Gene therapy for human bypass grafts

Autologous saphenous vein is the conduit of choice for the bypass of arterial occlusive disease, be it in the peripheral arterial tree or in the coronary system. This technique is limited by primary graft failure rates approaching 20% in the first year for peripheral arterial disease and 50% at 10 years for coronary artery bypass grafting. The PREVENT trial describes a novel, safe and effective means of ex vivo transfection of harvested vein grafts with an E2F decoy oligonucleotide, with 70-74% decreases in the level of proliferating cell nuclear antigen (PCNA) and c-myc mRNA expressed by the smooth muscle cells in the vein. This translated into a statistically significant reduction in primary graft failure when used to bypass peripheral arterial occlusions in a high-risk human patient population.