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CLINICAL RESEARCH: CLINICAL TRIAL

One-Year Results of the SCORPIUS Study

A German Multicenter Investigation on the Effectiveness of Sirolimus-Eluting Stents in Diabetic Patients

Department of Cardiology, West-German Heart Center, University Clinic Essen, University Duisburg-Essen, Essen, Germany.

Manuscript received February 19, 2007; revised manuscript received July 3, 2007, accepted July 8, 2007.

^_* Reprint requests and correspondence: Dr. Dietrich Baumgart, Preventicum—Center of Diagnostics Theodor-Althoff-Str. 47, 45133 Essen, Germany. (Email: dietrich.baumgart{at}preventicum.de).

Objectives: 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.

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CABG = coronary artery bypass graft   MACE = major adverse cardiac events   MLD = minimal luminal diameter   PCI = percutaneous coronary intervention   PTCA = percutaneous transluminal coronary angioplasty   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization

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