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Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry

OBJECTIVE: The dual-therapy stent combines an abluminal biodegradable drug-eluting coating, with a ‘pro-healing’ luminal layer. This bioengineered layer attracts circulating endothelial progenitor cells that can differentiate into normal endothelium. Rapid endothelialisation of the stent might allow...

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Autores principales: Kalkman, Deborah N, Woudstra, Pier, Menown, Ian B A, den Heijer, Peter, van't Hof, Arnoud WJ, Erglis, Andrejs, Suryapranata, Harry, Arkenbout, Karin E, Iñiguez, Andrés, Muller, Philippe, Tijssen, Jan G, Beijk, Marcel A M, de Winter, Robbert J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515182/
https://www.ncbi.nlm.nih.gov/pubmed/28761685
http://dx.doi.org/10.1136/openhrt-2017-000634
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author Kalkman, Deborah N
Woudstra, Pier
Menown, Ian B A
den Heijer, Peter
van't Hof, Arnoud WJ
Erglis, Andrejs
Suryapranata, Harry
Arkenbout, Karin E
Iñiguez, Andrés
Muller, Philippe
Tijssen, Jan G
Beijk, Marcel A M
de Winter, Robbert J
author_facet Kalkman, Deborah N
Woudstra, Pier
Menown, Ian B A
den Heijer, Peter
van't Hof, Arnoud WJ
Erglis, Andrejs
Suryapranata, Harry
Arkenbout, Karin E
Iñiguez, Andrés
Muller, Philippe
Tijssen, Jan G
Beijk, Marcel A M
de Winter, Robbert J
author_sort Kalkman, Deborah N
collection PubMed
description OBJECTIVE: The dual-therapy stent combines an abluminal biodegradable drug-eluting coating, with a ‘pro-healing’ luminal layer. This bioengineered layer attracts circulating endothelial progenitor cells that can differentiate into normal endothelium. Rapid endothelialisation of the stent might allow safe short dual antiplatelet therapy. We aim to assess clinical outcomes in patients treated with this novel device at 2-year follow-up. METHODS: A total of 1000 patients were included in the REMEDEE Registry to evaluate clinical outcomes after treatment with the dual-therapy stent. This prospective, multicentre, European registry included all-comers patients, which resulted in a high-risk patient population. Target lesion failure (TLF), a combined endpoint consisting of cardiac death, target vessel myocardial infarction (tv-MI) and target lesion revascularisation (TLR), at 2-year follow-up was the primary focus of this analysis. Subgroup analyses were performed according to diabetes mellitus (DM), gender, age, acute coronary syndrome, smoking, hypertension, hypercholesterolaemia, previous stroke, peripheral vascular disease and chronic renal failure. RESULTS: TLF at 2 years was observed in 84 patients (8.5%), with 3.0% cardiac death, 1.2% tv-MI and 5.9% TLR. Definite stent thrombosis at 2 years was 0.6%. In the presence of DM or chronic renal failure, a higher TLF was observed. CONCLUSIONS: The dual-therapy stent shows favourable clinical outcomes from 12 months onwards. Two years after stent placement, low TLF and very low stent thrombosis rates are observed in this large prospective all-comers cohort study. TRIAL REGISTRATION NUMBER: NCT01874002; Results.
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spelling pubmed-55151822017-07-31 Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry Kalkman, Deborah N Woudstra, Pier Menown, Ian B A den Heijer, Peter van't Hof, Arnoud WJ Erglis, Andrejs Suryapranata, Harry Arkenbout, Karin E Iñiguez, Andrés Muller, Philippe Tijssen, Jan G Beijk, Marcel A M de Winter, Robbert J Open Heart Interventional Cardiology OBJECTIVE: The dual-therapy stent combines an abluminal biodegradable drug-eluting coating, with a ‘pro-healing’ luminal layer. This bioengineered layer attracts circulating endothelial progenitor cells that can differentiate into normal endothelium. Rapid endothelialisation of the stent might allow safe short dual antiplatelet therapy. We aim to assess clinical outcomes in patients treated with this novel device at 2-year follow-up. METHODS: A total of 1000 patients were included in the REMEDEE Registry to evaluate clinical outcomes after treatment with the dual-therapy stent. This prospective, multicentre, European registry included all-comers patients, which resulted in a high-risk patient population. Target lesion failure (TLF), a combined endpoint consisting of cardiac death, target vessel myocardial infarction (tv-MI) and target lesion revascularisation (TLR), at 2-year follow-up was the primary focus of this analysis. Subgroup analyses were performed according to diabetes mellitus (DM), gender, age, acute coronary syndrome, smoking, hypertension, hypercholesterolaemia, previous stroke, peripheral vascular disease and chronic renal failure. RESULTS: TLF at 2 years was observed in 84 patients (8.5%), with 3.0% cardiac death, 1.2% tv-MI and 5.9% TLR. Definite stent thrombosis at 2 years was 0.6%. In the presence of DM or chronic renal failure, a higher TLF was observed. CONCLUSIONS: The dual-therapy stent shows favourable clinical outcomes from 12 months onwards. Two years after stent placement, low TLF and very low stent thrombosis rates are observed in this large prospective all-comers cohort study. TRIAL REGISTRATION NUMBER: NCT01874002; Results. BMJ Publishing Group 2017-07-11 /pmc/articles/PMC5515182/ /pubmed/28761685 http://dx.doi.org/10.1136/openhrt-2017-000634 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Interventional Cardiology
Kalkman, Deborah N
Woudstra, Pier
Menown, Ian B A
den Heijer, Peter
van't Hof, Arnoud WJ
Erglis, Andrejs
Suryapranata, Harry
Arkenbout, Karin E
Iñiguez, Andrés
Muller, Philippe
Tijssen, Jan G
Beijk, Marcel A M
de Winter, Robbert J
Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry
title Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry
title_full Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry
title_fullStr Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry
title_full_unstemmed Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry
title_short Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry
title_sort two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry
topic Interventional Cardiology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515182/
https://www.ncbi.nlm.nih.gov/pubmed/28761685
http://dx.doi.org/10.1136/openhrt-2017-000634
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