药物涂层球囊治疗TASC Ⅱ C/D级股腘动脉原发和支架内再狭窄病变的疗效观察

Efficacy of drug-coated balloons in treatment of TASCⅡC/D femoro-popliteal artery de novo stenosis and in-stent restenosis

目的评价药物涂层球囊(DCB)治疗股腘动脉外周动脉疾病管理跨大西洋学会间共识Ⅱ(TASCⅡ)C/D级原发病变和支架内再狭窄病变的中期临床疗效。方法回顾性分析2016年12月至2020年8月上海交通大学医学院附属仁济医院血管外科和上海市浦东新区人民医院普外科血管外科组行DCB治疗的126例TASCⅡC/D级股腘动脉病变患者资料,其中74例为股腘动脉病变未接受过腔内治疗者(原发病变组)、52例为有腔内治疗植入支架史者(支架内再狭窄组)。比较两组患者资料,评价围手术期并发症、一期及其辅助通畅率、二期通畅率,免于临床驱动的靶病变血管血运重建(f-TLR)通畅率及病死率、截肢率。采用Kaplan-Meier法评估靶血管通畅率,应用Cox逐步回归分析评估各因素相关风险度。结果原发病变组和支架内再狭窄组的病变长度分别为(21.25±12.64)和(34.71±12.02)cm,差异有统计学意义(t=33.74,P<0.001);病变累及到腘动脉P2、P3段者比例分别为33.8%(25/74)和15.4%(8/52),差异有统计学意义(χ^(2)=5.35,P=0.021);术前流出道评分(χ^(2)=3.54,P=0.170)、术后流出道评分(χ^(2)=0.77,P=0.679)、中重度钙化比例(χ^(2)=0.26,P=0.614)、小腿流出道重建比例(χ^(2)=0.62,P=0.431)差异均无统计学意义。手术均成功,成功率100.0%(126/126);围术期并发症发生率分别为6.8%(5/74)和1.9%(1/52)。原发病变组和支架内再狭窄组的中位随访时间分别为22(19.78±11.02)和17(20.02±11.32)个月,各有6例死亡;Kaplan-Meier法评估的术后6、12、24个月时一期通畅率分别为89.1%、73.4%、50.8%和87.8%、68.8%、42.0%,一期辅助通畅率分别为90.7%、78.4%、62.8%和89.3%、77.1%、62.8%,二期通畅率分别为95.1%、95.1%、88.7%和94.9%、88.9%、84.3%,f-TLR通畅率分别为97.3%、88.6%、79.2%和90.0%、77.7%、74.7%,两组比较,差异均无统计学意义(均P>0.05)。腘动脉P2、P3段受累为影响靶病变通畅率的相关因素(χ^(2)=9.22,P=0.033)。结论DCB治疗股腘动脉TASCⅡC/D级原发病变和支架内再狭窄病变的中期临床疗效较好。

Objective To evaluate the mid-term clinical efficacy of drug-coated balloons(DCB)in the treatment of femoro-popliteal artery TASCⅡC/D de novo stenosis and in-stent restenosis.Methods A total of 126 patients with TASCⅡC/D femoro-popliteal artery stenosis treated with DCB in Renji Hospital and Pudong New Area People's Hospital from December 2016 to August 2020 were retrospectively enrolled,including 74 cases of de novo stenosis(de novo group)and 52 cases of in-stent restenosis(ISR group).The clinical data and lesion characteristics were analyzed;the primary patency rate,primary-assisted patency rate,secondary patency rate,and the freedom from target lesion revascularization(f-TLR)rate were evaluated;the perioperative complications,mortality and amputation rate were compared between two groups.Kaplan-Meier method was used to evaluate the patency rate of target vessel lesions,and Cox regression analysis was used to evaluate the relative risk factors.Results There were 6 patients died in each group during the followup period.The lesion length of the de novo and ISR groups were(21.25±12.64)cm and(34.71±12.02)cm,respectively(t=33.74,P<0.001).The popliteal artery involvement was 33.8%(25/74)in the de novo group and 15.4%(8/52)in the ISR group(χ2=5.35,P=0.021).The operational success rate was 100.0%in both groups,and the perioperative complication rate was 6.8%(5/74)in the de novo group and 1.9%(1/52)in ISR group.The median follow-up time was 22 month and 17 months;the mean follow-up time were(19.78±11.02)months and(20.02±11.32)months in the de novo group and ISR group,respectively.The primary patency rates at 6,12 and 24 months after intervention were 89.1%,73.4%,50.8%in the Denovo group,and 87.8%,68.8%,42.0%in the ISR group,respectively;the primary assisted patency rate was 90.7%,78.4%,62.8%in the de novo group,and 89.3%,77.1%,62.8%in the ISR group,respectively;the secondary patency rate was 95.1%,95.1%,88.7%in de novo group,and 94.9%,88.9%,84.3%in ISR group,respectively;the f-TLR rate was 97.3%,88.6%,79.2%in de novo group,and 90.0%,77.7%,74.7%in ISR group,respectively(all P>0.05).Cox regression analysis showed that P2 and P3 segment involvement of the popliteal artery were independent factors affecting the patency rate of target lesion.Conclusions The mid-term clinical efficacy of DCB in the treatment of TASCⅡC/D femoro-popliteal artery de novo stenosis and in-stent restenosis is satisfactory.