Efficacy Of Drug-coated Balloon With Paclitaxel In The Treatment Of Femoral-popliteal Atherosclerotic Occlusive Disease

Objective:Peripheral arterial disease is a serious threat for people's health and the quality of life in today's society,even life.Femoral popliteal artery occlusive disease is the most common PAD,which is the hot and difficult treatment currently.In order to explore the efficacy and safety of the drug paclitaxel coated balloon(DCB)in the treatment of femoral popliteal artery occlusive disease,the objective of the test is to contrast and investigate the efficacy of DCB and plain old balloon angioplasty ordinary balloon angioplasty,(POBA)in the treatment of femoral popliteal artery occlusive disease.Methods:Collected the clinical data of 49 patients,who were diagnosed as femoral popliteal artery occlusive disease from May 2016 to May 2017 in Department of Vascular Surgery in Fifth Affiliated Hospital of Zhengzhou University,and will be selected randomly assigned to DCB treatment group(n=25)and POBA treatment group(n=24).All occlusive lesions involve the superficial femoral or popliteal artery and all patients had moderate or severe intermittent claudication or ischemic rest pain(Rutherford grade 2–5).Patients were followed up at 3,6 and 12 month postoperative.The results of complication,ankle brachial index(ABI),Rutherford classification,minimum lumen diameter(MLD)and late lumen loss(LLL)were recorded.Then to compare LLL,ABI,Rutherford classification,target vessel patency rate,restenosis rate,thrombosis rate and amputation rate.In order to explore the comparison of DCB and POBA in the treatment of femoral popliteal artery occlusive disease.Results:The 49 cases of patients were successfully operated,no amputation or death cases,no loss of prevention.1.Surgery and perioperative complications: DCB group of patients with intermittent claudication distance from preoperative(84 ± 68)m to improve the postoperative(468 ± 92)m,the difference was statistically significant(P < 0.05),ankle brachial index from preoperative(0.24 ± 0.31)to improve the postoperative(0.71±0.12),the difference was statistically significant(P < 0.05).Among them,1 cases of pulmonary infection were cured by antiseptic drugs.1 cases of hematoma at the puncturing point were treated with local pressure dressing and disappeared after 7-9 days.The incidence of complications was 8%(2/25).The interval of intermittent claudication in group POBA was increased from(79± 70)m before operation to(449 ±98)m after operation.The difference was statistically significant(P<0.05).The ankle brachial index was increased from(0.29± 0.26)to postoperative(0.72± 0,09),and the difference was statistically significant(P < 0.05).Among them,1 cases of contrast nephropathy were treated with hydration and diuretic treatment.1 cases of acute left heart failure were treated with sedation,oxygen inhalation and vasodilator treatment.1 cases of acute arterial embolization were treated with catheter thrombolysis and PTA,and the recovery was unobstructed.The incidence of complications was 12.5%(3/24).2.The target vessel patency rate changes: compared with POBA group,DCB group after 3 months of target vessel patency rate no significant difference(96.0%vs.87.5%,P>0.05),but after 6 and 12 months.The patency rate was significantly higher(88.o% vs.66.7%;84% vs.41.7%,P<0.05).3.Late lumen loss(LLL)changes: there was no significant difference in MLD difference between preoperative and postoperative 7d and 6 months(P>0.05).12 months after the operation,the MLD in group DCB was significantly higher than that in group POBA(P<0.05).12 months after the operation,LLL in group DCB was significantly lower than that in group POBA(P<0.05).There was no significant difference between the two groups before and after the operation,7d and 3 months after the operation(P>0.05).4.ABI and Rutherford classification changes: ABI comparison between the two groups: preoperative,postoperative 7d and 3 months,there was no significant difference in ABI between two groups(P>0.05),ABI growth value of DCB group was higher than that of POBA group at 6 and 12 months after operation,the difference was statistically significant(all P<0.05).Rutherford grading comparison: there was no significant difference in Rutherford classification between groups before,after and after 3,6 and 12 months after operation(P>0.05)Conclusions: 1.Drug-coated balloon has favorable efficacy and safety in the treatment of femoralpopliteal artery occlusive disease.It can reduce the rate of postoperative lumenrestenosis within 1 year.2.Drug-coated balloon also has a beneficial effect on the treatment of ISR,providing a new idea for the treatment of femoral popliteal artery ISR.