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Steroids increased MI risk for patients undergoing cardiac surgery
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WASHINGTON — In the SIRS study, methylprednisolone did not reduce rates of death or major morbidity, but was associated with increased risk for MI in high-risk patients at 30 days following cardiac surgery with the use of cardiopulmonary bypass.
Richard Whitlock, MD, PhD, and colleagues examined the use of methylprednisolone in 7,507 adults with a EUROScore ≥6. They hypothesized that methylprednisolone administration would improve outcomes by reducing the inflammatory response associated with cardiopulmonary bypass.
Use not recommended
According to Whitlock, “methylprednisolone should not be administered prophylactically to high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass.
Richard Whitlock
“This is important,” Whitlock, from Hamilton Health Sciences/McMaster University, Ontario, Canada, said at a press conference. “Globally, there is varying use of steroids to suppress this inflammatory response. This is standard of practice in many European countries. It is used less so in North America, however, many centers in North America do consider this standard of practice.”
The first co-primary outcome, total mortality at 30 days, was reported in 4.1% of the steroid group compared with 4.7% of the placebo group (RR=0.88; 95% CI, 0.71-1.09), Whitlock said.
Data also revealed no difference between the groups in the second co-primary outcome, a composite of death, MI, stroke, new renal failure and respiratory failure (steroid group, 24.2%; placebo group, 23.2%; RR=1.04; 95% CI, 0.96-1.13), he said.
However, when the researchers analyzed the components of the second co-primary outcome, the steroid group had a higher rate of MI at 30 days compared with the placebo group (steroid group, 13.3%; placebo group, 10.9%; RR=1.21; 95% CI, 1.07-1.37).
Connection with MI
While previous research had indicated a connection between MI and methylprednisolone, Whitlock said he and his colleagues did not anticipate the same connection between the drug and MI during or after surgery.
“We thought the mechanism of myocardial injury in cardiac surgery was quite different than the traditional coronary thrombosis with MI, so we did not think we would see this issue in our trial, but we did,” he said. Further investigation on potential mechanisms is needed, he noted.
There were no differences between the groups in the components of stroke (steroid group, 1.9%; placebo group, 2.1%; RR=0.9; 95% CI, 0.66-1.23), new renal failure (steroid group, 2.8%; placebo group, 3%; RR=0.94; 95% CI, 0.72-1.22) or respiratory failure (steroid group, 9.1%; placebo group, 10%; RR=0.91; 95% CI, 0.79-1.05), the researchers found.
Results for the primary outcomes were consistent across age, sex, diabetes status, EUROScore, surgery type and cardiopulmonary bypass duration, he said.
The steroid group also had a worse secondary outcome of death or MI at 30 days (16.5% vs. 14.3%; RR=1.16; 95% CI, 1.04-1.29).
For secondary safety outcomes, there were no between-group differences in infection, delirium, surgical site infection or gastrointestinal perforation or hemorrhage, according to the researchers. However, Whitlock said, the steroid group had higher peak blood glucose (12.7 mmol/L vs. 12.1 mmol/L; P=.04) and higher levels of postoperative insulin (50.3 U vs. 32.6 U; P<.00001). – by Erik Swain
For more information:
Whitlock R. Joint American College of Cardiology/New England Journal of Medicine Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Sessions; March 29-31, 2014; Washington, D.C.
Disclosure: Whitlock reports no relevant financial disclosures.
Perspective
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Amit Khera, MD, MSc, FACC
The most important finding from this study was that the hint that steroids should be used or could be beneficial in surgery was negated. We have a definitive study that says that higher doses of steroids should not be used. They are already being used broadly in several countries, and this should change practice. Equally important, if we look at some hints of atrial fibrillation and respiratory function, now that we’re seeing a sign of MI, we really have to be careful about using steroids of that magnitude for any indication in surgery.
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