Trial DesignsRationale and design of a randomized trial evaluating an external support device for saphenous vein coronary grafts
Section snippets
Shortcomings of saphenous vein coronary grafts
Coronary artery bypass grafting (CABG) is the optimal treatment of multi-vessel coronary artery disease.1 While the internal mammary artery is universally used to bypass the left anterior descending (LAD) coronary artery and other arterial grafts are increasingly being used,2 autologous saphenous vein grafts (SVGs) are still the secondary bypass conduits of choice. To date, progressive failure of SVGs remains the major shortcoming of CABG surgery.3,4 Approximately 25% of SVGs occlude within 1
Study design
The design of the VEST randomized trial, which is currently ongoing, is a within-patient, open label study of the safety and effectiveness of the VEST device. It is an industry-funded, pivotal clinical trial, leveraging the infrastructure of the NHLBI-supported Cardiothoracic Surgery Trials Network. The trial compares SVGs with and without VEST support in 224 patients undergoing isolated CABG at 17 highly experienced clinical centers in the U.S. and Canada. The planned enrollment period was 12
Funding
This trial was funded by Vascular Graft Solutions Ltd (Tel Aviv, Israel) and conducted by investigators within the Cardiothoracic Surgical Trials Network (CTSN).
Declarations of interest
Dr Puskas reports consultation agreements with Medtronic and Scanlan, outside the submitted work. Dr Alexander reports institutional research support from Bayer, Bristol-Myers Squibb, CryoLife, CSL Behring, Ferring, US Food and Drug Administration, Glaxosmithkline, Humacyte, US National Institutes of Health, and XaTek; he receives consultant and honoraria payments from AbbVie, Akros, Atricure, Bristol-Myers Squibb, CryoLife, Ferring, Glaxosmithkline, Janssen, Pfizer, Portola, and US Veterans
References (29)
- et al.
Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial
Lancet
(2013) - et al.
Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries
Lancet
(2001) - et al.
Stranger in a strange land: the pathogenesis of saphenous vein graft stenosis with emphasis on structural and functional differences between veins and arteries
Prog Cardiovasc Dis
(1991) - et al.
Twenty-year experience with off-pump coronary artery bypass grafting and early postoperative angiography
Ann Thorac Surg
(2020) - et al.
Endothelial cell injury in cardiovascular surgery
Ann Thorac Surg
(1996) Adaptive changes in autogenous vein grafts for arterial reconstruction: clinical implications
J Vasc Surg
(2010)- et al.
Pathologic findings in the aortocoronary vein grafts. A scanning electron microscope study
Atherosclerosis
(1978) - et al.
Prognostic factors for atherosclerosis progression in saphenous vein grafts: the postcoronary artery bypass graft (Post-CABG) trial. Post-CABG Trial Investigators
J Am Coll Cardiol
(2000) Prevention of focal intimal hyperplasia in rat vein grafts by using a tissue engineering approach
Atherosclerosis
(1998)- et al.
Towards the prevention of vein graft failure
Int J Cardiol
(1997)
A randomized trial of external stenting for saphenous vein grafts in coronary artery bypass grafting
Ann Thorac Surg
Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years
J Am Coll Cardiol
Coronary bypass graft fate: long-term angiographic study
J Am Coll Cardiol
Aortocoronary saphenous vein graft disease: pathogenesis, predisposition, and prevention
Circulation
Cited by (1)
Intimal hyperplasia, saphenous vein graft disease, and clinical outcomes: Insights from the CTSN VEST randomized trial
2022, Journal of Thoracic and Cardiovascular SurgeryCitation Excerpt :The trial was conducted under an Investigational Device Exemption application. Details of the study design and results for the primary outcome have been reported previously.13,14 Patients with multivessel atherosclerotic coronary artery disease scheduled to undergo CABG were enrolled.
This paper was handled by Guest Editor (Charles Maynard, PhD)