Methylprednisolone does not reduce risk of worse outcomes in infants undergoing heart surgery: STRESS trial

For the evaluation of the outcomes, registry data was used. One thousand two hundred sixty-three infants underwent randomization to receive methylprednisolone (30 mg per kilogram of body weight; n=599) or a placebo (n=601). The administration was done into the cardiopulmonary-bypass pump-priming fluid.

The primary endpoint was a ranked composite of heart transplantation, death, or any of 13 major complications. Patients not having any of these events were assigned a ranked outcome based on postoperative length of stay. In the primary analysis, a comparison was made of the rated outcomes between the trial groups. Secondary analyses comprised a win ratio, an unadjusted odds ratio, and safety results.

The authors reported the following findings:

• The possibility of a worse outcome did not differ significantly between the methylprednisolone group and the placebo group (adjusted odds ratio, 0.86).
• Secondary analyses (unadjusted for risk factors) showed an odds ratio for a worse outcome of 0.82 and a win ratio of 1.15 in the methylprednisolone group as compared with the placebo group, findings suggestive of a benefit with methylprednisolone; however, patients in the methylprednisolone group were more likely than those in the placebo group to receive postoperative insulin for hyperglycemia (19.0% vs. 6.7%).

"Prophylactic use of methylprednisolone in infants younger than 1-year undergoing surgery with cardiopulmonary bypass did not remarkably reduce the prospect of a worse outcome in an adjusted analysis and was linked with postoperative hyperglycemia development warranting insulin in a higher percentage of infants than placebo," the researchers wrote in their study.

Reference:

Hill KD, et al. LBS.03. Late-Breaking Science: High Impact Trials in Intervention and Surgery. Presented at: American Heart Association Scientific Sessions; Nov. 5-7, 2022; Chicago (hybrid meeting).