WASHINGTON – Administering methylprednisolone to patients undergoing cardiac surgery with cardiopulmonary bypass did not reduce the risks of death or major morbidity at 30 days, but was associated with an increased risk of early postoperative myocardial infarction, in a randomized controlled trial of about 7,500 high-risk surgical patients.
Based on the results of the study, the Steroids in Cardiac Surgery (SIRS) trial, "methylprednisolone should not be administered prophylactically to high-risk patients undergoing cardiac surgery" with cardiopulmonary bypass, Dr. Richard Whitlock said at the annual meeting of the American College of Cardiology.
Dr. Richard Whitlock
SIRS, a randomized controlled study, evaluated the effects of prophylactic steroids in patients undergoing cardiac surgery with cardiopulmonary bypass in 18 countries in North and South America, Europe, the Middle East, and Asia. The study addressed whether the use of prophylactic steroids can attenuate the "intense inflammatory response" that occurs with cardiopulmonary bypass and is associated with adverse outcomes, said Dr. Whitlock, a cardiac surgeon at McMaster University, Hamilton, Ont., and lead investigator in the study.
Whether this approach results in improved outcomes has been unclear, he said. A recent meta-analysis of 44 small studies suggested that steroids have clinical benefits in this setting, and this use of methylprednisolone is standard practice in many European countries. And although it is not used as extensively in the United States, it is still standard care at some U.S. centers, he noted.
In SIRS, patients were randomized to 500 mg methylprednisolone, administered intravenously during surgery (3,755 patients) or placebo (3,752). Patients were considered high risk; their mean age was 67 years, two-thirds were male, and their mean EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 7.1. Only one patient, who was in the treatment group, was lost to follow-up.
There were no significant differences between the two groups in the two primary endpoints: total mortality at 30 days and the combined endpoint of total mortality, stroke, MI, renal failure, or respiratory failure within 30 days. The results were consistent across different subgroups, including sex, diabetes status, age, EuroSCORE, type of surgery and duration of cardiopulmonary bypass.