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
Department of Cardiology, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.
Chin Med J (Engl). 2008 Mar 20;121(6):492-7.
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 2 stents in the treatment of patients with CAD.
This first-in-man study using the Firebird 2 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 2, 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.
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.
Compared with the bare cobalt alloy stent, the Firebird 2 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.
药物洗脱支架（DES）已被证明在治疗冠状动脉疾病（CAD）时可显著减少临床事件和血管造影再狭窄。本研究旨在评估基于聚合物的西罗莫司洗脱钴铬合金Firebird 2支架治疗CAD患者的长期疗效和安全性。
这项使用Firebird 2支架的首例人体研究是一项前瞻性、历史对照的多中心临床研究，纳入了67例接受西罗莫司洗脱钴铬合金支架治疗的CAD患者（Firebird 2组，上海微创医疗器械（集团）有限公司，Firebird 2），并与另外49例接受裸钴合金支架治疗的患者（Driver，美敦力公司，对照组）进行比较。在获得最初6个月的血管造影随访和1年的临床随访后，继续进行2年的临床随访。比较两组主要不良心脏事件（MACE）的发生率，包括心源性死亡、再梗死、靶病变血管重建（TLR）和支架血栓形成。
Firebird 2组的所有患者（100.0%）和对照组的48例患者（98.0%）完成了2年的临床随访。在1年随访时，Firebird 2支架的使用非常有效，TLR显著降低了94%（对照组为26.5%，Firebird 2组为1.5%，P<0.0001）。在2年随访时，TLR仍存在显著差异，Firebird 2组为1.5%，对照组为31.3%（P<0.0001）。在支架置入后1至2年期间，Firebird 2组未再发生TLR，而对照组有2例（P>0.05）。Firebird 2组在1年和2年随访时MACE的发生率分别为1.5%，而对照组分别为26.5%和33.3%（所有P<0.0001）。Firebird 2组1年和2年的累积无MACE生存率分别为98.5%，而对照组分别为73.5%和66.7%（对数秩检验P<0.0001）。Firebird 2组在2年随访期间未发生支架血栓形成病例，而对照组在支架置入后19个月有1例发生明确的支架血栓形成：该患者表现为不稳定型心绞痛，接受了球囊血管成形术治疗。
与裸钴合金支架相比，Firebird 2西罗莫司洗脱钴铬合金支架治疗CAD患者安全有效。使用该支架可带来持续的临床益处，并在支架置入后长达2年的时间里显著降低TLR和MACE的发生率。
