Effect And Safety Of Drug-coated Balloon For Treating Femoropopliteal Arteriosclerosis Obliterans

Objective The study is aiming at evaluating the effect and safety of drug-coated balloon(DCB)for treating femoropopliteal arteriosclerosis obliterans.Methods 54 qualified patients treated with percutaneous transluminal angioplasty(PTA)were randomly divided into the test group and control group after predilation successfully,and the former group were treated with DCB while the later with uncoated balloon(UCB).We made comparisons for the treatment effect and safety between the two groups as well as an additional analysis among those patients who had a non-flow-limiting dissection during the intervention 6 months after PTA.Results 6 months after PTA,there were 26 cases followed-up successfully in the test group and 20 in another group after getting rid of 8 cases lost to follow up.The test group showed significantly higher ankle brachial index(ABI)and minimal lumen diameter(MLD)of target lesion(P<0.05),and the Rutherford stage,degree of target lesion stenosis,late lumen lose(LLL),the rate of restenosis and target lesion revascularization(TLR)were lower than the control group(P<0.05).There were 14 and 8 patients who had a non-flow-limiting dissection in the test group and control group respectively;the ABI and Rutherford stage were similar in the two subgroups(P>0.05),but other indexes for evaluating effect in the test subgroup were superior remarkably(P<0.05).The rates of major adverse events and amputation were similar between the test group and control group(P>0.05).Conclusion DCB has a better short-term effect than UCB for patients suffering from femoropopliteal arteriosclerosis obliterans as safe as UCB.Meanwhile,DCB is better than UCB in those patients who have a non-flow-limiting dissections after PTA.