Author + information
- Received January 9, 2012
- Revision received June 12, 2012
- Accepted June 21, 2012
- Published online October 1, 2012.
- Krzysztof Milewski, MD, PhD⁎,
- Maxwell Eyram Afari, MD⁎,
- Armando Tellez, MD⁎,
- Michael S. Aboodi, BS⁎,
- Jung-Sun Kim, MD, PhD⁎,
- Yanping Cheng, MD⁎,
- Gerard B. Conditt, RCIS⁎,
- Jennifer C. McGregor, BS⁎,
- Geng Hua Yi, MD⁎,
- Mark Stenoien, BS†,
- Dan Langanki, BS†,
- Christian G. Krueger, BS‡,
- Greg L. Kaluza, MD, PhD⁎ and
- Juan F. Granada, MD⁎,⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Juan F. Granada, Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, 8 Corporate Drive, Orangeburg, New York 10962
Objectives The authors aimed to validate a novel iliofemoral in-stent restenosis (ISR) model for the efficacy evaluation of paclitaxel-coated balloons (PCB) using the familial hypercholesterolemic swine (FHS).
Background Most of the validation work regarding PCB technologies has been performed in the coronary territory of juvenile domestic swine. Although invaluable for safety evaluation, this model is not suited for the evaluation of the efficacy of peripheral PCB technologies.
Methods Twenty-four iliofemoral segments in 12 FHS underwent balloon injury and self-expanding stent placement. After 21 days, the resulting ISR lesions were treated with either 1 μg/mm2 dose (n = 8), or 3 μg/mm2 dose (n = 8) PCB (Cotavance, Bayer Pharma AG/MEDRAD, Indianola, Pennsylvania), or with an identical uncoated control balloon (n = 8).
Results At termination (28 days after treatment), the percent diameter stenosis by quantitative vascular analysis in the control group was higher (31.2 ± 13.7%) compared with the 1 μg/mm2 (19.3 ± 14.0%, 38% reduction) and 3 μg/mm2 (8.6 ± 10.7%, 72% reduction) PCB groups. Intravascular ultrasound analysis showed 36% (1 μg/mm2 dose, p = 0.04) and 55% (3 μg/mm2 dose, p < 0.01) reductions in neointimal volume stenosis. In the histological analysis, the control group showed the highest degree of percent area stenosis (65 ± 14.3%). The reductions in percent area stenosis was 13.2% (p = 0.5) and 26% (p = 0.04) in the 1 μg/mm2 and 3 μg/mm2 dose groups, respectively.
Conclusions The FHS model of iliofemoral ISR demonstrated a dose-dependent effect on the inhibition of neointimal proliferation of a clinically validated PCB technology. This model represents a positive step toward the efficacy evaluation of PCB in the peripheral vascular territory.
MEDRAD Interventional provided financial support and materials for this study. Mr. Langanski is a former employee of Bayer Interventional. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The first two authors contributed equally to this work
- Received January 9, 2012.
- Revision received June 12, 2012.
- Accepted June 21, 2012.
- American College of Cardiology Foundation