药物涂层球囊治疗膝下动脉硬化性狭窄或闭塞致严重下肢缺血

Drug-coated balloon for critical limb ischemia caused by subknee arteriosclerotic stenosis or occlusion

目的观察药物涂层球囊(DCB)治疗膝下动脉硬化性狭窄或闭塞致严重下肢缺血(CLI)的效果。方法回顾性分析96例膝下动脉硬化性狭窄或闭塞致CLI患者,其中50例接受DCB治疗(DCB组)、46例接受普通球囊治疗(对照组),比较2组治疗效果、安全性及预后。结果96例球囊均到达病变部位并成功完成扩张,未植入补救性支架。组间术前及术后即刻踝肱指数(ABI)、Rutherford分级及Wagner分级差异均无统计学意义(P均>0.05);术后6、12个月DCB组ABI高于、Rutherford分级及Wagner分级均低于对照组(P均<0.05)。术后6、12个月,DCB组一期通畅率均高于、管腔丢失均少于对照组(P均<0.05),组间截肢率差异均无统计学意义(P均>0.05)。Kaplan-Meier分析结果显示,术后12个月,DCB组免于临床驱动的靶病变血运重建率(CD-TLR)为89.81%,高于对照组的67.39%(P=0.0088)。结论DCB治疗膝下动脉硬化性狭窄或闭塞致CLI效果较好。

Objective To observe the effect of drug-coated balloon(DCB)for treating critical limb ischemia(CLI)caused by subknee arteriosclerotic stenosis or occlusion.Methods Totally 96 patients with CLI caused by subknee arteriosclerotic stenosis or occlusion were retrospectively analyzed,including 50 cases underwent DCB(DCB group)and 46 underwent conventional balloon treatment(control group).The efficacy,safety and prognosis were compared between groups.Results All balloon reached the lesion site,and balloon dilations were performed successfully in both groups without salvage stents.No significant differences of ankle branchial index(ABI),Rutherford grade nor Wagner grade was found between groups before operation and immediately after operation(all P>0.05).Six and 12 months after operation,ABI and Rutherford grade,as well as Wagner grade in DCB group were higher than those in control group(all P<0.05),the primary patency rate in DCB group were higher than that in control group,and the lumen loss in DCB group were lower than that in control group(all P<0.05).No significant difference of the rate of amputation between 2 groups 6 and 12 months after operation(both P>0.05).Kaplan-Meier analysis showed that 12 months after operation,the freedom from clinically-driven target lesion revascularization(CD-TLR)of DCB group was 89.81%,higher than that of control group(67.39%,P=0.0088).Conclusion DCB had good effect for treating CLI caused by stenosis or occlusion of lower extremity arteries.