Prospective follow-up at 2 years was obtained for 98.7%of the pooled 1,510 patients enrolled in SIRIUS, E-SIRIUS and C-SIRIUS, 3 randomized controlled trials that compared sirolimus-eluting stents(SESs)with bare metal...Prospective follow-up at 2 years was obtained for 98.7%of the pooled 1,510 patients enrolled in SIRIUS, E-SIRIUS and C-SIRIUS, 3 randomized controlled trials that compared sirolimus-eluting stents(SESs)with bare metal stents(BMSs) to treat long stenoses in small coronary arteries. By 720 days, clinically driven target lesion revascularizations were performed in 5.7%of patients with SESs versus 22.6%of patients with BMSs(risk ratio 0.25, 95%confidence interval 0.18 to 0.35, p< 0.001). Of these, late target lesion revascularization(from 271 to 720 days) was performed in 12 patients who received SESs(1.6%)compared with 37 patients with BMSs(4.9%)(risk ratio 0.32, 0.17 to 0.61, p< 0.001). Stent thromboses occurred in 7 of 758 patients with SESs(0.9%, 4 subacute, 3 late) and 5 of 752 patients with BMSs(0.7%, 1 subacute, 4 late)(risk ratio 1.39, 95%confidence interval 0.44 to 4.36, p=0.774). The Kaplan-Meier estimate of freedom from major cardiac adverse events was 89.3%for patients with SESs versus 73.4%for patients with BMSs(p< 0.001). This analysis demonstrates the sustained efficacy and safety of sirolimus-eluting stents at 2 years, characterized by a persistent significant benefit in freedom from repeat revascularization compared with BMSs and a low risk of late stent thrombosis, not different from BMSs.展开更多
Background-Sirolimus-eluting stents(SESs)reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high ris...Background-Sirolimus-eluting stents(SESs)reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis. Methods and Results-Angiographic follow-up at 240 days was obtained in 701 patients with long(15-to 25-mm)lesions in small diameter(2.5-to 3.5-mm)native vessels who were randomly assigned to treatment with SESs or bare-metal stents(BMSs)in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary(>50%diameter stenosis) angiographic restenosis within the segment(8.9%versus 36.3%with the BMS; P< 0.001)and within the stent(3.2%versus 35.4%with the BMS; P< 0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5-mm proximal and distal edges(all P< 0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of late aneurysms was similar in the 2 groups. Conclusions-Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions.展开更多
文摘Prospective follow-up at 2 years was obtained for 98.7%of the pooled 1,510 patients enrolled in SIRIUS, E-SIRIUS and C-SIRIUS, 3 randomized controlled trials that compared sirolimus-eluting stents(SESs)with bare metal stents(BMSs) to treat long stenoses in small coronary arteries. By 720 days, clinically driven target lesion revascularizations were performed in 5.7%of patients with SESs versus 22.6%of patients with BMSs(risk ratio 0.25, 95%confidence interval 0.18 to 0.35, p< 0.001). Of these, late target lesion revascularization(from 271 to 720 days) was performed in 12 patients who received SESs(1.6%)compared with 37 patients with BMSs(4.9%)(risk ratio 0.32, 0.17 to 0.61, p< 0.001). Stent thromboses occurred in 7 of 758 patients with SESs(0.9%, 4 subacute, 3 late) and 5 of 752 patients with BMSs(0.7%, 1 subacute, 4 late)(risk ratio 1.39, 95%confidence interval 0.44 to 4.36, p=0.774). The Kaplan-Meier estimate of freedom from major cardiac adverse events was 89.3%for patients with SESs versus 73.4%for patients with BMSs(p< 0.001). This analysis demonstrates the sustained efficacy and safety of sirolimus-eluting stents at 2 years, characterized by a persistent significant benefit in freedom from repeat revascularization compared with BMSs and a low risk of late stent thrombosis, not different from BMSs.
文摘Background-Sirolimus-eluting stents(SESs)reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis. Methods and Results-Angiographic follow-up at 240 days was obtained in 701 patients with long(15-to 25-mm)lesions in small diameter(2.5-to 3.5-mm)native vessels who were randomly assigned to treatment with SESs or bare-metal stents(BMSs)in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary(>50%diameter stenosis) angiographic restenosis within the segment(8.9%versus 36.3%with the BMS; P< 0.001)and within the stent(3.2%versus 35.4%with the BMS; P< 0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5-mm proximal and distal edges(all P< 0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of late aneurysms was similar in the 2 groups. Conclusions-Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions.
