刘丹,谢鹏昕,张瑞涛,曾勇,王乐丰,王贵松

• 1:北京大学第三医院心血管内科
• 2:首都医科大学附属北京安贞医院心血管内科
• 3:首都医科大学附属北京朝阳医院心血管内科

摘要(Abstract)：

目的 探索药物涂层球囊（DCB）在冠状动脉极小血管病变中应用的有效性和安全性。方法 本研究为一项多中心、前瞻性、单臂、开放标签的临床试验。前瞻性纳入2021年4—10月来自北京大学第三医院、首都医科大学附属北京安贞医院、首都医科大学附属北京朝阳医院的31例靶病变的血管直径1.75～2.00 mm的冠心病患者。所有患者均接受紫杉醇药物涂层的DCB治疗。术后给予标准双联抗血小板治疗。所有患者均在术后9个月复查冠状动脉造影评估靶血管情况，主要观察终点为晚期管腔丢失，并接受12个月临床事件随访。结果 31例患者平均年龄（60.14±9.62）岁，其中男29例（29/31），高血压24例（24/31），高脂血症28例（28/31），糖尿病14例（14/31）。靶病变的狭窄程度目测为90.00%(85.00%,95.00%)，应用DCB处理后残余狭窄程度（目测）为10.00%(5.00%,20.00%)。所有患者均实现靶病变成功处理，且无相关并发症发生。23例（23/31）患者完成了术后9个月冠状动脉造影随访，靶病变晚期管腔丢失为0.09(0.01,0.26)mm，术后9个月靶血管狭窄程度明显小于术前[35.12%(21.60%,45.91%)比70.77%(62.44%,83.95%),P<0.001]。12个月临床事件随访，共有2例（2/31）患者出现缺血驱动的靶病变失败。结论 本研究初步证实了对冠状动脉极小血管病变应用DCB的有效性和安全性。

关键词(KeyWords)： 药物涂层球囊;极小血管;冠状动脉性心脏病;经皮冠状动脉介入治疗

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 刘丹,谢鹏昕,张瑞涛,曾勇,王乐丰,王贵松

参考文献(References)：

• [1]Neumann FJ,Sousa-Uva M,Ahlsson A,et al.2018 ESC/E A C T S Guidelines on myocardial revascularization[J].Eur Heart J,2019,40(2):87-165.DOI:10.1093/eurheartj/ehy3 94.
• [2]Latib A,Colombo A,Castriota F,et al.A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxeleluting stent in small coronary vessels:the BELLO(Balloon Elution and Late Loss Optimization)study[J].J Am Coll Cardiol,2012,60(24):2473-2480.DOI:10.1016/j.j acc.2012.09.020.
• [3]Scheller B,Ohlow MA,Ewen S,et al.Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction:the randomised PEPCAD NSTEMI trial[J].EuroIntervention,2020,15(17):1527-153 3.DOI:10.4244/EIJ-D-19-00723.
• [4]Rissanen TT,Uskela S,Er??nen J,et al.Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk(DEBUT):a single-blind,randomised,non-inferiority[J].Lancet,2019,394(10194):230-239.DOI:10.1016/S0140-6736(19)31126-2.
• [5]Sanz Sánchez J,Chiarito M,Cortese B,et al.Drug-coated balloons vs.drug-eluting stents for the treatment of small coronary artery disease:a meta-analysis of randomized trials[J].Catheter Cardiovasc Interv,2021,98(1):66-75.DOI:10.1002/ccd.29111.
• [6]Kastrati A,Schühlen H,Sch??mig A.Stenting for small cononary vessels:a contestable winner[J].J Am Coll Cardiol,2001,3 8(6):1604-1607.DOI:10.1016/S0735-1097(01)01589-3.
• [7]Solomonica A,Roguin A.Best percutaneous coronary intervention approach for small caliber coronary arteries[J].J Thorac Dis,2016,8(10):E1268-E1270.DOI:10.21037/jtd.2016.10.18.
• [8]SabatéM.Drug-coated balloon for diabetic patients with small coronary vessels:is it the way to go?[J].JACC CardiovascInterv,2021,14(16):1799-1800.DOI:10.1016/j.jcin.2021.07.011.
• [9] Serruys PW,de Jaegere P,Kiemeneij F,et al.A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease.Benestent Study Group[J].N Engl J Med,1994,331(8):489-495.DOI:10.1056/NEJM199408253310801.
• [10]Wightman A,B arlis P,MacB ain M,et al.Small vessel disease and intracoronary plaque composition:a single centre cross-sectional observatio nal study[J].Sci Rep,2019,9(1):4215.DOI:10.1038/s41598-019-39989-3.
• [11]Bhogal N,Hill J,Mohamed W,et al.Drug-coated balloons for coronary artery disease:an updated review with future perspectives[J].Cardiovasc Revasc Med,2024,69:79-89.DOI:10.1016/j.carrev.2024.05.027.
• [12] Schunkert H,Harrell L,Palacios IF.Implications of small reference vessel diameter in patients undergoing percutaneous coronary revascularization[J].J Am Coll Cardiol,1999,34(1):40-48.DOI:10.1016/S073 5-1097(9 9)00181-3.
• [13]Elezi S,Kastrati A,Neumann FJ,et al.Vessel size and lon g-term outcome after coronary stent placement[J].Circulation,1998,98(18):1875-1880.DOI:10.1161/01.cir.98.18.1875.
• [14]Funatsu A,Nakamura S,Inoue N,et al.A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients with small vessel disease[J].Clin Res Cardiol,2017,106(10):824-832.DOI:10.1007/s00392-017-1126-x.
• [15]Cortese B,Di Palma G,Guimaraes MG,et al.Drugcoa t ed balloon versus drug-eluting stent for small coronary vessel disease:PICCOLETO II randomized clinical trial[J].JACC Cardiovasc Interv,2020,13(24):2840-2849.DOI:10.1016/j.jcin.2020.08.035.
• [16]Tenaglia AN,Fortin DF,Califf RM,et al.Predicting the risk of abrupt vessel closure after angioplasty in an individual patient[J].J Am Coll Cardiol,1994,24(4):1004-1011.DOI:10.1016/0735-1097(94)90862-1.
• [17]Lincoff AM,Popma JJ,Ellis SG,et al.Abrupt vessel closure complicating coronary angioplasty:clinical,angiographic and therapeutic profile[J].J Am Coll Cardiol,1992,19(5):926-935.DOI:10.1016/0735-1097(92)90272-o.
• [18]Post MJ,Borst C,Kuntz RE.The relative importance of arterial remodeling compared with intimal hyperplasia in lumen renarrowing after balloon angioplasty.A study in the normal rabbit and the hypercholesterolemic Yucatan micropig[J].Circulation,1994,89(6):2816-2821.DOI:10.1161/01.cir.89.6.2816.
• [19]Strauss BH,Chisholm RJ,Keeley FW,et al.Extracellular matrix remodeling after balloon angioplasty injury in a rabbit model of restenosis[J].Circ Res,1994,75(4):650-658.DOI:10.1161/01.res.75.4.650.
• [20]Tang Y,Qiao S,Su X,et al.Drug-coated balloon versus drugeluting stent for small-vessel disease:the RESTORE SVD China randomized trial[J].JACC Cardiovasc Interv,2018,11(23):23 81-23 92.DOI:10.1016/j.jcin.2018.09.009.
• [21]张明多,周渊,张闽,等.药物洗脱球囊治疗冠状动脉极小血管原位病变有效性与安全性[J].中国循证心血管医学杂志,2023,15(5):587-591.DOI:10.3969/j.issn.1674-4055.2023.05.16.
• [22]Korjian S,McCarthy KJ,Larnard EA,et al.Drug-coated balloons in the management of coronary artery disease[J].Circ Cardiovasc Interv,2024,17(1):e013302.DOI:10.1161/CIRCINTERVENTIONS.123.013302.
• [23]Wybraniec MT,Banka P,Bochenek T,et al.Small vessel coronary artery disease:how small can we go with myocardial revascularization?[J].Cardiol J,2020,27(5):661-676.DOI:10.5603/CJ.a2020.0127.