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. DESIGN: 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). CONCLUSION: 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.
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. DESIGN: 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). CONCLUSION: 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: Harry C Lowe; Robert S Schwartz; Briain D Mac Neill; Ik-Kyung Jang; Motoya Hayase; Campbell Rogers; Stephen N Oesterle Journal: Catheter Cardiovasc Interv Date: 2003-12 Impact factor: 2.692
Authors: Bruno Scheller; Christoph Hehrlein; Wolfgang Bocksch; Wolfgang Rutsch; Dariush Haghi; Ulrich Dietz; Michael Böhm; Ulrich Speck Journal: N Engl J Med Date: 2006-11-13 Impact factor: 91.245
Authors: F Beier; M Gyöngyösi; T Raeder; E von Eckardstein-Thumb; W Sperker; P Albrecht; C Spes; D Glogar; H Mudra Journal: Clin Res Cardiol Date: 2006-07-03 Impact factor: 5.460
Authors: G R Dussaillant; G S Mintz; A D Pichard; K M Kent; L F Satler; J J Popma; S C Wong; M B Leon Journal: J Am Coll Cardiol Date: 1995-09 Impact factor: 24.094
Authors: Alexandra J Lansky; Ricardo A Costa; Gary S Mintz; Yoshihiro Tsuchiya; Mark Midei; David A Cox; Charles O'Shaughnessy; Robert A Applegate; Louis A Cannon; Michael Mooney; Anthony Farah; Mark A Tannenbaum; Steven Yakubov; Dean J Kereiakes; S Chiu Wong; Barry Kaplan; Ecaterina Cristea; Gregg W Stone; Martin B Leon; William D Knopf; William W O'Neill Journal: Circulation Date: 2004-04-12 Impact factor: 29.690
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Authors: Holger M Nef; Helge Möllmann; Astrid Joseph; Christian Troidl; Sandra Voss; Maximilian Rauch; Ralf Kinscherf; Achim Vogt; Michael Weber; Christian W Hamm; Albrecht Elsässer Journal: Clin Res Cardiol Date: 2009-05-07 Impact factor: 5.460