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

[Display omitted] •PCBs are a clinically proven antirestenotic alternative to plain percutaneous transluminal angioplasty of superficial femoral arteries but their application in critical limb ischemia is inhibited by the concern that the downstream release of particulate paclitaxel may negatively impact distal lower limb’s circulation and its tissues already compromised by chronic ischemia.•To investigate this concern experimentally, we used an animal model of standardized distal limb wounds to determine the effect of downstream paclitaxel released during PCB treatment of superficial femoral arteries on distal wound healing process.•A clinically relevant concentration of paclitaxel in the vicinity of the wound did not impair the healing of preexisting distal cutaneous lesions in healthy swine even after multiple PCB deployments. 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.