BARI 2D Trial

Trial Details

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.

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 less than 7.0%.

Number of Patients: 2,368

Inclusion Criteria: diagnosis of both type 2 diabetes and coronary artery disease

Exclusion Criteria:

  • 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

Summary:

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).

Original Publication:

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