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...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-09-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/12/18/5807 |
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| author | Anna van Veelen I. Tarik Küçük Federico H. Fuentes Yirga Kahsay Hector M. Garcia-Garcia Ronak Delewi Marcel A. M. Beijk Alexander W. den Hartog Maik J. Grundeken M. Marije Vis José P. S. Henriques Bimmer E. P. M. Claessen |
| author_facet | Anna van Veelen I. Tarik Küçük Federico H. Fuentes Yirga Kahsay Hector M. Garcia-Garcia Ronak Delewi Marcel A. M. Beijk Alexander W. den Hartog Maik J. Grundeken M. Marije Vis José P. S. Henriques Bimmer E. P. M. Claessen |
| author_sort | Anna van Veelen |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-10T22:36:58Z |
| format | Article |
| id | doaj.art-28906558358f443e8f44b4cee415b8e9 |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-10T22:36:58Z |
| publishDate | 2023-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-28906558358f443e8f44b4cee415b8e92023-11-19T11:17:36ZengMDPI AGJournal of Clinical Medicine2077-03832023-09-011218580710.3390/jcm12185807First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP StudyAnna van Veelen0I. Tarik Küçük1Federico H. Fuentes2Yirga Kahsay3Hector M. Garcia-Garcia4Ronak Delewi5Marcel A. M. Beijk6Alexander W. den Hartog7Maik J. Grundeken8M. Marije Vis9José P. S. Henriques10Bimmer E. P. M. Claessen11Heart Center, Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, 1105 AZ Amsterdam, The NetherlandsHeart Center, Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, 1105 AZ Amsterdam, The NetherlandsMedStar Washington Hospital Center, Washington, DC 20010, USAMedStar Washington Hospital Center, Washington, DC 20010, USAMedStar Washington Hospital Center, Washington, DC 20010, USAHeart Center, Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, 1105 AZ Amsterdam, The NetherlandsHeart Center, Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, 1105 AZ Amsterdam, The NetherlandsHeart Center, Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, 1105 AZ Amsterdam, The NetherlandsHeart Center, Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, 1105 AZ Amsterdam, The NetherlandsHeart Center, Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, 1105 AZ Amsterdam, The NetherlandsHeart Center, Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, 1105 AZ Amsterdam, The NetherlandsHeart Center, Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, 1105 AZ Amsterdam, The NetherlandsPatients 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.https://www.mdpi.com/2077-0383/12/18/5807vulnerable plaquedrug-coated balloonintracoronary imagingintravascular ultrasoundnear-infrared spectroscopynon-ST-segment elevation acute coronary syndrome |
| spellingShingle | Anna van Veelen I. Tarik Küçük Federico H. Fuentes Yirga Kahsay Hector M. Garcia-Garcia Ronak Delewi Marcel A. M. Beijk Alexander W. den Hartog Maik J. Grundeken M. Marije Vis José P. S. Henriques Bimmer E. P. M. Claessen First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study Journal of Clinical Medicine vulnerable plaque drug-coated balloon intracoronary imaging intravascular ultrasound near-infrared spectroscopy non-ST-segment elevation acute coronary syndrome |
| 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 | vulnerable plaque drug-coated balloon intracoronary imaging intravascular ultrasound near-infrared spectroscopy non-ST-segment elevation acute coronary syndrome |
| url | https://www.mdpi.com/2077-0383/12/18/5807 |
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