Plain English Summary
Current plain English summary as of 26/10/2021:
Background and study aims
A coronary artery bypass graft (CABG) is a surgical procedure that diverts blood around narrowed or clogged arteries of the heart to improve blood flow and oxygen supply to the heart. CABG surgery provides excellent short- and intermediate-term success in treating coronary heart disease but its long-term success may be limited by failure of the veins that have been used to bypass the blood vessels of the heart. Ten years after CABG, around ½ of vein grafts have become blocked or diseased although current drug therapy such as aspirin and statins (which lower cholesterol) may reduce this failure. Blocked or diseased vein grafts means that the patient may develop recurrent angina (chest pain) and may require further treatment including the possibility of another operation. The artery grafts last better than the vein grafts. There is some circumstantial (but no definite) evidence that if both of the mammary arteries are used in the CABG operation instead of just one it may improve the longer-term outcome. The aim of this study is to determine if the use of both mammary arteries improves survival, and reduces the chance of recurrent angina and/or the need for further intervention (including surgery) compared to using one mammary artery. Patients will be followed up for 15 years after surgery.
Who can participate?
CABG patients with coronary heart disease.
What does the study involve?
Patients are randomly allocated to receive either a single internal mammary artery (SIMA) graft or a bilateral internal mammary artery (BIMA) graft during their CABG surgery. Patients are then followed up every year for up to 10 years after their surgery to collect data on their health status and quality of life, and then again at 15 years after surgery to determine their health status.
What are the possible benefits and risks of participating?
The possible disadvantages and risks of taking part are common to all patients undergoing CABG surgery. The possible disadvantages of BIMA grafting is that there may be a slightly increased risk of poor wound healing. The risk of poor wound healing with the standard SIMA operation is 1%-2% and this may increase by a further 1% in the BIMA group. However, this is usually only a problem in those with diabetes, or who are already very overweight or have severe breathing problems. A further consideration is that BIMA grafting has a slightly longer operation time (approximately 30 minutes in a three hour procedure) than SIMA grafting. Patients taking part in the study will be asked to complete quality of life questionnaires which may be regarded by some as an inconvenience. Both the SIMA grafting and the BIMA grafting should help treat the patient’s coronary heart disease. The possible advantages of BIMA grafting are that there may be a reduced risk of angina, heart attack and a requirement for further intervention, including the possibility of a second CABG operation in the long term. It is not possible to say definitively which type of grafting is better but the information from this study should help to decide the best treatment in the future for patients with coronary heart disease.
Where is the study run from?
Department of Cardiothoracic Surgery, The John Radcliffe (UK)
When is the study starting and how long is it expected to run for?
July 2004 to December 2023
Who is funding the study?
1. British Heart Foundation (UK) up to the 15-year follow up
2. Medical Research Council (UK) up to the 10-year follow up
Who is the main contact?
Prof. David Taggart
David.Taggart@ouh.nhs.uk
Background and study aims
A coronary artery bypass graft (CABG) is a surgical procedure that diverts blood around narrowed or clogged arteries of the heart to improve blood flow and oxygen supply to the heart. CABG surgery provides excellent short and intermediate term success in treating coronary heart disease but its long-term success may be limited by failure of the veins that have been used to bypass the blood vessels of the heart. Ten years after CABG, around ½ of vein grafts have become blocked or diseased although current drug therapy such as aspirin and statins (which lower cholesterol) may reduce this failure. Blocked or diseased vein grafts means that the patient may develop recurrent angina (chest pain) and may require further treatment including the possibility of another operation. The artery grafts last better than the vein grafts. There is some circumstantial (but no definite) evidence that if both of the mammary arteries are used in the CABG operation instead of just one it may improve the longer-term outcome. The aim of this study is to determine if the use of both mammary arteries improves survival, and reduces the chance of recurrent angina and/or the need for further intervention (including surgery) compared to using one mammary artery. Patients will be followed up for 10 years after surgery.
Who can participate?
CABG patients with coronary heart disease.
What does the study involve?
Patients are randomly allocated to receive either a single internal mammary artery (SIMA) graft or a bilateral internal mammary artery (BIMA) graft during their CABG surgery. Patients are then followed up every year for up to 10 years after their surgery. Data is collected on their health status and quality of life.
What are the possible benefits and risks of participating?
The possible disadvantages and risks of taking part are common to all patients undergoing CABG surgery.The possible disadvantages of BIMA grafting is that there may be a slightly increased risk of poor wound healing. The risk of poor wound healing with the standard SIMA operation is 1%-2% and this may increase by a further 1% in the BIMA group. However, this is usually only a problem in those with diabetes, or who are already very overweight or have severe breathing problems. A further consideration is that BIMA grafting has a slightly longer operation time (approximately 30 minutes in a three hour procedure) than SIMA grafting. Patients taking part in the study will be asked to complete quality of life questionnaires which may be regarded by some as an inconvenience. Both the SIMA grafting and the BIMA grafting should help treat the patient’s coronary heart disease. The possible advantages of BIMA grafting are that there may be a reduced risk of angina, heart attack and a requirement for further intervention, including the possibility of a second CABG operation in the long term. It is not possible to say definitively which type of grafting is better but the information from this study should help to decide the best treatment in the future for patients with coronary heart disease.
Where is the study run from?
Department of Cardiothoracic Surgery, The John Radcliffe (UK)
When is the study starting and how long is it expected to run for?
July 2004 to June 2014
Who is funding the study?
1. British Heart Foundation (UK)
2. Medical Research Council (UK)
Who is the main contact?
Prof. David Taggart
David.Taggart@ouh.nhs.uk
Study website
Contact information
Type
Scientific
Contact name
Prof David Taggart
ORCID ID
Contact details
Nuffield Department of Surgical Sciences
University of Oxford
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 221121
David.Taggart@ouh.nhs.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
G0200390
Study information
Scientific title
Arterial Revascularisation Trial - a randomised trial to compare survival following bilateral versus single internal mammary artery (IMA) grafting in coronary revascularisation
Acronym
ART
Study hypothesis
The main objective is to assess whether the use of both IMA during coronary artery bypass graft (CABG) surgery improves survival and reduces the need for further interventions over that observed with a single IMA.
Ethics approval(s)
Current ethics approval as of 26/10/2021:
Approved 09/04/2004, amendment for 15 year follow-up approved 13/12/19, HRA North East-York (NHSBT, Newcastle Blood Donor Centre, Holland Drive, HRA Jarrow, NE2 4NQ; +44 (0)207 104 8079; nrescommittee.northeast-york@nhs.net), ref: 04/3/006
Previous ethics approval:
HRA North East-York, 09/04/2004, ref: 04/3/006
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cardiovascular
Intervention
Current interventions as of 26/10/2021:
Patients were randomised to single internal mammary artery (SIMA) grafting or bilateral internal mammary artery (BIMA) grafting with supplemental vein or radial artery grafts as required. Patients will be followed-up for up to 15 years.
Previous interventions:
Patients will be randomised to single internal mammary artery (SIMA) grafting or bilateral internal mammary artery (BIMA) grafting with supplemental vein or radial artery grafts as required.
Intervention type
Procedure/Surgery
Primary outcome measure
Current primary outcome measure as of 26/10/2021:
Survival will be measured using patient telephone follow-up or by national databases where applicable at 10 and 15 years.
Previous primary outcome measure:
Survival
Secondary outcome measures
Current secondary outcome measures as of 26/10/2021:
1. Cause-specific mortality measured using patient telephone follow-up or by national databases where applicable at 10 and 15 years
2. Major Adverse Cardiovascular Events measured using patient telephone follow-up or by national databases where applicable at 15 years
3. 30 day mortality measured using patient telephone follow-up or by national databases where applicable at 30 days
4. Need for re-intervention by percutaneous coronary intervention or redo surgery other clinical events measured using patient telephone follow-up or by national databases where applicable at 10 years
5. Quality of life measured using the Short Form-36 (SF36), Rose, and EuroQol questionnaires at 10 years
6. Cost-effectiveness measured using patient telephone follow-up or by national databases where applicable at 10 years
Previous secondary outcome measures:
1. Cause-specific mortality
2. 30 day mortality
3. Need for re-intervention by percutaneous coronary intervention or redo surgery
other clinical events
4. Quality of life (SF36, Rose and EuroQol)
5. Cost-effectiveness
Overall study start date
01/07/2004
Overall study end date
31/12/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Coronary artery bypass graft (CABG) patients with multi-vessel coronary artery disease (including urgent and off pump CABG patients)
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
3000
Total final enrolment
3102
Participant exclusion criteria
1. Single graft
2. Redo CABG
3. Evolving myocardial infarction
4. Concomitant valve surgery
Recruitment start date
01/07/2004
Recruitment end date
20/12/2007
Locations
Countries of recruitment
Australia, Austria, Brazil, England, India, Italy, Poland, United Kingdom
Study participating centre
Department of Cardiothoracic Surgery, The John Radcliffe
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
+44 (0)1865 270000
B.Lees@rbh.nthames.nhs.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
British Heart Foundation (SP/03/001)
Alternative name(s)
the_bhf, The British Heart Foundation, BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Funder name
Medical Research Council (G0200390)
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The 10 year outcomes of ART have been published and the 15 year outcomes will be published in a high-impact peer-reviewed journal.
Intention to publish date
31/12/2024
Individual participant data (IPD) Intention to share
Yes
IPD sharing plan
Anonymised datasets available by request to the Chief Investigator, Professor David Taggart (David.Taggart@ouh.nhs.uk) on behalf of the ART Trial Management Group once the study has been completed and published.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/03/2006 | Yes | No | |
| Results article | results | 01/10/2010 | Yes | No | |
| Other publications | assessment of data quality | 26/09/2011 | Yes | No | |
| Results article | results | 01/06/2015 | Yes | No | |
| Results article | results | 01/07/2016 | Yes | No | |
| Results article | results | 29/12/2016 | Yes | No | |
| Results article | results | 01/08/2017 | Yes | No | |
| Results article | results | 01/11/2017 | Yes | No | |
| Results article | results | 03/03/2018 | Yes | No | |
| Results article | results | 31/01/2019 | Yes | No | |
| Results article | results | 01/08/2019 | 11/06/2020 | Yes | No |