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Levosimendan for Hemodynamic Support After Cardiac Surgery
Study Questions:
What is the effect of levosimendan treatment in addition to standard inotropic treatment on mortality among patients with perioperative cardiovascular dysfunction after cardiac surgery?
Methods:
The investigators conducted a multicenter, randomized, double-blind, placebo-controlled trial involving patients in whom perioperative hemodynamic support was indicated after cardiac surgery, according to prespecified criteria. Patients were randomly assigned to receive levosimendan (in a continuous infusion at a dose of 0.025-0.2 μg/kg of body weight/minute) or placebo, for up to 48 hours or until discharge from the intensive care unit (ICU), in addition to standard care. The primary outcome was 30-day mortality. A logistic regression model with stepwise selection was used to identify predictors of death.
Results:
The trial was stopped for futility after 506 patients were enrolled. A total of 248 patients were assigned to receive levosimendan and 258 to receive placebo. There was no significant difference in 30-day mortality between the levosimendan group and the placebo group (32 patients [12.9%] and 33 patients [12.8%], respectively; absolute risk difference, 0.1 percentage points; 95% confidence interval [CI], −5.7 to 5.9; p = 0.97). There were no significant differences between the levosimendan group and the placebo group in the durations of mechanical ventilation (median, 19 hours and 21 hours, respectively; median difference, −2 hours; 95% CI, −5 to 1; p = 0.48), ICU stay (median, 72 hours and 84 hours, respectively; median difference, −12 hours; 95% CI, −21 to 2; p = 0.09), and hospital stay (median, 14 days and 14 days, respectively; median difference, 0 days; 95% CI, −1 to 2; p = 0.39). There was no significant difference between the levosimendan group and the placebo group in rates of hypotension or cardiac arrhythmias.
Conclusions:
The authors concluded that treatment with low-dose levosimendan in addition to standard care did not result in lower 30-day mortality than placebo among patients who required perioperative hemodynamic support after cardiac surgery.
Perspective:
This multicenter, randomized, double-blind, placebo-controlled trial in patients who required hemodynamic support after cardiac surgery reports that the administration of levosimendan was not associated with lower 30-day mortality than placebo. Furthermore, there was no significant between-group difference in mortality in any subgroup, and no significant difference was seen between the levosimendan group and the placebo group in the incidence of hypotension or arrhythmias. Overall, these findings do not support the administration of levosimendan in addition to standard care in the management of cardiac dysfunction after cardiac surgery. Whether a subgroup of coronary artery bypass grafting patients with reduced ejection fraction at baseline may benefit from levosimendan needs further study.
Keywords: Arrhythmias, Cardiac, Body Weight, Cardiac Surgical Procedures, Coronary Artery Bypass, Heart Failure, Hemodynamics, Hypotension, Intensive Care Units, Length of Stay, Medical Futility, Perioperative Care, Respiration, Artificial
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