Acronym: Bypass Angioplasty Revascularization Investigation 2 Diabetes Trial
Purpose: Evaluated percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in patients with diabetes mellitus type II and severe coronary disease.
Treatment Group 1: coronary revascularization or medical therapy
Treatment Group 2: insulin-sensitization therapy or insulin-provision therapy to achieve a target glycated hemoglobin level of less than 7.0%.
Number of Patients: 2,368
Inclusion Criteria: diagnosis of both type 2 diabetes and coronary artery disease
- Required immediate revascularization
- Had left main coronary disease,
- Creatinine level of more than 2.0 mg per deciliter
- Glycated hemoglobin level of more than 13.0%
- Class III or IV heart failure
- Hepatic dysfunction or if they had undergone PCI or CABG within the previous 12 months
Primary Endpoint: mortality
Secondary Endpoint: composite rate of death, MI or stroke
Follow-up: mean, 5.3 years
The BARI -2D Trial found revascularization (either by PCI or CABG) did not reduce mortality or cardiovascular events compared to medical therapy. CABG reduced cardiovascular events while PCI did not reduce the primary endpoint (mortality) or the secondary endpoint (composite rate of death, MI or stroke).
Frye RL, et al. N Engl J Med. 2009;doi:10.1056/NEJMoa0805796.