药物涂层球囊联合支架植入与普通球囊联合支架植入治疗股腘动脉TASC D级病变的疗效比较

Comparing plain old balloon and drug-coated balloon supported bare metal stents in the treatment of femoral-popliteal TASC D lesions

目的比较药物涂层球囊(drug-coated balloon,DCB)联合金属裸支架(bare metal stent,BMS)植入与普通球囊(plain old balloon angioplasty,POBA)联合BMS植入治疗股腘动脉泛大西洋协作组(TASC)D级病变的疗效。方法回顾性分析复旦大学附属中山医院血管外科2017年1月至2020年3月以TASC D级股腘病变为标准纳入的接受DCB联合BMS植入及POBA联合BMS植入患者的临床及随访资料,观察其通畅率、免于靶血管再干预率和并发症等指标。结果共纳入115例符合股腘动脉TASC D级病变的患者,共120条患肢,平均闭塞长度(29.1±6.5)mm。DCB联合BMS组36例,37条患肢,POBA联合BMS组79例,83条患肢。中位随访时间18.1个月。两组术后3个月(89.2%比86.7%)、9个月(86.4%比76.9%)、1年(66.8%比70.9%)及2年(63.1%比56.9%)的一期通畅率差异无统计学意义(P=0.73);靶血管再干预率(FCD-TLR)术后3个月(100%比95.1%)、9个月(94.3%比82.3%)、1年(78.5%比80.6%)、2年(74.1%比68.9%)差异亦无统计学意义(P=0.69)。结论对于股腘TASC D级病变,相较于POBA联合BMS,DCB联合BMS的获益仍不明确。

Objective To compare the efficacy between drug-coated balloon(DCB)combined with bare metal stenting(BMS)and plain old balloon angioplasty(POBA)with BMS placement in the treatment of femoral-popliteal TASC D lesions.Methods According to the Trans-Atlantic Inter-Society Consensus(TASC)D grade femoral-popliteal lesions as the standard,we enrolled 115 cases(120 limbs)receiving DCB combined with BMS(group DCB,37 limbs in 36 cases)and POBA combined with BMS(group POBA,83 limbs in 79 cases)from Jan 2017 to Mar 2020 to observe patency rate,freedom from clinical-drived target lesion reintervention rate(FCD-TLR)and complications.Results The mean follow-up time was 18.1 months and the average occlusion length was(29.1±6.5)mm.In group DCB vs group POBA,the primary patency rates at 3-month,9-month,1-year and 2-year were 89.2%vs.86.7%,86.4%vs.76.9%,66.8%vs.70.9%and 63.1%vs.56.9%,respectively(P=0.73);FCD-TLRs were 100.0%vs.95.1%,94.3%vs.82.3%,78.5%vs.80.6%and 74.1%vs.68.9%(P=0.69),respectively.Conclusion The benefit of DCB combined with BMS over POBA combined with BMS in improving the early primary patency rate and reducing FCD-TLR was not definite.