Acotec药物涂层球囊治疗下肢动脉硬化闭塞症的临床效果

Efficacy of Acotec drug⁃coated balloonforarteriosclerosis obliterans disease

目的评价Acotec药物涂层球囊(DCB)治疗下肢慢性缺血性疾病的有效性和安全性。方法回顾性分析2016年4月至2020年1月期间收治的427例经DCB治疗的下肢慢性缺血性疾病患者,平均年龄为(67.3±9.97)岁,其中男329例,女98例,共481条下肢有528处闭塞性和(或)狭窄性病变。分为两组,股腘动脉组(n=351)与膝下动作组(n=76)。每隔6个月对患者进行一次随访,主要评价终点包括晚期管腔丢失(LLL)、靶病变再狭窄、靶病变血运重建(TLR)和严重临床事件。结果技术成功率为97.5%。DCB血管成形术后,59例(13.8%)因血流受限夹层或残余狭窄大于50%而植入支架。中位随访时间为27个月。术后1、2、3年的平均LLL分别为(1.00±0.30)、(1.73±0.41)、(2.14±0.40)mm。术后1年再狭窄率17.1%vs.24.1%(P=0.151),18.4%vs.29.8%(P=0.070)和26.7%vs.36.7%(P=0.277)。血运重建率分别为8.0%vs.16.5%(P=0.032),9.9%vs.19.3%(P=0.065)和15.9%vs.23.3%(P=0.303)。结论Acotec DCB治疗下肢慢性缺血性疾病安全有效,股腘动脉的临床结局优于膝下动脉。

Objective To evaluate the efficacy and safety of Acotec drug⁃coated balloon(DCB)for chronic ischemic disease in lower extremity.Methods Clinical data of 427 patients with 528 occlusive/stenotic lesions in 481 lower extremities treated by DCB from April 2016 to January 2020 were retrospectively analyzed.The mean age was 67 years.Rutherford stage 2,3,4,5,and 6 were classified in 12(2.5%),168(34.9%),179(37.2%),94(19.5%),and 28(5.8%)limbs,respectively.The mean length of the targeted lesions was 228.5 mm.Of all lesions,433 were located at femoral and/or popliteal arteries,and 95 were at infra⁃popliteal arteries.All the patients were followed up for 6 months.The major evaluation endpoints included late lumen loss(LLL),target lesion restenosis,target lesion revascularization(TLR),and severe clinical events including mortality and major amputation.Results The technique success rate was 97.5%.Stents were placed in 59(13.8%)cases for flow⁃limited dissections or remnant stenosis greater than 50%after DCB angioplasty.The median follow⁃up time was 27months(12~45 months).The mean LLL was(1.00±0.30),(1.73±0.41),(2.14±0.40)mm,respectively,1,2,and 3 years after operation.The restenosis rate at 1,2 and 3⁃year was 17.1%vs.24.1%(P=0.151),18.4%vs.29.8%(P=0.070),and 26.7%vs.36.7%(P=0.277),respectively,in femoropopliteal and BTK arm,and the TLR rate was 8.0%vs.16.5%(P=0.032),9.9%vs.19.3%(P=0.065),and 15.9%vs.23.3%(P=0.303),respectively.Twenty⁃three patients died and 33 received major amputation.Conclusions Acotec DCB was safe and effective in treating chronic ischemic diseases of lower extremities.Compared with infrapopliteal arteries,a better clinical outcome was achieved in femoro⁃popliteal arteries.