国产Firebird2^(TM)雷帕霉素洗脱支架与进口Endeavor Resolute药物洗脱支架疗效的临床研究

Clinical study on the efficacy of domestic Firebird2^(TM) rapamycin eluting stent and imported Endeavor Resolute stent

目的比较国产Firebird2^(TM)雷帕霉素洗脱支架和进口Endeavor Resolute药物洗脱支架治疗冠心病患者的的安全性和有效性。方法选取武汉亚洲心脏病医院2010-2015年行经皮冠状动脉介入治疗(percutaneous coronary intervention, PCI)的889例冠心病患者的临床资料进行回顾性分析, 采用病例对照研究, 根据应用支架类型分为国产Firebird2^(TM)组550例和进口Endeavor Resolute(简称Endeavor)组325例, 比较两组患者主要不良心血管事件(major adverse cardiovascular events, MACE)发生情况。所有患者术后均随访1年。结果 Firebird2^(TM) 组和Endeavor组性别、年龄、体质量指数、合并内科疾病、是否为急诊PCI、既往PCI史、冠状动脉搭桥史及左心室射血分数等比较, 差异均无统计学意义(均P>0.05)。两组患者病变部位、支架植入个数及支架大小比较差异均无统计学意义(均P>0.05)。两组患者PCI成功率均为100%, 术后两组患者靶血管TIMI血流均为3级, 术中无支架脱载, 且均行球囊预处理及后处理。1年随访结果显示:国产Firebird2^(TM)组与Endeavor组MACE发生率[3.1%(17/550)与2.2%(7/325)]以及各独立终点事件的发生率比较差异均无统计学意义(均P>0.05);两组患者生存率的比较差异亦无统计学意义(P>0.05)。结论国产支架Firebird2^(TM)雷帕霉素洗脱支架与进口Endeavor Resolute药物洗脱支架的临床疗效相同。

Objective To compare the safety and efficacy of domestic Firebird2^(TM) rapamycin eluting stent and imported Endeavor Resolute stent in the treatment of coronary heart disease patients.Methods The clinical data of 889 patients with coronary heart disease who underwent percutaneous coronary intervention(PCI)in Wuhan Asian heart hospital from 2010 to 2015 were analyzed retrospectively A case-control study was conducted.According to the type of stent used,550 cases were divided into domestic Firebird 2TM group and 325 cases were divided into imported endeavor resolve group The incidence of major adverse cardiovascular events(MACE)was compared between the two groups.All patients was followed up for 1 year.Results There was no significant difference in gender,age,body mass index,medical diseases,whether it was emergency PCI,previous PCI history,coronary artery bypass grafting history and left ventricular between the two groups(all P>0.05).The success rate of PCI in the two groups was 100%.The TIMI blood flow of target vessels in the two groups was grade 3.There was no stent unloading during the operation,and balloon pretreatment and post-treatment were performed.The results of one-year follow-up showed that there was no significant difference in the incidence of mace(3.1%(17/550)and 2.2%(7/325))and the incidence of independent end points between domestic Firebird 2TM group and endeavor group(all P>0.05);There was no significant difference in survival without mac between the two groups(P>0.05).Conclusion The domestic Firebird2^(TM) rapamycin eluting stent has the same clinical efficacy as the imported Endeavor Resolute drug eluting stent.