# Mechanisms of drug-coated balloon therapy

> **NIH NIH R01** · BOSTON UNIVERSITY MEDICAL CAMPUS · 2021 · $456,261

## Abstract

PROJECT SUMMARY
 Drug-coated balloons (DCBs) have evolved as a promising interventional strategy for peripheral arterial
disease (PAD). While paclitaxel (PTX)-based DCBs were emerging as the interventional standard of care for
many PAD lesions, a recent meta-analysis of randomized trials suggested excess late mortality in PTX-treated
patients. This result prompted the FDA to issue a warning that ultimately led to a marked reduction of the
clinical use of DCBs. This response by the clinical and regulatory communities underscores a need to develop
next-generation DCBs that could show improved efficacy and safety profiles. Drawing from our previous
experience related to studies on drug-eluting stents and more recently on DCBs, we propose two hypothesis-
driven design strategies to enhance DCB performance and safety. Aims I and II will consider balloon surface
hydrophilicity and coating composition, respectively, as critical DCB design variables, and seek to identify
mechanistic relations between these design variables, coating microstructure, drug delivery efficacy, as well as
local and systemic toxicity. We will predict optimal DCB designs for both acute and sustained drug delivery
using a biophysical contact model that computes deterministic interfacial mechanical interactions during DCB
deployment. Our material design space includes two excipients (urea and shellac) and two drugs (PTX and
dexamethasone (DEX)), with consideration of variable excipient-drug ratios and novel balloon pre-treatment
protocols prior to coating applications. We will use an in vivo model of rabbit atherosclerosis to evaluate
optimized DCBs, providing support for our approach to enhance PTX delivery and insight into the clinical
potential of DEX as an alternate DCB payload.

## Key facts

- **NIH application ID:** 10279523
- **Project number:** 1R01HL159620-01
- **Recipient organization:** BOSTON UNIVERSITY MEDICAL CAMPUS
- **Principal Investigator:** Vijaya B. Kolachalama
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $456,261
- **Award type:** 1
- **Project period:** 2021-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10279523

## Citation

> US National Institutes of Health, RePORTER application 10279523, Mechanisms of drug-coated balloon therapy (1R01HL159620-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10279523. Licensed CC0.

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