title: Effect of a novel drug-eluted balloon coated with genistein before stent implantation in porcine coronary arteries.
abstract: 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.
authors.affiliation: Interventional Cardiology, Division of Cardiology, University of Turin, San Giovanni Battista Hospital, Turin, Italy. isheiban@yahoo.com
authors.forename: Imad
authors.initials: I
authors.lastname: Sheiban
authors.forename: Matteo
authors.initials: M
authors.lastname: Anselmino
authors.forename: Claudio
authors.initials: C
authors.lastname: Moretti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Biondi-Zoccai
authors.forename: Marco
authors.initials: M
authors.lastname: Galloni
authors.forename: Cristina
authors.initials: C
authors.lastname: Vignolini
authors.forename: Mario
authors.initials: M
authors.lastname: Mattoni
authors.forename: Filippo
authors.initials: F
authors.lastname: Sciuto
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Omedè
authors.forename: Gian Paolo
authors.initials: GP
authors.lastname: Trevi
mesh_terms: 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
chemical_list: D000893:Anti-Inflammatory Agents; D019833:Genistein
references.citation: N Engl J Med. 2003 Apr 17;348(16):1537-45
references.pmid: 12700373
references.citation: Int J Cardiol. 1994 Mar 1;43(3):257-67
references.pmid: 8181884
references.citation: J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20
references.pmid: 14563585
references.citation: N Engl J Med. 2006 Nov 16;355(20):2113-24
references.pmid: 17101615
references.citation: Clin Res Cardiol. 2007 Feb;96(2):86-93
references.pmid: 17180577
references.citation: Catheter Cardiovasc Interv. 2003 Dec;60(4):515-23
references.pmid: 14624433
references.citation: Clin Res Cardiol. 2006 Oct;95(10):560-4
references.pmid: 16897146
references.citation: Clin Res Cardiol. 2006 Sep;95(9):455-60
references.pmid: 16799877
references.citation: Eur Heart J. 2003 Aug;24(15):1462-7
references.pmid: 12909076
references.citation: Endocrinology. 1998 Oct;139(10):4252-63
references.pmid: 9751507
references.citation: Curr Pharm Des. 2004;10(4):357-67
references.pmid: 14965197
references.citation: Heart. 2003 Feb;89(2):133-8
references.pmid: 12527658
references.citation: Clin Res Cardiol. 2007 Jun;96(6):375-82
references.pmid: 17453137
references.citation: Radiology. 2006 Aug;240(2):411-8
references.pmid: 16864669
references.citation: Cardiovasc Pathol. 2003 Jan-Feb;12(1):40-8
references.pmid: 12598017
references.citation: Circulation. 2004 Aug 17;110(7):810-4
references.pmid: 15302790
references.citation: J Am Coll Cardiol. 1998 Jan;31(1):224-30
references.pmid: 9426044
references.citation: Circulation. 1990 Dec;82(6):2190-200
references.pmid: 2146991
references.citation: Circulation. 1994 Oct;90(4):2070-84
references.pmid: 7923695
references.citation: J Am Coll Cardiol. 2004 Oct 6;44(7):1373-85
references.pmid: 15464316
references.citation: J Am Coll Cardiol. 1993 Apr;21(5):1166-74
references.pmid: 8459072
references.citation: Circulation. 1993 Oct;88(4 Pt 1):1788-803
references.pmid: 7691431
references.citation: N Engl J Med. 2003 Oct 2;349(14):1315-23
references.pmid: 14523139
references.citation: Arch Biochem Biophys. 1997 Sep 1;345(1):65-72
references.pmid: 9281312
references.citation: Heart. 2007 May;93(5):598-600
references.pmid: 17005712
references.citation: J Am Coll Cardiol. 1995 Sep;26(3):720-4
references.pmid: 7642865
references.citation: Circulation. 2004 Apr 27;109(16):1948-54
references.pmid: 15078794
references.citation: Circulation. 2000 May 9;101(18):2130-3
references.pmid: 10801750
references.citation: J Am Coll Cardiol. 1998 Dec;32(7):2087-94
references.pmid: 9857898
references.citation: Circulation. 1987 Aug;76(2):450-7
references.pmid: 2955956
references.citation: Clin Res Cardiol. 2007 Aug;96(8):548-56
references.pmid: 17534566
references.citation: J Am Coll Cardiol. 1992 Feb;19(2):267-74
references.pmid: 1732351
references.citation: J Am Coll Cardiol. 2002 Dec 4;40(11):1935-42
references.pmid: 12475452
references.citation: Circulation. 1996 Sep 15;94(6):1247-54
references.pmid: 8822976
references.citation: J Am Coll Cardiol. 1992 Aug;20(2):467-74
references.pmid: 1634687
references.citation: J Am Coll Cardiol. 2007 Jul 10;50(2):176-85
references.pmid: 17616304
references.citation: Invest Radiol. 2004 Mar;39(3):182-6
references.pmid: 15076010
references.citation: Clin Res Cardiol. 2007 Feb;96(2):70-6
references.pmid: 17146605
references.citation: Circulation. 1992 Dec;86(6 Suppl):III47-52
references.pmid: 1424051
references.citation: Curr Med Chem. 2007;14(24):2581-9
references.pmid: 17979711