Steroids in Cardiac Surgery - SIRS

Description:

The goal of the trial was to evaluate treatment with steroids compared with placebo among patients undergoing cardiac surgery with cardiopulmonary bypass.

Hypothesis:

Steroids will reduce perioperative adverse events.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients undergoing cardiac surgery with cardiopulmonary bypass

    Number of enrollees: 7,507 patients
    Duration of follow-up: 30 days

Primary Endpoints:

  • Coprimary outcome of death
  • Coprimary outcome of death, MI, stroke, renal failure, or respiratory failure

Drug/Procedures Used:

Patients undergoing surgery were randomized to methylprednisolone 500 mg IV (n = 3,755) versus placebo (n = 3,752).

Principal Findings:

Overall, 7,507 patients were randomized. The coprimary outcome of death occurred in 4.1% of the steroid group vs. 4.7% of the placebo group (p = 0.23). The coprimary outcome of death, myocardial infarction (MI), stroke, renal failure, or respiratory failure occurred in 24.3% of the steroid group vs. 23.3% of the placebo group (p = 0.31).

- MI: 13.5% vs. 11.2% (p = 0.001), respectively
- Stroke: 1.9% vs. 2.1% (p = 0.51), respectively
- Renal failure: 2.8% vs. 3.0% (p = 0.62), respectively
- Respiratory failure: 9.1% vs. 10.0% (p = 0.20), respectively

Interpretation:

Among patients undergoing cardiac surgery with cardiopulmonary bypass the, use of methylprednisolone did not reduce death or major morbidity at 30 days. In fact, methylprednisolone was associated with an increase in MI. The prophylactic use of steroids before cardiac surgery is not recommended.

References:

Presented by Dr. Richard Whitlock at the American College of Cardiology Scientific Session, Washington, DC, March 31, 2014.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Stroke, Renal Insufficiency, Follow-Up Studies, Pyridinolcarbamate, Methylprednisolone, Respiratory Insufficiency, Cardiopulmonary Bypass, Cardiac Surgical Procedures, ACC Annual Scientific Session


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