Korean Circulation Journal

  • 제54권6호
  • /
  • Pages.339-350
  • /
  • 2024
  • /
  • 1738-5520(pISSN)
  • /
  • 1738-5555(eISSN)
대한심장학회 (The Korean Society of Cardiology)
권호 표지
DOI QR코드

DOI QR Code

Efficacy and Safety of Sirolimus-Eluting Stent With Biodegradable Polymer UltimasterTM in Unselected Korean Population: A Multicenter, Prospective, Observational Study From Korean Multicenter Ultimaster Registry

  • Soohyung Park (Cardiovascular Center, Korea University Guro Hospital) ;
  • Seung-Woon Rha (Cardiovascular Center, Korea University Guro Hospital) ;
  • Byoung Geol Choi (Cardiovascular Research Institute, Korea University) ;
  • Jae-Bin Seo (Division of Cardiology, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center) ;
  • Ik Jun Choi (Division of Cardiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Sung-Il Woo (Division of Cardiology, Department of Internal Medicine, Inha University College of Medicine) ;
  • Soo-Han Kim (Department of Cardiology, Hallym Hospital) ;
  • Tae Hoon Ahn (Department of Cardiology, Na-Eun Hospital) ;
  • Jae Sang Kim (Division of Cardiology, Department of Internal Medicine, Sejong General Hospital) ;
  • Ae-Young Her (Division of Cardiology, Department of Internal Medicine, Kangwon National University School of Medicine) ;
  • Ji-Hun Ahn (Division of Cardiology, Department of Internal Medicine, Eulji University Hospital) ;
  • Han Cheol Lee (Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital) ;
  • Jaewoong Choi (Division of Cardiology, Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University, School of Medicine) ;
  • Jin Soo Byon (Division of Cardiology, Department of Internal Medicine, School of Medicine, Soonchunhyang University Gumi Hospital) ;
  • Markz RMP Sinurat (Cardiovascular Research Institute, Korea University) ;
  • Se Yeon Choi (Cardiovascular Research Institute, Korea University) ;
  • Jinah Cha (Cardiovascular Research Institute, Korea University) ;
  • Su Jin Hyun (Cardiovascular Research Institute, Korea University) ;
  • Cheol Ung Choi (Cardiovascular Center, Korea University Guro Hospital) ;
  • Chang Gyu Park (Cardiovascular Center, Korea University Guro Hospital)
  • 투고 : 2024.01.14
  • 심사 : 2024.02.29
  • 발행 : 2024.06.01
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Background and Objectives: UltimasterTM, a third-generation sirolimus-eluting stent using biodegradable polymer, has been introduced to overcome long term adverse vascular events, such as restenosis or stent thrombosis. In the present study, we aimed to evaluate the 12-month clinical outcomes of UltimasterTM stents in Korean patients with coronary artery disease. Methods: This study is a multicenter, prospective, observational registry across 12 hospitals. To reflect real-world clinical evidence, non-selective subtypes of patients and lesions were included in this study. The study end point was target lesion failure (TLF) (the composite of cardiac death, target vessel myocardial infarction [MI], and target lesion revascularization [TLR]) at 12-month clinical follow up. Results: A total of 576 patients were enrolled between November 2016 and May 2021. Most of the patients were male (76.5%), with a mean age of 66.0±11.2 years. Among the included patients, 40.1% had diabetes mellitus (DM) and 67.9% had acute coronary syndrome (ACS). At 12 months, the incidence of TLF was 4.1%. The incidence of cardiac death was 1.5%, MI was 1.0%, TLR was 2.7%, and stent thrombosis was 0.6%. In subgroup analysis based on the presence of ACS, DM, hypertension, dyslipidemia, or bifurcation, there were no major differences in the incidence of the primary endpoint. Conclusions: The present registry shows that UltimasterTM stent is safe and effective for routine real-world clinical practice in non-selective Korean patients, having a low rate of adverse events at least up to 12 months.

키워드

과제정보

The authors received research funding from the Terumo Korea Co., Ltd. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

참고문헌

  1. Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773-80.
  2. Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004;350:221-31.
  3. Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 2007;370:937-48.
  4. Nakazawa G, Finn AV, Vorpahl M, Ladich ER, Kolodgie FD, Virmani R. Coronary responses and differential mechanisms of late stent thrombosis attributed to first-generation sirolimus- and paclitaxeleluting stents. J Am Coll Cardiol 2011;57:390-8.
  5. Joner M, Finn AV, Farb A, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006;48:193-202.
  6. Serruys PW, Farooq V, Kalesan B, et al. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv 2013;6:777-89.
  7. Barbato E, Salinger-Martinovic S, Sagic D, et al. A first-in-man clinical evaluation of Ultimaster, a new drug-eluting coronary stent system: CENTURY study. EuroIntervention 2015;11:541-8.
  8. Saito S, Valdes-Chavarri M, Richardt G, et al. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial. Eur Heart J 2014;35:2021-31. 
  9. Godino C, Beneduce A, Ferrante G, et al. One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in all-comers population. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry). Int J Cardiol 2018;260:36-41.
  10. Valdes-Chavarri M, Kedev S, Neskovic AN, et al. Randomised evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study. EuroIntervention 2019;14:e1836-42.
  11. Codner P, Saada M, Sakhov O, et al. Proximal left anterior descending artery treatment using a bioresorbable polymer coating sirolimus-eluting stent: real-world outcomes from the multicenter prospective e-Ultimaster registry. J Am Heart Assoc 2019;8:e013786.
  12. Tadano Y, Kotani JI, Kashima Y, et al. Predictors of clinical outcomes after coronary implantation of bioresorbable polymer sirolimus-eluting Ultimaster stents in all-comers: a report of 1,727 cases. Catheter Cardiovasc Interv 2019;94:91-7.
  13. Iniguez A, Chevalier B, Richardt G, et al. Comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent: 5-year results of the CENTURY II randomized clinical trial. Catheter Cardiovasc Interv 2020;95:175-84.
  14. Thygesen K, Alpert JS, White HD, et al. Universal definition of myocardial infarction. Circulation 2007;116:2634-53.
  15. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344-51.
  16. Medina A, Suarez de Lezo J, Pan M. A new classification of coronary bifurcation lesions. Rev Esp Cardiol 2006;59:183.
  17. Thomas M, Hildick-Smith D, Louvard Y, et al. Percutaneous coronary intervention for bifurcation disease. A consensus view from the first meeting of the European Bifurcation Club. EuroIntervention 2006;2:149-53.
  18. Park TK, Park YH, Song YB, et al. Long-term clinical outcomes of true and non-true bifurcation lesions according to medina classification- results from the COBIS (COronary BIfurcation Stent) II registry. Circ J 2015;79:1954-62.
  19. Ellis SG, Vandormael MG, Cowley MJ, et al. Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease. Implications for patient selection. Multivessel Angioplasty Prognosis Study Group. Circulation 1990;82:1193-202.
  20. Zhang J. Stent thrombosis in patients with coronary artery disease treated with biodegradable polymer drug-eluting stents: an update meta-analysis. Int Heart J 2014;55:213-8.
  21. Luscher TF, Steffel J, Eberli FR, et al. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation 2007;115:1051-8.
  22. Byrne RA, Iijima R, Mehilli J, et al. Durability of antirestenotic efficacy in drug-eluting stents with and without permanent polymer. JACC Cardiovasc Interv 2009;2:291-9.
  23. Stefanini GG, Byrne RA, Serruys PW, et al. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials. Eur Heart J 2012;33:1214-22.
  24. Torii S, Jinnouchi H, Sakamoto A, et al. Drug-eluting coronary stents: insights from preclinical and pathology studies. Nat Rev Cardiol 2020;17:37-51.
  25. Pendyala LK, Matsumoto D, Shinke T, et al. Nobori stent shows less vascular inflammation and early recovery of endothelial function compared with Cypher stent. JACC Cardiovasc Interv 2012;5:436-44.
  26. Iantorno M, Lipinski MJ, Garcia-Garcia HM, et al. Meta-analysis of the impact of strut thickness on outcomes in patients with drug-eluting stents in a coronary artery. Am J Cardiol 2018;122:1652-60.
  27. Kandzari DE, Mauri L, Koolen JJ, et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet 2017;390:1843-52.
  28. Pilgrim T, Heg D, Roffi M, et al. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial. Lancet 2014;384:2111-22.