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

نویسندگان

  • 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
چکیده

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.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Six-month clinical outcomes of Firebird 2TM sirolimus-eluting stent implantation in real-world patients with coronary artery diseases.

BACKGROUND The Firebird 2(TM) sirolimus-eluting stent (Firebird 2 stent) is a second-generation sirolimus-eluting stent which has a cobalt-chromium alloy stent platform, a brand new bracket structure, and two layers of styrene-butylenes-styrene polymer coatings with better biocompatibility. The Firebird 2(TM) cObalt-Chromium alloy sirolimus-elUting Stent registry (FOCUS registry) aimed to evalu...

متن کامل

Evaluation of safety and efficacy of NexGen – an ultrathin strut and hybrid cell design cobalt-chromium bare metal stent implanted in a real life patient population – the Polish NexGen Registry

INTRODUCTION Despite the dominance of drug-eluting stents in modern interventional cardiology, there is still a niche for bare metal stents. AIM The aim of the Polish NexGen registry was to evaluate the safety and efficacy of a new generation cobalt-chromium NexGen stent in a real life patient population. MATERIAL AND METHODS A prospective multi-center registry was conducted in five clinica...

متن کامل

Clinical Performance of the Cobalt-Chromium Biodegradable Polymer Coated Sirolimus-Eluting Stent in an Unselected Real-World Population

OBJECTIVE: The primary objective of the S-CORE registry was to assess the safety and efficacy of the Supralimus-Core® sirolimus-eluting stent deployment for the treatment of coronary artery disease and event-free survival of patients treated with this coronary stent. METHODS: S-CORE Registry is an observational, single-arm, non-randomized, post-marketing surveillance multicenter registry in whi...

متن کامل

A randomized comparison of novel biodegradable polymer- and durable polymer-coated cobalt-chromium sirolimus-eluting stents.

OBJECTIVES The aim of this study was to investigate the hypothesis that a novel biodegradable polymer-coated, cobalt-chromium (CoCr), sirolimus-eluting stent (BP-SES) is noninferior in safety and efficacy outcomes compared with a durable polymer (DP)-SES. BACKGROUND No randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms, thereby isolating ...

متن کامل

Prospective registry evaluating safety and efficacy of cobalt-chromium stent implantation in patients with de novo coronary lesions.

BACKGROUND Cobalt-chromium (Co-Cr) stents are a new type of endovascular prostheses characterised by better mechanical properties than traditional stainless steel stents. AIM To assess the safety and efficacy of percutaneous coronary interventions (PCI) using the new Co-Cr Kos stent (Balton, Poland). METHODS A total of 59 patients with coronary artery diseases (76% men, aged 60+/-9 years, d...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره 32  شماره 

صفحات  -

تاریخ انتشار 2017