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中华诊断学电子杂志 ›› 2026, Vol. 14 ›› Issue (02) : 120 -125. doi: 10.3877/cma.j.issn.2095-655X.2026.02.008

所属专题: 文献

综述

腔内影像学与功能学评估指导下的西罗莫司涂层球囊在冠心病中的应用进展
刘莹1, 陈中闯1, 陈雪英2, 程云涛2, 甘立军2,()   
  1. 1272029 济宁医学院临床医学院
    2272029 济宁医学院附属医院心内科 山东省医药卫生心血管病学重点学科 山东省医药卫生心血管疾病诊疗重点实验室 济宁市冠脉介入精准治疗研究重点实验室
  • 收稿日期:2025-12-26 出版日期:2026-05-26
  • 通信作者: 甘立军
  • 基金资助:
    山东省重点研发计划(重大科技创新工程)(2025CXGC020301)

Progress in the application of sirolimus-coated balloons in coronary heart disease under the guidance of endovascular imaging and functional assessment

Ying Liu1, Zhongchuang Chen1, Xueying Chen2, Yuntao Cheng2, Lijun Gan2,()   

  1. 1College of Clinical Medicine, Jining Medical University, Jining 272029, China
    2Department of Cardiology, the Affiliated Hospital of Jining Medical University (Shandong Provincial Key Medical and Health Discipline of Cardiology; Shandong Provincial Key Medical and Health Laboratory of Diagnosis and Treatment of Cardiovascular Diseases; Jining Key Laboratory of Precise Therapeutic Research of Coronary Intervention), Jining 272029, China
  • Received:2025-12-26 Published:2026-05-26
  • Corresponding author: Lijun Gan
引用本文:

刘莹, 陈中闯, 陈雪英, 程云涛, 甘立军. 腔内影像学与功能学评估指导下的西罗莫司涂层球囊在冠心病中的应用进展[J/OL]. 中华诊断学电子杂志, 2026, 14(02): 120-125.

Ying Liu, Zhongchuang Chen, Xueying Chen, Yuntao Cheng, Lijun Gan. Progress in the application of sirolimus-coated balloons in coronary heart disease under the guidance of endovascular imaging and functional assessment[J/OL]. Chinese Journal of Diagnostics(Electronic Edition), 2026, 14(02): 120-125.

经皮冠状动脉介入治疗(PCI)可显著改善冠心病患者预后,但永久性金属支架长期留存,易引发晚期支架内血栓、新生动脉粥样硬化及血管舒缩功能受限等问题。药物涂层球囊(DCB)可于扩张过程中将抗增殖药物有效释放至血管壁,球囊撤出后无需留置永久植入物,充分践行"介入无植入"理念,有效减少植入物长期存留所致的相关并发症。西罗莫司涂层球囊(SCB)作为新一代DCB,兼具抗增殖和抗炎作用。近年来,SCB在支架内再狭窄、冠状动脉原位小血管病变及部分复杂冠状动脉病变治疗中的应用逐渐增加,现有临床证据表明其安全性和有效性良好。腔内影像学可精细评估参考血管直径、斑块形态、钙化严重程度及病变预处理效果;功能学评估则可明确靶病变的缺血相关性、术后血流动力学改善情况。腔内影像学与功能学评估的联合应用,有助于在SCB治疗中实现更精准的病变筛选、操作策略制定及疗效评价。本文综述SCB的作用机制、技术特点及其在腔内影像学和功能学评估指导下的临床应用进展,并进一步探讨现有证据的局限性及尚未解决的临床问题,以期为冠心病个体化介入治疗决策提供参考。

Percutaneous coronary intervention (PCI) significantly improves the prognosis of patients with coronary artery disease. However, the long-term presence of permanent metallic stents may lead to adverse events, including late in-stent thrombosis, neoatherosclerosis, and impaired vasomotor function. Drug-coated balloons (DCBs) effectively relases the antiproliferative drugs to the vascular wall during balloon inflation. Since no permanent implant remains after balloon withdrawal, DCBs embody the " intervention without implantation" concept, and significantly reducing complications associated with long-term implant retention. Sirolimus-coated balloons (SCBs), as a next-generation of DCBs, exert both antiproliferative and anti-inflammatory effects. In recent years, SCBs have been increasingly used for the treatment of in-stent restenosis, in situ small-vessel coronary lesions, and certain complex coronary lesions, with accumulating evidence suggesting favorable safety and efficacy. Intravascular imaging facilitates precise evaluation of reference vessel diameter, plaque morphology, calcification severity, and effect of lesion pretreatment, whereas coronary functional assessment helps determine the ischemic relevance of target lesions and evaluate post-operative hemodynamic improvement. The integrated application of intravascular imaging and functional assessment may facilitate more precise lesion screening, operational strategy formulation, and treatment response evaluation in SCB-based interventions. This review summarizes the mechanisms of action, technical characteristics, and clinical applications advancements of SCBs guided by intravascular imaging and functional assessment. Furthermore, it also discusses the limitations of current evidence and unresolved clinical issues, aiming to provide a reference for individualized interventional decision-making in coronary artery disease.

[1]
刘明波,王增武.《中国心血管健康与疾病报告2024》概要(心血管疾病流行及介入诊疗状况)[J].中国介入心脏病学杂志202533(12):687-695.DOI:10.3969/j.issn.1004-8812.2025.12.003.
[2]
李洁滢,胡琳,杨艳娟,等.雷帕霉素通过AKT/mTOR途径抑制川崎病冠状动脉内皮细胞炎症因子的表达[J].中国病理生理杂志202238(8):1376-1383.DOI:10.3969/j.issn.1000-4718.2022.08.005.
[3]
Kang NKim JKwon M,et al.Blockade of mTORC1 via rapamycin suppresses 27-hydroxycholestrol-induced inflammatory responses[J].Int J Mol Sci202425(19):10381.DOI:10.3390/ijms251910381.
[4]
Gherasie FACiomag Ianula RGherasie LM.Drug-coated balloon PCI in different plaque morphologies:a narrative review[J].Biomedicines202513(6):1472.DOI:10.3390/biomedicines13061472.
[5]
田文,程颖,赵卫华,等.雷帕霉素和紫杉醇对血管内皮细胞的增生抑制作用及细胞毒性的比较[J].中国医科大学学报200837(6):770-772.DOI:10.3969/j.issn.0258-4646.2008.06.018.
[6]
Chen YZeng YZhu X,et al.Significant difference between sirolimus and paclitaxel nanoparticles in anti-proliferation effect in normoxia and hypoxia:The basis of better selection of atherosclerosis treatment[J].Bioact Mater20216(3):880-889.DOI:10.1016/j.bioactmat.2020.09.005.
[7]
Kawai KKolodgie FDKawakami R,et al.Vascular response,downstream effect,and pharmacokinetics after sirolimus- and paclitaxel-coated balloons in porcine coronary arteries[J].Catheter Cardiovasc Interv2025105(6):1434-1444.DOI:10.1002/ccd.31482.
[8]
Clever YPPeters DCalisse J,et al.Novel sirolimus-coated balloon catheter:in vivo evaluation in a porcine coronary model[J].Circ Cardiovasc Interv20169(4):e003543.DOI:10.1161/CIRCINTERVENTIONS.115.003543.
[9]
唐雨,桑宏飞.西罗莫司涂层球囊在动脉硬化性闭塞症治疗中的研究进展 [J].中华血管外科杂志(中英文)202510(4):308-312.DOI:10.3760/cma.j.cn101411-20240608-00053.
[10]
Rao SVO′Donoghue MLRuel M,et al.2025 ACC/AHA/ACEP/NAEMSP/SCAI guideline for the management of patients with acute coronary syndromes:a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines[J].Circulation2025151(13):e771-e862.DOI:10.1161/CIR.0000000000001309.
[11]
Vrints CAndreotti FKoskinas KC,et al.2024 ESC guidelines for the management of chronic coronary syndromes[J].Eur Heart J202445(36):3415-3537.DOI:10.1093/eurheartj/ehae177.
[12]
高磊,陈韵岱.《药物涂层球囊临床应用中国专家共识(第二版)》解读[J].中国介入心脏病学杂志202432(2):108-111.DOI:10.3969/j.issn.1004-8812.2024.02.008.
[13]
Synetos AKoliastasis LKtenopoulos N,et al.Optical coherence tomography in acute coronary syndromes[J].Rev Cardiovasc Med202526(11):43321.DOI:10.31083/RCM43321.
[14]
Nguyen PSeto A.Contemporary practices using intravascular imaging guidance with IVUS or OCT to optimize percutaneous coronary intervention[J].Expert Rev Cardiovasc Ther202018(2):103-115.DOI:10.1080/14779072.2020.1732207.
[15]
Viana SMZhang DM.Intravascular ultrasound guiding percutaneous coronary interventions in complex higher risk-indicated patients (CHIPs):insight from clinical evidence[J].Rev Cardiovasc Med202425(12):443.DOI:10.31083/j.rcm2512443.
[16]
Gao XFGe ZKong XQ,et al.Intravascular ultrasound vs angiography-guided drug-coated balloon angioplasty:the ULTIMATE Ⅲ trial[J].JACC Cardiovasc Interv202417(13):1519-1528.DOI:10.1016/j.jcin.2024.04.014.
[17]
Holm NRAndreasen LDNeghabat O,et al.OCT or angiography guidance for PCI in complex bifurcation lesions[J].N Engl J Med2023389(16):1477-1487.DOI:10.1056/NEJMoa2307770.
[18]
Kang DYAhn JMYun SC,et al.Guiding intervention for complex coronary lesions by optical coherence tomography or intravascular ultrasound[J].J Am Coll Cardiol202483(3):401-413.DOI:10.1016/j.jacc.2023.10.017.
[19]
Sarti AErriquez ADal Passo B,et al.Complete revascularization in older patients with myocardial infarction with or without complex nonculprit lesions [J].Circ Cardiovasc Interv202518(11):e015902.DOI:10.1161/circinterventions.125.015902.
[20]
Cocco MCampo GGuiducci V,et al.Complete vs culprit-only revascularization in older patients with myocardial infarction with or without ST-segment elevation[J].J Am Coll Cardiol202484(20):2014-2022.DOI:10.1016/j.jacc.2024.07.028.
[21]
Lin LDing YTang Y,et al.Prognostic implications of increased and final quantitative flow ratios in patients treated with drug-coated balloons physiological evaluation after DCB in de novo lesions[J].BMC Cardiovasc Disord202424(1):743.DOI:10.1186/s12872-024-04413-w.
[22]
Koo BKHu XKang J,et al.Fractional flow reserve or intravascular ultrasonography to guide PCI[J].N Engl J Med2022387(9):779-789.DOI:10.1056/NEJMoa2201546.
[23]
Ono MAsano TNoguchi M,et al.Cutting balloon versus standard balloon for lesion preparation of drug-coated balloon treatment in de-novo coronary artery lesions:rationale and design of the randomized NATURE trial[J].Cardiovasc Revasc Med2025(81):48-56.DOI:10.1016/j.carrev.2025.03.009.
[24]
Kulyassa PMNémeth BTHizoh I,et al.The design and feasibility of optimal treatment for coronary drug-eluting stent in-stent restenosis (OPEN-ISR)-a prospective,randomised,multicentre clinical trial[J].J Pers Med202515(2):60.DOI:10.3390/jpm15020060.
[25]
Cortese BTesta LHeang TM,et al.Sirolimus-coated balloon in an all-comer population of coronary artery disease patients:the EASTBOURNE prospective registry[J].JACC Cardiovasc Interv202316(14):1794-1803.DOI:10.1016/j.jcin.2023.05.005.
[26]
Wańha W, Iwańczyk S, Januszek R, et al. Long-term outcomes following sirolimus-coated balloon or drug-eluting stents for treatment of in-stent restenosis[J].Circ Cardiovasc Interv202417(9):e014064.DOI:10.1161/CIRCINTERVENTIONS.124.014064.
[27]
Liu HLi YFu G,et al.Sirolimus- vs paclitaxel-coated balloon for the treatment of coronary in-stent restenosis:the SIBLINT-ISR randomized trial[J].JACC Cardiovasc Interv202518(8):963-971.DOI:10.1016/j.jcin.2024.12.024.
[28]
Oli PRShrestha DBDawadi S,et al.Comparison of different PCI strategies for coronary DES in-stent restenosis:a bayesian network meta-analysis[J].J Soc Cardiovasc Angiogr Interv20254(3Part A):102428.DOI:10.1016/j.jscai.2024.102428.
[29]
Jeger RVFarah AOhlow MA,et al.Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2):3-year follow-up of a randomised,non-inferiority trial[J].Lancet2020396(10261):1504-1510.DOI:10.1016/S0140-6736(20)32173-5.
[30]
Tang Y, Qiao S, Su X, et al. Drug-coated balloon versus drug-eluting stent for small-vessel disease:the RESTORE SVD China randomized trial[J].JACC Cardiovasc Interv201811(23):2381-2392.DOI:10.1016/j.jcin.2018.09.009.
[31]
Tian JTang YDQiao S,et al.Two-year follow-up of a randomized multicenter study comparing a drug-coated balloon with a drug-eluting stent in native small coronary vessels:the RESTORE small vessel disease China trial[J].Catheter Cardiovasc Interv2020(95 Suppl 1):587-597.DOI:10.1002/ccd.28705.
[32]
Cortese B, Testa G, Rivero F, et al. Long-term outcome of drug-coated balloon vs drug-eluting stent for small coronary vessels:PICCOLETO-Ⅱ 3-year follow-up[J].JACC Cardiovasc Interv202316(9):1054-1061.DOI:10.1016/j.jcin.2023.02.011.
[33]
Basavarajaiah SSharma VSticchi A,et al.Use of sirolimus-coated balloon in de novo coronary lesions; long-term clinical outcomes from a multi-center real-world population[J].Catheter Cardiovasc Interv2024104(6):1159-1167.DOI:10.1002/ccd.31244.
[34]
Gao CHe XOuyang F,et al.Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I):an open-label,randomised,non-inferiority trial[J].Lancet2024404(10457):1040-1050.DOI:10.1016/S0140-6736(24)01594-0.
[35]
Gobbi CGiangiacomi FMerinopoulos I,et al.Drug coated balloon angioplasty for de novo coronary lesions in large vessels:a systematic review and meta-analysis[J].Sci Rep202515(1):4921.DOI:10.1038/s41598-025-85734-4.
[36]
Krackhardt FBonaventura KWaliszewski M,et al.Effect of vessel diameter on the clinical benefits of drug-coated balloon angioplasty:insights from paclitaxel-coated balloon and polymer-free sirolimus-eluting stent studies[J/CD].Clin Res Cardiol,2026-01-08[2026-05-20].DOI:10.1007/s00392-025-02819-w.
[37]
Gobbi CGiangiacomi FPasero G,et al.Efficacy and safety of sirolimus-coated balloon angioplasty in de novo lesions in large coronary vessels:a propensity score-matched study[J].Catheter Cardiovasc Interv2025105(4):861-869.DOI:10.1002/ccd.31402.
[38]
Zhou YHu YZhao X,et al.Sirolimus-coated versus paclitaxel-coated balloons for bifurcated coronary lesions in the side branch:the SPACIOUS trial[J].EuroIntervention202521(6):e307-e317.DOI:10.4244/EIJ-D-24-00742.
[39]
Gao QLiu CXu G,et al.A prospective randomized open-label trial of sirolimus versus paclitaxel-coated balloons for the side branch of de novo coronary bifurcation lesion[J].J Thorac Dis202517(12):10869-10879.DOI:10.21037/jtd-2025-1243.
[40]
Fahrni G, Scheller B, Coslovsky M, et al. Drug-coated balloon versus drug-eluting stent in small coronary artery lesions:angiographic analysis from the BASKET-SMALL 2 trial[J].Clin Res Cardiol2020109(9):1114-1124.DOI:10.1007/s00392-020-01603-2.
[41]
Caiazzo GOliva ATesta L,et al.Sirolimus-coated balloon in all-comer population of coronary artery disease patients:the EASTBOURNE diabetes prospective registry[J].Cardiovasc Diabetol202423(1):52.DOI:10.1186/s12933-024-02139-9.
[42]
Mangieri ATesta LHeang TM,et al.Safety and efficacy of single antiplatelet therapy in a large cohort of patients treated with sirolimus-coated balloon:post hoc analysis from the prospective EASTBOURNE registry[J].Cardiovasc Revasc Med2025(74):52-56.DOI:10.1016/j.carrev.2024.07.024.
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