药物涂层球囊治疗股腘动脉硬化闭塞症的临床疗效及安全性

Effect and safety of drug-coated balloon for treating femoropopliteal arteriosclerosis obliterans

目的探讨药物涂层球囊(DCB)治疗股腘动脉硬化闭塞症的有效性及安全性。方法经预扩张筛选后,将拟接受经皮腔内血管成形术(PTA)的54例股腘动脉硬化闭塞症患者随机分为试验组(n=27)及对照组(n=27),PTA术中分别采用DCB及普通球囊。PTA术后随访6个月,比较2组疗效及安全性,并对术中出现的非限流性夹层患者进行对比分析。结果剔除失访者后,最终试验组26例、对照组20例患者纳入研究。试验组术后6个月踝肱指数(ABI)、股腘动脉最小管腔直径(MLD)均高于对照组(P均<0.05);Rutherford分级、股腘动脉狭窄程度、晚期管腔丢失(LLL)值、再狭窄率及靶病变血运重建(TLR)发生率均低于对照组(P均<0.05)。试验组及对照组出现非限流性夹层的患者分别为14例及8例;2组出现非限流性夹层的患者间术后6个月ABI、Rutherford分级差异均无统计学意义(P均>0.05),其余各疗效评价指标差异均有统计学意义(P均<0.05)。2组间主要不良事件发生率及截肢率差异均无统计学意义(P均>0.05)。结论 DCB治疗股腘动脉硬化闭塞症的近期疗效优于普通球囊,且二者安全性相似;对于PTA术中出现非限流性夹层患者,DCB疗效仍优于普通球囊。

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 transluminal 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.