Clinical Effect Of Drug-coated Balloon In The Treatment Of In-stent Restenosis In Superficial Femoral Artery

ObjectiveTo observe the mid and long-term clinical outcome of drug-coated balloon angioplasty in treatment of in-stent restenosis(ISR)after stent implantation in superficial femoral artery.MethodDatas of 53 patients with superficial femoral artery ISR treated from October 2016 to October 2018 in the fifth affiliated hospital of Zhengzhou University were analyzed.According to different treatment methods,they were divided into two groups:Drug-coated balloon angioplasty in 32 cases(DCB group),including 19 males,mean age(60.75±8.79)years,mean lesion length(15.50±5.38)cm;plain old balloon angioplasty in 21 cases(POBA group),including 14 males,mean age(62.19±7.38)years,mean lesion length(14.32 ± 6.55)cm.After an average of 24 months follow-up,the outcomes of clinical improvement,ankle brachial index(ABI),Rutherford classification,and major adverse events were recorded and analyzed by SPSS22.0 at 7 days,3,6,12,and 24 months.The mid and long-term clinical effect of the two methods was compared through the patency rate and freedom from target lesion revascularization(TLR).ResultThe operation success rate was 100% in both groups,no correlative complications(such as arterial dissection,vascular rupture,acute thrombosis,etc.)occurred.The perioperative complications in DCB group and POBA group were 9.4% and 4.8%,respectively,and the major adverse events at 24 months was 3.1% and 4.8%,respectively.There was no significant difference in the salvage rate of the stents between the two groups(12.5% vs.9.5%).The target vessel primary patency rate at 3,6,12,and 24 months after operation in DCB group and POBA group were 96.9%,87.5%,81.3%,65.6% vs.85.7%,57.1%,38.1%,23.8%.Log-rank test analysis showed that the DCB group had a higher long-term patency rate than POBA group(P<0.05).Freedom from target lesion revascularization(TLR)of the two groups at 3,6,12,and 24 months were 96.9%,93.7%,87.5%,78.1%,and 85.9%,81.0%,52.4%,and 33.3%,respectively.The intentional analysis showed that the freedom from TLR after operation in the DCB group was significantly higher than that in the POBA group(P<0.05).The ABI of postoperative was significantly higher than that of preoperative between the two groups.There was no significant difference between 7 days ABI,3 months ABI and 6 months ABI in the two groups(P>0.05),but at 12 and 24 months,DCB group showed a great advantage in ABI compared to POBA group(P<0.05).Compared with preoperative,except 1 patient in the POBA group had no improvement in clinical symptoms,and the other 52 patients showed different degrees of improvement in clinical symptoms.100% of DCB group and 95.2 of POBA group received mild and above clinical improvement after operation,respectively.It showed no significant differences in clinical improvement at 7 days,3 and 6 months(P>0.05)and differences at 12 and 24 months(P<0.05)in the two groups.ConclusionDrug-coated balloon has an better mid and long-term efficacy in the treatment of superficial femoral artery in-stent restenosis compared with plain old balloon angioplasty,which is a safe and effective treatment strategy.