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

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

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≥20mm）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3-5mm为准，置入术中经动脉鞘管注入肝素5000U，术后腹壁皮下注射低分子肝素钙0.4mg共3d，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（5mm）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。

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. 1.One 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. 2.Coronary angiography suggested no stent dislocation or vascular local hyperplasty in patients. 3.Logistic analysis of influential factors for long lesions showed that stent pattern was the most risk for restenosis after stenting. 4.Six 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.