Effect and safety of drug-coated balloon for treating femoropopliteal arteriosclerosis obliterans / 中国介入影像与治疗学

ABSTRACT

Objective To evaluate the effect and safety of drug-coated balloon (DCB) for treating femoropopliteal arteriosclerosis obliterans.Methods Totally 54 patients with femoropopliteal arteriosclerosis obliterans who underwent percutaneous translurninal angioplasty (PTA) were randomly divided into test group and control group after successful predilation during operation.Patients in test group were treated with DCB,while those in control group were treated with uncoated balloon (UCB) during PTA.A 6-month follow-up was performed after operation.The treatment effect and safety between the two groups were compared.Additional analysis among patients who had a non-flow-limiting dissection during PTA in each group was done.Results Six months after PTA,there were 26 patients in test group and 20 patients in control group after getting rid of 8 patients lost to follow-up.The ankle brachial index (ABI) and minimal lumen diameter (MLD) of target lesion were higher (both 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 (all P＜0.05) in test group than those in control group.There were 14 patients in test group (subgroup A) and 8 patients in control group (subgroup B) who had a non-flow-limiting dissection.Except for the ABI and Rutherford stage 6 months after PTA (both P＞0.05),the other effect indexes were statistically different between the two subgroups (all P＜0.05).The rates of major adverse events and amputation were similar between test group and control group (both P＞0.05).Conclusion DCB has better short-term effect than UCB for treating femoropopliteal arteriosclerosis obliterans as safe as UCB.Meanwhile,DCB is better than UCB in patients with a non-flow-limiting dissection during PTA.