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CORONARY: Safety similar with on-pump, off-pump CABG
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CHICAGO — No differences in safety measures, including death, MI, stroke and renal failure, were observed at 30 days among patients receiving on-pump or off-pump CABG, researchers for the CORONARY trial reported.
The trial enrolled 4,752 patients at 79 centers in 19 countries. Eligible patients slated for CABG were randomly assigned to off-pump or on-pump surgery after a thorough examination to ensure they were suitable candidates for either technique. Most of the patients were men (80.9%) and the mean age was 67.6 years. The average number of grafts was 3.1 per patient. The results were presented at the American College of Cardiology’s 61st Scientific Sessions by André Lamy, MD, of the division of cardiac surgery at McMaster University in Hamilton, Ontario.
The primary composite outcome of death, MI, kidney failure and stroke at 1 month following CABG was similar for the off-pump (9.9%) and on-pump (10.3%) patient groups. Likewise, there were no observable differences for individual events of the composite outcome.
Use of off-pump CABG resulted in reduced rates of transfusion, reoperation for perioperative bleeding, respiratory complications, and acute kidney injury but also resulted in an increased risk of early revascularization.
“We found that off-pump bypass would reduce the rate of respiratory infection, respiratory failure and acute kidney injury, as well as reduce the amount of blood products needed, reoperation for bleeding and pulmonary complications,” Lamy said at a press conference. “However, these benefits were balanced by the fact that we observed more widespread early revascularizations in off-pump patients.”
Revascularization occurred in 0.7% of patients on the off-pump group vs. 0.2% in the on-pump group.
“This is a neutral trial with benefits balanced on both sides,” Lamy said. “From our point of view, both procedures are beneficial and, in expert hands, the results are excellent and can be performed without significant difficulties. It will be interesting to see how the differences that we are seeing in the short-term morbidity will translate in the long term, and whether similar differences will be observed in long-term primary outcome results.”
Researchers will follow safety and efficacy outcomes, total costs and neurocognitive results out to 5 years. – by Robert Stott
For more information:
- Lamy A. Late-breaking clinical trials III. Presented at: the American College of Cardiology 61st Scientific Session & Expo; March 24-27, 2012; Chicago.
Disclosure: Dr. Lamy has received consulting fees from AstraZeneca.