Objectives: The purpose of this research was to determine the relative safety and efficacy of multiple(≥2) overlapping Cypher sirolimus-eluting stents(SES)(Johnson &Johnson, New Brunswick, New Jersey). Background...Objectives: The purpose of this research was to determine the relative safety and efficacy of multiple(≥2) overlapping Cypher sirolimus-eluting stents(SES)(Johnson &Johnson, New Brunswick, New Jersey). Background: Overlapping coronary stents are common. The periprocedural and late clinical and angiographic consequences of overlapped coronary stents are not clearly defined, particularly for drug-eluting stents. Methods: All patients enrolled into five clinical trials of the SES were analyzed. Three of these trials were prospective randomized comparisons of the SES to the bare-metal stent(BMS), and two were prospective non-randomized trials of SES-treated patients with historical controls. All clinical and angiographic outcomes in overlap-stent-treated patients were compared by stent type and with single-stent-treated patients for the same stent device. Results: In all, 575 patients with stent overlap(337 SES, 238 BMS) and 1,162 patients with single stents(697 SES, 465 BMS) were analyzed. Stent overlap was associated with a greater late lumen loss in stent and more frequent angiographic restenosis regardless of stent type. Among overlap-stent-treated patients, the SES provided similar magnitude of restenosis benefit as observed for single-stent-treated patients. Overlapped SES was not associated with an increase in myocardial infarction. Conclusions: The strategy of SES overlap, when required, is both safe and efficacious in reducing restenosis with no increase in the incidence of myocardial infarction or major adverse cardiovascular events, when compared with a bare metal coronary stent prosthesis.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Objectives: The purpose of this research was to determine the relative safety and efficacy of multiple(≥2) overlapping Cypher sirolimus-eluting stents(SES)(Johnson &Johnson, New Brunswick, New Jersey). Background: Overlapping coronary stents are common. The periprocedural and late clinical and angiographic consequences of overlapped coronary stents are not clearly defined, particularly for drug-eluting stents. Methods: All patients enrolled into five clinical trials of the SES were analyzed. Three of these trials were prospective randomized comparisons of the SES to the bare-metal stent(BMS), and two were prospective non-randomized trials of SES-treated patients with historical controls. All clinical and angiographic outcomes in overlap-stent-treated patients were compared by stent type and with single-stent-treated patients for the same stent device. Results: In all, 575 patients with stent overlap(337 SES, 238 BMS) and 1,162 patients with single stents(697 SES, 465 BMS) were analyzed. Stent overlap was associated with a greater late lumen loss in stent and more frequent angiographic restenosis regardless of stent type. Among overlap-stent-treated patients, the SES provided similar magnitude of restenosis benefit as observed for single-stent-treated patients. Overlapped SES was not associated with an increase in myocardial infarction. Conclusions: The strategy of SES overlap, when required, is both safe and efficacious in reducing restenosis with no increase in the incidence of myocardial infarction or major adverse cardiovascular events, when compared with a bare metal coronary stent prosthesis.
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.
