【摘要】 目的比较国产BuMA生物降解药物涂层支架与进口XIENCEⅤ支架临床疗效及手术治疗费用。方法 100例符合行经皮冠状动脉介入治疗指征患者,非随机分为BuMA支架组和XIENCEⅤ支架组各50例。分别观察两组手术即刻成功率、手术相关并发症及手术治疗费用,同时观察术后12个月主要心血管事件(MACE)的发生情况。结果两组患者冠状动脉病变支数比较差异无统计学意义(χ2=0.179,P=0.914)。两组患者冠状动脉病变特征及复杂病变例数、支架置入部位分布比较差异无统计学意义(P>0.05)。所有患者术中均顺利,即刻成功率为100%,无血栓、血管夹层现象发生,其中BuMA支架组中,1例为严重钙化病变,经旋磨治疗后顺利置入支架。两组各有1例在急诊手术处理右冠状动脉急性闭塞病变时出现慢血流现象,经冠状动脉内使用维拉帕米后,血流均恢复,术后造影靶血管血流均为TIMI 3级。两组在支架置入数量上差异无统计学意义(采用秩和检验比较,Z=-1.081,P=0.280)。但在手术治疗费用方面,XIENCEⅤ支架组中位数为59 568(37 984~110 025)元,BuMA支架组中位数为43 077(27 362~83 856)元,两组比较差异有统计学意义(Z=-3.895,P<0.001)。术后随访12个月,两组各有1例再发心肌缺血事件,其中BuMA支架组1例术后3个月自行停用双联抗血小板及他汀类药物治疗,复查造影提示右冠状动脉支架远端再狭窄,经切割球囊扩张后症状缓解。BuMA支架组14例复查冠状动脉造影,除前述1例再狭窄外,1例支架远端边缘节段有轻度内膜增生,但狭窄程度小于20%,余均未见明显新生内膜增生迹象。XIENCEⅤ支架组15例复查造影,1例支架中段轻度内膜增生,狭窄程度小于20%,余均未见明显新生内膜增生。BuMA支架组轻度内膜增生发生率为7.1%,XIENCEⅤ支架组轻度内膜增生发生率为6.7%,经Fisher确切概率法检验,两组数据差异无统计学意义(P>0.999)。结论国产BuMA生物降解药物涂层支架与进口XIENCEⅤ支架比较,其临床安全性和近、中期疗效相似,但手术治疗费用明显减少。更多还原

【Abstract】 Objective To investigate the efficacy,safety and costs of domestic BuMA stent and imported XIENCE Ⅴ stent in patients undergoing percutaneous coronary intervention( PCI). Methods One hundred patients with coronary artery disease,who were to received percutaneous coronary intervention therapy,were nonrandomized into XIENCE Ⅴ Group( n = 50) and BuMA Group( n = 50). The operation success rates,operation-correlated complications and cost were compared. The major adverse cardiovascular events( MACE) after 12 months of PCI were also observed. Results There was no significant difference in age,sex,hypertension,diabetes mellitus,smoking history,myocardial infarction history and the lesion characteristics of the affected vessels between the 2 groups. The operation success rates were 100% in both groups. There was 1 sub-acute thrombosis in the XIENCE Ⅴ group and 1 restenosis in the BuMA group and revascularization was performed for both. In the 14 and the 15 cases received coronary angiography in the BuMA group and the XIENCE Ⅴ group respectively,one case of mild neointimal hyperplasia were reported in both group without significant difference revealed( 7. 1% vs. 6. 7%,P > 0. 05). No statisticallysignificant difference in the number of stents was found between groups,but the cost of BuMA group was decreased significantly compared with XIENCE Ⅴ group( Median 59 568 yuan vs. 43 077 yuan,P < 0. 01). Conclusions Compared the domestic BuMA stents with imported XIENCE Ⅴ stent,the clinical safety and efficacy in short and medium-term are similar with significant reduction in cost.更多还原