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Research Article

Pressure-responsive pH-triggered layer-by-layer coating of paclitaxel-eluting balloon catheters for instant high-dose drug delivery for percutaneous coronary artery intervention

Jeong Yu Lee1,§, Shonit Nair Sharma2,3,§, Sung-Yu Hong4, Young-Guk Ko5, Yangsoo Jang4,5, Minjae Do1, Michael Christopher Stark2, Qiwen Peng2, Benjamin Allen Mossburg2, Bo Chan Seo2, Yuhan Lee2( )
Department of Materials Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon 305-701, Republic of Korea
Department of Anesthesiology, Perioperative, and Pain Medicine, Center for Accelerated Medical Innovation & Center for Nanomedicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02115, USA
Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, MA 02139, USA
Cardiovascular Product Evaluation Center, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea
Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul 120-752, Republic of Korea

§ Jeong Yu Lee and Shonit Nair Sharma contributed equally to this work.

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Graphical Abstract

A pressure-responsive pH-triggered layer-by-layer coating was developed and applied to paclitaxel-eluting balloon catheters. This novel coating facilitates controllable, rapid, high-dose drug delivery for percutaneous coronary artery intervention.

Abstract

Cardiovascular diseases remain the leading cause of mortality worldwide, with percutaneous coronary interventions (PCI) using drug-eluting stents (DES) as the standard treatment for coronary artery disease. Despite advancements in DES technology, challenges such as restenosis and stent thrombosis still necessitate further interventions and carry considerable risks, highlighting an urgent need for a novel therapeutic approach with lower restenosis rates and reduced reintervention risks. Drug-eluting balloons (DEBs) coated with anti-proliferative agents offer a novel method of local drug delivery for reducing restenosis by directly administering drugs to the lesion site. However, efficient delivery of drugs within the brief procedural window while minimizing drug loss during maneuvering to the target site remains a challenge. Herein, we developed a pressure-responsive and pH-triggered, paclitaxel (PTX) coated DEB catheter for rapid and high-dose delivery of paclitaxel to the lesion sites, overcoming the limitations of drug dispersion and inefficiencies associated with conventional DEBs. Using the charge reversion of albumin around its isoelectric point, paclitaxel-loaded human serum albumin nanoparticles (PTX-HSA-NPs) and heparin were coated using a layer-by-layer deposition method at pH 4.0. Upon exposure to physiological pH (i.e., 7.4), the coating is rapidly released from the balloon surface. Combined with a protective shellac coating, the DEB achieved controlled release of high-dose paclitaxel to the arterial tissue in vivo (up to 400 µg per gram tissue), exceeding current DEBs in the clinic. These results suggest the pH-responsive, multi-layer coated DEB’s potential for superior procedural outcomes, addressing a critical unmet need in PCI.

Keywords

drug-eluting balloonlayer-by-layer coatingcoronary artery diseasepaclitaxel

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Nano Research
Volume 17 Issue 10,
October 2024
Pages 9141-9151
DOI: 10.1007/s12274-024-6979-5
Cite this article:
Lee JY, Sharma SN, Hong S-Y, et al. Pressure-responsive pH-triggered layer-by-layer coating of paclitaxel-eluting balloon catheters for instant high-dose drug delivery for percutaneous coronary artery intervention. Nano Research, 2024, 17(10): 9141-9151. https://doi.org/10.1007/s12274-024-6979-5
Topics:
Biomaterials BiotechnologyBlood vessels Cardiovascular system Chemotherapy Controlled drug deliveryDrug deliveryDrug dosage NanobiotechnologyTargeted drug delivery

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Received: 21 March 2024
Revised: 22 August 2024
Accepted: 28 August 2024
Published: 12 September 2024
© Tsinghua University Press 2024
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