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Ministry of Health, Social Services and Equality, Government of Spain 2009"},{"DOI":"10.13039\/100007650","name":"Fundaci\u00f3n Canaria de Investigaci\u00f3n y Salud","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007650","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>This was a multicentre, randomized, double-blind, placebo-controlled clinical trial of intermittent levosimendan 0.1 \u03bcg\/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 &amp;gt;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\u20131.32; 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ehf2.13670","type":"journal-article","created":{"date-parts":[[2021,10,30]],"date-time":"2021-10-30T05:53:18Z","timestamp":1635573198000},"page":"4820-4831","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":55,"title":["Efficacy and Safety of Intermittent Repeated Levosimendan Infusions in Advanced Heart Failure Patients: The LAICA Study"],"prefix":"10.1093","volume":"8","author":[{"given":"Mart\u00edn J.","family":"Garc\u00eda-Gonz\u00e1lez","sequence":"first","affiliation":[{"name":"Acute Cardiac Care Unit, Department of Cardiology, Hospital Universitario de Canarias , Ctra. La Cuesta\u2014Taco, Ofra s\/n, 38320 San Crist\u00f3bal de La Laguna, Tenerife ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Aldea Perona","sequence":"additional","affiliation":[{"name":"Institut Municipal d'Investigacions M\u00e8diques (IMIM) , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Lara Padron","sequence":"additional","affiliation":[{"name":"Acute Cardiac Care Unit, Department of Cardiology, Hospital Universitario de Canarias , Ctra. La Cuesta\u2014Taco, Ofra s\/n, 38320 San Crist\u00f3bal de La Laguna, Tenerife ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Luis","family":"Morales Rull","sequence":"additional","affiliation":[{"name":"Heart Failure Unit, Department of Internal Medicine, Hospital Arnau de Vilanova, Institut de Recerca Biom\u00e9dica de Lleida (IRBLleida) , Lleida ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Mart\u00ednez-Sell\u00e9s","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Hospital Universitario Gregorio Mara\u00f1on, CIBERCV, Universidad Europea, Universidad Complutense , Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"de Mora Martin","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Hospital Universitario Regional Carlos Haya , M\u00e1laga 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