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. 2023 Sep 6;12(18):5807.
doi: 10.3390/jcm12185807.

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

Anna van Veelen  1 , I Tarik Küçük  1 , Federico H Fuentes  2 , Yirga Kahsay  2 , Hector M Garcia-Garcia  2 , Ronak Delewi  1 , Marcel A M Beijk  1 , Alexander W den Hartog  1 , Maik J Grundeken  1 , M Marije Vis  1 , José P S Henriques  1 , Bimmer E P M Claessen  1
Affiliations

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

Anna van Veelen et al. J Clin Med. .

Erratum in

Abstract

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.

Keywords: drug-coated balloon; intracoronary imaging; intravascular ultrasound; near-infrared spectroscopy; non-ST-segment elevation acute coronary syndrome; vulnerable plaque.

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Conflict of interest statement

The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Flowchart of study protocol. ACS denotes acute coronary syndrome, CAD coronary artery disease, CAG coronary angiography, IVUS intravascular ultrasound, LRP lipid-rich plaque, NIRS near-infrared spectroscopy, PCI percutaneous coronary intervention, PE-DCB paclitaxel-eluting drug-coated balloon. * Defined as a maximum lipid-core burden index in a 4 mm segment (maxLCBImm4) of >325; ** in case multiple LRPs are detected, only one will be treated.
Figure 2
Figure 2
Case example. (A) Depicts the coronary angiogram, wherein the proximal circumflex artery, as highlighted with the white arrow, a lipid-rich plaque was observed with intravascular ultrasound (IVUS, (B)) and near-infrared spectroscopy (NIRS, (C)). (D) This lesion was subsequently treated with paclitaxel-eluting drug-coated balloon (PE-DCB) as highlighted with the white arrow.
See this image and copyright information in PMC

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