Arterial Revascularization Trial (ART)

Lead Research Organisation: University of Oxford
Department Name: Surgical Sciences

Abstract

Around 25,000 coronary artery bypass grafting (CABG) operations are performed annually in the UK. Most patients need three bypass grafts and the standard CABG uses a single internal mammary artery (single IMA) from either side of the breastbone and supplemental vein grafts from the leg or a radial artery from the arm as necessary. This gives good results in the short-term but over ten years failure of vein grafts is higher than failure of the arteries. This can lead to reduced survival, recurrent angina and the need for further treatment including the possibility of a second operation. There is some evidence that using both arteries on either side of the breastbone (bilateral IMA grafts) may improve survival and reduce the need for redo surgery. However this operation takes longer to do and slightly increases the chance that the breastbone will not heal. To try and determine which is the better operation we propose to randomize (ie as if by the toss of a coin) patients to single or bilateral IMA grafts, along with other vein or artery as necessary. We will then follow up patients annually for at least 10 years after their operation.

Technical Summary

Coronary artery bypass grafting (CABG) is the most commonly performed major operation in the industrialised world and the National Service Framework recommends an increase in the UK from around 500 to 750 operations per million of population per annum(ie from around 30,000 to 45,0000). Most patients need three bypass grafts and the standard CABG uses a single internal mammary artery (SIMA) and supplemental vein grafts (or radial artery). Over the long-term vein graft failure leads to reduced survival, recurrent angina and the need for redo surgery. Evidence from observational studies suggest that bilateral IMA (BIMA) grafts improve survival and reduce the need for redo surgery, over that observed with a SIMA graft. However, few patients receive BIMA grafts because of no proven definitive benefit (there have been no randomized trials) and the perception of increased perioperative risk. To determine the role of BIMA grafts we propose a UK, multi-centre, open trial of BIMA versus SIMA on survival, need for further intervention and quality of life over a 10 year period in 4000 patients. Additionally, a blood sample will be requested from all partcipants for analysis of genetic factors (by DNA extraction) and intermediate phenotypes (ie plasma analytes) that may be related to short and long-term clinical outcomes after CABG.

Publications

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Benedetto U (2018) Off-pump versus on-pump coronary artery bypass grafting: Insights from the Arterial Revascularization Trial. in The Journal of thoracic and cardiovascular surgery

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Benedetto U (2017) Impact of dual antiplatelet therapy after coronary artery bypass surgery on 1-year outcomes in the Arterial Revascularization Trial. in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery

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Cook J (2014) The patient, GP and primary care team: Relationships on trial in British Journal of Cardiac Nursing

 
Guideline Title 32nd EACTS Annual Meeting clinical trials update: ART, IMPAG, MITRA-FR and COAPT. Eur J Cardiothorac Surg 2018; doi:10.1093/ejcts/ezy396.
Description 32nd EACTS Annual Meeting clinical trials update
Geographic Reach Europe 
Policy Influence Type Citation in clinical guidelines
Impact Quoted from the article "ART was a very well designed and conducted trial. The planned 10-year follow-up is at stark contrast with that available for other important questions such as the choice of intervention for left main disease where trials are too short to describe the entire experience of patients required to make informed decisions on treatment options. The primary outcome is an objective measure (all-cause mortality) which is important in open studies, and vital status was available for more than 98% of patients randomized at 10 years, an amazing achievement which demonstrates what is possible. The long wait for the final results is mitigated by the release of the 5-year outcomes, an interim analysis, but one released after the intervention has been delivered and when there can be no anticipated bias from knowledge of patient outcome.ART was funded by the British Heart Foundation and others; ART Current Controlled Trials number, ISRCTN46552265. The results of the ART trial do not suggest that a change in the recommendation (class IIa, level B) in the recently publishedEACTS/European Society of Cardiology (ESC) myocardial revascularization guidelines [5] is necessary"
 
Description BHF Project Grant (Angiographic and FMD studies)
Amount £180,000 (GBP)
Organisation British Heart Foundation (BHF) 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2006 
End 01/2012
 
Description NIHR EME
Amount £349,277 (GBP)
Funding ID (09/800/29) 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 01/2016 
End 06/2017
 
Description Randomised trial of bilateral versus single internal thoracic artery graft surgery follow up to 15 years: the Arterial Revascularisation Trial (ART)
Amount £148,513 (GBP)
Funding ID CS/F/21/190041 
Organisation British Heart Foundation (BHF) 
Sector Charity/Non Profit
Country United Kingdom
Start 05/2022 
End 06/2023
 
Description Medical University of Silesia, Katowice, Poland 
Organisation Medical University of Silesia
Country Poland 
Sector Hospitals 
PI Contribution We have collaborated for over 10 years now with Dr Lukasz Krzych, MD, PhD at the Medical University of Silesia, Katowice, Poland. At the outset of the ART sub-study, we invited a junior member of the ART team in Poland, Dr Lukasz Krzych, to travel to the UK to spend a few months (from January to May 2008) attached to the Clinical Trials and Evaluation Unit at the Royal Brompton Hospital who were co-ordinating and managing the ART study. During this time, Dr Krzych undertook training in clinical trial methodology and developed a research plan for the ART sub-study to evaluate data quality between developing and developed countries. We provided support and guidance to Dr Krzych to perform this data quality study and in the preparation of a manuscript. The ART co-ordinating centre (now based at the University of Oxford) are providing ongoing support to Dr Krzych to enable him to continue his very valuable work in ensuring the quality of the Polish data for the ART study and that the data are as complete and accurate as possible.
Collaborator Contribution Dr Krzych travelled from Poland to collaborate with the ART co-ordinating centre at the Clinical Trials and Evaluation Unit at the Royal Brompton Hospital in London. Dr Krzych undertook training in clinical trial methodology and developed a research plan for the ART sub-study to evaluate data quality between developing and developed countries. He collated and analysed the data and prepared a manuscript which was submitted and published in the journal Trials (2011, 12:212). Dr Krzych has also presented his work on the ART sub-study at scientific meetings in Poland and internationally. Subsequently, Dr Krzych has continued to collaborate with us to resolve queries, translate medical summaries and liaised with the cardiac surgeons and nurses at the 7 participating centres in Poland to ensure the Polish data for the ART study is as complete and accurate as possible.
Impact The collaboration resulted in a publication in the journal Trials (2011, 12:212) and in the successful completion of the study and subsequent publication in the New England Journal of Medicine (2019, 380(5):437-446).
Start Year 2007
 
Description Patient Newsletter December 2017 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Study participants or study members
Results and Impact Newsletter sent to patients updating them regarding the progress of the study and including a summary of the 5 year outcomes which was published in the New England Journal of Medicine (Taggart DP, Altman DG, Gray AM, Lees B, Gerry S, Benedetto U, Flather M; ART Investigators. Randomized Trial of Bilateral versus Single Internal-Thoracic-Artery Grafts. N Engl J Med. 2016 Dec 29;375(26):2540-9. doi:10.1056/NEJMoa1610021. Epub 2016 Nov 14. PubMed PMID: 27959712).
Year(s) Of Engagement Activity 2017
 
Description Patient newsletter - March 2019 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Study participants or study members
Results and Impact Newsletter is being sent to patients updating them regarding the progress of the study and including a summary of the 10 year outcomes which was published in the New England Journal of Medicine (Taggart DP, Benedetto U, Gerry S, Altman DG, Gray AM, Lees B, Gaudino M, Zamvar V, Bochenek A, Buxton B, Choong C, Clark S, Deja M, Desai J, Hasan R,
Jasinski M, O'Keefe P, Moraes F, Pepper J, Seevanayagam S, Sudarshan C, Trivedi U, Wos S, Puskas J, Flather M; Arterial Revascularization Trial Investigators. Bilateral versus Single Internal-Thoracic-Artery Grafts at 10 Years. N Engl J Med. 2019 Jan 31;380(5):437-446. doi: 10.1056/NEJMoa1808783. PubMed PMID:30699314).
Year(s) Of Engagement Activity 2019
 
Description Scientific meetings 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact formal scientific presentations

increasing professional awreness of the relevant issues
Year(s) Of Engagement Activity 2006,2007,2008,2009,2010,2011,2012,2013,2014,2015,2016