Arterial Revascularisation Trial - a randomised trial to compare survival following bilateral versus single internal mammary artery (IMA) grafting in coronary revascularisation
| ISRCTN | ISRCTN46552265 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46552265 |
| Secondary identifying numbers | G0200390 |
- Submission date
- 19/10/2004
- Registration date
- 17/01/2005
- Last edited
- 11/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Nuffield Department of Surgical Sciences
University of Oxford
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 221121 |
|---|---|
| David.Taggart@ouh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Arterial Revascularisation Trial - a randomised trial to compare survival following bilateral versus single internal mammary artery (IMA) grafting in coronary revascularisation |
| Study acronym | ART |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 3000 |
| Total final enrolment | 3102 |
| Key inclusion criteria | Coronary artery bypass graft (CABG) patients with multi-vessel coronary artery disease (including urgent and off pump CABG patients) |
| Key exclusion criteria | 1. Single graft 2. Redo CABG 3. Evolving myocardial infarction 4. Concomitant valve surgery |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 20/12/2007 |
Locations
Countries of recruitment
- Australia
- Austria
- Brazil
- England
- India
- Italy
- Poland
- United Kingdom
Study participating centre
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865 270000 |
|---|---|
| B.Lees@rbh.nthames.nhs.uk | |
| Website | http://www.ox.ac.uk |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| 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. |
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 |
Editorial Notes
11/07/2023: The following changes were made to the study record:
1. Contact details updated.
2. The overall study end date was changed from 30/06/2023 to 31/12/2023.
3. The intention to publish date was changed from 30/06/2023 to 31/12/2024.
4. IPD sharing statement added.
26/10/2021: The following changes have been made:
1. The ethics approval has been updated.
2. The overall trial end date has been changed from 30/06/2017 to 30/06/2023.
3. The intervention has been updated.
4. The primary outcome measure has been updated.
5. The secondary outcome measures have been updated.
6. The plain English summary has been updated.
7. The intention to publish date has been added.
8. The publication and dissemination plan has been added.
9. The individual participant data (IPD) sharing statement has been added and the IPD sharing summary has been changed from "Not provided at time of registration" to "Data sharing statement to be made available at a later date".
11/06/2020: Publication reference and total final enrolment number added.
11/02/2019: Publication reference added.
07/03/2018: Publication reference added.
05/06/2017: Publication reference added.
02/05/2017: Publication reference added.
20/12/2016: The overall trial end date has been updated from 30/06/2014 to 30/06/2017 and a publication reference has been added.
29/09/2016: Added plain English summary. Added date of ethics approval.
15/08/2016: Publication reference added. Changed recruitment end date from 30/06/2014 to 20/12/2007. Updated trial website URL.
