药物涂层球囊在冠脉原位病变中的研究进展
Research Progress of Drug-Coated Balloons in De Novo Coronary Lesions
DOI: 10.12677/acm.2025.151142, PDF,   
作者: 艾云锋*:延安大学医学院,陕西 延安;高 燕:延安大学附属医院高血压心衰科,陕西 延安
关键词: 药物涂层球囊冠脉原位病变经皮冠状动脉介入治疗DCB De Novo Coronary Lesions PCI
摘要: 药物涂层球囊(drug-coated balloon, DCB)作为经皮冠状动脉介入治疗(percutaneous coronary intervention, PCI)领域的新器械,在不留置永久性植入物的情况下有效抑制狭窄,特别在冠状动脉原位小血管病变(small vessel disease, SVD)和支架内再狭窄(in-stent restenosis, ISR)病变中显示出较优的疗效。随着影像学技术的发展,光学相干断层成像(optical coherence tomography, OCT)、血管内超声(intravascular ultrasound, IVUS)引导下的DCB治疗能够进一步提高其临床效果,降低主要不良心血管事件(major adverse cardiac events, MACE)的发生率,使其在冠脉病变治疗中的应用范围不断扩大。本文就目前DCB应用于冠脉原位病变做一综述。
Abstract: Drug-coated balloon (DCB), as a new device in the field of percutaneous coronary intervention (PCI), effectively inhibits stenosis without indwelling permanent implants. In particular, it has shown better efficacy in coronary primary small vessel disease (SVD) and in-stent restenosis (ISR) lesions. With the development of imaging technology, DCB treatment guided by optical coherence tomography (OCT) and intravascular ultrasound (IVUS) can further improve its clinical efficacy. It can reduce the incidence of major adverse cardiac events (MACE) and expand its application in the treatment of coronary artery disease. This article reviews the current application of DCB in de novo coronary lesions.
文章引用:艾云锋, 高燕. 药物涂层球囊在冠脉原位病变中的研究进展[J]. 临床医学进展, 2025, 15(1): 1063-1070. https://doi.org/10.12677/acm.2025.151142

参考文献

[1] Wang, H., Zhang, H. and Zou, Z. (2023) Changing Profiles of Cardiovascular Disease and Risk Factors in China: A Secondary Analysis for the Global Burden of Disease Study 2019. Chinese Medical Journal, 136, 2431-2441. [Google Scholar] [CrossRef] [PubMed]
[2] Shazly, T., Torres, W.M., Secemsky, E.A., Chitalia, V.C., Jaffer, F.A. and Kolachalama, V.B. (2022) Understudied Factors in Drug‐Coated Balloon Design and Evaluation: A Biophysical Perspective. Bioengineering & Translational Medicine, 8, e10370. [Google Scholar] [CrossRef] [PubMed]
[3] Haase, T., Speck, U., Bienek, S., Löchel, M., Brunacci, N., Gemeinhardt, O., et al. (2022) Drug-Coated Balloons: Drugs Beyond Paclitaxel? Frontiers in Bioscience-Landmark, 27, 283. [Google Scholar] [CrossRef] [PubMed]
[4] Villar-Matamoros, E., Stokes, L., Lloret, A., Todd, M., Tillman, B.W. and Yazdani, S.K. (2022) Understanding the Mechanism of Drug Transfer and Retention of Drug-Coated Balloons. Journal of Cardiovascular Pharmacology and Therapeutics, 27. [Google Scholar] [CrossRef] [PubMed]
[5] Colombo, M., Corti, A., Berceli, S., Migliavacca, F., McGinty, S. and Chiastra, C. (2021) 3D Modelling of Drug-Coated Balloons for the Treatment of Calcified Superficial Femoral Arteries. PLOS ONE, 16, e0256783. [Google Scholar] [CrossRef] [PubMed]
[6] Tian, J., Tang, Y., Qiao, S., Su, X., Chen, Y., Jin, Z., et al. (2020) 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. Catheterization and Cardiovascular Interventions, 95, 587-597. [Google Scholar] [CrossRef] [PubMed]
[7] Cortese, B., Testa, G., Rivero, F., Erriquez, A. and Alfonso, F. (2023) Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up. JACC: Cardiovascular Interventions, 16, 1054-1061. [Google Scholar] [CrossRef] [PubMed]
[8] Jeger, R.V., Farah, A., Ohlow, M., Mangner, N., Möbius-Winkler, S., Weilenmann, D., et al. (2020) 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. The Lancet, 396, 1504-1510. [Google Scholar] [CrossRef] [PubMed]
[9] Li, M., Guo, C., Lv, Y., Zhang, M. and Wang, Z. (2019) Drug-Coated Balloon versus Drug-Eluting Stent in De Novo Small Coronary Vessel Disease: A Systematic Review and Meta-Analysis. Medicine, 98, e15622. [Google Scholar] [CrossRef] [PubMed]
[10] Megaly, M., Rofael, M., Saad, M., Rezq, A., Kohl, L.P., Kalra, A., et al. (2018) Outcomes with Drug‐Coated Balloons in Small‐Vessel Coronary Artery Disease. Catheterization and Cardiovascular Interventions, 93, E277-E286. [Google Scholar] [CrossRef] [PubMed]
[11] Cortese, B., Testa, L., Heang, T.M., Ielasi, A., Bossi, I., Latini, R.A., et al. (2023) Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients: The EASTBOURNE Prospective Registry. JACC: Cardiovascular Interventions, 16, 1794-1803. [Google Scholar] [CrossRef] [PubMed]
[12] Kang, W.C., Park, S.M., Jang, A.Y., Oh, P.C., Shin, E., Yu, C.W., et al. (2021) Predictors of Favorable Angiographic Outcomes after Drug-Coated Balloon Use for De Novo Small Vessel Coronary Disease (DCB-Only). Angiology, 72, 986-993. [Google Scholar] [CrossRef] [PubMed]
[13] Latib, A., Agostoni, P., Dens, J., Patterson, M., Lancellotti, P., Tam, F., et al. (2021) Paclitaxel Drug-Coated Balloon for the Treatment of De Novo Small-Vessel and Restenotic Coronary Artery Lesions: 12-Month Results of the Prospective, Multicenter, Single-Arm PREVAIL Study. Journal of Invasive Cardiology, 33, E863-E869. [Google Scholar] [CrossRef] [PubMed]
[14] Seeger, J., Wöhrle, J., Scheller, B., Farah, A., Ohlow, M., Mangner, N., et al. (2023) Impact of Insulin-Treated Compared to Non-Insulin-Treated Diabetes Mellitus on Outcome of Percutaneous Coronary Intervention with Drug-Coated Balloons versus Drug-Eluting Stents in De Novo Coronary Artery Disease: The Randomized BASKET-SMALL 2 Trial. Journal of Cardiovascular Development and Disease, 10, Article No. 119. [Google Scholar] [CrossRef] [PubMed]
[15] Tsai, C., Yeh, C., Meng, S., Hung, C., Lin, M., Huang, C., et al. (2022) Comparison between Drug-Coated Balloons and Drug-Eluting Stents in Very Small Coronary Artery Interventions. Scientific Reports, 12, Article No. 10679. [Google Scholar] [CrossRef] [PubMed]
[16] Zhang, M., Yong, J., Zhou, Y., Zhang, M., Song, X., Qiao, S., et al. (2022) Efficacy and Safety of Drug-Coated Balloons in the Treatment of De Novo Coronary Lesions in Very Small Vessels: A Prospective, Multicenter, Single-Arm Trial. Annals of Translational Medicine, 10, 445-445. [Google Scholar] [CrossRef] [PubMed]
[17] Gao, G., Wang, H., Song, Y., Yin, D., Feng, L., Wang, H., et al. (2023) Feasibility and Safety of Drug-Coated Balloon for Treatment of De Novo Coronary Artery Lesions in Large Vessel Disease: A Large-Scale Multicenter Prospective Study. Reviews in Cardiovascular Medicine, 24, Article No. 277. [Google Scholar] [CrossRef] [PubMed]
[18] Rosenberg, M., Waliszewski, M., Krackhardt, F., Chin, K., Wan Ahmad, W.A., Caramanno, G., et al. (2019) Drug Coated Balloon-Only Strategy in De Novo Lesions of Large Coronary Vessels. Journal of Interventional Cardiology, 2019, Article ID: 6548696. [Google Scholar] [CrossRef] [PubMed]
[19] Yu, X., Ji, F., Xu, F., Zhang, W., Wang, X., Lu, D., et al. (2018) Treatment of Large De Novo Coronary Lesions with Paclitaxel-Coated Balloon Only: Results from a Chinese Institute. Clinical Research in Cardiology, 108, 234-243. [Google Scholar] [CrossRef] [PubMed]
[20] Lu, W., Zhu, Y., Han, Z., Sun, G., Qin, X., Wang, Z., et al. (2019) Short-Term Outcomes from Drug-Coated Balloon for Coronary De Novo Lesions in Large Vessels. Journal of Cardiology, 73, 151-155. [Google Scholar] [CrossRef] [PubMed]
[21] Jiang, J., Huang, Q. and Chen, M. (2024) Efficacy and Safety of Drug-Coated Balloon for De Novo Lesions of Large Coronary Arteries: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Heliyon, 10, e25264. [Google Scholar] [CrossRef] [PubMed]
[22] 李谦, 常尚, 张瑶俊, 等. 药物涂层球囊与药物洗脱支架治疗冠状动脉大血管原位原发病变疗效的对比研究[J]. 中华老年心脑血管病杂志, 2019, 21(12): 1273-1276.
[23] 贾高鹏, 曲泽, 李桂梅, 等. 药物涂层球囊治疗老年患者冠状动脉大血管原位病变的有效性和安全性: 一项队列研究[J]. 中国全科医学, 2024, 27(33): 4125-4131+4138.
[24] Liu, Y., Zhang, Y., Deng, L., Yin, Z., Hu, T., Wang, Q., et al. (2019) 12-Month Clinical Results of Drug-Coated Balloons for De Novo Coronary Lesion in Vessels Exceeding 3.0 mm. The International Journal of Cardiovascular Imaging, 35, 579-586. [Google Scholar] [CrossRef] [PubMed]
[25] Nakamura, H., Ishikawa, T., Mizutani, Y., Yamada, K., Ukaji, T., Kondo, Y., et al. (2023) Clinical and Angiographic Outcomes of Elective Paclitaxel-Coated Balloon Angioplasty in Comparison with Drug-Eluting Stents for De Novo Coronary Lesions in Large Vessels. International Heart Journal, 64, 145-153. [Google Scholar] [CrossRef] [PubMed]
[26] Sciahbasi, A., Salvi, N., Heang, T.M., Perez, I.S., Geraci, S., Vaccaro, G., et al. (2024) Long Term Clinical Outcome of Sirolimus Drug Coated Balloons in Large Coronary Vessels. Catheterization and Cardiovascular Interventions, 103, 532-538. [Google Scholar] [CrossRef] [PubMed]
[27] Ueda, H., Fujiwara, Y., Nishida, Y., Maenaka, M., Yoshimura, K., Oshida, Y., et al. (2024) Procedural Characteristics and Cardiovascular Outcomes in Patients Undergoing Drug-Coated Balloon Angioplasty for De Novo Lesions in Large Coronary Arteries: An Observational Study. Heart and Vessels, 39, 496-504. [Google Scholar] [CrossRef] [PubMed]
[28] Kasbaoui, S., Payot, L., Zabalawi, A., Delaunay, R., Amara, W.B., Boukhris, M., et al. (2023) Safety and Efficacy of a Hybrid Approach Combining a Paclitaxel-Coated Balloon with a New Generation Drug-Eluting Stent in Patients with De Novo True Coronary Bifurcation Lesions. Cardiovascular Revascularization Medicine, 54, 47-56. [Google Scholar] [CrossRef] [PubMed]
[29] Pellegrini, D., Donahue, M., Regazzoli, D., Tedeschi, D., Loffi, M., Pellicano, M., et al. (2023) Drug-Coated Balloon Combined with Drug-Eluting Stent for the Treatment of Coronary Bifurcation Lesions: Insights from the HYPER Study. European Heart Journal Supplements, 25, C79-C83. [Google Scholar] [CrossRef] [PubMed]
[30] Liu, H., Zhao, Y., Lu, Y., Zhou, S., Zhang, Y., Zhao, J., et al. (2022) The Drug Coated Balloon-Only Strategy for Treatment of De Novo Left Main Coronary Artery Bifurcation Lesion: Stentless Strategy. Clinical and Applied Thrombosis/Hemostasis, 28. [Google Scholar] [CrossRef] [PubMed]
[31] Her, A., Ann, S.H., Singh, G.B., Kim, Y.H., Okamura, T., Garg, S., et al. (2016) Serial Morphological Changes of Side-Branch Ostium after Paclitaxel-Coated Balloon Treatment of de Novo Coronary Lesions of Main Vessels. Yonsei Medical Journal, 57, Article No. 606. [Google Scholar] [CrossRef] [PubMed]
[32] Ke, D., He, X., Chen, C., Lin, C., Luo, Y., Fan, L., et al. (2023) Randomized Pilot Study to Compare DCB-Based versus DST-Based Strategies for the Treatment of True or Complex Coronary Bifurcation Lesions. Reviews in Cardiovascular Medicine, 24, Article No. 99. [Google Scholar] [CrossRef] [PubMed]
[33] Qin, Q., Chen, L., Ge, L., Qian, J., Ma, J. and Ge, J. (2023) Long-Term Clinical Outcomes of Drug-Coated Balloon for the Management of Chronic Total Occlusions. Coronary Artery Disease, 34, 555-561. [Google Scholar] [CrossRef] [PubMed]
[34] Shin, E., Her, A., Jang, M.H., Kim, B., Kim, S. and Liew, H.B. (2024) Impact of Drug-Coated Balloon-Based Revascularization in Patients with Chronic Total Occlusions. Journal of Clinical Medicine, 13, Article No. 3381. [Google Scholar] [CrossRef] [PubMed]
[35] Zhao, Y., Wang, P., Zheng, Z., Ma, Q., Shi, Y. and Liu, J. (2024) Efficacy and Safety of Drug-Coated Balloons in Chronic Total Coronary Occlusion Recanalization: A Systematic Review and Meta-Analysis. BMC Cardiovascular Disorders, 24, Article No. 324. [Google Scholar] [CrossRef] [PubMed]
[36] Ito, M., Iijima, R., Sato, M., Hara, H. and Moroi, M. (2024) Long-Term Clinical Outcomes of Drug-Coated Balloon Angioplasty for De Novo Coronary Lesions in Patients with Diabetes Mellitus. Heart and Vessels. [Google Scholar] [CrossRef] [PubMed]
[37] Ito, R., Ishii, H., Oshima, S., Nakayama, T., Sakakibara, T., Kakuno, M., et al. (2021) Outcomes after Drug-Coated Balloon Interventions for De Novo Coronary Lesions in the Patients on Chronic Hemodialysis. Heart and Vessels, 36, 1646-1652. [Google Scholar] [CrossRef] [PubMed]
[38] Funayama, N., Muratsubaki, S., Ito, R., Tobisawa, T. and Konishi, T. (2022) Drug-Coated Balloons versus Drug-Eluting Stents for Coronary De Novo Lesions in Dialysis Patients. Heart and Vessels, 38, 300-308. [Google Scholar] [CrossRef] [PubMed]
[39] Shan, Y., Lu, W., Han, Z., Pan, S., Li, X., Wang, X., et al. (2023) Long-Term Outcomes of Drug-Coated Balloon Treatment of Calcified Coronary Artery Lesions: A Multicenter, Retrospective, Propensity Matching Study. Frontiers in Cardiovascular Medicine, 10, Article ID: 1122290. [Google Scholar] [CrossRef] [PubMed]
[40] Li, C., Ding, X., Wang, L., Li, K., Yang, X., Liu, L., et al. (2022) Feasibility and Safety of Drug-Coated Balloon-Only Angioplasty for De Novo Ostial Lesions of the Left Anterior Descending Artery: Two-Center Retrospective Study. Frontiers in Cardiovascular Medicine, 9, Article ID: 874394. [Google Scholar] [CrossRef] [PubMed]
[41] Fong, A.Y.Y., Said, A., Oon, Y.Y., Koh, K.T., Ho, K.H., Shu, F.E.P., et al. (2024) A Comparison of 2 Paclitaxel-Coated Balloon Systems in Treatment of De Novo Coronary Artery Lesions. Journal of the Society for Cardiovascular Angiography & Interventions, 3, Article ID: 101295. [Google Scholar] [CrossRef] [PubMed]
[42] Merinopoulos, I., Gunawardena, T., Wickramarachchi, U., Richardson, P., Maart, C., Sreekumar, S., et al. (2020) Long-term Safety of Paclitaxel Drug-Coated Balloon-Only Angioplasty for De Novo Coronary Artery Disease: The SPARTAN DCB Study. Clinical Research in Cardiology, 110, 220-227. [Google Scholar] [CrossRef] [PubMed]
[43] Rosenberg, M., Waliszewski, M., Chin, K., Ahmad, W.A.W., Caramanno, G., Milazzo, D., et al. (2018) Prospective, Large‐Scale Multicenter Trial for the Use of Drug‐Coated Balloons in Coronary Lesions: The DCB‐Only All‐Comers Registry. Catheterization and Cardiovascular Interventions, 93, 181-188. [Google Scholar] [CrossRef] [PubMed]
[44] Venetsanos, D., Omerovic, E., Sarno, G., Pagonis, C., Witt, N., Calais, F., et al. (2021) Long Term Outcome after Treatment of De Novo Coronary Artery Lesions Using Three Different Drug Coated Balloons. International Journal of Cardiology, 325, 30-36. [Google Scholar] [CrossRef] [PubMed]
[45] Yu, X., Wang, X., Ji, F., Zhang, W., Yang, C., Xu, F., et al. (2021) A Non-Inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions. Cardiovascular Drugs and Therapy, 36, 655-664. [Google Scholar] [CrossRef] [PubMed]
[46] Zhang, W., Zhang, M., Tian, J., Zhang, M., Zhou, Y. and Song, X. (2023) Drug-Coated Balloon-Only Strategy for De Novo Coronary Artery Disease: A Meta-Analysis of Randomized Clinical Trials. Cardiovascular Therapeutics, 2023, Article ID: 3121601. [Google Scholar] [CrossRef] [PubMed]
[47] Li, L., Zhao, L., Wang, J., et al. (2021) Optical Coherence Tomography-Guided Drug Coated Balloon in Non-Small De Novo Coronary Artery Lesions: A Prospective Clinical Research. American Journal of Translational Research, 13, 11617-11624.
[48] Gao, X., Ge, Z., Kong, X., Chen, X., Han, L., Qian, X., et al. (2024) Intravascular Ultrasound vs Angiography-Guided Drug-Coated Balloon Angioplasty. JACC: Cardiovascular Interventions, 17, 1519-1528. [Google Scholar] [CrossRef] [PubMed]
[49] 刘洁银, 鲍骏, 苏衡, 等. 血管内超声指导药物涂层球囊介入治疗原位冠状动脉病变临床效果[J]. 介入放射学杂志, 2023, 32(10): 960-964.