Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
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
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
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cardiovascular
Intervention
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
Phase
Drug names
Primary outcome measure
Survival
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 trial start date
01/07/2004
Overall trial end date
30/06/2017
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
Patient
Age group
Adult
Gender
Both
Target number of participants
3000
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, India, Italy, Poland, United Kingdom
Trial 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
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
British Heart Foundation (SP/03/001)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Funder name
Medical Research Council (G0200390)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/16573820
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20805116
2011 assessment of data quality in: http://www.ncbi.nlm.nih.gov/pubmed/21943128
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25217501
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27112712
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27959712
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28450552
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28566338
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29502105
Publication citations
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Protocol
Taggart DP, Lees B, Gray A, Altman DG, Flather M, Channon K, , Protocol for the Arterial Revascularisation Trial (ART). A randomised trial to compare survival following bilateral versus single internal mammary grafting in coronary revascularisation [ISRCTN46552265]., Trials, 2006, 7, 7, doi: 10.1186/1745-6215-7-7.
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Results
Taggart DP, Altman DG, Gray AM, Lees B, Nugara F, Yu LM, Campbell H, Flather M, , Randomized trial to compare bilateral vs. single internal mammary coronary artery bypass grafting: 1-year results of the Arterial Revascularisation Trial (ART)., Eur. Heart J., 2010, 31, 20, 2470-2481, doi: 10.1093/eurheartj/ehq318.
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Assessment of data quality
Krzych LJ, Lees B, Nugara F, Banya W, Bochenek A, Cook J, Taggart D, Flather MD, Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery., Trials, 2011, 12, 212, doi: 10.1186/1745-6215-12-212.
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Results
Taggart DP, Altman DG, Gray AM, Lees B, Nugara F, Yu LM, Flather M, , Effects of on-pump and off-pump surgery in the Arterial Revascularization Trial., Eur J Cardiothorac Surg, 2014, doi: 10.1093/ejcts/ezu349.