Methylprednisolone does not reduce risk of worse outcomes in infants undergoing heart surgery: STRESS trial
USA: Perioperative administration of methylprednisolone for reduction of inflammation in infants undergoing surgery with cardiopulmonary bypass did not do better overall, according to the results from the STRESS trial. However, secondary outcomes and a Bayesian win ratio analysis indicated an advantage.
In the study published in the New England Journal of Medicine, methylprednisolone administration was associated with postoperative hyperglycemia development, warranting insulin in a more significant percentage of infants compared to placebo. The results were also presented at the American Heart Association's 2022 Scientific Sessions.
Perioperative prophylactic glucocorticoids have been utilized for decades, but whether they improve outcomes in infants following heart surgery with cardiopulmonary bypass is unknown. To fill this knowledge gap, Kevin D. Hill, Duke Pediatric and Congenital Heart Center in Durham, North Carolina, and colleagues performed a prospective, multicenter, placebo-controlled, randomized, registry-based trial including infants younger than 1-year undergoing heart surgery with cardiopulmonary bypass at 24 sites taking part in the Society of Thoracic Surgeons Congenital Heart Surgery Database.
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).
