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01.12.2006 | Study protocol | Ausgabe 1/2006 Open Access

Trials 1/2006

Protocol for the Arterial Revascularisation Trial (ART). A randomised trial to compare survival following bilateral versus single internal mammary grafting in coronary revascularisation [ISRCTN46552265]

Zeitschrift:
Trials > Ausgabe 1/2006
Autoren:
David P Taggart, Belinda Lees, Alastair Gray, Douglas G Altman, Marcus Flather, Keith Channon, the ART Investigators
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1745-6215-7-7) contains supplementary material, which is available to authorized users.

Competing interests

The author(s) declare that they have no competing interests.

Authors' contributions

DPT: conceived of the study and participated in the design and co-ordination and helped to draft the manuscript
BL: participated in the design and co-ordination and helped to draft the manuscript
AG: participated in the design and the health economic analysis and helped to draft the manuscript
DA: participated in the design and statistical analysis helped to draft the manuscript
MF: participated in the design and helped to draft the manuscript
KC: participated in the design and helped to draft the manuscript
All authors read and approved the final manuscript.

Abstract

Background

Standard coronary artery bypass graft surgery uses a single internal mammary artery and supplemental vein or radial artery grafts. Several observational studies have suggested a survival benefit with two internal mammary artery grafts compared to a single internal mammary artery graft, but this has not been tested in a randomised trial. The Arterial Revascularisation Trial is a Medical Research Council and British Heart Foundation funded, multi-centre international trial comparing single internal mammary artery grafting versus bilateral internal mammary artery grafting.

Methods/Design

Twenty centres in the UK, Australia, Poland and Brazil are planning to randomise 3000 coronary artery bypass graft surgery patients to single or bilateral internal mammary artery grafting. Supplemental grafts may be either saphenous vein or radial artery. Coronary artery bypass grafting can be performed as an on-pump or off-pump procedure. The primary outcome is survival at 10 years and secondary end-points include clinical events, quality of life and cost effectiveness. The effect of age, left ventricular function, diabetes, number of grafts, vein grafts and off-pump surgery are pre-specified subgroups.

Discussion

The Arterial Revascularisation Trial is one of the first randomised trials to evaluate the effects on survival and other clinical outcomes of single internal mammary artery grafting versus bilateral internal mammary artery grafting, and will help to establish the best approach for patients requiring coronary artery bypass graft surgery.
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