药物涂层球囊治疗老年下肢动脉硬化闭塞症经皮穿刺血管腔内成型术术后支架内再狭窄的疗效及安全性

Efficacy and safety of drug-coated balloon in the treatment of in-stent restenosis after percutaneous transluminal angioplasty for lower extremity arteriosclerosis obliterans in the elderly

目的研究药物涂层球囊治疗老年下肢动脉硬化闭塞症经皮穿刺血管腔内成型术术后支架内再狭窄的疗效及安全性。方法选取同济大学附属杨浦医院2018年1月至2020年6月期间收治的150例老年下肢动脉硬化闭塞症患者作为研究对象。按照随机数表法分为研究组和对照组各75例。对照组患者采用常规球囊治疗,研究组患者采用药物涂层球囊治疗。两组患者均进行经皮穿刺血管腔内成型术,术后1年进行随访,记录并比较两组患者的一期通畅率、靶病变处血运重建率、再狭窄率、治疗前后踝肱指数、靶动脉血管狭窄程度、靶动脉血管内径及不良事件发生情况。结果研究组患者的一期通畅率、靶病变处血运重建率分别为93.33%、86.67%,明显高于对照组的66.67%、60.00%,再狭窄率为8.00%,明显低于对照组的53.00%,差异均有统计学意义(P<0.05);治疗前,两组患者的踝肱指数、靶动脉血管狭窄程度、靶动脉血管内径比较差异均无统计学意义(P>0.05),治疗后,研究组患者的踝肱指数、靶动脉血管狭窄程度、靶动脉血管内径分别为0.72±0.16、(25.03±5.78)%、(7.92±0.06)mm,对照组患者的踝肱指数、靶动脉血管狭窄程度、靶动脉血管内径分别为0.49±0.18、(58.62±6.12)%、(7.21±0.16)mm,两组患者的踝肱指数、靶动脉血管内径均明显升高,且研究组明显高于对照组,两组患者的靶动脉血管狭窄程度明显降低,且研究组明显低于对照组,差异均有统计学意义(P<0.05);研究组患者术后不良事件总发生率为4.00%,略低于对照组的9.33%,但差异无统计学意义(P>0.05)。结论药物涂层球囊治疗老年下肢动脉硬化闭塞症经皮穿刺血管腔内成型术术后支架内再狭窄可有效地改善患者的一期通畅率、靶病变处血运重建率,降低患者的再狭窄率,且安全性高,具有临床应用价值。

Objective To study the efficacy and safety of drug-coated balloon in the treatment of in-stent restenosis after percutaneous transluminal angioplasty for lower extremity arteriosclerosis obliterans in the elderly.Methods A total of 150 elderly patients with lower extremity arteriosclerosis obliterans treated in Yangpu Hospital Affiliated to Tongji University from January 2018 to June 2020 were selected as the research objects.According to the random number table method,they were divided into a study group and a control group,with 75 patients in each group.The patients in the control group were treated with conventional balloon,and the patients in the study group were treated with drug-coated balloon.The patients in both groups underwent percutaneous transluminal angioplasty and were followed up one year after operation.The primary patency rate,target lesion revascularization rate,restenosis rate,ankle brachial index,target artery stenosis degree,target artery diameter,and adverse events were recorded and compared between the two groups.Results The primary patency rate and revascularization rate of target lesions in the study group were 93.33%and 86.67%,which were significantly higher than 66.67%and 60.00%in the control group,and the restenosis rate was 8.00%,which was significantly lower than 53.00%in the control group,all with statistically significant difference(P<0.05).Before treatment,there was no significant difference in ankle brachial index,target artery stenosis,and target artery diameter between the two groups(P>0.05);after treatment,the ankle brachial index,target artery stenosis,and target artery diameter were 0.72±0.16,(25.03±5.78)%,(7.92±0.06)mm in the study group,and 0.49±0.18,(58.62±6.12)%,(7.21±0.16)mm in the control group;the ankle brachial index and target artery diameter in the two groups were significantly increased compared with those before treatment,and those in the study group were significantly higher than those in the control group;the degree of target artery stenosis in the two groups was significantly reduced compared with that before treatment,and that in the study group was significantly lower than that in the control group;the differences were all statistically significant(P<0.05).The total incidence of postoperative adverse events in the study group was 4.00%,slightly lower than 9.33%in the control group,but there was no significant difference between the two groups(P>0.05).Conclusion Drug-coated balloon in the treatment of in-stent restenosis after percutaneous transluminal angioplasty in elderly patients with lower extremity arteriosclerosis obliterans can effectively improve the primary patency rate and the revascularization rate of target lesions,and reduce the restenosis rate of patients,which is safe and has significant clinical application value.