GrafDefense: Nano-polyplexes for Improving Saphenous Vein Graft Patency

摘要

Saphenous vein grafts are the most commonly used conduit in coronary and peripheral artery bypass surgery with approximately 1 million peripheral bypass grafts and 600k coronary artery bypass grafting surgeries annually (total of 1.6 million surgeries). Though bypass grafting may improve survival, there was a 45% per patient vein graft failure rate at 12-18 months in the PREVENT Ⅳ trial. Grafdefense has recently developed a technology, termed nano-polyplexes, for the pre-treatment of saphenous vein grafts ex vivo to improve graft patency. This technology has been examined in preclinical models of vein grafting including a rabbit model and excised human saphenous vein. In an in vivo rabbit jugular vein interposition model, vein grafts treated with a therapeutic pep tide (MK2i) incorporated into our proprietary NP formulation resulted in significantly reduced intimal hyperplasia and lower graft failure rates when compared to the therapeutic peptide alone . In an ex vivo human saphenous vein (HSV) organ culture model, HSV explants treated with the therapeutic MK2i peptide in the GrafDefense NP formulation resulted in complete abrogation of intimal hyperplasia whereas the MK2i therapeutic alone had a marginal effect.