Randomized Trial to Compare Bilateral Versus Single Internal Mammary Coronary Artery Bypass Grafting (CABG): One Year Results of the Arterial Revascularisation Trial (ART) DP Taggart, DG Altman, AM Gray, B Lees, F Nugara, LM Yu, H Campbell, M Flather, on behalf of the ART Investigators John Radcliffe Hospital Oxford, University of Oxford, Royal Brompton & Harefield NHS Foundation Trust London and Imperial College London ESC Hot Line 2010, Stockholm On Line publication in EHJ
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Randomized Trial to Compare Bilateral Versus Single ... A randomised trial to compare...New Delhi Escorts Heart Institute Mehawal, (Trehan) Oxford John Radcliffe Taggart, Ratnatunga
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Randomized Trial to Compare Bilateral Versus Single Internal Mammary Coronary Artery Bypass Grafting (CABG):
One Year Results of the Arterial Revascularisation Trial (ART)
DP Taggart, DG Altman, AM Gray, B Lees, F Nugara, LM Yu, H Campbell, M Flather, on behalf of the ART Investigators
John Radcliffe Hospital Oxford, University of Oxford, Royal Brompton & Harefield NHS Foundation Trust London and Imperial College London
ESC Hot Line 2010, StockholmOn Line publication in EHJ
Backgroundo CABG remains best therapy for severe CAD (SYNTAX trial)
o CABG is limited by eventual failure of vein grafts (50-75% by 10 years)
o 10 years after CABG an IMA risk of:
• Death (x1.6), MI (x1.4), angina (x1.25), redo surgery (x2)
• Patency rate of IMA > 95% at 10 years (veins = 25% - 50%)
o Benefits persist into 2nd and 3rd decade of follow up
o 4693 BIMA vs 11269o Matched for age, gender, LV function, DMo HR for death with BIMA:0.80 [95% CI=0.70 -0.94]
o NNT of 13-16 (to prevent one death)
Effect of Arterial Revascularization on
Survival: a Systematic Review of Studies
comparing bilateral and single internal
mammary arteries.
David P Taggart, Roberto D’Amico,
Douglas G Altman
Lancet 2001; 358: 870-5
Use of BIMA in Routine Clinical Practice
oUncommon• <10% of CABG patients in Europe• <5% of CABG patients in USA
oPotential reasons for NOT using BIMA • Technically more challenging• Adds to duration of operation• Increases early mortality• Increases early major morbidity• Increases risk of sternal wound breakdown
IMA
RA
SVG
1 2
3 4
Trial Designo Protocol published (Trials 2006, 7:7)
o Funded: UK Medical Research Council (MRC) & British Heart Foundation (BHF)
o Sample size• 3000 patients• 5% in 10 year mortality (from 25% to 20%)• 90% power, 5% alpha required 2928 patients
o Two arm randomised trial• Randomised 1:1 SIMA to BIMA• Supplementary vein/artery grafts as required
o On or Off-pump procedure
o Multi-centre (n=28 hospitals in 7 countries worldwide)
ART Endpoints
o Primary• Survival at 10 years
o Secondary• Cause specific & 30 day mortality• Need for re-intervention• Clinical events • Quality of Life (SF-36, Rose and EuroQol)• Cost effectiveness
o Sub-groups• Diabetes• Age (<70 yrs vs >70 yrs)• On vs off pump• Radial artery vs vein grafts• Number of grafts• Impaired ventricular function
Notes1 Patient consent for data collection (SIMA=2; BIMA=7)2 Including participants who died before 1 year follow up (SIMA=36; BIMA=38)
Received surgery, n= 1531 (98.9%)BIMA, n= 1294SIMA ,n= 215Other, n = 22
Did not receive surgery, n= 161
- 1 died prior to surgery- 3 surgery cancelled- 3 withdrew from surgery- 1 had PTCA- 8 withdrew from trial
Treatment received unknown, n=11
At 6 weeks follow-up, n= 1517
At 1 year follow-up, n= 1491
• 19 Died• 2 Lost to follow-up
Analysed at 1 year follow-up2, n= 1529
Received surgery, n= 1546 (99.5%)SIMA, n= 1494BIMA ,n= 38Other, n = 14
Did not receive surgery, n= 81
- 1 died prior to surgery- 2 surgery cancelled- 1 had PTCA- 4 withdrew from trial
At 6 weeks follow-up, n= 1525
At 1 year follow-up, n= 1504
Analysed at 1 year follow-up2, n= 1540
• 13 Died• 5 Lost to follow-up• 3 Unable to contact
Allocated to BIMAn= 1548
Allocated to SIMAN= 1554
Randomized patientsn= 3102
• 18 Died• 4 Lost to follow-up• 3 Unable to contact• 1 Withdrew
• 22 Died• 1 Withdrew
ART Patient Characteristics
SIMA (n=1554) BIMA (n=1548)
Age: years mean (±SD) 63.5 (9.1) 63.7 (8.7)
Male 86% 85%
Diabetes 23.4% 24%
Urgent CABG 7.9% 7.6%
Prior myocardial infarction 43.8% 40%
Prior stenting 16% 15.6%
Prior CVA 3.1% 2.7%
Peripheral arterial disease 7.6% 6.6%
ART Surgery
SIMA(n=1552)
BIMA (n=1542)
Δ
Off-Pump 40% 41.8%
Grafts
1 0.7% 0.5%
2 17.7% 17.8%
3 48.5% 50.4%
4+ 33.2% 31.3%
Surgery length: mins mean (SD) 199 (58) 222 (61) 23 mins
Ventilation length: mins mean (SD) 863 (3293) 968 (3029) 105 mins
Duration ITU stay: hours mean (SD) 38 (106) 41 (94) 3 hours
Duration of post-op stay: days mean (SD) 7.5 (7.6) 8.0 (7.4) 0.5 days
Re-exploration for any cause 3.5% 4.3%
Blood transfusion 12% 12%
Intra Aortic Balloon Pump 3.7% 4.4%
Renal support 4.4% 5.9%
ART Outcomes
SIMA (n=1552)
BIMA (n=1542)
Δ
30 days
All Mortality 1.2% 1.2%
CVA 1.2% 1.0%
MI 1.5% 1.4%
Revasc 0.4% 0.7%
Wound reconstruction 0.6% 1.9% 1.3%
1 year
All Mortality 2.3% 2.5%
CVA 1.8% 1.5%
MI 2.0% 2.0%
Revasc 1.3% 1.8%
ART Summary and Conclusionso ART is largest RCT in cardiac surgery comparing two operations
• Confirms feasibility of international multi-centre RCT
o Shows that routine use of BIMA is feasible in CABG patients
o Testament to safety of contemporary CABG with 1 or 2 IMA• 30 day mortality 1.2%; 1 year mortality 2.5%
o Use of BIMA does not increase • 30 day or 1 year mortality• duration of post op stay• risk of stroke, MI, revascularization
o Use of BIMA results in a slight increase in the risk of sternal wound reconstruction by 1.3%
o ART is funded for 10 years to determine if BIMA reduce mortality and need for repeat revascularization (expected completion 2015)
o ART will also report on costs, cost-effectiveness & QoL measures
ART Participating Centres (n=28)City Hospital SurgeonsBrighton Royal Sussex County Forsyth, Trivedi, Hyde, Cohen, Lewis