药物涂层球囊在NSTE-ACS患者中的安全性和有效性比较:9个月随访结果分析

桑震池; 李敏; 刘乐琳; 张文全; 刘又斌; 徐佑龙; 吕晓玭; 钱俊峰; 刘兴华; 刘宗军

doi:10.13201/j.issn.1001-1439.2020.01.009

药物涂层球囊在NSTE-ACS患者中的安全性和有效性比较:9个月随访结果分析

- 上海市普陀区中心医院心内科(上海, 200062)
基金项目:
普陀区卫生系统自主创新科研资助项目(No:17-PT-12)

详细信息

通讯作者: 刘宗军,E-mail:sangz@126.com

中图分类号: R541.4

收稿日期: 2019-10-01

Safety and efficacy of drug-coated balloon in patients with non-ST elevation acute coronary syndrome:9-month follow-up analysis

- Department of Cardiology, PuTuo Hospital Affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, 200062, China

More Information

Corresponding author: LIU Zongjun, E-mail: sangz@126.com

Received Date: 01 October 2019

摘要

摘要: 目的:探讨在非ST抬高型急性冠状动脉综合征(NSTE-ACS)患者中应用药物涂层球囊处理靶病变,并与药物涂层支架相比,观察其9个月有效性及安全性。方法:连续入选97例NSTE-ACS患者,入院给予冠状动脉(冠脉)造影,55例给予药物涂层支架治疗,42例给予药物球囊治疗,随访9个月并复查冠脉造影,观察两组主要不良心脏事件(MACE)。结果:两组患者术后即刻药物涂层支架组残余狭窄优于药物球囊组[(23.36±12.54)%∶(29.69±12.37)%;P=0.02],且药物球囊组A、B型夹层发生率明显高于药物涂层支架组(11.9%∶0%;P=0.00),9个月随访复测冠脉造影显示两组患者靶病变再狭窄率[(31.67±12.35)%∶(33.41±13.45)%;P=0.46]和晚期管腔丢失[(0.24±0.02)∶(0.21±0.02);P=0.56]无明显差异。两组总体MACE(9.1%∶9.5%,HR:1.07,95%CI:0.26~4.4;P=0.92)无显著差异,两组靶病变再次血运重建(5.5%∶9.5%,HR:1.91,95%CI:0.39~9.32;P=0.42)也无显著差异。结论:药物球囊在NSTE-ACS患者中是安全有效的。
- 药物球囊 /
- 非ST抬高型急性冠状动脉综合征 /
- 冠状动脉造影 /
- 安全性
Abstract: Objective:To compare the effect and safety of DCB in NSTE-ACS patients with DES.Method:The 97 consecutive patients with NSTE-ACS were enrolled in this study.Coronary angiography was performed on admission.DES were implanted in 55 patients and DCB in 42 patients.All patients were followed up for 9 months with coronary reangiography.Result:Residual stenosis after procedure in DES group was better than that in DCB group [(23.36±12.54)% vs.(29.69±12.37);P=0.02)],and the incidence of type A and B dissection in DCB group was significantly higher than that in DES group(11.9% vs.0%;P=0.00).Coronary angiography at 9 months follow-up showed that target lesions restenosis [(31.67±12.35)% vs.(33.41±13.45)%;P=0.46)] and late lumen loss [(0.24+0.02) vs.(0.21+0.02);P=0.56] in both groups have no significant difference.There was no significant difference in MACE(9.1% vs.9.5%,HR:1.07,95%CI:0.26-4.4;P=0.92) and TLR(5.5% vs.9.5%,HR:1.91,95%CI:0.39-9.32;P=0.42) between the two groups.Conclusion:DCB is safe and effective in patients with NSTE-ACS.
- drug-coated balloon /
- non-ST elevation acute coronary syndrome /
- coronary angiography /
- safety

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参考文献(15)

[1]	郑梅,李树仁.非ST段抬高型急性冠脉综合征合并多支血管病变处理方式的研究进展[J].临床心血管病杂志,2018,301(7):727-730.
[2]	Besic KM,Strozzi M,Margetic E,et al.Drug-eluting balloons in patients with non-ST elevation acute coronary syndrome[J].J Cardiol,2015,65(3):203-207.
[3]	Indermuehle A,Bahl R,Lansky AJ,et al.Drug-eluting balloon angioplasty for in-stent restenosis:a systematic review and meta-analysis of randomised controlled trials[J].Heart,2013,99(5):327-333.
[4]	Jeger RV,Farah A,Ohlow MA,BASKET-SMALL 2 Investigators.Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2):an open-label randomised non-inferiority trial[J].Lancet,2018,392(10150):849-856.
[5]	Kleber FX,Rittger H,Ludwig J,et al.Drug eluting balloons as stand alone procedure for coronary bifurcational lesions:results of the randomized multicenter PEPCAD-BIF trial[J].Clin Res Cardiol,2016,105(7):613-621.
[6]	Picard F,Doucet S,Asgar AW.Contemporary use of drug-coated balloons in coronary artery disease:Where are we now?[J].Arch Cardiovasc Dis,2017,110(4):259-272.
[7]	王辉波,杨简,杨俊,等.紫杉醇与西罗莫司洗脱支架在糖尿病患者冠状动脉介入治疗中的疗效与安全性的Meta分析[J].临床心血管病杂志,2016,32(10):983-988.
[8]	Scheller B,Hehrlein C,Bocksch W,et al.Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter[J].N Engl J Med,2006,355:2113-2124.
[9]	Byrne RA,Neumann FJ,Mehilli J,et al.Paclitaxel-eluting balloons,paclitaxel-eluting stents,and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3):a randomised,open-label trial[J].Lancet,2013,381(9865):461-467.
[10]	Indermuehle A,Bahl R,Lansky AJ,et al.Drug-eluting balloon angioplasty for in-stent restenosis:a systematic review and meta-analysis of randomised controlled trials[J].Heart,2013,99(5):327-333.
[11]	Jeger RV,Farah A,Ohlow MA.Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2):an open-label randomised non-inferiority trial[J].Lancet,2018,392(10150):849-856.
[12]	李成洋,陈宏.冠状动脉内超声指导下紫杉醇药物涂层球囊用于治疗冠状动脉狭窄26例近期临床疗效[J].临床心血管病杂志,2018,34(1):27-29.
[13]	Jim MH,Lee MK,Fung RC,et al.Six month angiographic result of supplementary paclitaxel-eluting balloon deployment to treat side branch ostium narrowing (SARPEDON)[J].Int J Cardiol,2015,187:594-597.
[14]	Costopoulos C,Latib A,Naganuma T,et al.The role of drug-eluting balloons alone or in combination with drug-eluting stents in the treatment of de novo diffuse coronary disease[J].JACC Cardiovasc Interv,2013,6(11):1153-1159.
[15]	Vos NS,Dirksen MT,Vink MA,et al.Safety and feasibility of a PAclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA):one-year clinical outcome of a pilot study[J].EuroIntervention,2014,10(5):584-590.