Less Is More: Methylprednisolone in Patients Undergoing Cardiopulmonary Bypass
Do prophylactic steroids benefit patients at high risk of morbidity and mortality undergoing cardiac surgery with cardiopulmonary bypass?
The SIRS (Steroids In caRdiac Surgery) trial was an international, multicenter, parallel-group, double-blind, randomized, placebo-controlled trial of adult patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. Patients were eligible if they had a EuroSCORE of at least 6. Patients were randomized to receive either methylprednisolone (250 mg at anesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Primary outcomes were mortality at 30 days after randomization and a composite of death, myocardial injury, stroke, and renal failure.
The analytic sample with complete 30-day data was available for 7,507 patients. Methylprednisolone, compared with placebo, did not reduce the risk of death at 30 days (154 [4%] vs. 177 [5%] patients; relative risk [RR], 0.87; 95% confidence interval [CI], 0.70-1.07; p = 0.19) or the risk of death or major morbidity (909 [24%] vs. 855 [24%]; RR, 1.03; 95% CI, 0.95-1.11; p = 0.52). Methylprednisolone was associated with an increase in non–Q-wave myocardial injury (RR, 1.24; 95% CI, 1.09-1.41).
Among high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass, administration of perioperative methylprednisolone did not have a significant effect on morbidity and mortality.
The results of the SIRS trial do not support the routine use of methylprednisolone for patients undergoing cardiopulmonary bypass. While the mechanism of myocardial injury associated with methylprednisolone in this context is uncertain, the authors’ finding of an increased risk for non–Q-wave injury further cautions against the use of methylprednisolone in patients undergoing cardiopulmonary bypass, especially in the absence of other benefits.
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