PROPHYLACTIC methylprednisolone has been used for decades; however, it was unknown whether perioperative use of this glucocorticoid improved outcomes in infants after cardiopulmonary bypass surgery. For this reason, a research team led by Kevin D. Hill, Division of Pediatric Cardiology, Duke University Medical Center, Durham, North Carolina, USA, conducted a multicentre, prospective, randomised, placebo-controlled trial to determine the efficacy of methylprednisolone in infants undergoing heart surgery with cardiopulmonary bypass. Results from the STRESS trial were presented at the American Heart Association’s (AHA’s) Scientific Sessions 2022, which took place in Chicago, Illinois, USA, and online between 5th and 7th November.
The study randomised 1,200 infants (<1 year of age) undergoing heart surgery with cardiopulmonary bypass at 24 sites participating in the Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database to either prophylactic methylprednisolone (30 mg per kg of body weight; n=599) or placebo (n=601). The primary endpoint was a ranked composite of death, heart transplantation, or 13 other major complications. Patients without these events were assigned a ranked outcome based on post-operative length of stay.
Overall, the likelihood of a worse outcome was not significantly different between the methylprednisolone group and the placebo group (adjusted odds ratio: 0.86; 95% confidence interval: 0.71–1.05; p=0.14). However, infants in the methylprednisolone group were more likely to receive post-operative insulin for hyperglycaemia compared with those in the placebo group (19% and 6.7%, respectively).
Describing the findings, Hill noted: “When we analysed the primary endpoint using a different approach known as the ‘win ratio’, there was evidence that steroids provided a small net benefit.” However, “other outcomes were comparable for the two groups, including mortality, post-operative infections and the need for mechanical ventilation and length of hospital stay,” said Hill.
Interestingly, there was also evidence suggesting potential benefit with methylprednisolone in infants undergoing lower complexity cardiac operations, cardiac operations with longer cardiopulmonary bypass times, and in infants who were not born prematurely.
Hill summarised the wider relevance of the study: “Although our primary analysis did not find a difference in outcomes for those treated with steroids, there were enough secondary signals indicating a benefit that the consensus of our investigative team, including multiple paediatric cardiologists and congenital heart surgeons, is that steroids may offer a small benefit.”