Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000864628
Ethics application status
Approved
Date submitted
10/07/2023
Date registered
11/08/2023
Date last updated
14/01/2024
Date data sharing statement initially provided
11/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Total Arterial Revascularisation in Coronary Artery Surgery on Angiographic and Clinical Outcomes: the TA trial
Scientific title
Impact of Total Arterial Revascularisation in Coronary Artery Surgery on Angiographic and Clinical Outcomes: the TA Trial
Secondary ID [1] 308947 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
TA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 328955 0
Heart Diseases 329441 0
Condition category
Condition code
Surgery 325944 325944 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325394 0
Treatment: Surgery
Comparator / control treatment
The control group receive non-total arterial coronary artery bypass grafting (the use of at least one saphenous vein graft conduit). No restriction will be applied to the number of saphenous vein grafts that can be used and applied to any coronary target. 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.
Control group
Active

Outcomes
Primary outcome [1] 333794 0
Number of perfect patent grafts in each arm at 24 months post-surgery, as defined by the presence of a conduit conducting dye which fills the distal coronary artery target (patent) and additionally, a smooth (not irregular) angiographic lumen indicative of a normal conduit (absence of any atherosclerosis)
This outcome will be assessed using Computer Tomography Coronary Angiography (CTCA).
Timepoint [1] 333794 0
24 months postoperatively
Secondary outcome [1] 418315 0
Number of patent grafts in each study arm over time
This outcome will be assessed using Computer Tomography Coronary Angiography (CTCA).
Timepoint [1] 418315 0
Sequential timepoints 3 months and 2 years postoperative
Secondary outcome [2] 418316 0
Percent of patent in each study arm.
This outcome will be assessed using Computer Tomography Coronary Angiography (CTCA).
Timepoint [2] 418316 0
Sequential timepoints 3 months and 2 years postoperatively
Secondary outcome [3] 418318 0
Major adverse cardiac and cerebrovascular events (MACCE), defined as a composite of all-cause death/ mortality (including time until death or end of follow-up), postoperative stroke, postoperative myocardial infarction, and repeat coronary revascularisation.
Relevant data will be obtained from patients' medical records. For participants who are discharged from the hospital, information will be gathered either during scheduled postoperative visits or via telephone interviews.
Timepoint [3] 418318 0
30 day, and every 6 months postoperative until end of 5 year project
Secondary outcome [4] 418319 0
Cardiac-related mortality
Relevant data will be obtained from patients' medical records.
Timepoint [4] 418319 0
30 day, and every 6 months postoperative until end of 5 year project
Secondary outcome [5] 418320 0
Quality of Recovery measured using the Postoperative Quality of Recovery Scale - a validated multidimensional scale assessing physiological, cognitive, activities of daily living, emotive, and nociceptive (including pain) domains, performed preoperatively,
Timepoint [5] 418320 0
Day 1, 3-5, 30 days, 3 months, 6, 12, 18 months, and 2 years post-operatively. It is validated for telephone use and for patients with mild cognitive impairment. These will align with the CTCA visits and performance of the EQ-5D-5L.
Secondary outcome [6] 418321 0
Independent living. It will be measured using the Functional Difficulties Questionnaire and Lawton and Brody Instrumental Activities of Daily Living Scale which accesses the skills necessary to live independently in the community.
Timepoint [6] 418321 0
Preoperatively and postoperative 6 months
Secondary outcome [7] 418322 0
6-month and DAH-30 (days at home up to 30 days) healthcare resource use (visits to healthcare professionals and hospitals).
Relevant data will be obtained from patients' medical records. For participants who are discharged from the hospital, information will be gathered either during scheduled postoperative visits or via telephone interviews.
Timepoint [7] 418322 0
30 day, and every 6 months postoperative until end of 5 year project
Secondary outcome [8] 418323 0
In-hospital infection, via checking participant's medical records during hospital admissions.
Timepoint [8] 418323 0
30 day, and every 6 months postoperative until end of 5 year project
At each timepoint, if the participant is under hospital care, the research team will check medical records to see if they have had any infections during hospital admissions.
Secondary outcome [9] 418326 0
In-hospital respiratory pathology diagnosed on chest X-Ray, CT scan or lung ultrasound, including pleural effusion, minor consolidation (atelectasis), consolidation, or pneumothorax.
Timepoint [9] 418326 0
30 day, and every 6 months postoperative until end of 5 year project
At each timepoint, if the participant is under hospital care, the research team will check medical records to see if they have had any respiratory pathology diagnosed on chest X-Ray, CT scan or lung ultrasound during hospital admissions.
Secondary outcome [10] 419860 0
Acute Kidney Injury (RIFLE stage 1-3)
Relevant data will be obtained from patients' medical records.
Timepoint [10] 419860 0
30 day, and every 6 months postoperative until end of 5 year project
Secondary outcome [11] 419861 0
Longitudinal measure of length of hospital stay
Relevant data will be obtained from patient's medical records.
Timepoint [11] 419861 0
30 day, and every 6 months postoperative until end of 5 year project
Secondary outcome [12] 424504 0
Longitudinal measures of return to the place of residence
Relevant data will be obtained from patient's medical records.
Timepoint [12] 424504 0
30 day and every 6 months postoperative until end of 5 year project
Secondary outcome [13] 424505 0
Percent of perfectly patent grafts in each study arm (assessment per graft)
This outcome will be assessed using Computer Tomography Coronary Angiography (CTCA).
Timepoint [13] 424505 0
Sequential time points 3 months and 2 years postoperative
Secondary outcome [14] 425306 0
Longitudinal measure of length of ICU stay
Relevant data will be obtained from patient's medical records.
Timepoint [14] 425306 0
30 day and every 6 months postoperative until end of 5 year project

Eligibility
Key inclusion criteria
Participating institutions within Australia. Primary isolated adult CABG patients with multivessel coronary disease requiring at least two grafts.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation codes will be via computer-generated randomisation sequences with variable block size, facilitating multi-site enrolment and ensuring close balance of the numbers in each group throughout the Trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessors for the primary outcome will be blinded to treatment allocation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome analysis: A 2 sample t-test will be used to compare the mean number of perfectly patent grafts between groups, based on the intention-to-treat principle. A non-parametric equivalent will be considered if the assumptions of the t-test are not satisfied.
Secondary outcome analysis: Continuous outcomes will be compared using 2 sample t-tests, with a Fisher’s exact test used to compare binary outcomes. Outcomes such as MACCE and mortality will be visualised using the Kaplan-Meier method as time-to-event data and compared using a Cox proportional hazard regression analysis. The estimated hazard ratios and associated 95% confidence interval will be reported. Non-parametric equivalents or transformations will be considered when assumptions of parametric methods are not satisfied.
Subgroup analysis: Subgroup analyses will assess the treatment-by-subgroup interaction for the following initial factors: diabetes, sex, age group and type of conduits.

Interim analysis: Interim analyses for efficacy and futility will be performed when 50% of the number of participants reaches their primary endpoint, using O’Brien-Fleming boundaries. The results of these analyses will not be binding but will be considered in the decision-making of the DSMB, along with other interim trial findings.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/09/2023
Actual
18/12/2023
Date of last participant enrolment
Anticipated
31/10/2026
Actual
Date of last data collection
Anticipated
30/09/2028
Actual
Sample size
Target
1000
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 23964 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 24333 0
Melbourne Private Hospital - Parkville
Recruitment hospital [3] 24334 0
The Alfred - Melbourne
Recruitment hospital [4] 24335 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [5] 24336 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [6] 24337 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [7] 24338 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [8] 24339 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [9] 24340 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [10] 24341 0
Liverpool Hospital - Liverpool
Recruitment hospital [11] 24342 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [12] 24343 0
Westmead Hospital - Westmead
Recruitment hospital [13] 24344 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [14] 24345 0
The Prince Charles Hospital - Chermside
Recruitment hospital [15] 24346 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [16] 24347 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 39912 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 39909 0
2050 - Camperdown
Recruitment postcode(s) [3] 39910 0
2065 - St Leonards
Recruitment postcode(s) [4] 39913 0
2145 - Westmead
Recruitment postcode(s) [5] 39911 0
2170 - Liverpool
Recruitment postcode(s) [6] 39904 0
3000 - Melbourne
Recruitment postcode(s) [7] 39452 0
3052 - Parkville
Recruitment postcode(s) [8] 39906 0
3065 - Fitzroy
Recruitment postcode(s) [9] 39907 0
3084 - Heidelberg
Recruitment postcode(s) [10] 39905 0
3168 - Clayton
Recruitment postcode(s) [11] 39908 0
3220 - Geelong
Recruitment postcode(s) [12] 39915 0
4032 - Chermside
Recruitment postcode(s) [13] 39914 0
4102 - Woolloongabba
Recruitment postcode(s) [14] 39916 0
5042 - Bedford Park
Recruitment postcode(s) [15] 39917 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 313159 0
Government body
Name [1] 313159 0
MRFF 2022 Cardiovascular Health Mission (NHMRC)
Country [1] 313159 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
300 Grattan St, Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 316126 0
None
Name [1] 316126 0
Address [1] 316126 0
Country [1] 316126 0
Other collaborator category [1] 282732 0
University
Name [1] 282732 0
University of Melbourne
Address [1] 282732 0
Grattan Street, Parkville, Victoria, 3010
Country [1] 282732 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312402 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 312402 0
Level 2
South West
300 Grattan Street
Parkville Victoria
3050
Ethics committee country [1] 312402 0
Australia
Date submitted for ethics approval [1] 312402 0
22/02/2023
Approval date [1] 312402 0
11/05/2023
Ethics approval number [1] 312402 0
MH HREC 2023.028

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124530 0
Prof Alistair Royse
Address 124530 0
Royal Melbourne Hospital, Centre for Medical Research building, Level 6 / 300 Grattan St, PO Box 2135 Royal Melbourne Hospital, Parkville, Victoria, Australia 3050
Country 124530 0
Australia
Phone 124530 0
+61 390354759
Fax 124530 0
+61 3 8679 4445
Email 124530 0
alistair.royse@unimelb.edu.au
Contact person for public queries
Name 124531 0
Dr Andrea Bowyer
Address 124531 0
Royal Melbourne Hospital, Centre for Medical Research building, Level 6 / 300 Grattan St, PO Box 2135 Royal Melbourne Hospital, Parkville, Victoria, Australia 3050
Country 124531 0
Australia
Phone 124531 0
+61 383445673
Fax 124531 0
+61 3 8679 4445
Email 124531 0
andrea.bowyer@unimelb.edu.au
Contact person for scientific queries
Name 124532 0
Prof Alistair Royse
Address 124532 0
Royal Melbourne Hospital, Centre for Medical Research building, Level 6 / 300 Grattan St, PO Box 2135 Royal Melbourne Hospital, Parkville, Victoria, Australia 3050
Country 124532 0
Australia
Phone 124532 0
+61 390354759
Fax 124532 0
+61 3 8679 4445
Email 124532 0
alistair.royse@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data incorporates the data routinely collected in surgical centres by the ANZSCTS database which is not a publically available data source.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19639Ethical approval    385368-(Uploaded-10-07-2023-10-43-47)-Study-related document.pdf
19643Study protocol  research@heartweb.com



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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