Korean Circulation Journal

  • 제52권6호
  • /
  • Pages.444-454
  • /
  • 2022
  • /
  • 1738-5520(pISSN)
  • /
  • 1738-5555(eISSN)
대한심장학회 (The Korean Society of Cardiology)
권호 표지
DOI QR코드

DOI QR Code

Clinical Results of Drug-Coated Balloon Treatment in a Large-Scale Multicenter Korean Registry Study

  • Sang Yeub Lee (Division of Cardiology, Chung-Ang University Gwangmyeong Hospital and Department of Internal Medicine, Chung-Ang University College of Medicine) ;
  • Yun-Kyeong Cho (Department of Cardiology, Keimyung University Dongsan Hospital) ;
  • Sang-Wook Kim (Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine) ;
  • Young-Joon Hong (Department of Internal Medicine, Chonnam National University Hospital, Chonnam National University College of Medicine) ;
  • Bon-Kwon Koo (Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine) ;
  • Jang-Whan Bae (Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine) ;
  • Seung-Hwan Lee (Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University, Wonju College of Medicine) ;
  • Tae Hyun Yang (Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine) ;
  • Hun Sik Park (Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University School of Medicine) ;
  • Si Wan Choi (Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine) ;
  • Do-Sun Lim (Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine) ;
  • Soo-Joong Kim (Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University College of Medicine) ;
  • Young Hoon Jeong (Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine) ;
  • Hyun-Jong Lee (Bucheon Sejong Hospital) ;
  • Kwan Yong Lee (Incheon Saint Mary's Hospital) ;
  • Eun-Seok Shin (Department of Internal Medicine, Ulsan University Hospital, Ulsan University College of Medicine) ;
  • Ung Kim (Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine) ;
  • Moo Hyun Kim (Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine) ;
  • Chang-Wook Nam (Department of Cardiology, Keimyung University Dongsan Hospital) ;
  • Seung-Ho Hur (Department of Cardiology, Keimyung University Dongsan Hospital) ;
  • Doo-Il Kim (Department of Cardiology, Inje University Haeundae Baek Hospital, Inje University College of Medicine) ;
  • Stent Failure Research Group (SFR) Drug coated balloon (DCB) registry investigators (Stent Failure Research Group (SFR))
  • 투고 : 2021.07.30
  • 심사 : 2022.02.23
  • 발행 : 2022.06.01
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Background and Objectives: The aim of this study was to demonstrate the efficacy and safety of treatment with drug-coated balloon (DCB) in a large real-world population. Methods: Patients treated with DCBs were included in a multicenter observational registry that enrolled patients from 18 hospitals in Korea between January 2009 and December 2017. The primary outcome was target lesion failure (TLF) defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically indicated target lesion revascularization at 12 months. Results: The study included 2,509 patients with 2,666 DCB-treated coronary artery lesions (1,688 [63.3%] with in-stent restenosis [ISR] lesions vs. 978 [36.7%] with de novo lesions). The mean age with standard deviation was 65.7±11.3 years; 65.7% of the patients were men. At 12 months, the primary outcome, TLF, occurred in 179 (6.7%), 151 (8.9%), 28 (2.9%) patients among the total, ISR, and de novo lesion populations, respectively. A history of hypertension, diabetes, acute coronary syndrome, previous coronary artery bypass graft, reduced left ventricular ejection fraction, B2C lesion and ISR lesion were independent predictors of 12 months TLF in the overall study population. Conclusions: This large multicenter DCB registry study revealed the favorable clinical outcome of DCB treatment in real-world practice in patient with ISR lesion as well as small de novo coronary lesion.

키워드

참고문헌

  1. Palmerini T, Benedetto U, Biondi-Zoccai G, et al. Long-term safety of drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol 2015;65:2496-507. https://doi.org/10.1016/j.jacc.2015.04.017
  2. Gada H, Kirtane AJ, Newman W, et al. 5-year results of a randomized comparison of XIENCE V everolimus-eluting and TAXUS paclitaxel-eluting stents: final results from the SPIRIT III trial (clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions). JACC Cardiovasc Interv 2013;6:1263-6. https://doi.org/10.1016/j.jcin.2013.07.009
  3. Yamaji K, Raber L, Zanchin T, et al. Ten-year clinical outcomes of first-generation drug-eluting stents: the Sirolimus-Eluting vs. Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) VERY LATE trial. Eur Heart J 2016;37:3386-95. https://doi.org/10.1093/eurheartj/ehw343
  4. Scheller B, Hehrlein C, Bocksch W, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 2006;355:2113-24. https://doi.org/10.1056/NEJMoa061254
  5. Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS guidelines on myocardial revascularization. EuroIntervention 2015;10:1024-94. https://doi.org/10.4244/EIJY14M09_01
  6. Buccheri D, Piraino D, Andolina G, Cortese B. Understanding and managing in-stent restenosis: a review of clinical data, from pathogenesis to treatment. J Thorac Dis 2016;8:E1150-62. https://doi.org/10.21037/jtd.2016.10.93
  7. Alfonso F, Scheller B. State of the art: balloon catheter technologies - drug-coated balloon. EuroIntervention 2017;13:680-95. https://doi.org/10.4244/EIJ-D-17-00494
  8. Kleber FX, Rittger H, Bonaventura K, et al. Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol 2013;102:785-97. https://doi.org/10.1007/s00392-013-0609-7
  9. Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J 2019;40:87-165. https://doi.org/10.1093/eurheartj/ehy394
  10. Wohrle J, Zadura M, Mobius-Winkler S, et al. SeQuentPlease World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol 2012;60:1733-8. https://doi.org/10.1016/j.jacc.2012.07.040
  11. Yerasi C, Case BC, Forrestal BJ, et al. Drug-coated balloon for de novo coronary artery disease: JACC state-of-the-art review. J Am Coll Cardiol 2020;75:1061-73. https://doi.org/10.1016/j.jacc.2019.12.046
  12. Jeger RV, Farah A, Ohlow MA, et al. Drug-coated balloons for small coronary artery disease (BASKETSMALL 2): an open-label randomised non-inferiority trial. Lancet 2018;392:849-56. https://doi.org/10.1016/S0140-6736(18)31719-7
  13. Latib A, Colombo A, Castriota F, et al. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol 2012;60:2473-80. https://doi.org/10.1016/j.jacc.2012.09.020
  14. Cortese B, Di Palma G, Guimaraes MG, et al. Drug-coated balloon versus drug-eluting stent for small coronary vessel disease: PICCOLETO II randomized clinical trial. JACC Cardiovasc Interv 2020;13:2840-9. https://doi.org/10.1016/j.jcin.2020.08.035
  15. Jeger RV, Eccleshall S, Wan Ahmad WA, et al. Drug-coated balloons for coronary artery disease: third report of the International DCB Consensus Group. JACC Cardiovasc Interv 2020;13:1391-402. https://doi.org/10.1016/j.jcin.2020.02.043
  16. Thygesen K, Alpert JS, Jaffe AS, et al. Fourth universal definition of myocardial infarction (2018). Eur Heart J 2019;40:237-69. https://doi.org/10.1093/eurheartj/ehy462
  17. Onuma Y, Serruys PW, Perkins LE, et al. Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial. Circulation 2010;122:2288-300. https://doi.org/10.1161/CIRCULATIONAHA.109.921528
  18. Wykrzykowska JJ, Kraak RP, Hofma SH, et al. Bioresorbable scaffolds versus metallic stents in routine PCI. N Engl J Med 2017;376:2319-28. https://doi.org/10.1056/NEJMoa1614954
  19. Chen Y, Gao L, Qin Q, et al. Comparison of 2 different drug-coated balloons in in-stent restenosis: the RESTORE ISR China randomized trial. JACC Cardiovasc Interv 2018;11:2368-77. https://doi.org/10.1016/j.jcin.2018.09.010
  20. Habara S, Kadota K, Shimada T, et al. Late restenosis after paclitaxel-coated balloon angioplasty occurs in patients with drug-eluting stent restenosis. J Am Coll Cardiol 2015;66:14-22. https://doi.org/10.1016/j.jacc.2015.05.002
  21. Lee HS, Kang J, Park KW, et al. Procedural optimization of drug-coated balloons in the treatment of coronary artery disease. Catheter Cardiovasc Interv 2021;98:E43-52. https://doi.org/10.1002/ccd.29492
  22. Park KW, Lee JM, Kang SH, et al. Safety and efficacy of second-generation everolimus-eluting Xience V stents versus zotarolimus-eluting resolute stents in real-world practice: patient-related and stent-related outcomes from the multicenter prospective EXCELLENT and RESOLUTE-Korea registries. J Am Coll Cardiol 2013;61:536-44. https://doi.org/10.1016/j.jacc.2012.11.015
  23. Kelley-Hedgepeth A, Lloyd-Jones DM, Colvin A, et al. Ethnic differences in C-reactive protein concentrations. Clin Chem 2008;54:1027-37. https://doi.org/10.1373/clinchem.2007.098996
  24. White RH, Keenan CR. Effects of race and ethnicity on the incidence of venous thromboembolism. Thromb Res 2009;123 Suppl 4:S11-7. https://doi.org/10.1016/S0049-3848(09)70136-7
  25. Mak KH, Bhatt DL, Shao M, et al. Ethnic variation in adverse cardiovascular outcomes and bleeding complications in the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) study. Am Heart J 2009;157:658-65. https://doi.org/10.1016/j.ahj.2008.08.031