Favorable Effects of Insulin Sensitizers Pertinent to Peripheral Arterial Disease in Type 2 Diabetes Results from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial

OBJECTIVEdThe aim of this manuscript was to report the risk of incident peripheral arterial disease (PAD) in a large randomized clinical trial that enrolled participants with stable coronary artery disease and type 2 diabetes and compare the risk between assigned treatment arms. RESEARCH DESIGN ANDMETHODSdThe Bypass Angioplasty Revascularization In-vestigation 2 Diabetes (BARI 2D) trial randomly assigned participants to insulin sensitization (IS) therapy versus insulin-providing (IP) therapy for glycemic control. Results showed similar 5-year mortality in the two glycemic treatment arms. In secondary analyses reported here, we examine the effects of treatment assignment on the incidence of PAD. A total of 1,479 BARI 2D partic-ipants with normal ankle-brachial index (ABI) (0.91–1.30) were eligible for analysis. The fol-lowing PAD-related outcomes are evaluated in this article: new low ABI#0.9, a lower-extremity revascularization, lower-extremity amputation, and a composite of the three outcomes. RESULTSdDuring an average 4.6 years of follow-up, 303 participants experienced one or more of the outcomes listed above. Incidence of the composite outcome was significantly lower among participants assigned to IS therapy than those assigned to IP therapy (16.9 vs. 24.1%; P, 0.001). The difference was significant in time-to-event analysis (hazard ratio 0.66 [95 % CI 0.51