DuraGraft vascular conduit preservation solution in patients undergoing coronary artery bypass grafting: rationale and design of a within-patient randomised multicentre trial

Walid Ben Ali, Pierre Voisine, Peter Skov Olsen, Hugues Jeanmart, Nicolas Noiseux, Tracy Goeken, Vilas Satishchandran, Filippo Cademartiri, Garry Cutter, Dave Veerasingam, Craig Brown, Maximilian Y Emmert, Louis P Perrault, Walid Ben Ali, Pierre Voisine, Peter Skov Olsen, Hugues Jeanmart, Nicolas Noiseux, Tracy Goeken, Vilas Satishchandran, Filippo Cademartiri, Garry Cutter, Dave Veerasingam, Craig Brown, Maximilian Y Emmert, Louis P Perrault

Abstract

Introduction: Saphenous vein grafts (SVGs) remain the most often used conduits in coronary artery bypass grafting (CABG). However, they are prone to vein graft disease (VGD) during follow-up, which may compromise clinical outcomes. Injury to the SVG endothelium during harvesting and storage promotes neointimal hyperplasia that can advance to atherosclerosis characterised by SVG failure. This trial investigates the potential benefit of DuraGraft, a novel, one-time intraoperative graft treatment developed to efficiently protect the structural and functional integrity of the vascular endothelium, on the development and progression of VGD in CABG patients.

Methods and analysis: This ongoing prospective randomised, double-blinded multicentre trial (NCT02272582/NCT02774824) includes patients undergoing isolated CABG requiring at least two SVGs. It compares the impact of DuraGraft, a novel treatment against VGD versus the standard-of-care (SOC; heparinised saline) using a within-patient randomisation (with one SVG treated with DuraGraft and the other treated with SOC). Besides clinical assessments, patients undergo longitudinal 64-slice or better multidetector CT (MDCT) angiography of paired grafts (within each patient) at 4-6 weeks, 3 months and 12 months. Primary endpoints will be the magnitude of change in mean wall thickness and lumen diameter (stenosis) of paired grafts, at 3 and 12 months, respectively. Besides the evaluation of overall safety, longitudinal assessment of each graft (secondary endpoint) is performed in order to obtain insight into graft behaviour after CABG. Enrolment of 119 patients was successfully completed, and analysis of MDCT angiography follow-up is ongoing with the completed analysis becoming available by end of first quarter of 2018.

Ethics and dissemination: The regional ethics committees have approved the trial. Results will be submitted for publication.

Clinical trial identifier: NCT02272582 and NCT02774824.

Keywords: coronary artery bypass grafting; endothelial damage inhibitor; myocardial infarction; patency; saphenous vein graft; vein graft failure; vein graft treatment.

Conflict of interest statement

Competing interests: MYE and LPP are consultants, TG is the CMO and VS is an employee of Somahlution Inc, Jupiter, Florida, USA.

Figures

Figure 1
Figure 1
DuraGraft treatment solution.
Figure 2
Figure 2
MDCT analysis protocol: each graft was evaluated from proximal to distal in 10 mm intervals. LD, lumen diameter; MDCT, multidetector CT; TVD, total vessel diameter; WT, wall thickness.
Figure 3
Figure 3
Exemplary primary short-term and long-term endpoint MDCT angiography calculation. LD, lumen diameter; MDCT, multidetector CT; TVD, total vessel diameter; WT, wall thickness.

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