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Decade of Histological Follow-Up for a Fully Biodegradable Poly- l -lactic Acid Coronary Stent (Igaki-Tamai Stent) in Humans

2014; Lippincott Williams & Wilkins; Volume: 129; Issue: 4 Linguagem: Inglês

10.1161/circulationaha.113.003769

1524-4539

Soji Nishio, Shinsaku Takeda, Kunihiko Kosuga, Masaharu Okada, Eisho Kyo, Takafumi Tsuji, Eiji Takeuchi, Tsuyoshi Terashima, Yasutaka Inuzuka, Tatsuhiko Hata, Yuzo Takeuchi, Takeshi Harita, Junya Seki, Shigeru Ikeguchi,

Cerebrovascular and Carotid Artery Diseases

HomeCirculationVol. 129, No. 4Decade of Histological Follow-Up for a Fully Biodegradable Poly-l-lactic Acid Coronary Stent (Igaki-Tamai Stent) in Humans Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBDecade of Histological Follow-Up for a Fully Biodegradable Poly-l-lactic Acid Coronary Stent (Igaki-Tamai Stent) in HumansAre Bioresorbable Scaffolds the Answer? Soji Nishio, MD, Shinsaku Takeda, MD, Kunihiko Kosuga, MD, PhD, FJCC, Masaharu Okada, MD, PhD, Eisho Kyo, MD, Takafumi Tsuji, MD, Eiji Takeuchi, MD, PhD, Tsuyoshi Terashima, MD, Yasutaka Inuzuka, MD, PhD, Tatsuhiko Hata, MD, PhD, Yuzo Takeuchi, MD, PhD, Takeshi Harita, MD, Junya Seki, MD and Shigeru Ikeguchi, MD, PhD Soji NishioSoji Nishio From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. , Shinsaku TakedaShinsaku Takeda From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. , Kunihiko KosugaKunihiko Kosuga From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. , Masaharu OkadaMasaharu Okada From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. , Eisho KyoEisho Kyo From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. , Takafumi TsujiTakafumi Tsuji From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. , Eiji TakeuchiEiji Takeuchi From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. , Tsuyoshi TerashimaTsuyoshi Terashima From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. , Yasutaka InuzukaYasutaka Inuzuka From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. , Tatsuhiko HataTatsuhiko Hata From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. , Yuzo TakeuchiYuzo Takeuchi From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. , Takeshi HaritaTakeshi Harita From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. , Junya SekiJunya Seki From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. and Shigeru IkeguchiShigeru Ikeguchi From the Departments of Cardiology (S.N., S.T., K.K., M.O., Y.I., T.H., Y.T., T.H., J.S., S.I.) and Pathology (E.T., T.T.), Shiga Medical Center for Adults, and Kusatsu Heart Center (E.K., T.T.), Shiga, Japan. Originally published28 Jan 2014https://doi.org/10.1161/CIRCULATIONAHA.113.003769Circulation. 2014;129:534–535IntroductionAn 83-year-old male with a history of angina pectoris presented with massive intracranial hemorrhage in June 2011, and he died 2 days after admission. Previously, he was included in the first in-human feasibility study of biodegradable poly-l-lactic acid (PLLA) coronary stents: the Igaki-Tamai stents (Kyoto Medical Planning Co Ltd, Kyoto, Japan).1,2 To assess the long-term behavior of PLLA coronary stents in humans, postmortem examination of his coronary arteries was performed.In November 1999, he was diagnosed with stable angina pectoris, and coronary angiography disclosed a single lesion at the middle part of left anterior descending coronary artery (Figure 1A). One Igaki-Tamai stent had been implanted with successful result (Figure 1B). He received follow-up coronary angiography at 6 months, which showed restenosis at the distal edge of the stent (Figure 1C). Because he was asymptomatic, reintervention was avoided. Additional coronary angiography at 2 and 6 years of follow-up revealed late lumen enlargement (Figure 1D and 1E).Download figureDownload PowerPointFigure 1. Coronary angiography of the left anterior descending coronary artery (LAD). The index lesion (A). One 4×12-mm Igaki-Tamai stent had been implanted (B). Follow-up angiography 6 months (C), 2 years (D), and 6 years (E) after implantation of the Igaki-Tamai stent. Although restenosis was observed at the distal edge of the stent (C), late lumen enlargement was observed at 2 and 6 years of follow-up (D and E). The yellow arrows indicate the radio-opaque gold markers at the edges of the stent. The white lines (F) indicate the sites corresponding to the histological cross-sections shown in Figure 2.The coronary arteries were examined histopathologically by hematoxylin and eosin staining and other histochemical methods. The spaces previously occupied by PLLA struts had disappeared, suggesting complete degradation of PLLA (Figure 2A, 2D, and 2G). Inflammatory cell infiltration, foreign body reaction, and thrombus were not observed. The neointima consisted of connective tissue (Figure 2B, 2E, and 2H) and smooth muscle cells (Figure 2C, 2F, and 2I), and this stable neointimal layer sealed off old preexisting atherosclerotic plaques. The phenomenon of so-called neoatherosclerosis was not observed.Download figureDownload PowerPointFigure 2. Cross-sectional histology of the left anterior descending coronary artery (LAD) at the site where an Igaki-Tamai stent had been implanted. A corresponds to the white line A in Figure 1F, and B corresponds to the white line B in Figure 1F. The spaces previously occupied by poly-l-lactic acid (PLLA) had completely disappeared (A, D). Inflammatory cell infiltration, foreign body reaction, and thrombus were not observed. The stable neointimal layer sealed off old preexisting atherosclerotic plaques. The phenomenon of so-called neoatherosclerosis was not observed. Magnified histology of the neointima (G, H, I). In the neointima, proliferation of connective tissue and smooth muscle cells are shown using Elastiva van Gieson (EVG) staining (B, E, H) and α-smooth muscle (SM) actin staining (C, F, I), respectively. H.E indicates hematoxylin and eosin.The Igaki-Tamai stent is the first in-human bioresorbable scaffold, and this is the first human histology case to show the complete biodegradation of PLLA. Although this is only a single case, the histological examination indicates the biocompatibility and the long-term safety of PLLA. This bioresorbable scaffold technology can be one of the ideal treatment choices for coronary artery disease, especially when viewed from a long-term standpoint.DisclosuresShiga Medical Center for Adults has participated in a clinical study which evaluates PLLA stent for peripheral artery disease, provided by Kyoto Medical Planning Co Ltd, Kyoto, Japan. The authors report no conflicts.FootnotesCorrespondence to Kunihiko Kosuga, MD, PhD, FJCC, Department of Cardiology, Shiga Medical Center for Adults, 5-4-30, Moriyama, Moriyama City, Shiga 524-8524, Japan. E-mail [email protected]References1. Nishio S, Kosuga K, Igaki K, Okada M, Kyo E, Tsuji T, Takeuchi E, Inuzuka Y, Takeda S, Hata T, Takeuchi Y, Kawada Y, Harita T, Seki J, Akamatsu S, Hasegawa S, Bruining N, Brugaletta S, de Winter S, Muramatsu T, Onuma Y, Serruys PW, Ikeguchi S. Long-Term (>10 Years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents.Circulation. 2012; 125:2343–2353.LinkGoogle Scholar2. Tamai H, Igaki K, Kyo E, Kosuga K, Kawashima A, Matsui S, Komori H, Tsuji T, Motohara S, Uehata H. Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans.Circulation. 2000; 102:399–404.LinkGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Fang H, Qi X, Zhou S, Yang S, Hang C, Tian Y and Wang C (2021) High-Efficient Vacuum Ultraviolet-Ozone Assist-Deposited Polydopamine for Poly(lactic- co -glycolic acid)-Coated Pure Zn toward Biodegradable Cardiovascular Stent Applications , ACS Applied Materials & Interfaces, 10.1021/acsami.1c21567, 14:2, (3536-3550), Online publication date: 19-Jan-2022. Kuwabara K, Zen K, Yashige M, Ito N, Kadoya Y, Wakana N, Yanishi K and Matoba S (2020) Comparative Analysis of the Paclitaxel-Eluting Peripheral Igaki-Tamai Stent and the Drug-Free Igaki-Tamai Stent Using Optical Coherence Tomography and Histological Analysis in a Porcine Iliac Artery Model, Circulation Journal, 10.1253/circj.CJ-20-0040, 84:5, (799-805), Online publication date: 24-Apr-2020. Raphael C, El-Sabbagh A, Corban M, Hajj S and Prasad A (2020) Emerging therapies in coronary balloon angioplasty, stenting, and bioabsorbable scaffolds Emerging Technologies for Heart Diseases, 10.1016/B978-0-12-813704-8.00024-3, (527-557), . Jinnouchi H, Torii S, Sakamoto A, Kolodgie F, Virmani R and Finn A (2018) Fully bioresorbable vascular scaffolds: lessons learned and future directions, Nature Reviews Cardiology, 10.1038/s41569-018-0124-7, 16:5, (286-304), Online publication date: 1-May-2019. Lee S, Jo H, Lim K, Lim D, Lee S, Lee J, Kim W, Jeong M, Lim J, Kwon I, Jung Y, Park J and Park S (2019) Heparin coating on 3D printed poly (l-lactic acid) biodegradable cardiovascular stent via mild surface modification approach for coronary artery implantation, Chemical Engineering Journal, 10.1016/j.cej.2019.122116, 378, (122116), Online publication date: 1-Dec-2019. Nikoubashman O, Heringer S, Feher K, Brockmann M, Sellhaus B, Dreser A, Kurtenbach K, Pjontek R, Jockenhövel S, Weis J, Kießling F, Gries T and Wiesmann M (2018) Development of a Polymer-Based Biodegradable Neurovascular Stent Prototype: A Preliminary In Vitro and In Vivo Study, Macromolecular Bioscience, 10.1002/mabi.201700292, 18:7, (1700292), Online publication date: 1-Jul-2018. Wang J, Li Y, Gao L, Wang S, Mao A and Liu B (2017) Preparation of the micro/nano structures of the biomimetic coating stent for loading MiRNA126 by four-beam laser interference, Optik, 10.1016/j.ijleo.2016.10.030, 128, (247-252), Online publication date: 1-Jan-2017. Zhu Y, Jiang H, Ye S, Yoshizumi T and Wagner W (2015) Tailoring the degradation rates of thermally responsive hydrogels designed for soft tissue injection by varying the autocatalytic potential, Biomaterials, 10.1016/j.biomaterials.2015.02.100, 53, (484-493), Online publication date: 1-Jun-2015. Plimpton S, Liu W and Kheradvar A (2015) Immunological and Phenotypic Considerations in Supplementing Cardiac Biomaterials with Cells Biomaterials for Cardiac Regeneration, 10.1007/978-3-319-10972-5_8, (239-273), . January 28, 2014Vol 129, Issue 4 Advertisement Article InformationMetrics © 2014 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.113.003769PMID: 24470476 Originally publishedJanuary 28, 2014 PDF download Advertisement SubjectsStent