Vascular responses to drug-coated balloon angioplasty in lipid-rich vs non-lipid-rich coronary lesions

BACKGROUND Lipid-rich plaques are strongly associated with adverse cardiac events. However, the vascular response of lipid-rich lesions to drug-coated balloon (DCB) angioplasty has not been fully elucidated. This study aimed to compare vascular responses following DCB angioplasty between lipid-rich and non-lipid-rich coronary lesions.

This study included patients scheduled for DCB angioplasty for de novo small vessel lesions between February 2021 and April 2024. All patients underwent pre- and post-procedural near-infrared spectroscopy combined with intravascular ultrasound (NIRS-IVUS), along with follow-up coronary angiography and NIRS-IVUS at 8 months. Lesions were categorized as lipid-rich or non-lipid-rich based on the pre-procedural maximum lipid core burden index over 4mm (maxLCBI4mm). Changes in plaque volume and maxLCBI4mm from post-procedure to the 8-month follow-up, as well as the incidence of late lumen enlargement (LLE), were compared between the two groups.

Forty-six patients were included in the final analysis: 15 in the lipid-rich group and 31 in the non-lipid-rich group. LLE occurred in 27% of the lipid-rich group and 39% of the non-lipid-rich group (P = 0.52). Percent plaque volume showed minimal change in the lipid-rich group (+0.3%), while a significant reduction was observed in the non-lipid-rich group (−3.6%; P = 0.045). Conversely, maxLCBI4mm significantly decreased in the lipid-rich group compared with the non-lipid-rich group (−240 vs. −42; P = 0.0030), resulting in comparable values at the 8-month follow-up.

Despite limited plaque regression, lipid-rich lesions demonstrated favorable vascular responses, including LLE and plaque stabilization, following DCB angioplasty. This study was registered in the UMIN Clinical Trials Registry (UMIN000043158). https://www.umin.ac.jp/ What is Known Vascular responses, such as vessel enlargement and plaque regression, are frequently observed following drug-coated balloon (DCB) angioplasty, contributing to late lumen enlargement (LLE). What the Study Adds Plaque regression is less likely to occur in lipid-rich lesions. LLE occurs at a similar rate between lipid-rich and non-lipid-rich lesions. Lipid-rich lesions show a significant reduction in lipid burden. Competing Interest Statement The authors have declared no competing interest. Clinical Trial This study was registered in the UMIN Clinical Trials Registry (UMIN000043158). Funding Statement No funding support. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was approved by the Medical Ethics Committee of Osaka Rosai Hospital (approval number: 2020-103) and the Ethics Committee of Osaka University (approval number: K25068). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability Data are available from the corresponding author upon reasonable request. ABBREVIATIONS LIST - DCB - drug-coated balloon - LLE - late lumen enlargement - maxLCBI4mm - maximum lipid core burden index over 4mm - NIRS-IVUS - near-infrared spectroscopy combined with intravascular ultrasound - QCA - quantitative coronary angiography