Author + information
- Maximilian Emmert1,
- Pierre Voisine2,
- Peter Skov Olson3,
- Nicolas Noiseux4,
- Hugues Jeanmart5,
- Dave Veerasingam6,
- Craig Brown7 and
- Louis Perrault8
- 1UniversitätsSpital Zürich, Zurich, Switzerland
- 2Institut Universitaire de Cardiologie et de Pneumologie, Quebec, Quebec, Canada
- 3Rigshopitalet University of Copenhagen, Copenhagen, Denmark
- 4Montreal Heart Institute, Montreal, Quebec, Canada
- 5Hopital du Sacre-Coeur, Montreal, Quebec, Canada
- 6Galway University Hospital, Galway, Ireland, Galway, Galway, Ireland
- 7New Brunswick Heart Centre, Saint John, New Brunswick, Canada
- 8Montreal Heart Institute, Montréal, Montreal, Quebec, Canada
Saphenous vein grafts (SVGs) are the most often used conduits in CABG, but are related to impaired long term patency rates due to the occurrence vein graft disease and failure (VGD/F) compromising clinical outcomes. This trial evaluates the potential impact, of DuraGraft, a one-time intraoperative treatment protecting the endothelial structure and function on the development and progression of VGD/F using longitudinal MDCT angiography in CABG patients.
In this prospective randomized, double-blinded multicenter trial (NCT02272582/02774824), 119 CABG patients requiring at least two SVGs were enrolled. Using an in-patient randomization, one graft was then treated with DuraGraft (treatment group), while the other graft was treated with standard of care (saline, controls). Patients were followed up clinically for the occurrence of cardiac adverse events and with MDCT angiography of paired grafts (cm intervals of both SVGs within each patient) at 4-6weeks (baseline), 3months and 12months. MDCT analysis included several graft parameters such as the magnitude of change in wall thickness, lumen diameter, degree of stenosis and other remodeling variables.
Enrollment was completed at 7 sites with well-matched subject and graft perioperative and conduit characteristics (>20; i.e. harvest location, quality, target-territory, etc.) indicated sufficient in-patient randomization. MDCT protocol efficacy was confirmed with ≥95% assessable coronary segments (n=5793). DuraGraft treatment was safe and no adverse events such as MI, need for repeat revasc, death or MACE occurred. Short term, 3 month, analysis of wall thickness (early signal for intimal hyperplasia) revealed a positive trend towards no increase in SVGs following DuraGraft treatment. This is further supported by preliminary results of the currently ongoing long-term MDCT analysis at 12-months.
This trial aims to determine if DuraGraft, a VGD/F inhibitor has the potential to reduce the occurrence of wall thickness/intima hyperplasia (early marker of VGF) and graft stenosis/occlusion (late marker) in CABG patients. While short term data appear to be promising, its long term effect on the prevention of VGD/F is to be proven.
CORONARY: Cardiac Surgery