课题背景：药物洗脱支架治疗冠心病的疗效已经显示出比金属裸支架更好的疗效，能显著降低置入后血管发生再狭窄率和心血管不良事件。国产药物洗脱支架(FIREBIRD)也有大规模、多中心临床注册研究，一些初步结果证实了良好的安全性、生物相容性及有效性。但国产药物洗脱支架在前降支长病变中相关问题尚需探讨。

同行评价：文章对比分析了国产雷帕霉素药物洗脱支架和金属裸支架置入冠状动脉长病变血管后的相关数据，认为国产雷帕霉素药物洗脱支架在用于降低冠状动脉长病变再狭窄方面安全有效，具有一定的临床意义。

相关链接：Firebird雷帕霉素药物洗脱支架中国注册登记研究的结果是在2007年CIT会议上由高润霖院士发布的。国产雷帕霉素Firebird支架与Cypher支架在中国的注册研究进行了横向的比较，可以看到主要不良心血管事件仅为3.6%，晚期管腔丢失是0.14，节段内再狭窄发生率为5.3%，这一结果显示了国产火鸟支架与进口药物支架Cypher有相似的安全性与有效性。

摘要
目的：对比国产雷帕霉素药物洗脱支架（firebird火鸟）和金属裸支架置入冠状动脉长病变血管后的安全性、生物相容性及血管重建作用。
方法：选取2005-07/2007-07抚顺矿务局总医院行支架置入治疗冠状动脉长病变（单根血管病变长度≥ 20 mm）患者215例为观察对象。置入药物洗脱支架134例，置入金属裸支架81例。支架均由微创医疗器械（上海）有限公司提供。置入者为本科从事冠状动脉介入治疗≥ 10年的副主任医师。根据病变血管近端及远端血管直径，按1：1比例选择支架，支架长度以超过病变两端3~5 mm为准，置入术中经动脉鞘管注入肝素5 000 U，术后腹壁皮下注射低分子肝素钙0.4 mg 共3 d，大部分患者使用球囊进行预扩张。冠状动脉造影定量分析支架内或支架临近血管(5 mm)管腔直径狭窄程度> 50%为血管造影再狭窄。
结果：共215例患者238处靶病变完成冠状动脉造影检查随访。①术后1个月复查血常规，凝血相检查，无一例出现造血系统细胞成份、数目、形态不良改变。②随访造影显示无一例支架松脱、移位；无一例血管局部增生反应。③对影响长病变支架再狭窄因素的logistic回归分析发现，支架类型是对长病变支架内再狭窄影响最大的危险因素。④置入后6个月随访置入药物洗脱支架组再狭窄率为15.49%，置入金属裸支架组再狭窄率为47.92%，两组比较差异有显著性意义 （P < 0.001），药物洗脱支架组靶病变血管重建率、置入支架后扩张的比例要明显好于金属裸支架组（P < 0.001）。
结论：国产雷帕霉素药物洗脱支架（firebird火鸟）在置入冠状动脉长病变后无特殊生物相容性反应，在降低再狭窄率及血管重建方面优于金属裸支架。
关键词：雷帕霉素；药物洗脱支架；冠状动脉；长病变；再狭窄；生物相容性

闫振明，朱福音，马兰，关文畅.金属裸支架与国产药物洗脱支架置入冠状动脉长病变后的血管重建及生物相容性效应[J].中国组织工程研究与临床康复，2008，12(17):3209-3212 [www.zglckf.com/zglckf/ejournal/upfiles/08-17/17k-3209(ps).pdf]

Revascularization and biocompatibility of domestic rapamycin drug-eluting stent versus bare metal stent in the treatment of long coronary artery lesions

Abstract

AIM: To compare the safety, biocompatibility and vascular rebuilding effect of domestic rapamycin drug-eluting stent (Firebird) and bare metal stent for long coronary lesions.
METHODS: From July 2005 to July 2007, 215 patients with long coronary lesions (single vascular lesion length ≥ 20 mm) undergoing stenting were selected from Mining Bureau General Hospital of Fushun. Of them, 134 cases were treated by drug-eluting stent, and 81 cases by bare metal stent. Both stents were provided by MicroPort Medical (Shanghai) Co., Ltd. The surgery was performed by associate chief physician engaging in coronary intervention for more than 10 years. According to proximal and distal affected vascular diameter, stent was selected at ratio of 1:1, and stent length was 3 to 5 mm larger than two ends of lesions. All patients were given arterial sheath injection of 5 000 U heparin, and abdominal subcutaneous injection of 0.4 mg low-molecular-weight heparin calcium after surgery for 3 days. Most of the patients underwent balloon pre-expansion. Quantitative analysis of coronary angiography or vascular (5 mm) luminal diameter adjacent to stent stenosis > 50% was regarded as angiographic restenosis.
RESULTS: 215 patients (238 target lesions) were followed-up by coronary angiography. ①One month after surgery, blood routine and coagulation examinations showed that no adverse changes were found in cell components, number and appearance of hematopoietic system of patients. ②Coronary angiography suggested no stent dislocation or vascular local hyperplasty in patients. ③Logistic analysis of influential factors for long lesions showed that stent pattern was the most risk for restenosis after stenting. ④Six months after stenting, restenosis rate of drug-eluting stent group was 15.49%, and bare metal stent group was 47.92%. There were significant differences between the two groups (P < 0.001). In addition, the target lesion revascularization rate and expansion ratio after stenting in drug-eluting stent group were significantly better than the bare metal stent group (P < 0.001).
CONCLUSION: In treatment of long coronary artery disease, domestic rapamycin drug-eluting stent (firebird) shows no specific biocompatibility and it has superior effect in revascularization rate and reducing restenosis rate than bare metal stents.

Yan ZM, Zhu FY, Ma L, Guan WC.Revascularization and biocompatibility of domestic rapamycin drug-eluting stent versus bare metal stent in the treatment of long coronary artery lesions. Zhongguo Zuzhi Gongcheng Yanjiu yu Linchuang Kangfu 2008;12(17):3209-3212(China) [www.zglckf.com/zglckf/ejournal/upfiles/08-17/17k-3209(ps).pdf]