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First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study

Patients with non-obstructive lipid-rich plaques (LRPs) on combined intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) are at high risk for future events. Local pre-emptive percutaneous treatment of LRPs with a paclitaxel-eluting drug-coated balloon (PE-DCB) may be a novel therape...

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Autores principales: van Veelen, Anna, Küçük, I. Tarik, Fuentes, Federico H., Kahsay, Yirga, Garcia-Garcia, Hector M., Delewi, Ronak, Beijk, Marcel A. M., den Hartog, Alexander W., Grundeken, Maik J., Vis, M. Marije, Henriques, José P. S., Claessen, Bimmer E. P. M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10531515/
https://www.ncbi.nlm.nih.gov/pubmed/37762747
http://dx.doi.org/10.3390/jcm12185807
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author van Veelen, Anna
Küçük, I. Tarik
Fuentes, Federico H.
Kahsay, Yirga
Garcia-Garcia, Hector M.
Delewi, Ronak
Beijk, Marcel A. M.
den Hartog, Alexander W.
Grundeken, Maik J.
Vis, M. Marije
Henriques, José P. S.
Claessen, Bimmer E. P. M.
author_facet van Veelen, Anna
Küçük, I. Tarik
Fuentes, Federico H.
Kahsay, Yirga
Garcia-Garcia, Hector M.
Delewi, Ronak
Beijk, Marcel A. M.
den Hartog, Alexander W.
Grundeken, Maik J.
Vis, M. Marije
Henriques, José P. S.
Claessen, Bimmer E. P. M.
author_sort van Veelen, Anna
collection PubMed
description Patients with non-obstructive lipid-rich plaques (LRPs) on combined intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) are at high risk for future events. Local pre-emptive percutaneous treatment of LRPs with a paclitaxel-eluting drug-coated balloon (PE-DCB) may be a novel therapeutic strategy to prevent future adverse coronary events without leaving behind permanent coronary implants. In this pilot study, we aim to investigate the safety and feasibility of pre-emptive treatment with a PE-DCB of non-culprit non-obstructive LRPs by evaluating the change in maximum lipid core burden in a 4 mm segment (maxLCBImm4) after 9 months of follow up. Therefore, patients with non-ST-segment elevation acute coronary syndrome underwent 3-vessel IVUS-NIRS after treatment of the culprit lesion to identify additional non-obstructive non-culprit LRPs, which were subsequently treated with PE-DCB sized 1:1 to the lumen. We enrolled 45 patients of whom 20 patients (44%) with a non-culprit LRP were treated with PE-DCB. After 9 months, repeat coronary angiography with IVUS-NIRS will be performed. The primary endpoint at 9 months is the change in maxLCBImm4 in PE-DCB-treated LRPs. Secondary endpoints include clinical adverse events and IVUS-derived parameters such as plaque burden and luminal area. Clinical follow-up will continue until 1 year after enrollment. In conclusion, this first-in-human study will investigate the safety and feasibility of targeted pre-emptive PE-DCB treatment of LRPs to promote stabilization of vulnerable coronary plaque at risk for developing future adverse events.
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spelling pubmed-105315152023-09-28 First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study van Veelen, Anna Küçük, I. Tarik Fuentes, Federico H. Kahsay, Yirga Garcia-Garcia, Hector M. Delewi, Ronak Beijk, Marcel A. M. den Hartog, Alexander W. Grundeken, Maik J. Vis, M. Marije Henriques, José P. S. Claessen, Bimmer E. P. M. J Clin Med Article Patients with non-obstructive lipid-rich plaques (LRPs) on combined intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) are at high risk for future events. Local pre-emptive percutaneous treatment of LRPs with a paclitaxel-eluting drug-coated balloon (PE-DCB) may be a novel therapeutic strategy to prevent future adverse coronary events without leaving behind permanent coronary implants. In this pilot study, we aim to investigate the safety and feasibility of pre-emptive treatment with a PE-DCB of non-culprit non-obstructive LRPs by evaluating the change in maximum lipid core burden in a 4 mm segment (maxLCBImm4) after 9 months of follow up. Therefore, patients with non-ST-segment elevation acute coronary syndrome underwent 3-vessel IVUS-NIRS after treatment of the culprit lesion to identify additional non-obstructive non-culprit LRPs, which were subsequently treated with PE-DCB sized 1:1 to the lumen. We enrolled 45 patients of whom 20 patients (44%) with a non-culprit LRP were treated with PE-DCB. After 9 months, repeat coronary angiography with IVUS-NIRS will be performed. The primary endpoint at 9 months is the change in maxLCBImm4 in PE-DCB-treated LRPs. Secondary endpoints include clinical adverse events and IVUS-derived parameters such as plaque burden and luminal area. Clinical follow-up will continue until 1 year after enrollment. In conclusion, this first-in-human study will investigate the safety and feasibility of targeted pre-emptive PE-DCB treatment of LRPs to promote stabilization of vulnerable coronary plaque at risk for developing future adverse events. MDPI 2023-09-06 /pmc/articles/PMC10531515/ /pubmed/37762747 http://dx.doi.org/10.3390/jcm12185807 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
van Veelen, Anna
Küçük, I. Tarik
Fuentes, Federico H.
Kahsay, Yirga
Garcia-Garcia, Hector M.
Delewi, Ronak
Beijk, Marcel A. M.
den Hartog, Alexander W.
Grundeken, Maik J.
Vis, M. Marije
Henriques, José P. S.
Claessen, Bimmer E. P. M.
First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study
title First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study
title_full First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study
title_fullStr First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study
title_full_unstemmed First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study
title_short First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study
title_sort first-in-human drug-eluting balloon treatment of vulnerable lipid-rich plaques: rationale and design of the debut-lrp study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10531515/
https://www.ncbi.nlm.nih.gov/pubmed/37762747
http://dx.doi.org/10.3390/jcm12185807
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