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Peer-reviewedCC BY 4.0PLOS One

Surface micro-patterned drug-coated balloon enhances early biological efficacy in a porcine coronary in-stent restenosis model

  • Seunghwan Kim1
  • Seul-Gee Lee2
  • Joonoh Park3
  • Jino Park4
  • Dong-Kie Kim5
  • Ki-Hun Kim6
  • Doo-Il Kim7
  • Se-Il Park8
  • Ok-Hee Jeon
  • Yong-Jun Lee
  • Oh-Hyun Lee
  • Dong-Eon Kim
2 more authors
  • WonHyoung Ryu
  • Jung-Sun Kim
8 affiliations
  1. 1Division of Cardiology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea
  2. 2Yonsei University College of Medicine, Seoul, Korea
  3. 3Integrative Research Center for Cerebrovascular and Cardiovascular Diseases, Division of Cardiology, Yonsei University College of Medicine, Seoul, Korea
  4. 4Cardiovascular Product Evaluation Center, Yonsei University College of Medicine, Seoul, Korea
  5. 5Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea
  6. 6Division of Cardiology, Yongin Severance Hospital, Yonsei University College of Medicine, Gyeonggi-do, Korea
  7. 7Division of Cardiology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
  8. 8Department of Mechanical Engineering, Yonsei University, Seoul, Korea
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Abstract

Background: Drug-coated balloon (DCB) therapy for in-stent restenosis (ISR) relies on efficient drug transfer during balloon–artery contact. Surface micro-patterning has been proposed to enhance transfer efficiency without altering the antiproliferative drug. This study evaluated a linear micro-patterned DCB (LMDCB) compared with a comparator paclitaxel-coated DCB in a porcine coronary ISR model. Methods: ISR was induced by bare-metal stent implantation followed by a 4-week maturation period. In two prespecified cohorts (1 month: 10 animals, 20 segments; 3 months: 4 animals, 8 segments), paired ISR segments within each animal were treated with LMDCB or a comparator paclitaxel-coated DCB (3.0 µg/mm2). Endpoints included quantitative coronary angiography (QCA), optical coherence tomography (OCT), and histology. Results: At 1 month, LMDCB demonstrated a larger minimum lumen diameter (2.3 ± 0.2 mm vs 1.9 ± 0.4 mm; p = 0.019) and lower percent diameter stenosis (13.3 ± 4.8% vs 23.7 ± 9.3%; p = 0.003). OCT showed lower mean neointimal thickness (0.2 ± 0.1 mm vs 0.3 ± 0.1 mm; p = 0.008). Histology showed lower neointimal area (2.4 ± 0.7 mm2 vs 2.9 ± 1.1 mm2; p = 0.011) and percent area stenosis (36.6 ± 10.4% vs 44.4 ± 17.8%; p = 0.013), with comparable vascular healing indices. In the independent 3-month cohort, QCA and OCT findings were similar between groups. Exploratory histology in a limited subset suggested a larger lumen and lower percent area stenosis with LMDCB. Conclusions: In this porcine coronary ISR model, LMDCB was associated with reduced neointimal proliferation and improved luminal dimensions at 1 month compared with a comparator paclitaxel-coated DCB, without impaired vascular healing. In a separate 3-month cohort, imaging findings were comparable between devices, while histology remained exploratory.

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Cite

BibTeXRIS
BibTeX
@article{kim2026surface,
  title = {{Surface micro-patterned drug-coated balloon enhances early biological efficacy in a porcine coronary in-stent restenosis model}},
  author = {Seunghwan Kim and Seul-Gee Lee and Joonoh Park and Jino Park and Dong-Kie Kim and Ki-Hun Kim and Doo-Il Kim and Se-Il Park and Ok-Hee Jeon and Yong-Jun Lee and Oh-Hyun Lee and Dong-Eon Kim and WonHyoung Ryu and Jung-Sun Kim},
  journal = {PLOS One},
  year = {2026},
  month = sep,
  doi = {10.1371/journal.pone.0359232},
  url = {https://doi.org/10.1371/journal.pone.0359232},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Surface micro-patterned drug-coated balloon enhances early biological efficacy in a porcine coronary in-stent restenosis model
AU  - Seunghwan Kim
AU  - Seul-Gee Lee
AU  - Joonoh Park
AU  - Jino Park
AU  - Dong-Kie Kim
AU  - Ki-Hun Kim
AU  - Doo-Il Kim
AU  - Se-Il Park
AU  - Ok-Hee Jeon
AU  - Yong-Jun Lee
AU  - Oh-Hyun Lee
AU  - Dong-Eon Kim
AU  - WonHyoung Ryu
AU  - Jung-Sun Kim
PY  - 2026
DA  - 2026/09/25
JO  - PLOS One
DO  - 10.1371/journal.pone.0359232
UR  - https://doi.org/10.1371/journal.pone.0359232
AB  - Background: Drug-coated balloon (DCB) therapy for in-stent restenosis (ISR) relies on efficient drug transfer during balloon–artery contact. Surface micro-patterning has been proposed to enhance transfer efficiency without altering the antiproliferative drug. This study evaluated a linear micro-patterned DCB (LMDCB) compared with a comparator paclitaxel-coated DCB in a porcine coronary ISR model. Methods: ISR was induced by bare-metal stent implantation followed by a 4-week maturation period. In two prespecified cohorts (1 month: 10 animals, 20 segments; 3 months: 4 animals, 8 segments), paired ISR segments within each animal were treated with LMDCB or a comparator paclitaxel-coated DCB (3.0 µg/mm2). Endpoints included quantitative coronary angiography (QCA), optical coherence tomography (OCT), and histology. Results: At 1 month, LMDCB demonstrated a larger minimum lumen diameter (2.3 ± 0.2 mm vs 1.9 ± 0.4 mm; p = 0.019) and lower percent diameter stenosis (13.3 ± 4.8% vs 23.7 ± 9.3%; p = 0.003). OCT showed lower mean neointimal thickness (0.2 ± 0.1 mm vs 0.3 ± 0.1 mm; p = 0.008). Histology showed lower neointimal area (2.4 ± 0.7 mm2 vs 2.9 ± 1.1 mm2; p = 0.011) and percent area stenosis (36.6 ± 10.4% vs 44.4 ± 17.8%; p = 0.013), with comparable vascular healing indices. In the independent 3-month cohort, QCA and OCT findings were similar between groups. Exploratory histology in a limited subset suggested a larger lumen and lower percent area stenosis with LMDCB. Conclusions: In this porcine coronary ISR model, LMDCB was associated with reduced neointimal proliferation and improved luminal dimensions at 1 month compared with a comparator paclitaxel-coated DCB, without impaired vascular healing. In a separate 3-month cohort, imaging findings were comparable between devices, while histology remained exploratory.
SN  - 1932-6203
ER  -