European Sirolimus-Eluting Stent in Coronary Lesions - E-SIRIUS
The goal of the E-SIRIUS trial was to compare the safety and effectiveness of sirolimus-eluting stents with bare stents in de novo native coronary lesions.
Patients Enrolled: 352
Mean Follow Up: Nine months reported (will follow through five years)
Mean Patient Age: Mean age 62 years
Single de novo coronary lesion; target vessel diameter 2.5-3.0 mm on visual estimate; lesion length 15-32 mm; stenosis >50% to <100%; and Canadian Cardiovascular Society angina or unstable angina or silent ischemia
In-stent MLD at eight-month angiographic follow-up
MACE at 1, 6, 9, and 12 months and 2-5 years; binary restenosis and in-lesion MLD at eight-month angiographic follow-up; TLR, target vessel revascularization, and target vessel failure at nine months; intravascular ultrasound substudy in 60 patients; and cost-effectiveness
Patients with single de novo coronary lesions were randomized to sirolimus-eluting stents (n=175) or bare stents (n=177). A maximum of two stents were to be used, and direct stenting or predilatation could be used.
Angiographic follow-up at nine months was available in 308 patients (87.5%). Angina was the reason for revascularization in 81.1% of patients in the sirolimus arm and 81.9% of patients in the control arm (p=0.891). There was no difference in single-vessel disease (62.5% in the sirolimus arm and 64.6% in the control arm) or left anterior descending lesion location (57% and 56%, respectively). Only 16% of patients received glycoprotein IIb/IIIa inhibitors.
In-stent minimal lumen diameter (MLD) at eight-month angiographic follow-up was larger in the sirolimus arm (2.22 mm vs. 1.32 mm, p<0.001), as was in-lesion MLD (1.97 mm vs. 1.29 mm, p<0.001). Percent diameter stenosis was smaller in the sirolimus arm (24.3% vs. 48.7%, p<0.001), and binary restenosis occurred less frequently (in-stent 3.9% vs. 42.3%, p<0.001).
Major adverse cardiac events (MACE) at nine months occurred less frequently in the sirolimus arm (8.0% vs. 22.6%, p<0.001), driven primarily by a reduction in target lesion revascularization (TLR) (4.0% vs. 20.9%, p<0.001). There was no difference in mortality (1.1% vs. 0.6%, p=0.622) or myocardial infarction (MI) (4.6% vs. 2.3%, p=0.257). MACE remained lower at the one-year clinical follow-up (8.6% vs. 26.6%).
By two years, the MACE rate was 10.3% in the sirolimus arm and 29.9% in the bare stent group (p<0.001), again driven by the initial and sustained reduction in target vessel revascularization (5.1% vs. 26.6%, p<0.001) with no difference in death (2.3% vs. 2.8%) or MI (5.7% vs. 3.4%, p=NS).
Among patients with de novo native coronary lesions, treatment with sirolimus-eluting stents was associated with improvements in the primary endpoint of in-stent MLD at eight-month angiographic follow-up compared with bare stents. Additionally, the nine-month MACE was lower in the sirolimus arm, although the reduction was driven by TLR, with few deaths or Q wave MIs in either arm.
Compared with patients in the SIRIUS trial, more patients enrolled in the E-SIRIUS trial had prior MI, were current smokers, and had longer lesions in smaller vessels. Despite the higher risk profile, similar angiographic and clinical findings were observed in the two trials, suggesting similar benefit with a sirolimus-eluting stent in more difficult lesions.
As with the other sirolimus-eluting stent trials, patients will be followed for up to five years for clinical events, which will be important in determining if the need for repeat revascularization is simply delayed in the sirolimus arm or not required, as well as determining if use of the eluting stent will result in a clinical reduction in death or MI, as too few events occurred by nine months to draw conclusions regarding death and MI. By two years, the results were maintained and there was no apparent "catch-up" in target vessel revascularization in the present trial.
Schofer J. E-SIRIUS: Two year clinical follow-up in patients with de novo lesions treated with
sirolimus-eluting stent. Paper presented at the European Society of Cardiology Congress 2004, 29 August-1 September, Munich, Germany.
Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G, for the E-SIRIUS Investigators. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003;362:1093-99.
Presented by Dr. Joachim Schofer, at a satellite session prior to the ACC Annual Scientific Session, March 2003, Chicago, IL
Presented at the European Society of Cardiology, Vienna, Austria, September 2003.
Keywords: Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Drug-Eluting Stents, Constriction, Pathologic, Sirolimus, Stents
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