
| Follow-up | 3 - 6 years |
| Primary endpoint | Rate of death |
| Secondary endpoint(s) | Composite of death, myocardial infarction, or stroke (major cardiovascular events) |
| Details | . |
| Brief summary: | PCI not superior to medical therapy. CABG reduced CV events. |
| PAPER: A randomized trial of therapies for type 2 diabetes and coronary artery disease. | |
|---|---|
| Date | 11 Jun 2009 |
| Journal | N Engl J Med. 2009 Jun 11;360(24):2503-15. |
| Information | Revasc (CABG or PCI) vs. medical therapy for T2DM & IHD -No difference in survival (p=0.97) -No difference in CV events (death, MI or stroke) (p=0.70) -PCI subgroup: no significant difference endpoints -CABG subgroup: significant reduction in CV events (p=0.01) N.B. Physician decided whether patients for CABG or PCI - Not randomised |