药物涂层球囊治疗股腘动脉段支架内再狭窄的多中心研究  

Drug-coated balloon for in-stent restenosis in femoropopliteal segment:1-year clinical outcomes from a multicenter study in China

作　　者：马博[1] 徐坤 赵豪 樊雪强[1] 郑夏[1] 陈洁[1] 来志超[3] 邵江[3] 张新[3] 张碧辉[4] 牛国晨[4] 闫子光[4] 刘暴[3] 杨敏[4] 叶志东[1] Ma Bo;Xu Kun;Zhao Hao;Fan Xueqiang;Zheng Xia;Chen Jie;Lai Zhichao;Shao Jiang;Zhang Xin;Zhang Bihui;Niu Guochen;Yan Ziguang;Liu Bao;Yang Min;Ye Zhidong(Department of Cardiovascular Surgery,China-Japan Friendship Hospital,Beijing 100029,China;Department of Cardiovascular Surgery,Peking University Health Science Center China-Japan Friendship Medical School,Beijing 100029,China;Department of Vascular Surgery,Peking Union Medical College Hospital,Beijing 100730,China;Department of Interventional Radiology and Vascular Surgery,Peking University First Hospital,Beijing 100034,China)

机构地区：[1]中日友好医院心脏血管外科,北京100029 [2]北京大学中日友好临床医学院心脏血管外科,北京100029 [3]北京协和医院血管外科,北京100730 [4]北京大学第一医院介入血管外科,北京100034

出　　处：《中华普通外科杂志》2022年第8期588-591,共4页Chinese Journal of General Surgery

基　　金：国家国际科技合作专项项目(2013DFA31900)。

摘　　要：目的评价药物涂层球囊(drug-coated balloon,DCB)治疗股腘动脉段支架内再狭窄(in-stent restenosis,ISR)的安全性和有效性。方法本研究是一项多中心回顾性队列研究的一部分,该研究纳入了2016年7月至2019年6月期间252例接受Orchid DCB治疗股腘段动脉狭窄的患者。本研究对此队列研究中49例因股腘段ISR接受DCB治疗的患者的临床及随访资料进行回顾性分析。结果49例患者慢性完全闭塞29例(59.2%),血栓形成7例(14.3%),中、重度钙化14例(28.6%)。病变平均长度为(215.9±97.1)mm。69.4%的病变为闭塞性病变(TosakaⅢ级)。仅植入1枚补救支架。98%的患者有严重的跛行(RC 3级)或静息痛甚至组织缺损(RC>3级)。治疗后34例(73.9%)表现出RC的改善,11例(23.9%)没有改变,仅1例(2.2%)在随访终点观察到损害(RC分级升高)。术前踝肱指数(ABI)平均值为0.478±0.264,术后随访终点时为0.907±0.207,RC和ABI均有显著改善(均P<0.01)。术后1年一期通畅率为80.4%。随访期间,全因死亡及主要肢体截肢均未发生。结论此多中心研究的1年跟踪随访结果显示DCB治疗复杂股腘动脉段ISR病变是有效的。Objective To evaluate the safety and efficacy at 1-year follow-up of the use of drug-coated balloon(DCB)for the treatment of femoropopliteal in-stent restenosis(ISR).Methods This study enrolled 252 patients undergoing Orchid DCB angioplasty for peripheral arterial disease in the femoral-popliteal segment.The clinical data were retrospectively analyzed.Results Forty-nine patients were eligible,including 29(59.2%)chronic total occlusions belonging to TransAtlantic Inter-Society Consensus-Ⅱ(TASCⅡ)D,7(14.3%)thrombosis,and 14(28.6%)moderate to severe calcifications.The mean lesion length was(215.9±97.1)mm.69.4%were of occlusive lesions(TosakaⅢcategory).Only 1 provisional stent was implanted.98%patients had severe claudication or even worse.Of these cases,34(73.9%)showed improvements in Rutherford category,while 11(23.9%)did not change and 1(2.2%)case deteriorated.The average value of ABI was 0.478±0.264 before surgery and 0.907±0.207 at the end of follow-up.The improvement in Rutherford category(P<0.01)and ABI(P<0.005)were both significant.The primary patency(PP)was 80.4%,and the freedom from clinically driven TLR was 84.8%at 1 year.During the follow-up period,there was no all-cause death and major limb amputation.Conclusion This multicenter study demonstrated the effectiveness of DCB as a treatment for complicated and extensive ISR lesions within 12 months.

关 键 词：血管成形术 气囊 外周动脉疾病 支架内再狭窄 多中心研究 

分 类 号：R654.4[医药卫生—外科学]