Objectives. We compared the clinical outcomes following coronary stent implantation in insulin-treated diabetes mellitus (IDDM), non IDDM patients, and nondiabetic patients. Background. Diabetic patients have increased restenosis and late morbidity following balloon angioplasty. The impact of diabetes mellitus (DM), especially IDDM, on in-stent restenosis is not known. Methods. We studied 954 consecutive patients with native coronary artery lesions treated with elective Palmaz-Schatz stents implantation using conventional coronary angiographic and intravascular ultrasound methodology. Procedural success, major in-hospital complications, and 1-year clinical outcome were compared according to the diabetic status. Results. In-hospital mortality was 2% in IDDM, significantly higher (p <0.02) compared with non-IDDM (0%) and nondiabetics (0.3%). Stent thrombosis did not differ among groups (0.9% in IDDM vs. 0% in non-IDDM and 0% in nondiabetics, p >0.1). During follow up, target lesion revascularization (TLR) was 28% in IDDM, significantly higher (p <0.05) compared with non IDDM (17.6%) and nondiabetics (16.3%). Late cardiac event-free survival (including death, myocardial infarction [MI], and any coronary revascularization procedure) was significantly lower (p = 0.0004) in IDDM (60%) compared with non-IDDM (70%) and nondiabetic patients (76%). By multivariate analysis, IDDM was an independent predictor for any late cardiac event (OR = 2.05, p = 0.0003) in general and TLR (odds ratio = 2.51, p = 0.0001) in particular. Conclusions. In a large consecutive series of patients treated by elective stent implantation, IDDM patients were at higher risk for in-hospital mortality and subsequent TLR and, as a result, had a significantly lo,ver cardiac event-free survival rate. On the other hand, acute and long term procedural outcome was found to be similar for non-IDDM compared with nondiabetic patients. (J Am Coil Cardiol 1998;32:584-9) (C) 1998 by the American College of Cardiology.