Efficacy Of Drug-coated Balloon In Treatment Of Lower Limb Atherosclerosis Obliterans

Objection: The aim of this study was to appraise 12-month outcomes after percutaneous treatment of lower limb atherosclerosis obliterans(ASO)using drug-coated balloon(DCB).Methods: According to inclusion and exclusion criteria,the clinical data of patients,who were diagnosed as lower limb ASO and treated with DCB in Department of Vascular Surgery,The Third Affiliated Hospital of Soochow University,were analyzed.Patients were followed up at 1,6 and 12 months postoperative.The primary efficacy endpoint was primary patency,defined as freedom from restenosis with peak systolic velocity ratio(PSVR)<2.4,ankle brachial indx(ABI)and clinically driven targetlesion revascularization.The primary safety endpoint was freedom from device and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and death through 12 months.Results: From Aguest 2015 to May 2018,32 patients with lower limb ASO were treated with DCB.15 patients followd up for 12 months,11 male and 4 female patients were in the series,the mean age was(71 ± 7)years,and the mean lesion length was(64 ± 43)mm.Rate of technical success was 15/15(100%).All patients achieved significant remission of pain or claudication and had a significant improvement in ABI after surgery(0.87 ± 0.12 > 0.56 ± 0.11,P < 0.05).At 12-month postoperative,primary patency by independent duplex core lab evaluation was 12/15(80%).ABI,rate of restenosis and CD-TLR were(0.74 ± 0.16,P < 0.05),3/15 and 0,respectively.There was no intraoperative or procedure-related death occurred and no major amputation was required.Conclusion: DCB with paclitaxel is safe in patients with lower limb ASO,and associated with favorable clinical outcomes at 12-month postoperative.