García-González, Martín J.Aldea-Perona, AnaLara-Padrón, AntonioMorales Rull, José LuisMartínez-Sellés, ManuelMora Martin, Manuel deLópez Díaz, JavierLópez Fernández, SilviaOrtiz Oficialdegui, PilarJiménez Sosa, Alejandro2022-06-022022-06-022021García-González MJ, Aldea Perona A, Lara Padron A, Morales Rull JL, Martínez-Sellés M, de Mora Martin M, et al. Efficacy and safety of intermittent repeated levosimendan infusions in advanced heart failure patients: the LAICA study. ESC Heart Fail. 2021 Dec; 8(6): 4820-31. DOI: 10.1002/ehf2.136702055-5822http://hdl.handle.net/10230/53359Aims: The aim of the LAICA study was to evaluate the long-term effectiveness and safety of intermittent levosimendan infusion in patients with advanced heart failure (AdHF). Methods and results: This was a multicentre, randomized, double-blind, placebo-controlled clinical trial of intermittent levosimendan 0.1 μg/kg/min as a continuous 24-h intravenous infusion administered once monthly for 1 year in patients with AdHF. The primary endpoint [incidence of rehospitalization (admission to the emergency department or hospital ward for >12 h) for acute decompensated HF or clinical deterioration of the underlying HF] occurred in 23/70 (33%) of the levosimendan group (Group I) and 12/27 (44%) of the placebo group (Group II) (P = 0.286). The incidence of hospital readmissions for acute decompensated HF (Group I vs. Group II) at 1, 3, 6, and 12 months was 4.2% vs. 18.2% (P = 0.036); 12.8% vs. 33.3% (P = 0.02); 25.7% vs. 40.7% (P = 0.147); 32.8% vs. 44.4% (P = 0.28), respectively. In a secondary pre-specified time-to-event analysis no differences were observed in admission for acute decompensated HF between patients treated with levosimendan compared with placebo (hazard ratio 0.66; 95% CI, 0.32-1.32; P = 0.24). Cumulative incidence for the aggregated endpoint of acute decompensation of HF and/or death at 1 and 3 months were significatively lower in the levosimendan group than in placebo group [5.7% vs. 25.9% (P = 0.004) and 17.1% vs. 48.1% (P = 0.001), respectively], but not at 6 and 12 months [34.2% vs. 59.2% (P = 0.025); 41.4% vs. 66.6% (P = 0.022), respectively]. Survival probability was significantly higher in patients who received levosimendan compared with those who received placebo (log rank: 4.06; P = 0.044). There were no clinically relevant differences in tolerability between levosimendan and placebo and no new safety signals were observed. Conclusions: In our study, intermittent levosimendan in patients with AdHF produced a statistically non-significant reduction in the incidence of hospital readmissions for acute decompensated HF, a significantly lower cumulative incidence of acute decompensation of HF and/or death at 1 and 3 month of treatment and a significant improvement in survival during 12 months of treatment.application/pdfengCopyright © 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.Efficacy and safety of intermittent repeated levosimendan infusions in advanced heart failure patients: the LAICA studyinfo:eu-repo/semantics/articlehttp://dx.doi.org/10.1002/ehf2.13670Advanced heart failureInodilatorIntermittent administrationLevosimendanRehospitalizationinfo:eu-repo/semantics/openAccess