Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS)

Sirolimus-eluting stents have been developed to prevent restenosis in the treatment of coronary artery disease. We investigated the risk of restenosis with use of sirolimus-eluting stents compared with bare-metal stents to assess possible differences. We enrolled 352 patients in whom one coronary ar...

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Bibliographic Details
Published in:The Lancet (British edition) 2003-10, Vol.362 (9390), p.1093-1099
Main Authors: Schofer, Joachim, Schlüter, Michael, Gershlick, Anthony H, Wijns, William, Garcia, Eulogio, Schampaert, Erick, Breithardt, Günter
Format: Article
Language:English
Subjects:
Angina pectoris
Angioplasty, Balloon - methods
Arteries
Arteriosclerosis
Atherosclerosis
Blood clots
Calcification
Cardiovascular disease
Coronary Angiography
Coronary artery
Coronary artery disease
Coronary Artery Disease - therapy
Coronary Restenosis - diagnostic imaging
Coronary Restenosis - prevention & control
Coronary vessels
Double-blind studies
Drug Delivery Systems - methods
Evidence-based medicine
Female
Health risks
Heart
Heart diseases
Humans
Immunosuppressive Agents - administration & dosage
Implantation
Implants
Lesions
Male
Medical treatment
Metals
Middle Aged
Motivation
Patients
Polymers
Rapamycin
Restenosis
Sirolimus - administration & dosage
Stainless steel
Stents
Surgical implants
Transplants & implants
Treatment Outcome
Velocity
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Summary:Sirolimus-eluting stents have been developed to prevent restenosis in the treatment of coronary artery disease. We investigated the risk of restenosis with use of sirolimus-eluting stents compared with bare-metal stents to assess possible differences. We enrolled 352 patients in whom one coronary artery required treatment, with diameter 2·5–3·0 mm and lesion length 15–32 mm. We randomly assigned patients sirolimus-eluting stents (n=175) or bare-metal stents (control, n=177). At 8 months we assessed differences in minimum lumen diameter and binary restenosis within the lesion (restenosis of ≤50% diameter, including 5 mm vessel segments proximal and distal to stented segment). Patients were also followed up for 9 months for major adverse cardiac events. Analysis was by intention to treat. Stent implantation was successful in 100% of sirolimus-stent patients and 99·4% of controls. The mean diameter of treated coronary arteries was 2·55 mm (SD 0·37) and mean lesion length was 15·0 mm (6·0). Multiple stents were implanted in 170 (48%) patients. At 8 months, minimum lumen diameter was significantly higher with sirolimus-eluting stents than with control stents (2·22 vs 1·33 mm, p
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(03)14462-5