title: One-year results of the SCORPIUS study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients.
abstract: OBJECTIVE
  This study sought to analyze the effectiveness of drug-eluting stents in a high-risk group of diabetic patients. Previously, this had been analyzed only in substudies of larger trials or in clinical investigations enrolling a small number of patients.
  
  
  BACKGROUND
  Drug-eluting stents are highly effective in reducing the rate of in-stent restenosis.
  
  
  METHODS
  Two hundred patients with diabetes and de novo coronary artery lesions were enrolled in 16 centers: 98 were randomly assigned to sirolimus-eluting stents (SES) and 102 received bare-metal stents (BMS). The primary end point was in-segment late luminal loss. Major adverse cardiac events (MACE) rate was analyzed at 30 days and 8 and 12 months.
  
  
  RESULTS
  The extent of in-segment late luminal loss in the SES group was 0.18 mm compared with 0.74 mm in the BMS group. In-segment restenosis was identified on follow-up angiography in 8.8% of the patients in SES and in 42.1% in BMS (p < 0.0001). Target lesion revascularization was performed in 5.3% of the patients in SES and in 21.1% of the patients in BMS (p = 0.002). The SES was effective in the treatment group with oral diabetic medication as well as in the insulin-dependent treatment group (3.6% SES vs. 38.8% BMS). There was no subacute stent thrombosis in the SES group up to 1 year. The MACE rate was not significantly different at 30 days. At 12 months, MACE rate was 14.7% in SES versus 35.8% in BMS.
  
  
  CONCLUSIONS
  The SES is safe and highly effective in patients with diabetes mellitus and coronary artery disease and associated with a significant decrease in the extent of late luminal loss.
authors.affiliation: Department of Cardiology, West-German Heart Center, University Clinic Essen, University Duisburg-Essen, Essen, Germany. dietrich.baumgart@preventicum.de
authors.forename: Dietrich
authors.initials: D
authors.lastname: Baumgart
authors.forename: Volker
authors.initials: V
authors.lastname: Klauss
authors.forename: Frank
authors.initials: F
authors.lastname: Baer
authors.forename: Franz
authors.initials: F
authors.lastname: Hartmann
authors.forename: Helmut
authors.initials: H
authors.lastname: Drexler
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Motz
authors.forename: Heinrich
authors.initials: H
authors.lastname: Klues
authors.forename: Stefan
authors.initials: S
authors.lastname: Hofmann
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Völker
authors.forename: Thomas
authors.initials: T
authors.lastname: Pfannebecker
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Stoll
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
mesh_terms: D000368:Aged; D017023:Coronary Angiography; D023903:Coronary Restenosis; D023921:Coronary Stenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D048909:Diabetes Complications / Q000628:therapy*; D016503:Drug Delivery Systems / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D009203:Myocardial Infarction / Q000209:etiology; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects; D013927:Thrombosis / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus