None listed
Conditions
Brief summary
This prospective multicenter, open-label, randomised clinical trial will be assessing coronary artery bypass grafting (CABG) using two surgical approaches: the novel total arterial revascularization (TAR) versus the conventional use of one or more saphenous vein grafts (SVG) (non-TAR). Participating institutions will include major heart centers in Australia. The eligibility criteria for participants will be primary adult isolated CABG patients with multivessel coronary disease requiring at least two grafts. The primary endpoint is the number of perfectly patent grafts in each arm at 24 months post-surgery, as defined by the absence of atherosclerotic occlusions and lumen irregularities on cardiac imaging. The primary hypothesis of the TA trial is that patients undergoing primary isolated non-emergent bypass surgery with exclusive use of arterial conduits will be associated with an increased rate of perfect patency. The secondary hypothesis is that in these patients, the use of TAR compared to non-TAR is associated with similar survival and freedom from major adverse cardiac events at 24 months. This trial will address a major gap in cardiac surgery research and drive a substantial or transformative shift in international health practice.
Interventions
The intervention group receive total (exclusively) arterial revascularization (use of arterial grafts [conduits] with the exclusion of any saphenous vein graft). The specific graft reconstruction methods, selection of which arterial conduits selected or specific coronary artery targets are at the discretion of the surgeon and their personal and institutional practice.
The approximate duration of the surgery is typically 2-6 hours, but is heavily dependent upon number of grafts. The procedure wil
The intervention group receive total (exclusively) arterial revascularization (use of arterial grafts [conduits] with the exclusion of any saphenous vein graft). The specific graft reconstruction methods, selection of which arterial conduits selected or specific coronary artery targets are at the discretion of the surgeon and their personal and institutional practice. The approximate duration of the surgery is typically 2-6 hours, but is heavily dependent upon number of grafts. The procedure will be performed by the cardiothoracic surgeon.
Sponsors
Melbourne Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participating institutions within Australia. Primary isolated adult CABG patients with multivessel coronary disease requiring at least two grafts.
Exclusion criteria
Previous cardiac surgery involving sternotomy Emergency operation Preoperative myocardial infarction within 48 hours Planned hybrid revascularisation Preoperative severe end-organ dysfunction (Troponin I > 20,000 within five days of surgery Ejection fraction less than or equal to 20% Current inotrope or vasoconstrictor requirement Respiratory pressure support or intubation Acute renal failure or renal replacement therapy <4 weeks Cerebrovascular event of any kind <6 weeks before surgery Cancer or any comorbidity that reduces life expectancy to less than five years Planned concomitant procedure (including coronary endarterectomy and excepting for left atrial appendage occlusion or epicardial pacemaker lead placement) Inability to participate in postoperative follow-up or CTCA including allergy to radiology contrast medium will be excluded
Outcome results
None listed