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LICORN: Levosimendan shows no benefit for cardiac output after CABG
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Among people with low ejection fraction, levosimendan did not significantly reduce incidence of low cardiac output syndrome after cardiac surgery compared with placebo, according to recent findings from the LICORN randomized clinical trial.
“Several studies and meta-analyses have suggested that levosimendan (Orion Pharma) could help prevent low cardiac output syndrome and reduce morbidity and even mortality after cardiac surgery,” Bernard Cholley, MD, PhD, of the department of anesthesiology and critical care medicine at the Hôpital Européen Georges Pompidou, Paris, and colleagues wrote. “However, two recent, large, randomized, clinical trials did not confirm these findings when levosimendan was used prophylactically, ie, before cardiac surgery, or implemented in the presence of an already manifest postoperative low cardiac output syndrome.”
Cholley and colleagues included participants from 13 French cardiac centers who had left ventricular ejection fraction up to 40% and were scheduled for isolated or combined CABG with cardiopulmonary bypass. Patients were enrolled from June 2013 to May 2015 and were followed up for 6 months.
Patients were randomly assigned to a 24-hour infusion of levosimendan 0.1 µg/kg per minute (n = 167) or placebo (n = 168).
The primary endpoint was low cardiac output syndrome, represented by a composite outcome of need for catecholamine infusion, need for a LV mechanical assist device or failure to wean from it or need for renal replacement therapy.
Three participants did not complete the trial. Of those who did (n = 333; mean age, 68 years; 16% women), the primary endpoint occurred in 52% of the levosimendan group and 61% of the control group (absolute risk difference, –7%; 95% CI, –17 to 3).
No interaction was found with LVEF less than 30%, type of surgery and preoperative use of beta-blockers, intra-aortic balloon pump or catecholamines.
Adverse events did not significantly differ between the two groups.
“Among patients with low ejection fraction who were undergoing CABG with cardiopulmonary bypass, levosimendan compared with placebo did not result in a significant difference in the composite endpoint of prolonged catecholamine infusion, use of left ventricular mechanical assist device or renal replacement therapy. These findings do not support the use of levosimendan for this indication,” the researchers concluded. – by Cassie Homer
Disclosures: Cholley reports receiving an honorarium from Orion Pharma. Two other authors report financial ties with Baxter, Edwards Lifesciences, Gecko Biomedical and Xenios.
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