紫杉醇药物球囊治疗股腘动脉硬化性闭塞症的早期临床结果分析

Short-term efficacy of paclitaxel-coated balloon in the treatment of femoropopliteal artery disease

目的:评价紫杉醇药物涂层球囊(drug-coated balloon,DCB)在股腘动脉粥样硬化性闭塞症(arteriosclerosis obliterans,ASO)腔内治疗中的安全性及有效性。方法:对2016年12月至2018年12月在上海交通大学医学院附属仁济医院血管外科连续收治并接受DCB治疗的慢性股腘动脉闭塞患者的随访资料进行回顾性分析。评价腔内操作的围手术期并发症发生率、术后12个月靶血管一期通畅率、一期辅助通畅率、二期通畅率、免于临床症状驱动的靶病变血运重建率(freedom from clinically-driven target lesion revascularization,F-TLR)、大截肢率以及全因死亡率。结果:83例患者(95条下肢)接受了DCB治疗。其中慢性完全闭塞病变(chronic total occlusion,CTO)50条(52.6%),平均病变长度为(18.35±10.61)cm,中重度钙化病变24条(25.3%)。一期补救性支架植入率29.5%。中位随访时间17.5个月。术后12个月全因死亡率6.0%、大截肢率为4.3%、一期通畅率60.6%、一期辅助通畅率72.4%、二期通畅率83.4%、F-TLR为77.0%。中重度钙化是影响DCB术后通畅率的独立危险因素。结论:DCB是一种安全有效的股腘动脉硬化性闭塞症的血管腔内治疗手段。

Objective To evaluate the efficacy and safety of drug-coated balloon(DCB)with paclitaxel in the treatment of femoropopliteal arteriosclerosis obliterans(ASO).Methods From Dec 2016 to Dec 2018,clinical data of femoropopliteal artery disease patients treated with paclitaxel DCB in Renji Hospital,School of Medicine,Shanghai Jiaotong University were retrospectively analyzed.Results A total of 83 patients(95 lower limbs)underwent DCB therapy.Including 50 chronic total occlusion(CTO)lesions(52.6%)with mean lesion length of(18.35±10.61)cm.Twenty-four lesions(25.3%)were moderately or severely calcified.Bail-out stent implantation was performed in 29.5%cases.The mean follow-up time was 17.5 months.Twelve months after intervention,the all-cause mortality rate was 6.0%,the major amputation rate was 4.3%,the primary patency rate was 60.6%,the primary assisted patency rate was 72.4%,the secondary patency rate was 83.4%,and the freedom rate from clinically-driven target lesion revascularization(F-TLR)was 77.0%.Moderate to severe calcification was an independent risk factor for the primary patency of DCB therapy.Conclusion DCB is a safe and effective endovascular therapy for femoropopliteal artery disease.