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Ballon actif dans la population tunisienne versus stent platine-chromeEverolimus pour lésion coronaire de-novo

Research Problem : Drug-eluting balloon (DEB) angioplasty is a well-established treatment modality for in-stent restenosis, however its safety and efficacy in de-novo lesion especially in large vessel remains undetermined. Theoretically, DEB sight to eliminate stent thrombosis and reduce restenosis...

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Autores principales: Hajlaoui, Nadhem, Noamen, Aymen, Ben Amara, Ahmed, Raddaoui, Haythem, Haggui, Abdeddayem, Fehri, Wafa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Tunisian Society of Medical Sciences 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10498760/
https://www.ncbi.nlm.nih.gov/pubmed/37551532
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author Hajlaoui, Nadhem
Noamen, Aymen
Ben Amara, Ahmed
Raddaoui, Haythem
Haggui, Abdeddayem
Fehri, Wafa
author_facet Hajlaoui, Nadhem
Noamen, Aymen
Ben Amara, Ahmed
Raddaoui, Haythem
Haggui, Abdeddayem
Fehri, Wafa
author_sort Hajlaoui, Nadhem
collection PubMed
description Research Problem : Drug-eluting balloon (DEB) angioplasty is a well-established treatment modality for in-stent restenosis, however its safety and efficacy in de-novo lesion especially in large vessel remains undetermined. Theoretically, DEB sight to eliminate stent thrombosis and reduce restenosis rates by leaving no metal behind. Aim: To compare the results of angioplasty of de novo lesions by DEB (SEQUENT PLEASE) versus DES (Promus Premier and Promus Elite) in a Tunisian population. The endpoints will be primarily the Late Lumen Loss at 12 months and secondarily the Major Cardiovascular Event rate 5MACE) at 12 months. Investigative process : This is a randomized controlled non-inferiority trial including 290 patients with chronic coronary disease or non-ST elevation myocardial infarction with de novo lesions. After coronarography, angiographic parameters concerning lesion location and quantitative analysis will be collected. Patients will be treated with DEB or DES according to their allocation group. Before removal of the guide, post-procedural angiographic parameters will be evaluated. Follow-up will be performed for 12 months and an angiographic examination will be performed either as an emergency or at 12 months. The significance level will be 5%. A univariate analysis will be performed to search for predictive factors of MACE. Research Plan : Ethical considerations will be undertaken and respected. The study will run for 15 months starting August 25, 2021 Trial registration: NCT05516446
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spelling pubmed-104987602023-09-14 Ballon actif dans la population tunisienne versus stent platine-chromeEverolimus pour lésion coronaire de-novo Hajlaoui, Nadhem Noamen, Aymen Ben Amara, Ahmed Raddaoui, Haythem Haggui, Abdeddayem Fehri, Wafa Tunis Med Article Research Problem : Drug-eluting balloon (DEB) angioplasty is a well-established treatment modality for in-stent restenosis, however its safety and efficacy in de-novo lesion especially in large vessel remains undetermined. Theoretically, DEB sight to eliminate stent thrombosis and reduce restenosis rates by leaving no metal behind. Aim: To compare the results of angioplasty of de novo lesions by DEB (SEQUENT PLEASE) versus DES (Promus Premier and Promus Elite) in a Tunisian population. The endpoints will be primarily the Late Lumen Loss at 12 months and secondarily the Major Cardiovascular Event rate 5MACE) at 12 months. Investigative process : This is a randomized controlled non-inferiority trial including 290 patients with chronic coronary disease or non-ST elevation myocardial infarction with de novo lesions. After coronarography, angiographic parameters concerning lesion location and quantitative analysis will be collected. Patients will be treated with DEB or DES according to their allocation group. Before removal of the guide, post-procedural angiographic parameters will be evaluated. Follow-up will be performed for 12 months and an angiographic examination will be performed either as an emergency or at 12 months. The significance level will be 5%. A univariate analysis will be performed to search for predictive factors of MACE. Research Plan : Ethical considerations will be undertaken and respected. The study will run for 15 months starting August 25, 2021 Trial registration: NCT05516446 Tunisian Society of Medical Sciences 2022-12 2022-12-01 /pmc/articles/PMC10498760/ /pubmed/37551532 Text en https://creativecommons.org/licenses/by-nc-nd/4.0/This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit https://creativecommons.org/licenses/by-nc-nd/4.0/
spellingShingle Article
Hajlaoui, Nadhem
Noamen, Aymen
Ben Amara, Ahmed
Raddaoui, Haythem
Haggui, Abdeddayem
Fehri, Wafa
Ballon actif dans la population tunisienne versus stent platine-chromeEverolimus pour lésion coronaire de-novo
title Ballon actif dans la population tunisienne versus stent platine-chromeEverolimus pour lésion coronaire de-novo
title_full Ballon actif dans la population tunisienne versus stent platine-chromeEverolimus pour lésion coronaire de-novo
title_fullStr Ballon actif dans la population tunisienne versus stent platine-chromeEverolimus pour lésion coronaire de-novo
title_full_unstemmed Ballon actif dans la population tunisienne versus stent platine-chromeEverolimus pour lésion coronaire de-novo
title_short Ballon actif dans la population tunisienne versus stent platine-chromeEverolimus pour lésion coronaire de-novo
title_sort ballon actif dans la population tunisienne versus stent platine-chromeeverolimus pour lésion coronaire de-novo
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10498760/
https://www.ncbi.nlm.nih.gov/pubmed/37551532
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