One-year results of the SCORPIUS study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients.
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.
Baumgart
Dietrich
D
Department of Cardiology, West-German Heart Center, University Clinic Essen, University Duisburg-Essen, Essen, Germany. dietrich.baumgart@preventicum.de
Klauss
Volker
V
Baer
Frank
F
Hartmann
Franz
F
Drexler
Helmut
H
Motz
Wolfgang
W
Klues
Heinrich
H
Hofmann
Stefan
S
Völker
Wolfgang
W
Pfannebecker
Thomas
T
Stoll
Hans-Peter
HP
Nickenig
Georg
G
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
D007166:Immunosuppressive Agents; D020123:Sirolimus