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Efficacy of a novel anti-inflammatory drug-eluting balloon coated with genistein before stent implantation in porcine

Efficacy of a novel anti-inflammatory drug-eluting balloon coated with genistein before stent implantation in porcine coronary arteries. I. Sheiban, C. Moretti, M. Anselmino, G. Biondi-Zoccai, P. Omedé, F. Sciuto, M. Galloni, and G. P. Trevi

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Efficacy of a novel anti-inflammatory drug-eluting balloon coated with genistein before stent implantation in porcine

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  1. Efficacy of a novel anti-inflammatory drug-eluting balloon coated with genistein before stent implantation in porcine coronary arteries I. Sheiban, C. Moretti, M. Anselmino, G. Biondi-Zoccai, P. Omedé, F. Sciuto, M. Galloni, and G. P. Trevi University of Turin, Turin, Italy (gbiondizoccai@gmail.com)

  2. BACKGROUND • Drug-eluting stents using cytostatic drugs significantly reduce restenosis after percutaneous coronary intervention, but may be associated with persistent local inflammation. • Coating coronary devices with potent anti-inflammatory agents such as the flavonoid genistein may provide significant benefits, without unduly promoting inflammation.

  3. BACKGROUND • A novel genistein-eluting balloon has been developed by Sahajanand (Gujarat, India), with promising in vitro data, but no in vivo/preclinical data. • We thus aimed to test in a porcine model the safety and efficacy of a novel genistein-eluting balloon before coronary stent implantation.

  4. METHODS • Female piglets underwent PCI in 25 coronary segments in a randomized fashion with either a genistein-eluting balloon or a standard balloon, followed by bare-metal stent implantation at 1.1:1.0 balloon to artery ratio. • Pigs were then sacrificed at different time points to appraise safety (i.e. endothelialization) and efficacy (i.e. anti-inflammatory and anti-proliferative effects): 1, 4, and 6 to 8 weeks after PCI.

  5. STUDY PROFILE DEB=drug-eluting balloon SB=standard balloon

  6. RESULTS • Overall analysis was conducted on 14 piglets treated with 25 standard bare-metal stents were implanted, of which 13 with conventional angioplasty balloon and 12 with the genistein-eluted angioplasty balloon. • The genistein-eluting balloon proved safe, as no untoward effects were found in any of the animals, including those sacrificed as early as 1 week post-PCI, with healing and endothelialization appearing almost universal in all stent struts within four weeks.

  7. RESULTS • The drug-eluting balloon also showed significant biologic efficacy, as at 4 weeks animals treated with this device had a significant reduction in peri-stent inflammatory cells (39±32 vs 96±29, p= 0.019). • This statistically significant anti-inflammatory effect translated into non-significant trends towards reduced neointimal hyperplasia (measured as neointimal thickness) at eight weeks (0.13±0.11 mm vs. 0.15±0.09 mm, p>0.05).

  8. RESULTS ,3 35 p=0,319 p=0,788 28 ,2 Neointimal thickness (mm) % stenosis 21 ,1 14 0,0 7 N = 6 4 N = 6 4 no yes no yes Drug-eluting balloon Drug-eluting balloon

  9. RESULTS 1,2 160 p=0,630 p=0,019 1,0 120 ,8 MNCs x mm2 Injury score ,6 80 ,4 40 ,2 0,0 0 N = 6 4 N = 6 4 no yes no yes Drug-eluting balloon Drug-eluting balloon

  10. HISTOLOGY OF GENISTEIN-ELUTING BALLOON (A) VERSUS CONVENTIONAL ANGIOPLASTY BALLOON (B) FOLLOWED BY CORONARY STENTING AT FOUR WEEKS

  11. 4-WEEK PERI-STENT CELLULARITY AFTER CONVENTIONAL BALLOON (TOTAL CELLULARITY IN A, MNC IN B) VS GENISTEIN-ELUTING BALLOON (TOTAL CELLULARITY IN C, MNC IN D) WITH ARROWS INDICATING MNC.

  12. CONCLUSIONS • This study provides the first in vivo demonstration of the anti-inflammatory effects of a novel genistein-eluting balloon in percutaneous coronary stenting. • Further research is warranted to appraise whether the combination of a genistein-eluting balloon with standard drug-eluting stent can provide both anti-restenotic and anti-inflammatory effects.

  13. For further slides on these topics please feel free to visit the metcardio.org website:http://www.metcardio.org/slides.html

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