The Safety And Effectiveness Of Paclitaxel-coated Balloon In The Treatment Of Femoropopliteal Disease

Purpose:To assess the safety and effectiveness of drug-coated balloon for the treatment of femoropopliteal disease comparison with percutaneous transluminal angioplasty(PTA)with an uncoated balloon.Methods:A retrospective study of 57 patients with peripheral artery disease(mean age 63.30±7.95 years old,50 males)who were treated with paclitaxel DCB and general balloon PTA at the Affiliated Hospital of Qingdao University from 2016 to 2017,Inculd-ing 32 patients in the DCB group(32 limbs)and 25 patients in the PTA group(28 limbs).Baseline characteristics were similar between the groups,Hypertension,diabetes and hyperlipidemia account for 54.4%,52.6%,and 33.3%,Respectively.The mean target lesion length was 57.97±31.10mm,Only 3 lesions were restenotic lesions and 71.7%were completely occlusive Lesions,74.1%of the lesions were grade 3 Rutherford,The primary effectiveness outcome was primary patency at 24 months,defined as freedom from clinically-driven target lesion revascularization(CD-TLR)and freedom from restenosis.The safety outcome was a composite of 30-day device and procedure related death and target limb major amputation and clinically-driven target vessel lesion revascularization(CD-TVR)within 24 months.Results:Both groups of patients have achieved technical success.The mean postoperative follow-up time was 21.6 months,and the median follow-up time was 24months.The ABI in the DCB group and the PTA group were significantly improved on the first day after surgery compared with the preoperative period.In the DCB group,there were no statistically significant differences in ABI between 1 day and 3 months after surgery,3 months and 6 months after surgery,and 6 months and 12 months after surgery(P>0.05),while there were statistically significant differences in ABI between 12 months and 24 months after surgery(t=-2.903,P<0.05).The PTA group showed statistically significant differences in ABI between 3 months and 6 months after surgery(Z=-2.360,P<0.05),and significant differences in ABI between 12 months and 24 months after surgery(Z=-2.048,P<0.05).Compared with the PTA group,the primary patency rate in the DCB group at 12 months after surgery was 93.9%higher,and the primary patency rate in the PTA group was 71.6%.The difference was statistically significant(X~2=4.963,P<0.05).The primary patency rate was 87.0%in the DCB group and 63.6%in PTA group 24 months after operation,with statistically significant differences(X~2=4.963,P<0.05).in the postoperative follow-up 24 months of DCB group CD-TLR rate is lower in the PTA group,24 months after surgery in DCB group TLR rate was 6.7%,the PTA group was 30.8%,The difference in rates was statistically significant(X~2=3.996,P<0.05).The CD-TLR rate of Kaplan-Meier analysis was 93.7%in the DCB group and 70.8%in the PTA group at 24 months after operation.The difference was statistically significant(X~2=5.446,P<0.05),the average time for the first CD-TLR in the DCB group was438.5±277.9 days,and the PTA group was 365±199.6 days.More patients in the DCB group achieved continuous clinical improvement at 24 months after surgery.The DCB group was 86.7%and the PTA group was 57.6%.The difference was statistically significant(X~2=5.963,P<0.05).There was no significant difference in the incidence of postoperative complications between the two groups(P>0.05).The all-cause mortality in DCB group and PTA group was 6.3%and 8.0%,respectively,with no statistically significant difference.Conclusion:In the 24-month follow-up,DCB has higher patency and lower CD-TLR rate compared with uncoated balloon PTA,and the all-cause mortality is similar,which proves that the DCB treatment of femoropopliteal artery PAD in the short and medium termis safe and effective.