Adding prompt revascularization to medical therapy did not reduce mortality or CV events in patients with type 2 diabetes and CAD

Randomized, 2 x 2 factorial, controlled trial (Bypass Angioplasty Revascularization Investigation 2 Diabetes [BARI 2D]). ClinicalTrials.gov NCT00006305.

{Concealed}*.†

Blinded (laboratory staff and event adjudication committee).†

Mean 5.3 years.

49 sites in the USA, Canada, Brazil, Mexico, Czech Republic, and Austria.

2368 patients (mean age 62 y, 70% men) who had type 2 diabetes and coronary artery disease and were candidates for elective percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. Exclusion criteria were need for immediate revascularization, left main coronary disease, creatinine level > 177 µmol/L (2 mg/dL), glycated hemoglobin level > 13%, class III or IV heart failure, hepatic dysfunction, or PCI or CABG within the past 12 months.

PR plus intensive MT and insulin sensitization therapy (n = 584), PR plus intensive MT and insulin provision therapy (n = 592), intensive MT and insulin sensitization therapy (n = 599), or intensive MT and insulin provision therapy (n = 593). Randomization was stratified by intended revascularization strategy (PCI, n = 1605; CABG, n = 763).

Mortality. Principal secondary outcome was a composite of major CV events (death, myocardial infarction, or stroke). The trial with extended follow-up had 88% power to detect a 30% relative reduction in mortality from 14% to 9.8%.

93% ({100%}* included in intention-to-treat analysis).

The main results are in the Table. PR reduced major CV events more than MT in patients selected for CABG but not those selected for PCI (21% vs 30% and 23% vs 21%, respectively, P = 0.002 for interaction).

In patients with type 2 diabetes and coronary artery disease, adding prompt revascularization to medical therapy did not reduce mortality or major cardiovascular events; it did reduce major cardiovascular events in patients who were selected for bypass surgery for revascularization. Different types of insulin therapies had similar outcomes.