Efficacy Analysis Of Combined Treatment Of Femoropopliteal Artery Occlusion Disease Using SilverHawk Atherectomy And Drug-coated Balloon

Objective:Femoropopliteal artery occlusion disease(FAD)is a common chronic ischemic disease of vascular surgery occurred in elderly patients,which is an important cause of lower limb amputation influencing the life quality of the patients seriously.By analyzing the clinical data of 45 FAD patients,the research compared the clinical results of adjunctive treatment with drug-coated balloon(DCB)and plain old balloon angioplasty(POBA)after SilverHawk atherectomy,and analyzed the related risk factors affecting primary patency rate,which can provide certain theoretical basis for the clinical treatment of FAD.Methods:The clinical data of 45 patients with FAD treated in the vascular surgery of the Fifth Affiliated Hospital of Zhengzhou University during from February 2016 to February 2017 was analyzed retrospectively.There were 18 cases in DCB group(SilverHawk combined with DCB therapy),and 16 cases in the POBA group(SilverHawk combined with POBA therapy).The mean follow-up time was 12 months.The target vessels were examined by color doplex ultrasound and CT angiography(CTA).Preoperative and postoperative minimal lumen diameter(MLD),ankle brachial index(ABI),Rutherford category,late lumen loss(LLL),complications were recorded.And SPSS 22.0 was used to compare the efficacy and safety of data in the two groups.Results:All 45 patients completed endovascular interventional treatment successfully.The technical success rate was 100% and the procedural success rate was 93.3%.The average follow-up was 12 months with the follow-up rate being 100%.1.The change of MLD and LLL: preoperative and immediate postoperative MLD between two groups showed no significant difference(both P>0.05),while MLD of DCB group was higher than that of POBA group at 6,12 months after operation(both P<0.05).The LLL of DCB group(0.43±0.37)was significantly lower than that of POBA group(1.75±0.56),which difference was statistically significant(P=0.021).2.The changes of ABI and Rutherford category: there was no significant difference between preoperative ABI and 1 week postoperative ABI in both groups(both P>0.05).The ABI increase of 6,12 months postoperatively in DCB group,compared with preoperative ABI,were higher than the increase of ABI in POBA group(both P<0.05).The difference in Rutherford category between two groups was not statistically significant before operation(P>0.05).All the patients had reached the Rutherford category 1,except for 1 case in DCB group and 3 cases in POBA group respectively.There was significant difference in Rutherford category between the two groups at 6 months after operation(P = 0.013),while the difference disappeared at 12 months after operation(P=0.349).3.Primary patency rate and TLR: there was no amputation or death occurring in two groups.The 3-,6-and 12-month primary patency rate after operation of DCB group and POBA group were 94.4%,88.9%,83.3% and 85.2%,74.1%,63.0% respectively.And the primary patency rate of DCB group was higher than that of POBA group(all P<0.05).In the DCB group,only 3 patients had target vessel stenosis>50%,1 case of conservative treatment of drugs combined with functional exercise,2 cases of implantation of bare metal stents,and the TLR was 16.7%.In the POBA group,there were 10 patients with target vessel stenosis>50%,2 patients were treated conservatively,3 patients were treated with DCB,5 patients were implanted with bare metal stents and the TLR was 37.0%.4.Factors affecting target vessel patency rate: A Cox regression model was used to analyze factors affecting vessel patency rate showing chronic total occlusions being the main risk factor for the vessel patency rate(HR=6.371,P=0.037)and combined treatment using SilverHawk atherectomy and drug-coated balloon being the protective factor for vessel patency rate(HR=0.162,P=0.015).Conclusions:1.Combined treatment of FAD using SilverHawk atherectomy and DCB is the safe and effective method,which has better short and mid-term efficacy than SilverHawk combined with POBA.2.Chronic total occlusion is the risk factor of affecting target vessel primary rate.