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One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis

BACKGROUND: Polymer‐free amphilimus‐eluting stents (PF‐AES) represent a novel elution‐technology in coronary stenting. We aimed to assess 1‐year clinical outcomes of PF‐AES as compared to latest‐generation permanent polymer zotarolimus‐eluting stents (PP‐ZES) in a real‐world all‐comers setting. METH...

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Autores principales: Rozemeijer, Rik, van Muiden, Ivar G., Koudstaal, Stefan, Leenders, Geert E., Timmers, Leo, Rittersma, Saskia Z., Kraaijeveld, Adriaan O., Doevendans, Pieter A., Voskuil, Michiel, Stella, Pieter R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6619187/
https://www.ncbi.nlm.nih.gov/pubmed/30604493
http://dx.doi.org/10.1002/ccd.28041
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author Rozemeijer, Rik
van Muiden, Ivar G.
Koudstaal, Stefan
Leenders, Geert E.
Timmers, Leo
Rittersma, Saskia Z.
Kraaijeveld, Adriaan O.
Doevendans, Pieter A.
Voskuil, Michiel
Stella, Pieter R.
author_facet Rozemeijer, Rik
van Muiden, Ivar G.
Koudstaal, Stefan
Leenders, Geert E.
Timmers, Leo
Rittersma, Saskia Z.
Kraaijeveld, Adriaan O.
Doevendans, Pieter A.
Voskuil, Michiel
Stella, Pieter R.
author_sort Rozemeijer, Rik
collection PubMed
description BACKGROUND: Polymer‐free amphilimus‐eluting stents (PF‐AES) represent a novel elution‐technology in coronary stenting. We aimed to assess 1‐year clinical outcomes of PF‐AES as compared to latest‐generation permanent polymer zotarolimus‐eluting stents (PP‐ZES) in a real‐world all‐comers setting. METHODS: A prospective registry of patients treated with either PF‐AES or PP‐ZES between 2014 and 2016 was conducted. The primary outcome was defined as major adverse cardiac and cerebrovascular events (MACCE), and the secondary outcome was defined as target‐lesion failure (TLF) at 1 year. To account for measured confounders, a propensity‐score adjusted Cox proportional‐hazard model was built to evaluate clinical outcomes. RESULTS: A total of 734 consecutive patients with 1,269 DES implantations were enrolled. The population was characterized by 28% diabetes, 24% ST‐segment elevation myocardial infarction, and a high number of complex lesions (69%). The rate of MACCE was 11.5% for PF‐AES and 13.6% for PP‐ZES, p(log‐rank) = 0.11. TLF was numerically lower in PF‐AES as compared to PP‐ZES (5.4 vs. 6.1%, p(log‐rank) = 0.68). After propensity‐score adjustment, PF‐AES showed a trend toward a lower rate of MACCE and a favorable rate of TLF as compared to PP‐ZES (HR 0.70; 95%CI 0.45 to 1.10, P = 0.12; and HR 0.88; 95%CI 0.47 to 1.65, P = 0.68, respectively). Rates of definite ST were low (0.8 vs. 0.3%, p(log‐rank) = 0.62). CONCLUSIONS: Our study suggests that implantation of PF‐AES was safe and effective in real‐world patients, with low‐rates of MACCE and TLF at 1 year. Our data needs to be confirmed by a large trial to evaluate the clinical outcomes of this novel polymer‐free, eluting‐technology used in PF‐AES.
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spelling pubmed-66191872019-07-22 One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis Rozemeijer, Rik van Muiden, Ivar G. Koudstaal, Stefan Leenders, Geert E. Timmers, Leo Rittersma, Saskia Z. Kraaijeveld, Adriaan O. Doevendans, Pieter A. Voskuil, Michiel Stella, Pieter R. Catheter Cardiovasc Interv CORONARY ARTERY DISEASE BACKGROUND: Polymer‐free amphilimus‐eluting stents (PF‐AES) represent a novel elution‐technology in coronary stenting. We aimed to assess 1‐year clinical outcomes of PF‐AES as compared to latest‐generation permanent polymer zotarolimus‐eluting stents (PP‐ZES) in a real‐world all‐comers setting. METHODS: A prospective registry of patients treated with either PF‐AES or PP‐ZES between 2014 and 2016 was conducted. The primary outcome was defined as major adverse cardiac and cerebrovascular events (MACCE), and the secondary outcome was defined as target‐lesion failure (TLF) at 1 year. To account for measured confounders, a propensity‐score adjusted Cox proportional‐hazard model was built to evaluate clinical outcomes. RESULTS: A total of 734 consecutive patients with 1,269 DES implantations were enrolled. The population was characterized by 28% diabetes, 24% ST‐segment elevation myocardial infarction, and a high number of complex lesions (69%). The rate of MACCE was 11.5% for PF‐AES and 13.6% for PP‐ZES, p(log‐rank) = 0.11. TLF was numerically lower in PF‐AES as compared to PP‐ZES (5.4 vs. 6.1%, p(log‐rank) = 0.68). After propensity‐score adjustment, PF‐AES showed a trend toward a lower rate of MACCE and a favorable rate of TLF as compared to PP‐ZES (HR 0.70; 95%CI 0.45 to 1.10, P = 0.12; and HR 0.88; 95%CI 0.47 to 1.65, P = 0.68, respectively). Rates of definite ST were low (0.8 vs. 0.3%, p(log‐rank) = 0.62). CONCLUSIONS: Our study suggests that implantation of PF‐AES was safe and effective in real‐world patients, with low‐rates of MACCE and TLF at 1 year. Our data needs to be confirmed by a large trial to evaluate the clinical outcomes of this novel polymer‐free, eluting‐technology used in PF‐AES. John Wiley & Sons, Inc. 2019-01-02 2019-07-01 /pmc/articles/PMC6619187/ /pubmed/30604493 http://dx.doi.org/10.1002/ccd.28041 Text en © 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle CORONARY ARTERY DISEASE
Rozemeijer, Rik
van Muiden, Ivar G.
Koudstaal, Stefan
Leenders, Geert E.
Timmers, Leo
Rittersma, Saskia Z.
Kraaijeveld, Adriaan O.
Doevendans, Pieter A.
Voskuil, Michiel
Stella, Pieter R.
One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis
title One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis
title_full One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis
title_fullStr One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis
title_full_unstemmed One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis
title_short One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis
title_sort one‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: a propensity‐score adjusted analysis
topic CORONARY ARTERY DISEASE
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6619187/
https://www.ncbi.nlm.nih.gov/pubmed/30604493
http://dx.doi.org/10.1002/ccd.28041
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