Effect of a novel drug-eluted balloon coated with genistein before stent implantation in porcine coronary arteries.
BACKGROUND
The major drawback of stent implantation in native human coronary vessels is the occurrence of restenosis. Drug-eluting stents significantly reduce restenosis after percutaneous coronary intervention (PCI), but may be associated with persistent local inflammation involved in the restenosis mechanisms. In this setting coating coronary devices with anti-inflammatory agents represents an intriguing alternative to stent-based local drug delivery. The aim of the present study was to test in a porcine model the safety and efficacy of a novel Genistein-eluting balloon preceding coronary stenting.


METHODS
Female piglets underwent PCI in a randomized fashion with either a Genistein-eluting or a standard balloon angioplasty, followed in all vessels by bare-metal stent implantation. Pigs were sacrificed at different time points to appraise safety (i.e. endothelialization) and efficacy (i.e. anti-inflammatory and anti-proliferative effects): 1, 4, and 6-8 weeks following PCI.


RESULTS
Overall analysis was conducted on 14 piglets. Twenty-five bare-metal stents were implanted preceded by angioplasty with a conventional balloon in 13 vessels and by the Genistein-eluted balloon in 12. No untoward effects were reported in either group. Healing and endothelialization appeared universal within 4 weeks. The Genistein-eluted balloon group disclosed a significant reduction, at four weeks from implantation, of the peri-stent inflammatory cells count (mononucleocytes 39 +/- 32 Vs. 96 +/- 29 per square millimetre, P = 0.019). This effect did not clearly translate into a trend towards a reduced neointimal hyperplasia at 6-8 weeks (0.13 +/- 0.11 Vs. 0.14 +/- 0.09, P = 0.835).


CONCLUSIONS
This study provides the first in vivo demonstration of the anti-inflammatory effects of a Genistein-eluting balloon in PCI, warranting further research including the combination of a Genistein-eluting balloon with standard drug-eluting stent.
Sheiban
Imad
I
Interventional Cardiology, Division of Cardiology, University of Turin, San Giovanni Battista Hospital, Turin, Italy. isheiban@yahoo.com
Anselmino
Matteo
M
Moretti
Claudio
C
Biondi-Zoccai
Giuseppe
G
Galloni
Marco
M
Vignolini
Cristina
C
Mattoni
Mario
M
Sciuto
Filippo
F
Omedè
Pierluigi
P
Trevi
Gian Paolo
GP
D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000379:methods*; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D000818:Animals; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D004195:Disease Models, Animal; D054855:Drug-Eluting Stents / Q000009:adverse effects; D004730:Endothelium, Vascular / Q000187:drug effects / Q000473:pathology; D005260:Female; D019833:Genistein / Q000008:administration & dosage* / Q000009:adverse effects; D006965:Hyperplasia / Q000209:etiology / Q000517:prevention & control; D007249:Inflammation / Q000209:etiology / Q000517:prevention & control; D011897:Random Allocation; D015607:Stents; D013552:Swine; D013997:Time Factors; D017539:Tunica Intima / Q000187:drug effects / Q000473:pathology
D000893:Anti-Inflammatory Agents; D019833:Genistein
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