The Arterial Revascularisation Trial (ART) – a randomised controlled trial to compare survival following bilateral versus single internal mammary grafting in coronary revascularisation
Jill Mollison and Doug Altman with David Taggart, Alistair Gray and Keith Channon (Oxford), and Marcus Flather (London)
Coronary artery bypass grafting (CABG) is the optimal therapy for multi-vessel ischaemic heart disease. Most CABG patients require three grafts and the standard operation uses a single internal mammary artery (SIMA) and supplemental vein or artery grafts. CABG provides excellent short and intermediate term outcomes but its long-term efficacy is limited by vein graft failure. Ten years after CABG around half of vein grafts are blocked and of the remaining 50% half are severely diseased, whereas 95% of IMA conduits remain disease free. In addition to reducing long-term survival, vein graft failure significantly increases the risk of recurrent angina, late myocardial infarction and the need for further intervention. Evidence from observational studies has indicated that bilateral IMA (BIMA) may improve survival and reduce the need to redo CABG, however, uncertainty remains since there is no randomised evidence.
ART is a multi-centre two arm parallel group randomised controlled trial to assess whether the use of both IMA during CABG (BIMA) improves survival and reduces the need for further interventions over that observed with a single IMA. The primary outcome is all-cause mortality; secondary outcomes include cause-specific mortality, 30-day mortality, need for re-intervention, other clinical events (i.e. recurrent angina, unstable angina, myocardial infarction, wound dehiscence, major bleeding, cerebrovascular accident and other serious adverse events), quality of life and cost effectiveness. Patients will be followed up for 10 years with analysis planned at 5 years and 10 years. Target sample size is 3000; recruitment commenced in July 2004.
Website: http://www.cteu.org/projects/ART/
