Abstract 23242: SOMVC001(DuraGraft) Vascular Graft Treatment in Patients Undergoing Coronary ArteryBypass Grafting
Background: The principal mechanism thought to limit the benefits of CABG is saphenous vein graft disease leading to vein graft failure (VGF). Injury to the saphenous vein graft (SVG) endothelium during harvesting and implantation promotes inflammation and neointimal hyperplasia that can lead to subsequent graft atherosclerosis and occlusion. We investigated the impact of a novel intraoperative vein graft treatment SOMVC001 (DuraGraft) on angiographic early graft wall thickness and late lumen loss in patients undergoing CABG.
Methods: This is a prospective randomized, double-blinded study designed to compare within patient the impact of DuraGraft vs. the standard of care by evaluating the magnitude of change in the mean wall thickness of paired grafts within patients from 4-6 weeks to 3 months and the change from 4-6 weeks to 12 months in mean lumen diameter over each graft plus the lumen diameter at maximal stenosis within-person following CABG surgery using 64-slice or better multi-detector computed tomography (MDCT) angiography.
Results: Enrollment of 134 patients from seven investigational sites was completed. Patient baseline and procedural characteristics is representative of a contemporary population of individuals undergoing initial CABG with at least two SVG. MDCT angiographic follow-up is ongoing and scheduled to be completed in October 2016.
Conclusions: The study data will establish whether SVGs pretreated with DuraGraft can prevent early (1 to 3 months) graft wall thickness as an expression of intima hyperplasia and late (12 months) graft lumen loss as an expression of VGF in patients undergoing CABG surgery.
Author Disclosures: L. Perrault: None.
- © 2016 by American Heart Association, Inc.