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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 ou tcomes in patients enrolled in the Sirolimus-Eluting Stent in De Novo Native Coonary Disonary 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 RESULTS: Between one and two y ears, there were infrequent additional clinical events that were not equally distributed between the sirolimus and control groups. After two years, the 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 with o ut evidence for either disproportionate late restenosis or late stent thrombosis.