title: Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt-chromium coronary stent system.
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.
authors.affiliation: Department of Cardiology, Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita, Kitakyushu, Fukuoka, 802-8555, Japan. kenji-ando@live.jp.
authors.forename: Kenji
authors.initials: K
authors.lastname: Ando
authors.affiliation: Department of Cardiology, Kansai Electric Power Hospital, Osaka, Japan.
authors.forename: Katsuhisa
authors.initials: K
authors.lastname: Ishii
authors.affiliation: Department of Cardiology, Kansai Electric Power Hospital, Osaka, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Tada
authors.affiliation: Department of Cardiology, Nabari City Hospital, Nabari, Japan.
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Kataoka
authors.affiliation: Department of Cardiology, The Sakakibara Heart Institute of Okayama, Okayama, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Hirohata
authors.affiliation: Department of Cardiovascular Medicine, Fukuyama Cardiovascular Hospital, Fukuyama, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Goto
authors.affiliation: Department of Cardiovascular Medicine, Ageo Central General Hospital, Ageo, Japan.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kobayashi
authors.affiliation: Department of Cardiovascular Medicine, Suwa Red Cross Hospital, Suwa, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tsutsui
authors.affiliation: Department of Cardiology, Fukuyama City Hospital, Fukuyama, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Nakahama
authors.affiliation: Department of Cardiovascular Medicine, National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Nakashima
authors.affiliation: Department of Cardiology, Azumino Red Cross Hospital, Azumino, Japan.
authors.forename: Shinichiroh
authors.initials: S
authors.lastname: Uchikawa
authors.affiliation: Department of Cardiovascular Medicine, Asahi General Hospital, Asahi, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Kanda
authors.affiliation: Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yasuda
authors.affiliation: The Cardiovascular Institute, Tokyo, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Yajima
authors.affiliation: Department of Cardiovascular Medicine, Ina Central Hospital, Ina, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kitabayashi
authors.affiliation: Department of Cardiology, Marunouchi Hospital, Tokyo, Japan.
authors.forename: Shumpei
authors.initials: S
authors.lastname: Sakurai
authors.affiliation: Department of Internal Medicine, Ibaraki Seinan Medical Center Hospital, Sashima, Japan.
authors.forename: Keita
authors.initials: K
authors.lastname: Nakanishi
authors.affiliation: Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan.
authors.forename: Naoto
authors.initials: N
authors.lastname: Inoue
authors.affiliation: Department of Cardiovascular Medicine, Toho University Medical Center Sakura Hospital, Sakura, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Noike
authors.affiliation: Department of Radiology, Tokai University Hachioji Hospital, Hachioji, Japan.
authors.forename: Terumitsu
authors.initials: T
authors.lastname: Hasebe
authors.affiliation: Department of Cardiovascular Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Sato
authors.affiliation: Department of Cardiology, NTT Medical Center Tokyo, Tokyo, Japan.
authors.forename: Masao
authors.initials: M
authors.lastname: Yamasaki
authors.affiliation: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
mesh_terms: D000368:Aged; D001807:Blood Vessel Prosthesis / Q000009:adverse effects; D002244:Carbon; D002858:Chromium Alloys; D003327:Coronary Disease / Q000601:surgery*; D023903:Coronary Restenosis / Q000453:epidemiology / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods; D011446:Prospective Studies; D011475:Prosthesis Failure; D012042:Registries; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D002858:Chromium Alloys; D002244:Carbon
keywords: Coronary stent; Diamond-like carbon (DLC); Restenosis; Thrombosis