Systematic Analysis of the Incidence of Coronary Stent Fracture and Adverse Events in Japan  [in Japanese] Systematic Analysis of the Incidence of Coronary Stent Fracture and Adverse Events in Japan  [in Japanese]

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Author(s)

    • Yutaka MATSUI MATSUI Yutaka
    • Cooperative major in advanced biomedical sciences, graduate school of advanced science and engineering, Waseda University (Tokyo Women's Medical University-Waseda University joint institution for advanced biomedical sciences) Cooperative major in advanced biomedical sciences, graduate school of advanced science and engineering, Waseda University (Tokyo Women's Medical University-Waseda University joint institution for advanced biomedical sciences)
    • Mitsuo UMEZU UMEZU Mitsuo
    • Cooperative major in advanced biomedical sciences, graduate school of advanced science and engineering, Waseda University (Tokyo Women's Medical University-Waseda University joint institution for advanced biomedical sciences) Cooperative major in advanced biomedical sciences, graduate school of advanced science and engineering, Waseda University (Tokyo Women's Medical University-Waseda University joint institution for advanced biomedical sciences)
    • Hiroshi KASANUKI KASANUKI Hiroshi
    • Cooperative major in advanced biomedical sciences, graduate school of advanced science and engineering, Waseda University (Tokyo Women's Medical University-Waseda University joint institution for advanced biomedical sciences) Cooperative major in advanced biomedical sciences, graduate school of advanced science and engineering, Waseda University (Tokyo Women's Medical University-Waseda University joint institution for advanced biomedical sciences)
    • Kiyotaka IWASAKI IWASAKI Kiyotaka
    • Cooperative major in advanced biomedical sciences, graduate school of advanced science and engineering, Waseda University (Tokyo Women's Medical University-Waseda University joint institution for advanced biomedical sciences) Cooperative major in advanced biomedical sciences, graduate school of advanced science and engineering, Waseda University (Tokyo Women's Medical University-Waseda University joint institution for advanced biomedical sciences)

Abstract

冠動脈ステントの破断は, 再狭窄やステント血栓症のリスクとして認識されている. しかし, 実際の発生頻度は明確になっていない. 本研究は, 査読付き論文を調査することによって国内におけるステント破断の発生状況を評価し, 不具合報告の現状を明らかにすることを目的としている. 2014年4月1日にPubMedおよび医学中央雑誌 (医中誌) を用いてステント破断の発生に関する文献分析を実施した. PubMedでは, 「stent fracture」を検索単語として使用した. 医中誌では, 「冠動脈」「ステント」「fracture」「破断」「破損」を検索単語として使用した. PubMed検索で895報が検索された. これらの中で, 日本以外の施設にて実施された文献が792報, 冠動脈が対象ではない文献が45報, ステント破断とは関係のない文献が17報, 同一症例を対象としていると考えられる文献が11報あった. これらを除外し, 14報の観察研究および16報の症例報告で合計30報を解析対象とした. 査読付き論文では643病変でのステント破断, 不具合報告では105病変でのステント破断が報告されていた. 14報の観察研究から, ステント破断の発生頻度は5.4% (10,927病変中595病変) であった. 不具合報告から得られたステント破断の発生件数は, 文献分析によって得られた発生件数より6.1倍少なかった. これらの結果から, 不具合報告によって把握できる発生状況は, 実臨床で発生している状況の一部分を表しているに過ぎないことが定量的に示された.

Coronary stent fracture (SF) is recognized as a risk of restenosis or stent thrombosis. However, the actual incidence is unclear in real world clinical settings in Japan. This study aims to estimate the incidence of SF in Japan by surveying peer-reviewed journals, and to elucidate the actual situation of adverse event reports. We conducted literature analysis regarding the incidence of SF using PubMed and ICHUSHI on April 1 2014. For PubMed, the term "stent fracture" was used. For ICHUSHI, "coronary artery" (in Japanese), "stent" (in Japanese), "fracture" (in English), "fracture" (in Japanese), and "damage" (in Japanese) were used. PubMed search initially yielded 895 papers. Of these, 792 studies had been conducted in countries outside of Japan, 45 studies were related to non-coronary artery, 17 studies did not deal with incidences of SF, and 11 studies targeted duplicated cases during the same implantation period. After these studies were excluded, we analyzed 30 remaining papers comprising 14 observational studies and 16 case reports. There were 643 SF cases in the scientific papers and 105 SF cases in the adverse event reports. Through the 14 observational studies, the SF incidence was estimated as 5.4% (595/10,927 lesions). We found a significant difference in SF incidences between the paper and adverse event report (6.1-hold). These data indicated that the adverse event report showed a partial picture of the real situation.

Journal

  • Regulatory Science of Medical Products

    Regulatory Science of Medical Products 6(1), 1-10, 2016

    Society for Regulatory Science of Medical Products

Codes

  • NII Article ID (NAID)
    130005125322
  • NII NACSIS-CAT ID (NCID)
    AA12678631
  • Text Lang
    JPN
  • ISSN
    2185-7113
  • NDL Article ID
    027306494
  • NDL Call No.
    Z74-J319
  • Data Source
    NDL  J-STAGE 
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