Downstream Paclitaxel Released Following Drug-Coated Balloon Inflation and Distal Limb Wound Healing in Swine

Juan F Granada; Marco Ferrone; Gilberto Melnick; Lesley Crookall; Daniel Schulz-Jander; Stefan Tunev; Robert J Melder; Grzegorz L Kaluza

doi:10.1016/j.jacbts.2021.01.012

Downstream Paclitaxel Released Following Drug-Coated Balloon Inflation and Distal Limb Wound Healing in Swine

JACC Basic Transl Sci. 2021 Mar 31;6(5):416-427. doi: 10.1016/j.jacbts.2021.01.012. eCollection 2021 May.

Authors

Juan F Granada¹, Marco Ferrone^{1

2

3}, Gilberto Melnick^{1

4}, Lesley Crookall⁵, Daniel Schulz-Jander⁵, Stefan Tunev⁵, Robert J Melder⁵, Grzegorz L Kaluza¹

Affiliations

¹ CRF Skirball Center for Innovation, Orangeburg, New York, USA.
² Department of Advanced Biomedical Sciences, Division of Cardiology, "Federico II" University, Naples, Italy.
³ Division of Invasive Cardiology, Montevergine Clinic, Mercogliano, Italy.
⁴ Complexo Hospital de Clinicas, Universidade Federal do Parana, Curitiba, Brazil.
⁵ Medtronic CardioVascular, Santa Rosa, California, USA.

Abstract

The authors evaluated the presence of paclitaxel and healing of distal hind limb wounds created in 27 swine using biopsy punches followed by paclitaxel-coated balloon (PCB) use in the iliofemoral arteries of healthy swine. After 14 and 28 days, no differences were seen in time course, appearance, and histopathology of wound healing between the single or triple PCB and uncoated balloon treatment despite clinically relevant paclitaxel concentrations in the skin adjacent to the healing wounds. Presence of paclitaxel downstream from the PCB treatment site does not impair the wound healing response of preexisting distal cutaneous lesions in healthy swine.

Keywords: BTK, below the knee; CLI, critical limb ischemia; PCB, paclitaxel coated balloon; PTA, percutaneous transluminal angioplasty; SFA, superficial femoral artery; histopathology; paclitaxel-coated balloon; swine; translational; wound healing.