紫杉醇药物球囊在药物洗脱支架术后支架内再狭窄的应用价值分析

Application value of paclitaxel coated balloon in-stent restenosis after drug eluting stent

目的研究紫杉醇药物球囊在药物洗脱支架(DES)术后支架内再狭窄病变中的应用价值,评估其安全性及有效性。方法选取2015年7月1日至2017年3月31日共57例DES植入术后再发冠心病症状而入院的患者。分为再次植入DES组(31例)及紫杉醇药物球囊(PCB)组(26例)。术后12个月复查冠状动脉造影,对比两组患者最小管腔内径、晚期管腔丢失内径、管腔狭窄率、再狭窄率(类型)及主要不良心血管事件(MACE)的发生率。结果DES组及PCB组的临床基线资料、再狭窄血管特点(冠状动脉再狭窄病变的数量、再狭窄病变的分布及类型)、治疗前参考血管直径、最小管腔直径、管腔狭窄率差异均无统计学意义(P>0.05)。PCB组的术后即刻最小管腔直径更小[(2.56±0.35)mmvs.(3.02±0.28)mm,P<0.001]、治疗后的血管残余狭窄率则更高[(15.34±2.38)%vs.(13.64±2.39)%,P=0.005]。术后12个月复查冠状动脉造影,两组患者最小管腔直径[(2.02±0.57)mmvs.(1.99±0.88)mm,P=0.877]、管腔丢失内径[(0.88±0.68)mmvs.(1.03±0.84)mm,P=0.420]、管腔狭窄率[(33.55±19.26)%vs.(38.51±26.02)%,P=0.380]差异均无统计学意义。两组患者经治疗后的病变处其再狭窄的发生率、再狭窄的发生类型的差异无统计学意义(P>0.05)。在介入治疗术后的第12个月对患者随访,两组均未出现死亡病例,两组间MACE的发生率同样差异无统计学意义(22.6%vs.15.4%,P=0.493)。结论PCB治疗DES术后支架内病变时,其安全性与有效性与再次植入支架相当,可用于支架内再狭窄的治疗。

Objective To study the application value of paclitaxel coated balloon in in-stent restenosis after drug eluting stent(DES),and to assess its safety and effectiveness.Methods A total of 57 patients hospitalized for symptoms of coronary heart disease after DES implantation from July 1,2015 to March 31,2017 were included.The patients were divided into the DES reimplantation group(31 cases)and the paclitaxel coated balloon(PCB)treatment group(26 cases).Coronary angiography was performed 12 months after surgery to compare the incidence of minimal lumen diameter,late lumen loss diameter,lumen stenosis rate,secondary stenosis rate(type),and major adverse cardiovascular events(MACE)in the two groups.Results There was no statistical difference in the DES group and the PCB group in baseline data,the characteristics of restenosis vessels(the number of restenosis lesions,the distribution and type of restenosis lesions in coronary artery),the reference vessel diameter before treatment,the minimal lumen diameter,and the stenosis rate of lumen(P>0.05).In the PCB group,the immediate minimum lumen diameter was smaller[(2.56±0.35)mmvs.(3.02±0.28)mm,P<0.001],and the residual vascular stenosis rate was higher[(15.34±2.38)%vs.(13.64±2.39)%,P=0.005].After 12 months of coronary angiography,there was no statistical difference in the minimal lumen diameter of the two groups[(2.02±0.57)mmvs.(1.99±0.88)mm,P=0.877],the diameter of the late lumen loss[(0.88±0.68)mmvs.(1.03±0.84)mm,P=0.420],and the lumen diameter stenosis rate[(33.55±19.26)%vs.(38.51±26.02)%,P=0.380].There was no significant difference in the incidence of secondary restenosis and the occurrence type of secondary restenosis between the two groups(P>0.05).At 12 months of following-up after interventional therapy,there was no deaths in either group,and there was no statistically significant difference in the incidence of MACE between the two groups(22.6%vs.15.4%,P=0.493).Conclusion The safety and efficacy of PCB in the treatment of stent lesions after DES are comparable to that of re-implantation of stent,which can be used for the treatment of in-stent restenosis.