Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery.

Area of Science:

• Cardiology
• Pharmacology
• Clinical Trials

Background:

• Levosimendan is an inotropic agent investigated for preventing low cardiac output syndrome post-cardiac surgery.
• Small studies suggested potential benefits, necessitating larger trials.

Purpose of the Study:

• To evaluate the efficacy and safety of prophylactic levosimendan in patients undergoing cardiac surgery with reduced left ventricular ejection fraction (LVEF ≤ 35%).
• To assess levosimendan's impact on a composite of adverse clinical events including death, renal replacement therapy, myocardial infarction, and mechanical cardiac support.

Main Methods:

• A multicenter, randomized, placebo-controlled, phase 3 trial involving 882 patients undergoing cardiac surgery with cardiopulmonary bypass.
• Patients received either intravenous levosimendan or placebo, initiated before surgery.
• Primary endpoints included a four-component composite (death, renal-replacement therapy, myocardial infarction, mechanical support) and a two-component composite (death or mechanical support).

Main Results:

• The four-component composite endpoint occurred in 24.5% of the levosimendan group and 24.5% of the placebo group (adjusted odds ratio, 1.00; 99% CI, 0.66 to 1.54).
• The two-component composite endpoint occurred in 13.1% of the levosimendan group and 11.4% of the placebo group (adjusted odds ratio, 1.18; 96% CI, 0.76 to 1.82).
• Adverse event rates were not significantly different between the levosimendan and placebo groups.

Conclusions:

• Prophylactic levosimendan did not reduce the rate of short-term composite adverse events compared to placebo in patients with reduced LVEF undergoing cardiac surgery.
• The findings do not support the routine use of levosimendan for preventing low cardiac output syndrome in this patient population.