药物涂层球囊治疗股腘动脉硬化闭塞症真实临床结果

Clinical outcomes of drug-coated balloon for the treatment of femoropopliteal arteriosclerosis obliterans

目的探讨现实临床中药物涂层球囊(DCB)治疗股腘动脉硬化闭塞症的安全性和有效性。方法回顾性分析2017年4月至2022年9月在南京医科大学附属南京医院接受OrchidⓇDCB治疗的股腘动脉硬化闭塞症患者临床资料。主要观察指标为末次随访时患肢一期和二期通畅情况。次要观察指标包括技术成功率及随访期主要不良事件(MAE)截肢、病变段血栓形成及全因死亡。使用Kaplan-Meier法分析评估患肢通畅率,Cox比例风险模型分析确定影响一期通畅率的风险因素。结果共入组146例患者(163条患肢),年龄为(71.7±9.7)岁;病变长度为(276.60±112.61)mm;97条(59.5%)患肢存在重症下肢缺血(CLI),57条(35.0%)患肢为股腘动脉病变。术后随访(583.2±261.84)d。MAE发生率为8.9%(13/146),死亡率为5.5%(8/146)。Kaplan-Meier分析显示,术后1、2、3年一期通畅率分别为92.2%、78.1%、69.0%,二期通畅率分别为97.2%、87.5%、74.7%。Cox比例风险模型分析显示,CLI是影响一期通畅率的风险因素。Kaplan-Meier分析显示,术后1、2、3年一期通畅率在间歇性跛行组分别为98.2%、89.1%、82.3%,CLI组分别为88.2%、78.0%、56.6%。CLI组的MAE发生率为16.5%(15/91)。结论DCB治疗股腘动脉硬化闭塞症安全有效,间歇性跛行组疗效优于CLI组。

Objective To investigate the safety and effectiveness of OrchidⓇdrug-coated balloon(DCB)dilatation for the treatment of femoropopliteal arteriosclerosis obliterans.Methods The clinical data of patients with femoropopliteal arteriosclerosis obliterans,who received OrchidⓇDCB dilatation treatment at the Affiliated Nanjing Hospital of Nanjing Medical University of China between April 2017 and September 2022,were retrospectively analyzed.The main observation indicators were the primary and secondary patency rates of the diseased limb at the last follow-up visit.The secondary observation indicators included technical success rate and major adverse events(MAE)occurring during the follow-up period,including amputation,thrombosis in the lesion segment,and all-cause mortality.Kaplan-Meier analysis was used to estimate the patency rates,and Cox proportional hazard model was used to determine the risk factors affecting the primary patency rate.Results A total of 146 patients(163 affected limbs in total)were enrolled in this study.The mean age was(71.7±9.7)years,the mean length of lesion was(276.60±112.61)mm.A total of 97 affected limbs(59.5%)had critical limb ischemia(CLI),and 57 affected limbs(35.0%)were femoropopliteal artery lesions.The patients were followed up for a mean of(583.20±261.84)days.The incidence of MAE was 8.9%(13/146),and the mortality was 5.5%(8/146).Kaplan-Meier analysis showed that the postoperative one-,2-and 3-year primary patency rates were 92.2%,78.1%and 69.0%respectively,and the postoperative one-,2-and 3-year secondary patency rates were 97.2%,87.5%and 74.7%respectively.Cox proportional hazard model analysis revealed that CLI was a risk factor affecting the primary patency rate.Kaplan-Meier analysis indicated that the postoperative one-,2-and 3-year primary patency rates in the intermittent claudication group were 98.2%,89.1%and 82.3%respectively,which in the CLI group were 88.2%,78.0%and 56.6%respectively.The incidence of MAE in the CLI group was 16.5%(15/91).Conclusion For the treatment of femoropopliteal arteriosclerosis obliterans,DCB dilatation treatment is clinically safe and effective,its therapeutic effect in intermittent claudication group is superior to that in CLI group.