European Sirolimus-Eluting Stent in Coronary Lesions - E-SIRIUS Direct Stent vs. Predilatation Substudy
The goal of the substudy was to evaluate the effect of direct stenting versus predilatation in patients with long lesions treated with bare stent or sirolimus-eluting stents in de novo native coronary lesions.
Patients Enrolled: 352
Mean Follow Up: 9 months
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 the E-SIRIUS trial, 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 at the discretion of the investigator.
Overall, 45 patients (25.7%) in the sirolimus-eluting stent arm and 47 patients (26.6%) in the control arm were directly stented. There were no significant differences between directly stenting and predilatating in the sirolimus-eluting stent arm for the endpoints of late loss (0.13 mm with direct stent vs. 0.23 mm with predilatation), restenosis (2.5% vs. 7.2%), or major adverse cardiac events (MACE) at nine months (4.4% vs. 9.2%).
There were also no differences in the control group: late loss (1.04 mm with direct stent vs. 1.05 mm with predilatation), restenosis (37.5% vs. 44.0%), or MACE at nine months (21.3% vs. 23.1%). Preprocedure diameter stenosis was smaller in patients treated with direct stenting versus predilatated lesions.
Among patients treated with sirolimus-eluting stents using direct stenting, there was no significant difference in late loss, restenosis, or MACE compared with predilatation. The presenter interpreted the data to suggest that direct stenting is as safe and effective as predilatation stenting with sirolimus-eluting stents.
However, the study has several limitations, including the nonrandomized, retrospective nature of the analysis, the small sample size, the lack of significant benefit, and the apparent selection bias of lower risk lesions, as demonstrated by the smaller preprocedure diameter stenosis in patients treated with direct stenting versus predilatated lesions. Further randomized trials would be needed to fully evaluate the effect of direct stenting with sirolimus-eluting stents.
Presented by Joachim Schofer at the European Society of Cardiology Congress, Vienna, Austria, September 2003.
Keywords: Coronary Artery Disease, Drug-Eluting Stents, Selection Bias, Research Personnel, Constriction, Pathologic, Sirolimus, Stents
< Back to Listings