Analysis Of Curative Effect And Safety Of Drug-coated Balloon In The Treatment Of Femoral Popliteal Artery Diseases And Discussion Of Influential Factors Of Curative Effect

Objective: in this study,we retrospectively analyzed and followed up the cases of femoral popliteal artery treated with drug-coated balloon,to evaluate the efficacy and safety of drug-coated balloon in the treatment of femoral popliteal artery lesions,and to explore the risk factors affecting short-term efficacy.Methods: a total of 45 patients with femoral popliteal artery lesions treated with drugcoated balloon(DCB)from August 2016 to May 2018 in the department of vascular surgery of the first affiliated hospital of fujian medical university were collected.Inclusion criteria :(1)severe stenosis or occlusion of femoral artery and/or popliteal artery;(2)rutherford grade 2 ~ 5,with obvious symptoms of lower limb ischemia;(3)after the intervention,DSA angiography showed that at least one blood vessel in the inferior knee outflow tract was unobstructed;(4)TASC is rated A,B or C.Exclusion criteria :(1)patients treated with DCB for non-femoral popliteal artery lesions;(2)no obvious clinical symptoms;(3)patients with grade D TASC.Routine anticoagulation,dual antiplatelet,lipid-lowering and vasodilatation were given before operation.All operations were performed under DSA,the external balloon was eluted by the Orchid drug,the coated drug was paclitaxel,and the drug concentration was 3.0ug/mm2.Partial severe calcification and long-segment CTO lesions were combined with Turbo Hawk Directional atherectomy.Postoperative routine anticoagulation for 3 days,dual antiplatelet for 1 year,blood routine,liver and kidney function were detected.The efficacy was evaluated by comparing preoperative and postoperative ankle-brachial index(ABI)and rutherford grading improvement by T test or chi-square test(at least 2 grades of postoperative grading decline was considered to be significant).Grading down by 1 level is considered effective;Class invariant consideration is invalid;Grading increases to consider deterioration).During the 12-month follow-up,the lower limb artery color doppler ultrasound or CTA was regularly reviewed to determine whether the target vessel was unobstructed,and the time of restenosis or TLR(days)was recorded.Meanwhile,ABI and rutherfoot grading changes were recorded in each follow-up.Cox regression analysis was used to evaluate the risk factors affecting the first-stage unobstructed rate of the target vessel within 12 months after DCB surgery.Risk factors were grouped and kaplan-meier survival analysis was used to represent the first-phase patency rate.Results: all the 45 patients successfully completed DSA under the femoral popliteal artery DCB drug-coated balloon dilation,the success rate of surgery was 100%,no death,amputation cases.Among them,4 patients were implanted with salvage stents(a total of 4 stents),and 1 patient had middle segment of superficial femoral artery dissection after expansion during the operation.Postoperative bleeding and petechiae at the inguinal puncture site occurred in 2 patients.the incidence of perioperative complications was 6.67%.The ABI increased from 0.53±0.12 before surgery to 0.92 ±0.11 after surgery,with statistical difference(P<0.05).The rutherford classification decreased from 3.82±1.07 before the operation to 1.78±0.80 after the operation,and the decrease was more than two rutherford grades,with statistical difference(P<0.05).During the follow-up,2 patients died,1 patient developed target intravascular thrombosis,and 1 patient was treated with TLR again.The incidence of adverse events was 8.89%.The primary target vessel patency rate was 100%(45/45),95.6%(43/45),86.7%(39/45)and 66.7%(30/45)at 1,3,6 and 12 months after surgery,respectively.Cox regression analysis showed that damage to the inferior knee outflow tract(RR=7.030,P= 0.032)and severe calcification(RR=6.924,P=0.004)were risk factors for target vessel patency rate,and Hawk Directional atherectomy(RR=0.030,P= 0.003)was the protective factor for target vessel patency rate.Conclusions: 1.The drug-coated balloon has a significant effect on the treatment of femoral popliteal artery lesions and is safe and reliable.2.Severe calcification of the target artery and damage to the subgenicular outflow tract are risk factors affecting the efficacy of the drug-coated balloon,and combination with Hawk Directional atherectomy is its protective factor.3.DCB combined with Hawk Directional atherectomy expected to improve the long-term patency rate of femoral popliteal artery lesions.