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CABG Off- or On-Pump Revascularization Study - CORONARY
Contribution To Literature:
The CORONARY trial failed to show that off-pump CABG reduced adverse cardiovascular events compared with on-pump CABG.
Description:
The goal of the trial was to evaluate off-pump compared with on-pump technique among patients undergoing coronary artery bypass grafting (CABG).
Study Design
- Randomized
- Parallel
Patient Populations:
Patients undergoing CABG with one or more of the following risk factors:- ≥70 years of age
- Peripheral arterial disease
- Cerebrovascular disease or carotid stenosis >70%
- Renal insufficiency
Patients between 60 and 69 years of age were eligible to participate with one or more of the following risk factors:
- Diabetes
- Urgent revascularization
- Left ventricular ejection fraction ≤35%
- Smoking within the last year
Patients between 55 and 59 years of age were eligible to participate with two or more of the above risk factors.
Number of enrollees: 4,752
Duration of follow-up: 30 days, anticipated to 5 years
Mean patient age: 68 years
Percentage female: 20%
Exclusions:
- Planned valve surgery
- Contraindication to off-pump or on-pump CABG or a decision that one of the two techniques was not feasible for the patient
- Limited life expectancy
- Emergency or repeat CABG
- Previous enrollment in the CORONARY trial
Primary Endpoints:
- Death, MI, stroke, or renal failure requiring dialysis at 30 days
Secondary Endpoints:
- Death, MI, stroke, renal failure requiring dialysis, or repeat revascularization at 5 years
- Blood transfusion
- Recurrent angina
- Cardiovascular death
Drug/Procedures Used:
Patients with multivessel coronary artery disease undergoing CABG were randomized to have the procedure off-pump (n = 2,375) versus on-pump (n = 2,377).
Surgeons were required to have >2 years of experience and to have performed >100 of each type of surgical procedure.
Principal Findings:
Overall, 4,752 patients were randomized. The mean age was 68 years, 20% were women, 47% had diabetes, and 34% had prior myocardial infarction. The primary composite outcome occurred in 9.8% of the off-pump group versus 10.3% of the on-pump group (p = 0.59). There was no modification of treatment effect according to numerous tested subgroups.
Thirty days: Death: 2.5% versus 2.5%, myocardial infarction: 6.7% versus 7.2%, stroke: 1.0% versus 1.1%, and renal failure requiring dialysis: 1.2% versus 1.1%, respectively.
Blood transfusion: 51% versus 63% (p < 0.001), reoperation for perioperative bleeding: 1.4% versus 2.4% (p = 0.02), respiratory complications: 5.9% versus 7.5 (p = 0.03), repeat revascularization: 0.7% versus 0.2% (p = 0.01), respectively, for off-pump versus on-pump.
Bypass grafts per patient: 3.0 versus 3.2 (p < 0.001), incomplete revascularization: 11.8% versus 10.0% (p = 0.05), duration of surgery: 4.0 hours versus 4.2 hours (p < 0.001), and duration of ventilator support: 9.6 hours versus 11.2 hours (p < 0.001), respectively.
One year: Off-pump versus on-pump primary outcome: 12.1% versus 13.3%, p = 0.24; death (5.1% vs. 5.0%), myocardial infarction (MI) (6.8% vs. 7.5%), stroke (1.5% vs. 1.7%), and need for repeat revascularization (1.4% vs. 0.8%, p = 0.07).
Kidney function substudy (n = 2,932 patients):
- Acute kidney injury at 30 days: 17.5% with off-pump CABG vs. 20.8% with on-pump CABG (p = 0.01).
- Loss of kidney function at 1 year: 17.1% with off-pump CABG vs. 15.3% with on-pump CABG (p = 0.23).
Five years: Off-pump versus on-pump primary outcome: 23.1% versus 23.6%, p = 0.72; death (14.6% vs. 13.5%), MI (7.5% vs. 8.2%), stroke (2.3% vs. 2.8%), and need for repeat revascularization (2.8% vs. 2.3%).
Interpretation:
Among patients with multivessel coronary artery disease undergoing CABG, the off-pump technique did not improve the primary composite outcome of death, MI, stroke, or renal failure requiring dialysis up to 5 years of follow-up. Although hard clinical outcomes were not improved, off-pump CABG reduced the need for transfusion, reoperation for bleeding, acute kidney injury, and respiratory complications within 30 days. Unfortunately, prevention of acute kidney injury at 30 days was not associated with preservation in long-term renal function. Slightly fewer bypass grafts were performed with off-pump CABG. There was no reduction in stroke with off-pump CABG, possibly due to 102 crossovers from the on-pump group to the off-pump group due to a calcified aorta.
Off-pump CABG is a viable technique for surgical revascularization. Long-term follow-up is needed to determine if receipt of fewer bypass grafts will adversely affect outcomes.
References:
Lamy A, Devereaux PJ, Prabhakaran D, et al. Five-year outcomes after off-pump or on-pump coronary-artery bypass grafting. N Engl J Med 2016;Oct 23:[Epub ahead of print].
Presented by Dr. Andre Lamy at the Canadian Cardiovascular Congress, October 23, 2016, Montréal, Quebec.
Garg AX, Devereaux PJ, Yusuf S, et al. Kidney function after off-pump or on-pump coronary artery bypass graft surgery: a randomized clinical trial. JAMA 2014;311:2191-8.
Lamy A, Devereaux PJ, Dorairaj P, et al., on behalf of the CORONARY Investigators. Effects of off-pump and on-pump coronary-artery bypass grafting at 1 year. N Engl J Med 2013;Mar 11:[Epub ahead of print].
Presented by Dr. Andre Lamy at ACC.13, San Francisco, March 11, 2013.
Lamy A, Devereaux PJ, Prabhakaran D, et al., on behalf of the CORONARY Investigators. Off-Pump or On-Pump Coronary Artery Bypass Grafting at 30 days. N Engl J Med 2012;Mar 26:[Epub ahead of print].
Presented by Dr. Andre Lamy at ACC.12 & ACC-i2 with TCT, Chicago, IL, March 26, 2012.
Keywords: Coronary Artery Disease, Myocardial Infarction, Stroke, Follow-Up Studies, Pyridinolcarbamate, Acute Kidney Injury, Peripheral Arterial Disease, Risk Factors, Smoking, Blood Transfusion, Renal Dialysis, Reoperation, Stroke Volume, Carotid Stenosis, Coronary Artery Bypass, Diabetes Mellitus
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