Paclitaxel-iopromide coated balloon followed by "bail-out" bare metal stent in porcine iliofemoral arteries: First report on biological effects in peripheral circulation

Krzysztof Milewski, Armando Tellez, Michael S. Aboodi, Gerard B. Conditt, Geng Hua Yi, Troels Thim, Mark Stenoien, Jennifer C. McGregor, William A. Gray, Renu Virmani, Juan F. Granada, Grzegorz L. Kaluza

Research output: Contribution to journalArticlepeer-review

11 Scopus citations

Abstract

Aims: Despite recent abundance of data on drug-coated balloon technology, the biological effects of paclitaxel coated balloon (PCB) treatment followed by bare metal stent (BMS) implantation in peripheral arteries (simulating bail-out stenting, a common clinical scenario), have not been published. Methods and results: PCB technology containing a paclitaxel-iopromide coating and identical iopromide-coated controls (without paclitaxel) were used in 16 porcine ilio-femoral arteries. The biological effects of inflating one (PCBx1) or two sequential (PCBx2) paclitaxel coated balloons before BMS implantation were compared to the single application of a control balloon (CCBx1; contrast coated balloons). At 30 days PCBx2 displayed significantly reduced late lumen loss by angiography (58% reduction vs. CCBx1; p=0.04) and neointimal area by histomorphometry (35% reduction vs. CCBx1 and 30% vs. PCBx1; p=0.02). Similarly, percent area stenosis in the PCBx2 group was reduced by 45% as compared to CCBx1 and PCBx1 (p=0.04). At this time, all parameters of vessel wall healing (including injury score, inflammation, and endothelialisation) following drug coated balloon treatment were comparable to the control group. Conclusions: Paclitaxel delivery to porcine ilio-femorals using PCB followed by BMS implantation effectively decreased neointimal proliferation. More extensive and prolonged proliferative response of the vessel after stenting (necessitating higher drug dose) could potentially explain the undetectable effect of PEBx1 relative to CCBx1 in this pilot study. Histological analysis confirmed the safety and biocompatibility of PCB technology.

Original languageEnglish (US)
Pages (from-to)362-368
Number of pages7
JournalEuroIntervention
Volume7
Issue number3
DOIs
StatePublished - Jul 2011
Externally publishedYes

Keywords

  • Drug coated balloon
  • Paclitaxel
  • Peripheral stent
  • Porcine

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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