Prophylactic use of methylprednisolone in infants undergoing cardiopulmonary bypass heart surgery did not improve post-operative outcomes compared with placebo, according to results from the STRESS trial presented Nov. 6 at AHA 2022 in Chicago and published in the New England Journal of Medicine. Additionally, prophylactic methylprednisolone was associated with postoperative development of hyperglycemia warranting insulin in a higher percentage of infants, researchers said.

The study randomized 1,200 infants (<1 year of age) undergoing heart surgery at 24 sites participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database to either methylprednisolone (30 mg per kilogram of body weight; n=599) or placebo (n=601). Roughly 50% of infants in the study were female, 16% were Black and 12% were Hispanic, with an average age of four months at time of surgery. More than 30% of patients were younger than 30 days old at the time of surgery, researchers said.

The primary endpoint was a ranked composite of death, heart transplantation or 13 other major complications. Infants without any of these events were assigned a ranked outcome based on length of hospital stay.

Overall results found "the likelihood of a worse outcome did not differ significantly between the methylprednisolone group and the placebo group (adjusted odds ratio, 0.86; 95% CI, 0.71 to 1.05; p=0.14). However, researchers noted that infants in the methylprednisolone group (19%) were more likely to receive post-operative insulin for hyperglycemia, compared with those in the placebo group (6.7%).

In secondary analyses, researchers observed that patients receiving steroids had lower odds of bleeding requiring another operation. "When we analyzed the primary endpoint using a different approach known as the 'win ratio,' there was evidence that steroids provided a small net benefit," said Kevin D. Hill, MD, MS, "but other outcomes were comparable for the two groups including mortality, post-operative infections and the need for mechanical ventilation and length of hospital stay."

Hill and colleagues also noted there was evidence indicating potential benefit with methylprednisolone in infants undergoing lower complexity cardiac operations, in infants undergoing cardiac operations with longer cardiopulmonary bypass times, and in infants that were not born prematurely.

"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 pediatric cardiologists and congenital heart surgeons, is that steroids may offer a small benefit," Hill said.

Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Prevention, Cardiac Surgery and CHD and Pediatrics, Congenital Heart Disease, CHD and Pediatrics and Interventions, CHD and Pediatrics and Prevention, Interventions and Structural Heart Disease, Stress

Keywords: AHA Annual Scientific Sessions, AHA22, Cardiac Surgical Procedures, Steroids, Oxidative Stress, Heart Defects, Congenital

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