摘要
OBJECTIVES: The purpose of this study was to examine the two-year clinical ou tcomes in patients enrolled in the Sirolimus-Eluting Stent in De Novo Native Co ronary Lesions(SIRIUS) study. BACKGROUND: The SIRIUS study was a double-blinded randomized study which demonstrated that sirolimus-eluting stents(SES) signifi cantly improved angiographic results(at 8 months) and clinical outcomes(at 9 and 12 months) compared with bare-metal stents(BMS). METHODS: Patients with de nov o native coronary artery lesions randomized to either SES(533 patients) or contr ol BMS(525 patients) were followed for two years. RESULTS: Between one and two y ears, there were infrequent additional clinical events that were equally distrib uted between the sirolimus and control groups. After two years, target lesion re vascularization was 5.8%and 21.3%in SES and control patients, respectively(p< 0.001), and major adverse cardiovascular events and target vessel failure rates were 10.1%versus 24.4%and 12.0%versus 26.7%, respectively(p< 0.0001 for both ). There were no differences in death, myocardial infarction, and stent thrombosis between the two groups. CONCLUSIONS: Clinical outcomes two years af ter implantation of SES continue to demonstrate significant reduction in the nee d for repeat target lesion(and vessel) revascularization compared with BMS witho ut evidence for either disproportionate late restenosis or late stent thrombosis .
OBJECTIVES： The purpose of this study was to examine the two-.year clinical outcomes in patients enrolled in the Sirolimus-Eluting Stent in De Novo Native Coronary Lesions（SIRIUS） study. BACKGROUND： The SIRIUS study was a double-blinded randomized study which demonstrated that sirolimus-eluting stents（SES） significantly improved angiographic results （at 8 months） and clinical outcomes （at 9 and 12 months） compared with bare-metal stents（BMS）. METHODS： Patients with de novo native coronary artery lesions randomized to either SES（533 patients） or control BMS（525 patients） were followed for two years. RESULTS： Between one and two years, there were infrequent additional clinical events that were equally distributed between the sirolimus and control groups. After two years, target lesion revascularization was 5.8% and 21.3% in SES and control patients, respectively（p 〈 O. 001）, and major adverse cardiovascular events and target vessel failure rates were 10. 1% versus 24.4% and 12. 0% versus 26. 7%, respectively（p 〈 0. 0001 for both） . There were no differences in death, myocardial infarction, and stent thrombosis between the two groups.
