摘要
目的探讨国产药物涂层球囊(DCB)治疗长段闭塞性股腘动脉病变的疗效及安全性。方法本研究为回顾性队例研究,分析2019年1月至2022年5月中日友好医院心脏血管外科行下肢动脉DCB治疗的54例患者(55条患肢)的临床资料,病变均为慢性完全闭塞性病变,病变长度为(22.6±7.3)cm。通过Kaplan-Meier生存曲线分析12及24个月的一期通畅率、免于临床相关血运重建(F-TLR)率及临床症状改善率,观察死亡、截肢等负性事件的发生情况。结果54例患者(55条患肢)手术均获成功,手术成功率100%,11例患者(11条患肢)同期植入支架。中位随访时间为31.2(24.7,36.4)个月,其中44例患者完成24个月随访。患者12及24个月临床症状改善率分别为66.0%(33/50)和59.1%(26/44)。Kaplan-Meier曲线显示术后12及24个月一期通畅率分别为61.0%和53.4%,F-TLR率分别为76.4%和74.0%。随访期内,2条患肢行截肢术,4例患者因恶性肿瘤、肺部感染或心力衰竭死亡。在亚组分析中,原发性病变组(43条患肢)24个月一期通畅率和F-TLR率均优于支架内再狭窄闭塞组(12条患肢),差异有统计学意义(一期通畅率:61.5%比25.0%Log-rankХ^(2)=7.844,P=0.005;F-TLR率:80.6%比50.0%,Log-rankХ^(2)=4.658,P=0.031)。同期补救性支架植入组(11条患肢)与无支架植入组(44条患肢)24个月一期通畅率及F-TLR率差异无统计学意义(一期通畅率:45.7%比54.5%,Log-rankX^(2)=0.006,P=0.941;F-TLR率:65.5%比75.0%,Log-rankХ^(2)=0.024,P=0.878)。严重钙化组(15条患肢)与非严重钙化组(40条患肢)24个月一期通畅率及F-TLR率差异无统计学意义(一期通畅率:49.2%比55.0%,Log-rankХ^(2)=0.523,P=0.470;F-TLR率:80.0%比72.1%,Log-rankХ^(2)=0.173,P=0.678)。结论国产DCB治疗长段完全闭塞性股腘动脉病变疗效尚可,是一种相对安全的治疗方式。
Objective To evaluate the efficacy and safety of drug-coated balloon(DCB)for treatment of long-segment occlusive femoropopliteal artery diseases.Methods This was a retrospective cohort study that analyzed the clinical data of 54 patients(55 limbs)who accepted DCB dilation treatment for lower extremity arterial disease at Department of Cardiovascular Surgery of China-Japan Friendship Hospital from January 2019 to May 2022.All lesions were chronic total occlusive with a length of(22.6±7.3)cm.The study assessed the primary patency rates,freedom from clinically driven target lesion revascularization(F-TLR)rates,and clinical symptom improvement rates using Kaplan-Meier survival curves at 12 and 24 months and observed the incidence of major adverse events such as death and amputation.Results All 54 patients(55 limbs)were successfully operated and 11 patients(11 limbs)were implanted with bare metal stents(BMS)during the same period.The median follow-up period was 31.2(24.7,36.4)months and 44 patients completed 24-month follow-up.The clinical symptom improvement rates of patients at 12 and 24 months were 66.0%(33/50)and 59.1%(26/44),respectively.The Kaplan-Meier curve showed that the primary patency rates at 12 and 24 months after surgery were 61.0%and 53.4%and F-TLR rates were 76.4%and 74.0%.During the period of follow-up,2 limbs accepted amputation surgery,and 4 patients died due to malignant tumors,lung infections or heart failure.In subgroup analysis,the 24-month primary patency rate and F-TLR rate in de novo lesion group(43 limbs)were much higher than in-stent restenosis group(12 limbs)with statistically significant differences(primary patency rate:61.5%vs.25.0%,Log-rank Х^(2)=7.844,P=0.005;F-TLR rate:80.6%vs.50.0%,Log-rank Х^(2)=4.658,P=0.031).There was no significant difference in the 24-month primary patency rate and F-TLR rate between DCB combined with BMS group(11 limbs)and DCB without BMS group(44 limbs;primary patency rate:45.7%vs.54.5%,Log-rank Х^(2)=0.006,P=0.941;F-TLR rate:65.5%vs.75.0%,Log-rank Х^(2)
作者
赵起健
张建彬
贺斌
马博
陈洁
陈冲
叶志东
Zhao Qijian;Zhang Jianbin;He Bin;Ma Bo;Chen Jie;Chen Chong;Ye Zhidong(Department of Cardiovascular Surgery,Peking University China-Japan Friendship School of Clinical Medicine,Beijing 100029,China;Department of Cardiovascular Surgery,China-Japan Friendship Hospital,Beijing100029,China)
出处
《中华血管外科杂志》
2024年第1期31-36,共6页
Chinese Journal of Vascular Surgery
基金
中央高水平医院临床科研基金(2022-NHLHCRF-YGJE-03)。
关键词
药物涂层球囊
金属裸支架
股腘动脉
动脉粥样硬化闭塞症
Drug-coated balloon
Bare metal stent
Femoral-popliteal artery
Arterio-sclerosis obliterans
