Steroids to Reduce Systemic Inflammation After Infant Heart Surgery - STRESS

Feb 03, 2023
Font Size
A
A
A
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Center for Advancing Translational Sciences
Date Published:
11/06/2022
Date Updated:
02/03/2023
Original Posted Date:
02/03/2023
References

Contribution To Literature:

The STRESS trial showed that perioperative use of methylprednisolone among infants undergoing on-pump cardiac surgery did not significantly reduce the likelihood of a worse outcome.

Description:

The goal of the trial was to assess the safety and efficacy of perioperative prophylactic glucocorticoids among infants after heart surgery with cardiopulmonary bypass.

Study Design

Patients were randomized in a 1:1 fashion to either receive methylprednisolone at a dose of 30 mg/kg of body weight (n = 599) or placebo (n = 601), both of which were administered into the cardiopulmonary-bypass pump-priming fluid.

The Society of Thoracic Surgeons Congenital Heart Surgery Database was used in the trial to facilitate data collection.

  • Total number of enrollees: 1,200
  • Duration of follow-up: 30 days
  • Age: 125 days
  • Percentage female: 46%

Inclusion criteria:

  • Age <1 year

Exclusion criteria:

  • Adjusted gestational age (i.e., the gestational age at birth plus the age at the time of surgery) of <37 weeks at the time of surgery
  • Received any glucocorticoids within 2 days before surgery
  • Had any infection contraindicating the use of glucocorticoids
  • Receiving preoperative mechanical circulatory support or active resuscitation at the time of randomization
  • Receiving known cytochrome P450 3A4 inhibitors at the time of surgery

Other salient features/characteristics:

  • White race: 73%
  • Median duration of cardiopulmonary bypass: 122 minutes
  • Types of surgery: tetralogy of Fallot repair: 12%, ventricular septal defect repair: 14%, complete atrioventricular canal repair: 12%

Principal Findings:

The primary endpoint—a hierarchically assessed composite of operative death (death during the initial hospitalization or within 30 days after the surgery if discharged), heart transplantation during hospitalization, or the occurrence of any of 13 individual major complications—for methylprednisolone vs. placebo: adjusted odds ratio 0.86, 95% confidence interval 0.71-1.05 (p = 0.14).

Secondary analyses for methylprednisolone vs. placebo:

  • Bleeding requiring reoperation: 2.0% vs. 5.0% (p < 0.05)
  • Operative death: 2.0% vs. 2.8%
  • Heart transplantation during hospitalization: 0.5% vs. 1.2%
  • Postoperative cardiac arrest, multisystem organ failure, kidney failure with temporary dialysis, or mechanical ventilator support for >7 days: 4.0% vs. 3.7%
  • Composite of death or major complication: 17.2% vs. 20.3% (p > 0.05)
  • Median postoperative length of stay: 10 vs. 11 days
  • Wound infection: 2.3% vs. 3.5%
  • Hyperglycemia requiring postoperative insulin: 19.0% vs. 6.7% (p < 0.001)

Interpretation:

The results of this registry-based randomized controlled trial indicate that perioperative use of methylprednisolone (30 mg/kg) among infants undergoing on-pump cardiac surgery did not significantly reduce the likelihood of a worse outcome but was associated with a higher likelihood of the patient receiving insulin for the treatment of hyperglycemia.

References:

Hill KD, Kannankeril PJ, Jacobs JP, et al., on behalf of the STRESS Network Investigators. Methylprednisolone for Heart Surgery in Infants — A Randomized, Controlled Trial. N Engl J Med 2022;387:2138-49.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Implantable Devices, SCD/Ventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and Heart Failure, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Interventions, Heart Transplant, Interventions and Structural Heart Disease

Keywords: Cardiac Surgical Procedures, Cardiopulmonary Bypass, Coronary Artery Bypass, Off-Pump, Glucocorticoids, Heart Arrest, Heart Defects, Congenital, Heart Transplantation, Hyperglycemia, Infant, Insulin, Methylprednisolone, Patient Discharge, Pediatrics, Renal Dialysis, Renal Insufficiency, Tetralogy of Fallot, Ventilators, Mechanical


< Back to Listings