Effect of a novel drug-eluted balloon coated with Genistein before stent implantation in porcine coronary arteries

Abstract

This is an author version of the contribution published on: Questa è la versione dell'autore dell'opera: [Effect of a novel drug-eluted balloon coated with genistein before stent implantation in porcine coronary arteries.Sheiban I, Anselmino M, Moretti C, Biondi-Zoccai G, Galloni M, Vignolini C, Mattoni M, Sciuto F, Omedè P, Trevi GP. Clin Res Cardiol. 2008 Dec;97(12):891-8. doi: 10.1007/s00392-008-0705-2.] The definitive version is available at: La versione definitiva è disponibile alla URL: [http://link.springer.com/article/10.1007%2Fs00392-008-0705-2] Phone: +39-011-6334446. Fax: +39-0116967053. Email: isheiban@yahoo.com 3 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. antiinflammatory 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 four 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 six-eight 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 Genisteineluting balloon with standard drug-eluting stent.4

Drug-eluting balloon: new tool in the box

“…Other agents, such as the naturally occurring MAPK inhibitor genistein and Ca 2+ activated K + channel inhibitor, have been tested for use as a coating on DEBs. In 2008, Sheiban et al reported that although the application of a genistein-coated angioplasty balloon prior to bare-metal stenting in a porcine model of coronary stenosis resulted in significant reduction of peri-stent mononucleocyte count at 4 weeks, this did not translate into reduced neointimal hyperplasia at 6-8 weeks [41]. Taxanes such as paclitaxel have high lipophilicity and bind tightly to various cell constituents [42], resulting in effective local retention at the site of delivery [43].…”

Drug-Eluting Stents in Interventional Cardiology

“…The Sparrow stent (Biosensors, Singapore, Singapore) is ideally posed to become a useful adjunct to the interventionist's armamentarium aiming to treat distal and tortuous lesions [27], whereas bioabsorbable endoprostheses (Absorb, Abbott Vascular) appear as very promising alternatives to standard metallic stents when permanency of the metallic platform is called into question [26]. Finally, drug-eluting balloons might become a routine means to revascularize patients with coronary artery disease as they may represent a suitable middle man between standard balloons and drug-eluting stents [28,29].…”

Drug-Eluting Balloon

“…Sheiban et al 28 tested the efficacy of a genistein-coated balloon (anti-inflammatory falconoid, 0.7 g/mm 2 ) in a porcine coronary artery stent model. They reported that at 4 weeks, peri-stent inflammatory cell count (mononucleocytes) was significantly less in vessels treated with genistein-coated balloons compared with those treated with noncoated balloons (39Ϯ32 versus 96Ϯ29 mm 2 , Pϭ0.019).…”