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
Heart Center, Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, 1105 AZ Amsterdam, The Netherlands.
MedStar Washington Hospital Center, Washington, DC 20010, USA.
J Clin Med. 2023 Sep 6;12(18):5807. doi: 10.3390/jcm12185807.
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.
血管内超声（IVUS）和近红外光谱（NIRS）检查显示为非阻塞性富脂斑块（LRP）的患者未来发生不良事件的风险很高。采用紫杉醇洗脱药物涂层球囊（PE-DCB）对LRP进行局部抢先经皮治疗，可能是一种预防未来冠状动脉不良事件的新治疗策略，且不会留下永久性冠状动脉植入物。在这项前瞻性研究中，我们旨在通过评估随访9个月后4毫米节段的最大脂质核心负担指数（maxLCBI4mm）的变化，研究使用PE-DCB对非罪犯非阻塞性LRP进行抢先治疗的安全性和可行性。因此，非ST段抬高型急性冠状动脉综合征患者在罪犯病变治疗后接受了三支血管的IVUS-NIRS检查，以识别其他非阻塞性非罪犯LRP，随后用与管腔1:1匹配尺寸的PE-DCB对其进行治疗。我们招募了45例患者，其中20例（44%）有非罪犯LRP的患者接受了PE-DCB治疗。9个月后，将进行IVUS-NIRS重复冠状动脉造影。9个月时的主要终点是PE-DCB治疗的LRP中maxLCBI4mm的变化。次要终点包括临床不良事件和IVUS衍生参数，如斑块负荷和管腔面积。临床随访将持续至入组后1年。总之，这项首次人体研究将调查对LRP进行靶向抢先PE-DCB治疗的安全性和可行性，以促进有发生未来不良事件风险的易损冠状动脉斑块的稳定。
