TY - JOUR
T1 - First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques
T2 - Rationale and Design of the DEBuT-LRP Study
AU - van Veelen, Anna
AU - Küçük, I. Tarik
AU - Fuentes, Federico H.
AU - Kahsay, Yirga
AU - Garcia-Garcia, Hector M.
AU - Beijk, Marcel A. M.
AU - den Hartog, Alexander W.
AU - Grundeken, Maik J.
AU - Vis, M. Marije
AU - Henriques, José P. S.
AU - Claessen, Bimmer E. P. M.
N1 - Funding Information: This research was funded by Health~Holland, by a public–private partnership grant (TKI-LSH-DT2O19-AMC), with in-kind and in-cash contributions from B. Braun Melsungen AG, Germany, and Infraredx Inc., Bedford, MA, USA. Publisher Copyright: © 2023 by the authors.
PY - 2023/9/1
Y1 - 2023/9/1
N2 - 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.
AB - 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.
KW - drug-coated balloon
KW - intracoronary imaging
KW - intravascular ultrasound
KW - near-infrared spectroscopy
KW - non-ST-segment elevation acute coronary syndrome
KW - vulnerable plaque
UR - http://www.scopus.com/inward/record.url?scp=85172453045&partnerID=8YFLogxK
U2 - https://doi.org/10.3390/jcm12185807
DO - https://doi.org/10.3390/jcm12185807
M3 - Article
C2 - 37762747
SN - 2077-0383
VL - 12
JO - Journal of clinical medicine
JF - Journal of clinical medicine
IS - 18
M1 - 5807
ER -