BARI 2D: A Reanalysis Focusing on Cardiovascular Events

OBJECTIVE: To reanalyze the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial using a new composite cardiovascular disease (CVD) outcome to determine how best to treat patients with type 2 diabetes mellitus (T2DM) and stable coronary artery disease (CAD). METHODS: From January 1, 2001 to November 30, 2008, 2,368 T2DM patients with angiographically defined CAD were randomly assigned to insulin sensitizing (IS) or insulin providing (IP) therapy and simultaneously to coronary revascularization (REV) versus no or delayed revascularization (MED) with all patients receiving intensive medical treatment. The outcome for this analysis was a composite of eight CVD events. RESULTS: Four-year composite CVD outcome Kaplan-Meier rates were 35.8% (95% CI: 33.1–38.5%) with IS versus 41.6% (38.7–44.5%) with IP (P=.004). Most of this difference was associated with lower in-trial levels of fibrinogen, c-reactive protein, and hemoglobin A1c (HbA1c) with IS. Four-year composite CVD rates were 32.7% (30.0–35.4%) with REV versus 44.7% (41.8–47.6%) with MED (P