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国产与进口雷帕霉素洗脱支架在冠状动脉粥样硬化性心脏病中的疗效比较

Effect comparison of domestic rapamycin eluting stent versus imported rapamycin eluting stent in patients with coronary atherosclerotic heart disease

  • 摘要: 目的:比较国产雷帕霉素药物洗脱支架(Firebird 2)和进口雷帕霉素药物洗脱支架(Cypher Select)在冠状动脉粥样硬化性心脏病(冠心病)患者经皮冠状动脉介入术中的临床疗效。方法:选择2010年5月—2011年12月在上海市第六人民医院心内科采用雷帕霉素药物洗脱支架治疗的冠心病患者。根据植入支架种类分为Firebird 2组和Cypher组。随访时间25~40个月,平均 (32.54±3.90)个月,其中Firebird 2组完成随访139例,Cypher组完成随访125例。比较两组患者随访期间主要心血管不良事件(MACE,包括心源性死亡、非致死性心肌梗死、靶血管再次血运重建)以及支架内再狭窄、确定的支架内血栓发生情况。结果:Firebird 2组男性患者比例低于Cypher组(P<0.05)。Firebird 2组患者血浆N末端B型钠尿肽前体(NTproBNP)含量、靶病变长度、每处病变植入支架数大于Cypher组(P<0.05)。Firebird 2组患者和Cypher组患者在心源性死亡(4.3% vs 3.2%)、非致死性心肌梗死(1.4% vs 1.6%)、靶血管再次血运重建(4.3% vs 5.6%)、MACE(9.4% vs 8.8%)方面差异均无统计学意义。Firebird 2组患者和Cypher组患者支架内再狭窄、确定的支架内血栓发生差异亦无统计学意义。Logistic回归分析显示:年龄(OR=1.11,95%CI 1.05~1.18,P=0.000)、糖尿病(OR=2.70,95%CI 1.02~7.15,P=0.045)是随访期间MACE发生的独立危险因素;支架种类(OR=0.88,95%CI 0.34~2.24,P=0.782)不是MACE发生的独立危险因素。结论:Firebird 2雷帕霉素药物洗脱支架和Cypher雷帕霉素药物洗脱支架在冠心病治疗中的长期临床疗效及安全性基本类似。

     

    Abstract: Objective:To compare the application effects of domestic polymer based rapamycin eluting stent (Firebird 2) and imported polymer based rapamycin eluting stent (Cypher Select) in percutaneous coronary intervention for patients with coronary atherosclerotic heart disease (CHD). Methods:CHD patients who were treated with polymer based rapamycin eluting stent from May 2010 to December 2011 at Shanghai Sixth People’s Hospital were enrolled. Patients were divided into the Firebird 2 group (n=139) and the Cypher group(n=125). The followup period was 2540 months, average (32.54±3.90)months. Major adverse cardiovascular events (MACE, include cardiac death, nonfatal myocardial infarction, revascularization), instent restenosis, and definite stent thrombosis during followup period were collected and analyzed. Results:Compared with Cypher group, patients in Firebird 2 group had lower rate of male patients (P<0.05), higher levels of Nterminal proBtype natriuretic peptide (NT proBNP), longer target lesion, and the number of stents implanted per lesion was greater (P<0.05). Incidences of cardiac death(4.3% vs 3.2%), nonfatal myocardial infarction(1.4% vs 1.6%), revascularization(4.3% vs 5.6%), MACE(9.4% vs 8.8%), instent restenosis and definite stent thrombosis all had no significant differences between the two groups. Logistic regression analysis showed that age(OR=1.11,95%CI 1.051.18,P=0.000), diabetes (OR=2.70,95%CI 1.027.15, P=0.045) were independent risk factors of MACE, stent type(OR=0.88,95%CI 0.342.24, P=0.782) was not an independent risk factor of MACE. Conclusions:Firebird 2 rapamycin eluting stent and Cypher rapamycin eluting stent have similar longterm clinical efficacy and safety in the treatment of CHD.

     

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