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Steroids In caRdiac Surgery (SIRS) Trial Population Health Research Institute Hamilton Health Sciences/McMaster University Hamilton, Canada 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 Diagram Randomized (n = 7,507) Allocated to steroid* (n = 3,755) Allocated to Placebo (n = 3,752) Lost to follow-up (n = 1) Did not receive study drug (n = 105) Analyzed by intention-to-treat (n = 3,755) Complete follow-up data (n = 3,754) Lost to follow-up (n = 0) Did not receive study drug (n = 106) Analyzed by intention-to-treat (n = 3,752) Complete follow-up data (n = 3,751) *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 Second Co-Primary - 155 (4.1) 176 (4.7) 0.88 (0.71-1.09) 0.23 Composite death, MI, stroke, new renal failure, respiratory failure 913 (24.3) 875 (23.3) 1.04 (0.96-1.13) 0.31 508 (13.5) 419 (11.2) 1.21 (1.07-1.37) 0.001 Stroke 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 Components of Composite MI 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 postoperative 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.