Details

Autor(en) / Beteiligte

• XU Bo ZHANG Qi YANG Yue-jin QIAO Shu-bin ZHANG Rui-yan ZHANG Jian-sheng HU Jian QIN Xue-wen HONG Tao LI Jian-ping CHEN Ji-lin HUO Yong GAO Run-lin SHEN Wei-feng

Titel

Sirolimus-eluting cobalt-chromium stents： two-year dinical results from first-in-man study on the Firebird 2^TM stent

Ist Teil von

• Chinese medical journal, 2008, Vol.121 (6), p.492-497

Erscheinungsjahr

2008

Link zum Volltext

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• 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.