Background Recent data have shown that sirolimus-eluting stents （SES） reduced not only the incidences of restenosis but also of target vessel revascularization （TVR）. CYPHER and FIREBIRD stents are both widely use...Background Recent data have shown that sirolimus-eluting stents （SES） reduced not only the incidences of restenosis but also of target vessel revascularization （TVR）. CYPHER and FIREBIRD stents are both widely used SES in China. However, comparative data concerning differences in long-term safety and efficacy regarding CYPHER and FIREBIRD stents in the Chinese population are still not available.展开更多
Background Drug-eluting stents （DES） have been shown to significantly reduce clinical events and angiographic restenosis in the treatment of coronary artery disease （CAD）. This study was conducted to assess the lo...Background Drug-eluting stents （DES） have been shown to significantly reduce clinical events and angiographic restenosis in the treatment of coronary artery disease （CAD）. This study was conducted to assess the long-term efficacy and safety of the polymer-based sirolimus-eluting cobalt-chromium Firebird 2TM stents in the treatment of patients with CAD. Methods This first-in-man study using the Firebird 2TM stent is a prospective, historically-controlled multicenter clinical study, which enrolled 67 patients with CAD who were treated with the sirolimus-eluting cobalt-chromium stent （Firebird 2TM, Microport Shanghai, Firebird 2 group）, compared to another 49 patients treated with a bare cobalt alloy stent （Driver, Medtronic, control group）. Continued 2-year clinical follow-up was performed after getting the initial 6-month angiographic and 1-year clinical follow-up. The incidence of major adverse cardiac events （MACE） including cardiac death, reinfarction and target lesion revascularization （TLR） and stent thrombosis were compared between the two groups. Results All patients in the Firebird 2 group （100.0%） and 48 patients in the control group （98.0%） completed the 2-year clinical follow-up. At the 1-year follow-up the use of the Firebird 2 stent was highly effective, resulting in a significant 94% decrease of TLR （26.5% in the control group and 1.5% in the Firebird 2 group, P〈0.0001）. A significant difference in TLR was maintained at 2-year follow-up, Firebird 2 group 1.5% and the control group 31.3% （P〈0.0001）. Between 1- and 2-year post-stenting, no more TLR occurred in the Firebird 2 group compared with two cases in the control group （P〉0.05）. There was a 1.5% incidence of MACE at 1- and 2-year follow-up in the Firebird 2 group, compared with 26.5% and 33.3% in the control group, respectively （all P〈0.0001）. The cumulative 1- and 2-year MACE free survival rates were 98.5% in the Firebird 2 group vs 73.5% and 66.7% in the control group （log rank P〈0.0001）. No case of stent thrombosis occurred during 2-year follow-up in the Firebird 2 group, compared with one case that suffered a definite stent thrombosis in the control group at 19-month post-stenting： this patient presented with unstable angina pectoris and was treated by balloon angioplasty. Conclusions Compared with the bare cobalt alloy stent, the Firebird 2TM sirolimus-eluting cobalt-chromium stent is safe and effective in treating patients with CAD. The use of this stent was associated with a sustained clinical benefit and significantly lower rate of TLR and MACE up to 2 years post-stenting.展开更多
Background Recent studies have shown that drug eluting stent （DES） implantation improved clinical outcome concerning efficacy compared with bare-metal stent （BMS） implantation, and sirolimus-eluting stent （SES） ...Background Recent studies have shown that drug eluting stent （DES） implantation improved clinical outcome concerning efficacy compared with bare-metal stent （BMS） implantation, and sirolimus-eluting stent （SES） seemed superior to paclitaxel-eluting stent （PES） in improving the outcomes. Firebird SES is the most widely used SES in China. Long-term comparison of safety and efficacy between Firebird SES and Taxus PES in Chinese popuation is still not available. The aim of this research was to compare the safety and efficacy at 24 months after the successful implantation of Firebird SES and TAXUS PES in Chinese population.Methods From April 2004 to October 2006, 3110 consecutive patients who underwent successful DES （Firebird SES 2274; Taxus PES 836） implantation were prospectively enrolled into this study. All enrolled patients were divided into two groups based on stent type. By outpatient clinic visit and telephone interview, we obtained 24-month clinical outcome including death, myocardial infarction （Ml）, thrombosis, target lesion revascularization （TLR）, target vessel revascularization （TVR）, and major adverse cardiac events （MACE, the composite of death, Ml, and TVR）. We used Cox＇s proportional-hazards models to assess relative risks of all the outcome measures before and after propensity match. Results Unadjusted clinical outcomes indicated that the patients treated with Firebird SES were associated with lower risk of TLR （HR0.38, 95%CI 0.26-0.54）, TVR （HR 0.51,95%CI 0.38-0.68） and MACE （HR 0.53, 95%CI 0.41-0.68）. The results after propensity match were consistent with that before matching, lower risk of TLR （HR 0.33, 95%CI 0.19-0.58）, TVR （HR 0.41, 95%CI 0.26-0.64）, MACE （HR 0.48, 95%CI 0.33-0.68） in Firebird group.Conclusion Compared with Taxus PES, the use of domestic Firebird SES may decrease the risk of TLR, TVR and MACE in daily practice.展开更多
文摘Background Recent data have shown that sirolimus-eluting stents （SES） reduced not only the incidences of restenosis but also of target vessel revascularization （TVR）. CYPHER and FIREBIRD stents are both widely used SES in China. However, comparative data concerning differences in long-term safety and efficacy regarding CYPHER and FIREBIRD stents in the Chinese population are still not available.
文摘Background Drug-eluting stents （DES） have been shown to significantly reduce clinical events and angiographic restenosis in the treatment of coronary artery disease （CAD）. This study was conducted to assess the long-term efficacy and safety of the polymer-based sirolimus-eluting cobalt-chromium Firebird 2TM stents in the treatment of patients with CAD. Methods This first-in-man study using the Firebird 2TM stent is a prospective, historically-controlled multicenter clinical study, which enrolled 67 patients with CAD who were treated with the sirolimus-eluting cobalt-chromium stent （Firebird 2TM, Microport Shanghai, Firebird 2 group）, compared to another 49 patients treated with a bare cobalt alloy stent （Driver, Medtronic, control group）. Continued 2-year clinical follow-up was performed after getting the initial 6-month angiographic and 1-year clinical follow-up. The incidence of major adverse cardiac events （MACE） including cardiac death, reinfarction and target lesion revascularization （TLR） and stent thrombosis were compared between the two groups. Results All patients in the Firebird 2 group （100.0%） and 48 patients in the control group （98.0%） completed the 2-year clinical follow-up. At the 1-year follow-up the use of the Firebird 2 stent was highly effective, resulting in a significant 94% decrease of TLR （26.5% in the control group and 1.5% in the Firebird 2 group, P〈0.0001）. A significant difference in TLR was maintained at 2-year follow-up, Firebird 2 group 1.5% and the control group 31.3% （P〈0.0001）. Between 1- and 2-year post-stenting, no more TLR occurred in the Firebird 2 group compared with two cases in the control group （P〉0.05）. There was a 1.5% incidence of MACE at 1- and 2-year follow-up in the Firebird 2 group, compared with 26.5% and 33.3% in the control group, respectively （all P〈0.0001）. The cumulative 1- and 2-year MACE free survival rates were 98.5% in the Firebird 2 group vs 73.5% and 66.7% in the control group （log rank P〈0.0001）. No case of stent thrombosis occurred during 2-year follow-up in the Firebird 2 group, compared with one case that suffered a definite stent thrombosis in the control group at 19-month post-stenting： this patient presented with unstable angina pectoris and was treated by balloon angioplasty. Conclusions Compared with the bare cobalt alloy stent, the Firebird 2TM sirolimus-eluting cobalt-chromium stent is safe and effective in treating patients with CAD. The use of this stent was associated with a sustained clinical benefit and significantly lower rate of TLR and MACE up to 2 years post-stenting.
文摘Background Recent studies have shown that drug eluting stent （DES） implantation improved clinical outcome concerning efficacy compared with bare-metal stent （BMS） implantation, and sirolimus-eluting stent （SES） seemed superior to paclitaxel-eluting stent （PES） in improving the outcomes. Firebird SES is the most widely used SES in China. Long-term comparison of safety and efficacy between Firebird SES and Taxus PES in Chinese popuation is still not available. The aim of this research was to compare the safety and efficacy at 24 months after the successful implantation of Firebird SES and TAXUS PES in Chinese population.Methods From April 2004 to October 2006, 3110 consecutive patients who underwent successful DES （Firebird SES 2274; Taxus PES 836） implantation were prospectively enrolled into this study. All enrolled patients were divided into two groups based on stent type. By outpatient clinic visit and telephone interview, we obtained 24-month clinical outcome including death, myocardial infarction （Ml）, thrombosis, target lesion revascularization （TLR）, target vessel revascularization （TVR）, and major adverse cardiac events （MACE, the composite of death, Ml, and TVR）. We used Cox＇s proportional-hazards models to assess relative risks of all the outcome measures before and after propensity match. Results Unadjusted clinical outcomes indicated that the patients treated with Firebird SES were associated with lower risk of TLR （HR0.38, 95%CI 0.26-0.54）, TVR （HR 0.51,95%CI 0.38-0.68） and MACE （HR 0.53, 95%CI 0.41-0.68）. The results after propensity match were consistent with that before matching, lower risk of TLR （HR 0.33, 95%CI 0.19-0.58）, TVR （HR 0.41, 95%CI 0.26-0.64）, MACE （HR 0.48, 95%CI 0.33-0.68） in Firebird group.Conclusion Compared with Taxus PES, the use of domestic Firebird SES may decrease the risk of TLR, TVR and MACE in daily practice.
