First-in-man six-month results of a surface-modified coronary stent system in native coronary stenosis

© Europa Digital & Publishing 2017. All rights reserved. Aims: In preclinical studies, a bare metal cobalt-chromium stent with an active surface oxide layer modification (BMSmod) has been shown to inhibit neointimal hyperplasia effectively. We sought to assess both the clinical safety and feas...

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Main Authors: Pannipa Suwannasom, Yohei Sotomi, Roberto Corti, David J. Kurz, Marco Roffi, Clemens Von Birgelen, Stefano Buzzi, Arik Zucker, Jouke Dijkstra, Joanna J. Wykrzykowska, Robbert J. De Winter, Stephan Windecker, Yoshinobu Onuma, Patrick W. Serruys, Joost Daemen, Lorenz Räber, Fernando Alfonso
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Published: 2018
Online Access:https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85021133390&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/47206
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spelling th-cmuir.6653943832-472062018-04-25T07:26:13Z First-in-man six-month results of a surface-modified coronary stent system in native coronary stenosis Pannipa Suwannasom Yohei Sotomi Roberto Corti David J. Kurz Marco Roffi Clemens Von Birgelen Stefano Buzzi Arik Zucker Jouke Dijkstra Joanna J. Wykrzykowska Robbert J. De Winter Stephan Windecker Yoshinobu Onuma Patrick W. Serruys Joost Daemen Lorenz Räber Fernando Alfonso © Europa Digital & Publishing 2017. All rights reserved. Aims: In preclinical studies, a bare metal cobalt-chromium stent with an active surface oxide layer modification (BMSmod) has been shown to inhibit neointimal hyperplasia effectively. We sought to assess both the clinical safety and feasibility of the BMSmod. Methods and results: In this prospective, non-randomised, first-in-man multicentre study, a total of 31 patients with de novo coronary lesions, reference lumen diameters of 2.5-3.5 mm and lesion length ≤16 mm, were enrolled. Quantitative coronary angiography and optical coherence tomography (OCT) were performed at baseline and six-month follow-up. Primary angiographic and OCT endpoints included in-stent late lumen loss (LLL) and mean neointimal thickness at six months. The device-oriented composite end-point (DoCE), defined as cardiac death, myocardial infarction not clearly attributable to a non-intervention vessel, and clinically indicated target lesion revascularisation (CI-TLR), was analysed according to the intention-to-treat princi ple. In 31 patients (33 lesions), the procedural success rate was 93.5%. At six months, angiographic LLL was 0.91±0.45 mm and binary angiographic restenosis occurred in 23.3% of lesions. Out of 33 lesions, OCT was performed in 27 lesions at both time points. Mean neointimal thickness amounted to 348±116 μm. At six months, the DoCE was 19.4% due to the occurrence of CI-TLR in five patients (including one late definite stent thrombosis of a non-study stent). Conclusions: In contrast to previous preclinical pathophysiological work, the BMSmod did not prevent neointimal hyperplasia in a first-in-man clinical setting. 2018-04-25T07:26:13Z 2018-04-25T07:26:13Z 2017-04-01 Journal 19696213 1774024X 2-s2.0-85021133390 10.4244/EIJ-D-16-00975 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85021133390&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/47206
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
description © Europa Digital & Publishing 2017. All rights reserved. Aims: In preclinical studies, a bare metal cobalt-chromium stent with an active surface oxide layer modification (BMSmod) has been shown to inhibit neointimal hyperplasia effectively. We sought to assess both the clinical safety and feasibility of the BMSmod. Methods and results: In this prospective, non-randomised, first-in-man multicentre study, a total of 31 patients with de novo coronary lesions, reference lumen diameters of 2.5-3.5 mm and lesion length ≤16 mm, were enrolled. Quantitative coronary angiography and optical coherence tomography (OCT) were performed at baseline and six-month follow-up. Primary angiographic and OCT endpoints included in-stent late lumen loss (LLL) and mean neointimal thickness at six months. The device-oriented composite end-point (DoCE), defined as cardiac death, myocardial infarction not clearly attributable to a non-intervention vessel, and clinically indicated target lesion revascularisation (CI-TLR), was analysed according to the intention-to-treat princi ple. In 31 patients (33 lesions), the procedural success rate was 93.5%. At six months, angiographic LLL was 0.91±0.45 mm and binary angiographic restenosis occurred in 23.3% of lesions. Out of 33 lesions, OCT was performed in 27 lesions at both time points. Mean neointimal thickness amounted to 348±116 μm. At six months, the DoCE was 19.4% due to the occurrence of CI-TLR in five patients (including one late definite stent thrombosis of a non-study stent). Conclusions: In contrast to previous preclinical pathophysiological work, the BMSmod did not prevent neointimal hyperplasia in a first-in-man clinical setting.
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author Pannipa Suwannasom
Yohei Sotomi
Roberto Corti
David J. Kurz
Marco Roffi
Clemens Von Birgelen
Stefano Buzzi
Arik Zucker
Jouke Dijkstra
Joanna J. Wykrzykowska
Robbert J. De Winter
Stephan Windecker
Yoshinobu Onuma
Patrick W. Serruys
Joost Daemen
Lorenz Räber
Fernando Alfonso
spellingShingle Pannipa Suwannasom
Yohei Sotomi
Roberto Corti
David J. Kurz
Marco Roffi
Clemens Von Birgelen
Stefano Buzzi
Arik Zucker
Jouke Dijkstra
Joanna J. Wykrzykowska
Robbert J. De Winter
Stephan Windecker
Yoshinobu Onuma
Patrick W. Serruys
Joost Daemen
Lorenz Räber
Fernando Alfonso
First-in-man six-month results of a surface-modified coronary stent system in native coronary stenosis
author_facet Pannipa Suwannasom
Yohei Sotomi
Roberto Corti
David J. Kurz
Marco Roffi
Clemens Von Birgelen
Stefano Buzzi
Arik Zucker
Jouke Dijkstra
Joanna J. Wykrzykowska
Robbert J. De Winter
Stephan Windecker
Yoshinobu Onuma
Patrick W. Serruys
Joost Daemen
Lorenz Räber
Fernando Alfonso
author_sort Pannipa Suwannasom
title First-in-man six-month results of a surface-modified coronary stent system in native coronary stenosis
title_short First-in-man six-month results of a surface-modified coronary stent system in native coronary stenosis
title_full First-in-man six-month results of a surface-modified coronary stent system in native coronary stenosis
title_fullStr First-in-man six-month results of a surface-modified coronary stent system in native coronary stenosis
title_full_unstemmed First-in-man six-month results of a surface-modified coronary stent system in native coronary stenosis
title_sort first-in-man six-month results of a surface-modified coronary stent system in native coronary stenosis
publishDate 2018
url https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85021133390&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/47206
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