• Interventional Techniques & Devices
• Cardiology Clinical Trials

• Cardiology & Cardiovascular Medicine
• Interventional Techniques & Devices
• Cardiology Clinical Trials

Findings of the Steroids in Cardiac Surgery Trial [SIRS Trial; NCT00427388] were presented by Richard Whitlock, MD, PhD, Hamilton Health Services/McMaster University, Hamilton, Ontario, Canada.

Inflammation triggered by cardiopulmonary bypass can be diminished using prophylactic steroids, which may produce clinical benefits. The SIRS trial assessed the hypothesis of whether methylprednisolone would reduce perioperative adverse events in high-risk patients undergoing cardiac surgery involving cardiopulmonary bypass.

A total of 7507 patients were randomized to intraoperative methylprednisolone (500 mg intravenously) (n=3755) or placebo (n=3752). The coprimary outcomes were total mortality within 30 days following surgery, and a composite of all-cause mortality, myocardial infarction (MI), stroke, renal failure, or respiratory failure over the same time. Secondary efficacy and safety outcomes were also evaluated.

The steroid and placebo groups were well-matched in terms of age (67.5±13.6 vs 67.3±13.8 years), male percentage (60.1% vs 60.8%), previous MI (26.2% vs 24.7%) or stroke (8.1% vs 8.4%), congestive heart failure (26.8% vs 27.2%), prevalence of diabetes (26.2% vs 26.4%), and EuroSCORE (both 7.1±2.0). The similarities between groups extended to any prior valve procedure (n=2646, 70.4% vs n=2723, 72.6%), prior coronary artery bypass graft (CABG; n=1838, 48.4% vs n=1796, 47.9%), isolated valve procedure (n=1206, 32.1% vs n=1228, 32.7%), and isolated CABG (n=826, 22.0% vs n=762, 20.3%)

Overall there was no difference in the rate of the coprimary outcomes between patients receiving steroids compared with those receiving placebo at 30 days (Table 1). Analysis of the individual components of the composite outcome revealed a significantly higher rate of MI in patients randomized to methylprednisolone (Table 1). In subanalyses, the results were consistent when stratified by gender, diabetes, age, EuroSCORE, type of surgery, and duration of cardiopulmonary bypass.

Of the secondary outcomes, the prevalence of death or MI, and the postoperative level of insulin were significantly greater in the steroid group (Table 2).

The investigators concluded that the trial demonstrated that routine use of methylprednisolone in high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass was ineffective in reducing death or major morbidity at 30 days and appeared to increase the risk of early postoperative MI.

• © 2014 MD Conference Express®