Congress Review | Editors Choice | AHA Scientific Sessions 2024
 

Re-Analysis of the STRESS Trial shows benefits of Prophylactic Steroids in Infant Heart Surgery


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Published on MedED:  25 November 2024
Originally Published: 11 November 2024
Sourced: Circulatory
Type of article: Conference Review | In Brief
MedED Catalogue Reference:
 MCABC007
Category: Cardiovascular Disease
Cross Reference: Medical Devices, Infection Control

Keywords: paediatric patients, methylprednisone, systemic inflammatory response
 

Key Takeaway
This re-analysis of the STRESS trial demonstrated that methylprednisolone is likely to reduce systemic inflammation in paediatric patients undergoing cardiac surgery, with minimal risk.

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Presented at AHA Scientific Sessions 2024, and published in Circulatory, 11 November 2024.This summary does not represent the original research, nor is it intended to replace the original research. Content Disclaimer

 


 

Prophylactic steroids, such as methylprednisolone, are often used in infants undergoing heart surgery to mitigate the systemic inflammatory response caused by cardiopulmonary bypass. 
 

The STRESS trial1 previously reported no significant difference in outcomes between infants receiving methylprednisolone and those receiving a placebo based on a risk-adjusted primary analysis. However, secondary unadjusted analyses suggested potential benefits.

The researchers of this study conducted a Bayesian re-analysis to assess further the probability of benefit or harm associated with methylprednisolone.


The results were presented at AHA Scientific Sessions 2024 and were published as an Abstract in Circulatory.



Study Intention


To re-analyse the results of the STRESS trial using Bayesian analytics to assess the probability of benefit with methylprednisolone.


Study Design

 

The re-analysis utilized the STRESS trial data, focusing on the original trial's primary outcome: a ranked composite measure including death, transplant, major complications, and postoperative length of stay. 

A covariate-adjusted proportional odds model was applied to estimate the effects of methylprednisolone versus placebo.

Bayesian methods were employed to evaluate the probability of benefit, harm, or neutrality across various thresholds of odds ratios (OR). Sensitivity analyses considered prior beliefs ranging from pessimistic (low likelihood of benefit) to optimistic (high likelihood of benefit) and adjusted the strength of prior beliefs.



Results
 

Primary Analysis:
 

The posterior probability of benefit with methylprednisolone was 92%, while the probability of harm was only 8%. The estimated mean absolute benefit was 12%.


Sensitivity Analyses:
 

The probability of benefit exceeded 79% across most prior assumptions, including neutral and optimistic beliefs. The exception was the most pessimistic prior, where the probability of benefit fell below this threshold.


The Bayesian approach demonstrated the convergence of posterior distributions, ensuring robust results across different analytical conditions.



Study Implications
 

This re-analysis supports a high probability of methylprednisolone's providing clinical benefit in this context and a low likelihood of harm. 

 


Conclusion
 

Prophylactic methylprednisolone appears beneficial for infants undergoing heart surgery, as demonstrated by a high posterior probability of benefit. 

Bayesian analytics provide a more informative framework for evaluating clinical interventions, effectively accommodating uncertainty and prior evidence.

The researchers comment that further studies using this approach could refine decision-making in paediatric cardiac care.

 


Limitations
 

Not available at the time of this review



Original Research
 

Hill, K., Koerner, J., Hong, H., Li, J., Jacobs, M., Kannankeril, P., Baldwin, S., & O’Brien, S., et al. (2024). Bayesian re-analysis of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial [Abstract 4125939]. Circulation, 150(Suppl_1). https://doi.org/10.1161/circ.150.suppl_1.4125939


Additional Reference Material 

1. Hill KD, Kannankeril PJ, Jacobs JP, Baldwin HS, ..; STRESS Network Investigators. Methylprednisolone for Heart Surgery in Infants - A Randomized, Controlled Trial. N Engl J Med. 2022 Dec 8;387(23):2138-2149. doi: 10.1056/NEJMoa2212667. Epub 2022 Nov 6. PMID: 36342116; PMCID: PMC9843240.

2.ClinicalTrials.gov. (n.d.). STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS). Retrieved November 27, 2024, from https://clinicaltrials.gov/study/NCT03229538


Funding


Not available at the time of this review


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