The TA-Trial (Total Arterial) is one of the most important clinical trials in cardiac surgery.
The trial seeks to test the large-scale retrospective evidence indicating a survival advantage for patients who have not received any vein grafts (total arterial) of approximately 22% difference.
Coronary artery disease affects 4 million Australians annually and occurs in patients with multiple coexisting cardiovascular comorbidities undergoing coronary artery bypass surgery (CABG). Complications are related to the failure of bypass grafts to remain open (patent). This multi-centre RCT proposes that the exclusive use of arterial grafts vs some use of venous grafts (in addition to arterial grafts – the current standard of care) will improve patient outcomes and survival.
Patients will be randomised to receive (or not) any saphenous vein graft. These grafts will then be assessed by a CT coronary angiogram at 3 months and at 2 years postoperative. The target recruitment is 1,000 patients across all of the leading cardiac surgery centres in Australia.
Synopsis
Coronary artery disease (CAD) is the leading single cause of disease burden (12.3%) and death (44,000 per year) affecting 4 million Australians annually.
Patients presenting for treatment of coronary disease represent a cohort of patients with a high burden of co-existing cardiovascular co-morbidities and risk factors who are at risk of complications post CABG in multiple organ systems.
Graft failure post CABG occurs in approximately 12.9% of patients in the short to medium term, affecting 2,193 Australians/annum and can lead directly to cardiac dysfunction and indirectly to increased risk of cerebral (stroke, neurocognitive impairment), renal dysfunction and/or death. A major contributor of graft failure and the need for reintervention is the type of graft (arterial vs venous) used at surgery.
Arterial grafts are associated with reduced atherosclerosis compared to venous grafts. Unlike most vein grafts, arterial grafts rarely develop progressive atherosclerosis. By 10 years, 40-50% of vein grafts have completely failed (occluded). Total arterial revascularisation (TAR) uses arterial grafts exclusively and represents 5% of total CABG internationally, compared to the current standard of care, which uses one or more venous grafts (non-TAR).
Our multicentre RCT proposes that TAR (vs non-TAR) will be associated with superior perfect patency of grafts and, hence, a reduction in direct and indirect cardiac, neurocognitive, cerebrovascular and renal complications.
The results of this trial will be used to advocate for TAR to become the standard of care for patients undergoing CABG, thus improving postoperative outcomes and survival of patients with cardiovascular disease.
Team
Co-ordinating Principal Investigator
Professor Alistair Royse
MBBS, MD, FRACS, FCSANZ, GAICD
E: Alistair.Royse@gmail.com
T: +613 9035 4759
F: +613 8679 4445
Uni Melb Profile: https://findanexpert.unimelb.edu.au/profile/4572-alistair-royse
LinkedIn: https://au.linkedin.com/in/alistairroyse
ResearchGate: https://www.researchgate.net/profile/Alistair_Royse
Principal Investigators
Prof Rinaldo Bellomo |
Prof Julian Smith |
Prof Paul Bannon |
Prof Christopher Reid |
Prof Colin Royse |
Prof Michael Vallely |
Assoc Prof Elaine Lui |
Assoc Prof David Eccleston |
Dr Sandy Clarke-Errey |
Prof Guy Ludbrook |
Dr Andrea Bowyer |
Dr David Tian |