ANZCTR - Registration

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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]

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

Heart Diseases

Condition category

Condition code

Surgery

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]

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]

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]

24 months postoperatively

Secondary outcome [1]

Number of patent grafts in each study arm over time
This outcome will be assessed using Computer Tomography Coronary Angiography (CTCA).

Timepoint [1]

Sequential timepoints 3 months and 2 years postoperative

Secondary outcome [2]

Percent of patent in each study arm.
This outcome will be assessed using Computer Tomography Coronary Angiography (CTCA).

Timepoint [2]

Sequential timepoints 3 months and 2 years postoperatively

Secondary outcome [3]

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]

30 day, and every 6 months postoperative until end of 5 year project

Secondary outcome [4]

Cardiac-related mortality
Relevant data will be obtained from patients' medical records.

Timepoint [4]

30 day, and every 6 months postoperative until end of 5 year project

Secondary outcome [5]

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]

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]

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]

Preoperatively and postoperative 6 months

Secondary outcome [7]

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]

30 day, and every 6 months postoperative until end of 5 year project

Secondary outcome [8]

In-hospital infection, via checking participant's medical records during hospital admissions.

Timepoint [8]

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]

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]

Secondary outcome [10]

Acute Kidney Injury (RIFLE stage 1-3)
Relevant data will be obtained from patients' medical records.

Timepoint [10]

30 day, and every 6 months postoperative until end of 5 year project

Secondary outcome [11]

Longitudinal measure of length of hospital stay
Relevant data will be obtained from patient's medical records.

Timepoint [11]

30 day, and every 6 months postoperative until end of 5 year project

Secondary outcome [12]

Longitudinal measures of return to the place of residence
Relevant data will be obtained from patient's medical records.

Timepoint [12]

30 day and every 6 months postoperative until end of 5 year project

Secondary outcome [13]

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]

Sequential time points 3 months and 2 years postoperative

Secondary outcome [14]

Longitudinal measure of length of ICU stay
Relevant data will be obtained from patient's medical records.

Timepoint [14]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,TAS,VIC

Recruitment hospital [1]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [2]

Melbourne Private Hospital - Parkville

Recruitment hospital [3]

The Alfred - Melbourne

Recruitment hospital [4]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [5]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [6]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [7]

Barwon Health - Geelong Hospital campus - Geelong

Recruitment hospital [8]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [9]

Royal North Shore Hospital - St Leonards

Recruitment hospital [10]

Liverpool Hospital - Liverpool

Recruitment hospital [11]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [12]

Westmead Hospital - Westmead

Recruitment hospital [13]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [14]

The Prince Charles Hospital - Chermside

Recruitment hospital [15]

Flinders Medical Centre - Bedford Park

Recruitment hospital [16]

Royal Hobart Hospital - Hobart

Recruitment postcode(s) [1]

3052 - Parkville

Recruitment postcode(s) [2]

3000 - Melbourne

Recruitment postcode(s) [3]

3168 - Clayton

Recruitment postcode(s) [4]

3065 - Fitzroy

Recruitment postcode(s) [5]

3084 - Heidelberg

Recruitment postcode(s) [6]

3220 - Geelong

Recruitment postcode(s) [7]

2050 - Camperdown

Recruitment postcode(s) [8]

2065 - St Leonards

Recruitment postcode(s) [9]

2170 - Liverpool

Recruitment postcode(s) [10]

2010 - Darlinghurst

Recruitment postcode(s) [11]

2145 - Westmead

Recruitment postcode(s) [12]

4102 - Woolloongabba

Recruitment postcode(s) [13]

4032 - Chermside

Recruitment postcode(s) [14]

5042 - Bedford Park

Recruitment postcode(s) [15]

7000 - Hobart

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

MRFF 2022 Cardiovascular Health Mission (NHMRC)

Address [1]

16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Hospital

Name

Melbourne Health

Address

300 Grattan St, Parkville VIC 3050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

University of Melbourne

Address [1]

Grattan Street, Parkville, Victoria, 3010

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Human Research Ethics Committee

Ethics committee address [1]

Level 2
South West
300 Grattan Street
Parkville Victoria
3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/02/2023

Approval date [1]

11/05/2023

Ethics approval number [1]

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

Prof Alistair Royse

Address

Royal Melbourne Hospital, Centre for Medical Research building, Level 6 / 300 Grattan St, PO Box 2135 Royal Melbourne Hospital, Parkville, Victoria, Australia 3050

Country

Australia

Phone

+61 390354759

Fax

+61 3 8679 4445

[email protected]

Contact person for public queries

Name

Andrea Bowyer

Address

Royal Melbourne Hospital, Centre for Medical Research building, Level 6 / 300 Grattan St, PO Box 2135 Royal Melbourne Hospital, Parkville, Victoria, Australia 3050

Country

Australia

Phone

+61 383445673

Fax

+61 3 8679 4445

[email protected]

Contact person for scientific queries

Name

Alistair Royse

Address

Royal Melbourne Hospital, Centre for Medical Research building, Level 6 / 300 Grattan St, PO Box 2135 Royal Melbourne Hospital, Parkville, Victoria, Australia 3050

Country

Australia

Phone

+61 390354759

Fax

+61 3 8679 4445

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
19639	Ethical approval					385368-(Uploaded-10-07-2023-10-43-47)-Study-related document.pdf
19643	Study protocol			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically