Randomized comparison of single versus double mammary coronary artery bypass grafting: 5 year outcomes of the Arterial Revascularization Trial David Taggart Professor of Cardiac Surgery University of Oxford, UK On behalf of Arterial Revascularization Trial investigators Embargoed until 10:45 a.m. CT, Monday, Nov. 14, 2016
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Randomized comparison of single versus double mammary coronary artery bypass grafting:
5 year outcomes of the Arterial Revascularization Trial
David TaggartProfessor of Cardiac Surgery
University of Oxford, UKOn behalf of Arterial Revascularization Trial
investigators
Embargoed until 10:45 a.m. CT, Monday, Nov. 14, 2016
Bruno Paolino
Funding and declarations
• No conflicts of interest declared by presenter• Funded by UK Medical Research Council, British Heart Foundation,
UK National Institute of Health Research Efficacy and Mechanistic Evaluation
• Sponsored by University of Oxford, UK• Design, conduct and analysis conducted independently of funding
Stephen Gerry, Umberto Benedetto, Marcus Flather) take full responsibility for conduct and results from the trial
• Presented on behalf of all investigators and patients participating in ART
Background• Coronary artery bypass grafting (CABG) is effective for
management of symptomatic multi-vessel coronary artery disease
• Left internal mammary artery has excellent long term patency rates and is established as standard of care for CABG
• Evidence that vein grafts fail over time especially >5 years• Long term excellent patency of the right internal mammary• Observational studies have estimated up to 20% reduction in
mortality with bilateral versus single mammary artery grafts
Design and outcome measures
Randomized multi-center comparison of left internal mammary artery (plus vein grafts) versus bilateral internal mammary artery grafting on• All-cause mortality at five years (interim outcome: this
analysis)• Sternal wound complications • All-cause mortality at ten years (primary outcome)• Mortality, myocardial infarction or stroke at five and ten
years (secondary outcomes)
Sample size
• Estimated that bilateral internal mammary artery grafting would result in an absolute 5% reduction in 10-year mortality (i.e. from 25% to 20%) compared with single internal mammary artery grafting.
• To detect this expected reduction with 90% power at the 5% significance level requires 2928 patients.
• Aim was to enrol at least 3000 patients (1500 in each arm) over a 2- to 3-year recruitment period.
Eligibility
INCLUSION• Patients with symptomatic multi-vessel coronary artery
disease scheduled for coronary artery bypass grafting (including urgent cases and planned “off pump” surgery)
EXCLUSIONS• Single graft planned• Redo CABG• Evolving myocardial infarction• Concomitant valve surgery
Results
• Enrolment from June 2004 to December 2007 • 28 cardiac surgery centres• 7 countries (UK, Poland, Australia, Brazil, India, Italy, Austria)• 3102 patients in total• 1554 patients randomized to the single-graft group• 1548 to the bilateral-graft group• Use of aspirin (89%), statins (89%), ACE-inhibitor/ Angiotensin
receptor blockers (73%), beta blockers (75%) at 5 years
Patient flow
129 Died **62 lost to follow up by 5 years **
9 Withdrew **
Randomized patientsn= 3102
Allocated bilateral mammary n= 1548
Received surgery, n= 1531 (98.9%)Bilateral mammary n= 1294Single mammary n= 215Other n = 22
Did not receive surgery n= 16- 1 died prior to surgery*- 3 surgery cancelled- 3 withdrew from surgery- 1 had PCI- 8 withdrew from trial*
Treatment received unknown, n=1
133 Died **71 lost to follow up by 5 years **
5 Withdrew**
Known to be alive at 5 years, n= 1330**
Allocated single mammary n= 1554
Received surgery, n= 1546 (99.5%)Single mammary n= 1494Bilateral mammary n= 38Other n = 14
Did not receive surgery n= 8- 1 died prior to surgery*- 2 surgery cancelled- 1 had PCI- 4 withdrew from trial*