Impact of sirolimus-eluting stents on outcome in diabetic patients: A SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) substudy

• Published in: Circulation (New York, N.Y.) N.Y.), 2004-05, Vol.109 (19), p.2273-2278
• Main Authors: MOUSSA, Issam, LEON, Martin B, KUNTZ, Richard E, MOSES, Jeffrey W, BAIM, Donald S, O'NEILL, William W, POPMA, Jeffery J, BUCHBINDER, Maurice, MIDWALL, Jay, SIMONTON, Charles A, KEIM, Emily, WANG, Patrick
• Format: Article
• Language: English
• Subjects: Aged; Anticoagulants - therapeutic use; Biological and medical sciences; Blood and lymphatic vessels; Cardiology. Vascular system; Coronary Angiography; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - epidemiology; Coronary Restenosis - prevention & control; Coronary Stenosis - complications; Coronary Stenosis - drug therapy; Coronary Stenosis - therapy; Diabetes Complications; Diabetes Mellitus - diet therapy; Diabetes Mellitus - drug therapy; Disease-Free Survival; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Double-Blind Method; Drug Implants; Female; Follow-Up Studies; Growth Inhibitors - administration & dosage; Growth Inhibitors - therapeutic use; Humans; Hypertension - complications; Immunosuppressive Agents - administration & dosage; Immunosuppressive Agents - therapeutic use; Incidence; Insulin - therapeutic use; Male; Medical sciences; Middle Aged; Mortality; Myocardial Infarction - epidemiology; Myocardial Infarction - prevention & control; Sirolimus - administration & dosage; Sirolimus - therapeutic use; Stents - statistics & numerical data; Treatment Outcome
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/01.CIR.0000129767.45513.71

Randomized clinical trials have shown that a sirolimus-eluting stent significantly reduces restenosis after percutaneous coronary revascularization. Diabetic patients are known to have a higher risk of restenosis compared with nondiabetic patients. The purpose of this analysis was to determine the impact of sirolimus-eluting stents on outcomes of diabetic compared with nondiabetic patients. The SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) trial is a randomized, double-blind study that compared sirolimus-eluting and bare metal stent implantation in 1058 patients with de novo native coronary artery lesions. Diabetes mellitus was present in 279 (26%) patients (diabetes mellitus group, 131 patients received sirolimus-eluting stents and 148 patients received bare metal stents) and was absent in 778 patients (no-diabetes mellitus group, 402 patients received sirolimus-eluting stents and 376 patients received bare metal stents). At 270 days, target lesion revascularization was reduced in diabetic patients from 22.3% with bare metal stents to 6.9% with sirolimus-eluting stents (P