BARI 2D Trial

Trial Details

Acronym: Bypass Angioplasty Revascularization Investigation 2 Diabetes Trial

Purpose: Evaluated percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) in patients with type 2 diabetes and severe coronary disease.

Format: Randomized

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 < 7.0%

Number of Patients: 2,368

Inclusion Criteria: Diagnosis of both type 2 diabetes and CAD

Exclusion Criteria:

  • required immediate revascularization;
  • had left main coronary disease;
  • creatinine level > 2.0 mg/dL
  • glycated hemoglobin level of > 13.0%;
  • class III or IV HF; and
  • hepatic dysfunction, or 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

Summary:

The BARI -2D Trial found revascularization (either by PCI or CABG) did not reduce mortality or CV events compared with medical therapy. CABG reduced CV events, while PCI did not reduce the primary endpoint (mortality) or the secondary endpoint (composite rate of death, MI or stroke).

Original Publication:

Frye RL, et al. N Engl J Med. 2009;doi:10.1056/NEJMoa0805796.