Population HealthResearch Institute

Population Health Research InstituteHamilton Health Sciences/McMaster

UniversityHamilton, Canada

Steroids In caRdiac Surgery (SIRS) Trial

SIRS was funded by grants from the Canadian Institutes of Health Research (CIHR)and the Canadian Network and Centre for Trials Internationally (CANNeCTIN)

Trial Flow DiagramRandomized (n = 7,507)

Allocated to steroid* (n = 3,755)

Allocated to Placebo (n = 3,752)

Analyzed by intention-to-treat (n = 3,755)

Complete follow-up data (n = 3,754)

Analyzed by intention-to-treat (n = 3,752)

Complete follow-up data (n = 3,751)

Lost to follow-up (n = 1)Did not receive study drug (n =

105)

Lost to follow-up (n = 0)Did not receive study drug (n =

106)

*500 mg IV Methylprednisolone given intra-operatively

Co-Primary Outcomes (30 days)

30-Day Outcome Steroid Placebo RR (95% CI) p-value

First Co-Primary - Death 155 (4.1) 176 (4.7) 0.88 (0.71-1.09) 0.23Second Co-Primary - Composite death, MI, stroke, new renal failure, respiratory failure

913 (24.3) 875 (23.3) 1.04 (0.96-1.13) 0.31

Components of Composite

MI 508 (13.5) 419 (11.2) 1.21 (1.07-1.37) 0.001Stroke 72 (1.9) 80 (2.1) 0.90 (0.66-1.23) 0.51

New Renal Failure 107 (2.8) 114 (3.0) 0.94 (0.72-1.22) 0.62

Respiratory Failure 343 (9.1) 375 (10.0) 0.91 (0.79-1.05) 0.20

Conclusion

Methylprednisolone does not reduce death or major morbidity at 30 days for high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass.

Methylprednisolone increases the risk of early post-operative myocardial infarction, defined by CK-MB biomarker release.

Implications

Methylprednisolone should not be administered prophylactically to high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass.

Further work is necessary to understand the mechanism of steroid-driven myocardial infarction.