Download Steroids In caRdiac Surgery (SIRS) Trial

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.