Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt–chromium coronary stent system View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2016-07-22

AUTHORS

Kenji Ando, Katsuhisa Ishii, Eiji Tada, Kazuaki Kataoka, Atsushi Hirohata, Kenji Goto, Katsuyuki Kobayashi, Hiroshi Tsutsui, Makoto Nakahama, Hitoshi Nakashima, Shinichiroh Uchikawa, Junji Kanda, Satoshi Yasuda, Junji Yajima, Hiroshi Kitabayashi, Shumpei Sakurai, Keita Nakanishi, Naoto Inoue, Hirofumi Noike, Terumitsu Hasebe, Tetsuya Sato, Masao Yamasaki, Takeshi Kimura

ABSTRACT

The purpose of this multi-center, non-randomized, and open-label clinical trial was to determine the non-inferiority of diamond-like carbon (DLC)-coated cobalt–chromium coronary stent, the MOMO DLC coronary stent, relative to commercially available bare-metal stents (MULTI-LINK VISION®). Nineteen centers in Japan participated. The study cohort consisted of 99 patients from 19 Japanese centers with single or double native coronary vessel disease with de novo and restenosis lesions who met the study eligibility criteria. This cohort formed the safety analysis set. The efficacy analysis set consisted of 98 patients (one case was excluded for violating the eligibility criteria). The primary endpoint was target vessel failure (TVF) rate at 9 months after stent placement. Of the 98 efficacy analysis set patients, TVF occurred in 11 patients (11.2 %, 95 % confidence interval 5.7–19.2 %) at 9 months after the index stent implantation. The upper 95 % confidence interval for TVF of the study stent was lower than that previously reported for the commercially available MULTI-LINK VISION® (19.6 %), demonstrating non-inferiority of the study stent to MULTI-LINK VISION®. All the TVF cases were related to target vascular revascularization. None of the cases developed in-stent thrombosis or myocardial infarction. The average in-stent late loss and binary restenosis rate at the 6-month follow-up angiography were 0.69 mm and 10.5 %, respectively, which are lower than the reported values for commercially available bare-metal stents. In conclusion, the current pivotal clinical study evaluating the new MOMO DLC-coated coronary stent suggested its low rates of TVF and angiographic binary restenosis, and small in-stent late loss, although the data were considered preliminary considering the small sample size and single arm study design. More... »

PAGES

225-232

Journal

Author Affiliations

  • Department of Cardiology, Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita, 802-8555, Kitakyushu, Fukuoka, Japan
  • Department of Cardiology, Kansai Electric Power Hospital, Osaka, Japan
  • Department of Cardiology, Nabari City Hospital, Nabari, Japan
  • Department of Cardiology, The Sakakibara Heart Institute of Okayama, Okayama, Japan
  • Department of Cardiovascular Medicine, Fukuyama Cardiovascular Hospital, Fukuyama, Japan
  • Department of Cardiovascular Medicine, Ageo Central General Hospital, Ageo, Japan
  • Department of Cardiovascular Medicine, Suwa Red Cross Hospital, Suwa, Japan
  • Department of Cardiology, Fukuyama City Hospital, Fukuyama, Japan
  • Department of Cardiovascular Medicine, National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan
  • Department of Cardiology, Azumino Red Cross Hospital, Azumino, Japan
  • Department of Cardiovascular Medicine, Asahi General Hospital, Asahi, Japan
  • Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan
  • The Cardiovascular Institute, Tokyo, Japan
  • Department of Cardiovascular Medicine, Ina Central Hospital, Ina, Japan
  • Department of Cardiology, Marunouchi Hospital, Tokyo, Japan
  • Department of Internal Medicine, Ibaraki Seinan Medical Center Hospital, Sashima, Japan
  • Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan
  • Department of Cardiovascular Medicine, Toho University Medical Center Sakura Hospital, Sakura, Japan
  • Department of Radiology, Tokai University Hachioji Hospital, Hachioji, Japan
  • Department of Cardiovascular Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan
  • Department of Cardiology, NTT Medical Center Tokyo, Tokyo, Japan
  • Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s12928-016-0407-z

    DOI

    http://dx.doi.org/10.1007/s12928-016-0407-z

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1013212263

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/27448025


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