Medium-term Safety And Efficacy Analysis Of Drug-coated Balloon In The Treatment Of Type TASC C/D Femoropopliteal Artery Lesions

Study Objective:This study conducted a single-center retrospective analysis of drug-coated balloon(DCB),percutaneous transluminal angioplasty(PTA)and Bare metal stent implantation(BMS)in the treatment of type TASC C/D femoropopliteal artery lesions,and the interim efficacy and incidence of adverse events in the three groups were compared,so as to provide a personalized surgical plan for the treatment of patients with complex femoropopliteal arteriosclerosis occlusion.Methods:The clinical data of patients with type TASC C/D femoropopliteal arteriosclerosis occlusion in the Department of Vascular Surgery of the Second Affiliated Hospital of Guangzhou Medical University retrospectively from June 2012 to June 2019 were selected.30 patients were included in the drug coated-balloon treatment group,31 cases in the group percutaneous transluminal angioplasty(PTA),and 29 cases in the group Bare metal stent(BMS),for patient with postoperative 1,6,12 and 24 months of follow-up,Follow-up process through artery doppler ultrasound or CT angiography(CTA)observation target vascular patency,three groups of patients with perioperative and postoperative complications and vascular patency,ankle brachial index(ABI),Rutherford classification,vascular restenosis,issue of patency rate,free of target lesion revascularization(TLR),late lumen loss(LLL)of target lesions,amputation rate within 1 year,all-cause mortality and other indicators,through SPSS 26.0 statistical software for two groups of patients with ABI,LLL,restenosis rate,the primary of patency rate follow-up indexes such as statistical analysis,compare the efficacy and safety of these indicators.Results:Accord with the standard set of 90 patients completed endovascular intracavitary treatment,aged 51-83 years old,The average age is 67.06±10.27 years old and lesion length is 21.10±3.57cm.There were 61 male patients and 29 female patients,including 43 of the left limb and 47 of the right limb,and 78 patients with hypertension.There were 48 cases of diabetes mellitus,43 cases of hyperlipidemia and 74 cases of patients with smoking history.There was 30 patients in DCB group,and the mean lesion length was 22.12±3.88cm.ABI of preoperative、one-month postoperative、half-year postoperative、12 month postoperative and 2-year postoperative respectively was 0.35±0.08,0.97±0.18,0.95±0.15,0.90±0.13,0.79±0.22.Perioperative complications occurred in 5 cases.In the PTA group of 31 patients,the average length of lesions was 21.05±3.58cm.ABI of preoperative、one-month postoperative、half-year postoperative、12-month postoperative and 2-year postoperative was 0.38±0.08,0.95±0.12,0.94±0.11,0.77±0.19,0.72±0.15 respectively.Perioperative complications occurred in 5 cases.In the BMS group of 29 patients,the average length of lesions was 20.10±3.00.The ABI was 0.33±0.09,0.94±0.11,0.91 ±0.17,0.86±0.18,0.88±0.17 before,1 month,6 months,12 months and 24 months after surgery,respectively.Perioperative complications occurred in 4 cases.Three groups of patients with preoperative baseline data,TASC classification,Rutherford classification changes,and number of subknee outflow tract were not statistically significant with clinical symptoms improve.There were statistically significant differences in ABI between the three groups at 12 and 24 months postoperative.The clinical efficacy evaluation indexes of DCB group and BMS group were higher than those of PTA group(p<0.05).The results of clinical efficacy evaluation indexes of DCB group were similar to those of BMS group 12 and 24 months postoperative.The restenosis rate was statistically significant among the three groups 24 months postoperative,and the DCB group was lower than BMS group and PTA group,The complications were hematoma at the puncture site,femoral arteriovenous fistula,dissection,thrombosis,and renal insufficiency.The incidence was similar in each group,and there was no statistical difference between the three groups.There was no significant difference in the 1-year amputation rate and 2-year transferred to the ICU due to heart failure during the re-examination.One patient in the PTA group died of stroke at home.Conclusions:1.DCB is effective in the treatment of type TASC C/D femoropopliteal arteriosclerosis occlusion.Postoperative ABI and primary restenosis rate are significantly improved.2.Compared with PTA and BMS,DCB has higher primary patency rate,free revascularization rate(CD-TLR)and lower late lumen loss(LLL)in the treatment of type TASC C/D femoropopliteal arteriosclerosis occlusion.3.The mid-term all-cause mortality rate and one-year amputation rate in DCB group are lower,and the mid-term efficacy is safe and reliable.