Short And Medium Term Observation Of Drug Coated Balloon In The Treatment Of In-stent Restenosis In Lower Extremity Arteriosclerosis Obliterans

Objective:The aim of this study was to estimate the efficacy and safety of drug-coated balloon（DCB）in the treatment of in-stent restenosis（ISR）of lower extremity arteriosclerosis obliterans（LEASO）.Methods:This study is a prospective,single arm,single center observational study.From June 2018 to September 2020,a total of 30 patients（30 limbs）with ISR were enrolled in this study.Thirty patients were prospectively treated with DCB.The primary patency rate at 12 months was the primary end point.The primary safety endpoints included perioperative death（30 days before and after surgery）,all-cause death and main target limb amputation.The secondary end points were improvement of Rutherford classification at 6 and 12 months,and improvement of clinically driven target lesion revascularization（CD-TLR）and ankle brachial index（ABI）at 12 months.In addition,the patency of patients with different TOSAKA types of ISR at 12 months was compared.Results: At baseline,there were 20 males and 10 females with an average age of 72.57 ±6.21 years old.Rutherford grade was 2-5 and the average lesion length was 14.18 ±4.91 cm,The cases of TOSAKA type I,type II and type III were 11,10 and 9 respectively..The Rutherford grade was significantly improved at 3 days,6 months and 12 months after operation（all P < 0.05）.ABI of 3 days and 12 months after operation were 0.82 ± 0.11 and 0.78 ± 0.13 respectively,which were significantly improved compared with 0.29 ±0.11 at baseline（all P < 0.05）;According to Kaplan Meier estimation,the primary patency rate was 85.7% at 12 months and the freedom from CD-TLR was 89.3% at 12 months.No adverse events related to DCB were observed.At 12 months after operation,the number of restenosis cases of TOSAKA type I,type II and type III were 0,0 and 4 respectively.The incidence of restenosis in patients with TOSAKA type III was significantly higher than that in patients with TOSAKA type I and type II（P < 0.05）.Conclusion: In the short and medium-term observation,DCB is safe and effective in the treatment of ISR in patients with LEASO after stent implantation.The therapeutic effect of drug coated balloon in the treatment of TOSAKA Ⅲ in stent restenosis is worse than TOSAKAⅠand Ⅱ.