Background Several clinical trials have shown that sirolimus-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention （PCI）. The FIREBIRD stent （coated with durable polyme...Background Several clinical trials have shown that sirolimus-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention （PCI）. The FIREBIRD stent （coated with durable polymer） and the EXCEL stent （coated with bioabsorbable polymer） are two different types of sirolimus-eluting stents made in China; both have been approved for clinical use in China by the State Food and Drug Administration. The mid-term （6-month） angiographic and clinical results of both stents have been confirmed exciting perspective outcomes. However, it is unclear whether there are differences in the long-term safety and efficacy between the two types of stents in daily practice.Methods All consecutive patients undergoing elective PCI with EXCEL or FIREBIRD stents between June 1,2006 and December 31, 2006 at Fu Wai Hospital in Beijing were included. Patients were classified from the index admission according to stent types （EXCEL or FIREBIRD） used. Clinical and procedural risk factors were collected prospectively. With propensity score matching without replacement, the frequency of major adverse cardiac events （MACE, a composite of death, myocardial infarction or target vessel revascularization） and stent thrombosis during a 2-year follow-up period were compared between the two groups.Results A total of 474 patients were treated with EXCEL, and 640 were treated with FIREBIRD. Three hundred and ninety-seven EXCEL patients were matched to 397 FIREBIRD patients, 2-year risk-adjusted MACE rates were 6.1% in EXCEL group and 7.6% in FIREBIRD group （HR 0.84, 95%CI0.50-1.43）, whereas the respective rates for mortality, myocardial infarction and target-vessel revascularization were 2.3% vs 2.8% （HR 0.74, 95%CI0.30-0.85）, 1.8% vs 1.3% （HR 1.41,95%CI 0.45-4.43） and 2.5% vs 4.0% （HR 0.62, 95%CI0.28-0.37）, respectively. Cumulative incidence of stent thrombosis at 2 years was 1.8% in the EXCEL group vs 1.3% in the FIREBIRD group （P=0.5610）, whereas the rate of very late stent thrombosis was 0.5% vs 1.3% （P=0.2550）.Conclusions Results from this long-term, relatively large size, single-center study showed that both of the EXCEL and the FIREBIRD sirolimus-eluting stent had similar and lower incidence of MACE after PCI in daily practice.展开更多
Background Several clinical trials have shown that rapamycin-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention （PCI）. The Firebird stent and the Excel stent （coated...Background Several clinical trials have shown that rapamycin-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention （PCI）. The Firebird stent and the Excel stent （coated with bioabsorbable polymer） are two different types of rapamycin-eluUng stents made in China, both have been recently approved for clinical use in China by State Food and Drug Administration. However, it is unclear whether there are differences in safety and efficacy between the two types of stents in daily practice. Methods In the month of June 2006, a total of 190 consecutive patients were treated exclusively with Firebird stents （n=93, Firebird group） or Excel stents （n=97, Excel group） in our center and were included in this study. The frequency of major adverse cardiac events （MACE, a composite of death, myocardial infarction or target lesion revascularization）, binary restenosis, and late lumen loss and stent thrombosis dudng a six-month follow-up period were compared between the two groups. Results Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low in hospital and at 6 months （2.1% in the Excel group and 0% in the Firebird group, P〉 0.05）. The 6-month angiographic in-stent restenosis rate was 0% in both groups, with an associated late loss of （0.15 ± 0.21） mm versus （0.14 ± 0.20） mm （P=0.858） and the in-segment restenosis rate was also 0% for the Excel group and the Firebird group. There was no definite stent thrombosis identified in either group during the six-month follow-up period and only one patient in the Excel group had probable stent thrombosis in hospital. Conclusions Results from this mid-term, single-center study showed that both of the Firebird and the Excel rapamycin eluUng stent had similar effects on reducing the incidence of MACE and the risk of restenosis （both in-stent and in-segment binary restenosis） after PCI in daily practice.展开更多
Background First generation drug-eluting stents （DESs） were based on 316L stainless steel and coated with a permanent polymer. The vessel wall of these DESs was inflammatory and late in-stent thrombosis was reported...Background First generation drug-eluting stents （DESs） were based on 316L stainless steel and coated with a permanent polymer. The vessel wall of these DESs was inflammatory and late in-stent thrombosis was reported. Hence, cobalt chromium based DES coated with a bioabsorbable polymer was an alternate choice. Methods Cobalt chromium based DES with bioabsorbable polymer （Simrex stent） as well as control stents （Polymer stent and EXCELTM stent） were implanted into porcine arteries. At a designated time, angiography, quantitative coronary angiography （QCA） analysis, histomorphometry, and electron-microscopical follow-up were performed. Results A total of 98 stents of all the three groups were harvested. At week 24, percent diameter stenosis （%DS）, late loss （LL）, and percent area stenosis （%AS） of Simrex was （12.9±0.4）%, （0.35±0.02） mm, and （24.5±4.2）%, respectively, without significant difference in comparison to commercialized EXCELTM stent. Slight inflammatory reaction was seen around the stent strut of Simrex, just as in the other two groups. Electron-microscopical follow-up suggested that it might take 4-12 weeks for Simrex to complete its re-endothelialization process. Conclusions Cobalt chromium based, bioabsorbable polymer coated sirolimus-eluting stent showed excellent biocompatibility. During 24 weeks observation in porcine model, it was proved that this novel DES system successfully inhibited neointima hyperplasia and decreased in-stent stenosis. It is feasible to launch a clinical evaluation to improve the current prognosis of DES implantation.展开更多
文摘Background Several clinical trials have shown that sirolimus-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention （PCI）. The FIREBIRD stent （coated with durable polymer） and the EXCEL stent （coated with bioabsorbable polymer） are two different types of sirolimus-eluting stents made in China; both have been approved for clinical use in China by the State Food and Drug Administration. The mid-term （6-month） angiographic and clinical results of both stents have been confirmed exciting perspective outcomes. However, it is unclear whether there are differences in the long-term safety and efficacy between the two types of stents in daily practice.Methods All consecutive patients undergoing elective PCI with EXCEL or FIREBIRD stents between June 1,2006 and December 31, 2006 at Fu Wai Hospital in Beijing were included. Patients were classified from the index admission according to stent types （EXCEL or FIREBIRD） used. Clinical and procedural risk factors were collected prospectively. With propensity score matching without replacement, the frequency of major adverse cardiac events （MACE, a composite of death, myocardial infarction or target vessel revascularization） and stent thrombosis during a 2-year follow-up period were compared between the two groups.Results A total of 474 patients were treated with EXCEL, and 640 were treated with FIREBIRD. Three hundred and ninety-seven EXCEL patients were matched to 397 FIREBIRD patients, 2-year risk-adjusted MACE rates were 6.1% in EXCEL group and 7.6% in FIREBIRD group （HR 0.84, 95%CI0.50-1.43）, whereas the respective rates for mortality, myocardial infarction and target-vessel revascularization were 2.3% vs 2.8% （HR 0.74, 95%CI0.30-0.85）, 1.8% vs 1.3% （HR 1.41,95%CI 0.45-4.43） and 2.5% vs 4.0% （HR 0.62, 95%CI0.28-0.37）, respectively. Cumulative incidence of stent thrombosis at 2 years was 1.8% in the EXCEL group vs 1.3% in the FIREBIRD group （P=0.5610）, whereas the rate of very late stent thrombosis was 0.5% vs 1.3% （P=0.2550）.Conclusions Results from this long-term, relatively large size, single-center study showed that both of the EXCEL and the FIREBIRD sirolimus-eluting stent had similar and lower incidence of MACE after PCI in daily practice.
文摘Background Several clinical trials have shown that rapamycin-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention （PCI）. The Firebird stent and the Excel stent （coated with bioabsorbable polymer） are two different types of rapamycin-eluUng stents made in China, both have been recently approved for clinical use in China by State Food and Drug Administration. However, it is unclear whether there are differences in safety and efficacy between the two types of stents in daily practice. Methods In the month of June 2006, a total of 190 consecutive patients were treated exclusively with Firebird stents （n=93, Firebird group） or Excel stents （n=97, Excel group） in our center and were included in this study. The frequency of major adverse cardiac events （MACE, a composite of death, myocardial infarction or target lesion revascularization）, binary restenosis, and late lumen loss and stent thrombosis dudng a six-month follow-up period were compared between the two groups. Results Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low in hospital and at 6 months （2.1% in the Excel group and 0% in the Firebird group, P〉 0.05）. The 6-month angiographic in-stent restenosis rate was 0% in both groups, with an associated late loss of （0.15 ± 0.21） mm versus （0.14 ± 0.20） mm （P=0.858） and the in-segment restenosis rate was also 0% for the Excel group and the Firebird group. There was no definite stent thrombosis identified in either group during the six-month follow-up period and only one patient in the Excel group had probable stent thrombosis in hospital. Conclusions Results from this mid-term, single-center study showed that both of the Firebird and the Excel rapamycin eluUng stent had similar effects on reducing the incidence of MACE and the risk of restenosis （both in-stent and in-segment binary restenosis） after PCI in daily practice.
文摘Background First generation drug-eluting stents （DESs） were based on 316L stainless steel and coated with a permanent polymer. The vessel wall of these DESs was inflammatory and late in-stent thrombosis was reported. Hence, cobalt chromium based DES coated with a bioabsorbable polymer was an alternate choice. Methods Cobalt chromium based DES with bioabsorbable polymer （Simrex stent） as well as control stents （Polymer stent and EXCELTM stent） were implanted into porcine arteries. At a designated time, angiography, quantitative coronary angiography （QCA） analysis, histomorphometry, and electron-microscopical follow-up were performed. Results A total of 98 stents of all the three groups were harvested. At week 24, percent diameter stenosis （%DS）, late loss （LL）, and percent area stenosis （%AS） of Simrex was （12.9±0.4）%, （0.35±0.02） mm, and （24.5±4.2）%, respectively, without significant difference in comparison to commercialized EXCELTM stent. Slight inflammatory reaction was seen around the stent strut of Simrex, just as in the other two groups. Electron-microscopical follow-up suggested that it might take 4-12 weeks for Simrex to complete its re-endothelialization process. Conclusions Cobalt chromium based, bioabsorbable polymer coated sirolimus-eluting stent showed excellent biocompatibility. During 24 weeks observation in porcine model, it was proved that this novel DES system successfully inhibited neointima hyperplasia and decreased in-stent stenosis. It is feasible to launch a clinical evaluation to improve the current prognosis of DES implantation.
