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Levosimendan in acute heart failure following primary percutaneous coronary intervention‐treated acute ST‐elevation myocardial infarction. Results from the LEAF trial: a randomized, placebo‐controlled study
Author(s) -
Husebye Trygve,
Eritsland Jan,
Müller Carl,
Sandvik Leiv,
Arnesen Harald,
Seljeflot Ingebjørg,
Mangschau Arild,
Bjørnerheim Reidar,
Andersen Geir Øystein
Publication year - 2013
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1093/eurjhf/hfs215
Subject(s) - levosimendan , medicine , conventional pci , cardiology , cardiogenic shock , heart failure , myocardial infarction , placebo , percutaneous coronary intervention , clinical endpoint , randomized controlled trial , alternative medicine , pathology
Aims The calcium sensitizer levosimendan may counteract stunning after reperfusion of ischaemic myocardium, but no randomized placebo‐controlled trials exist regarding its use in PCI‐treated ST‐segment elevation infarction (STEMI). We evaluated the efficacy and safety of levosimendan in patients with a primary PCI‐treated STEMI complicated by symptomatic heart failure (HF). Methods and results A total of 61 patients developing clinical signs of HF within 48 h after a primary PCI‐treated STEMI (including cardiogenic shock) were randomized double‐blind to a 25 h infusion of levosimendan or placebo. The primary endpoint was change in wall motion score index (WMSI) from baseline to day 5 measured by echocardiography. There was a significantly larger improvement in WMSI from baseline to day 5 in the levosimendan group compared with placebo (from 1.94 ± 0.20 to 1.66 ± 0.31 vs. 1.99 ± 0.22 to 1.83 ± 0.26, respectively, P = 0.031). There were significantly more episodes of hypotension during study drug infusion in the levosimendan group (67% vs. 36%, P = 0.029), but no significant difference in blood pressure at the end of infusion or in use of vasopressors. No significant between‐group differences in changes in NT‐proBNP levels, clinical composite score, frequency of atrial fibrillation or ventricular arrhythmia, infarct size at 6 weeks, or new clinical events up to 6 months were found. One and four patients died in the levosimendan and placebo group, respectively. Conclusions Levosimendan treatment improved contractility in post‐ischaemic myocardium in patients with PCI‐treated STEMI complicated by HF. The treatment was well tolerated, without any increase in arrhythmias. Trial registration : NCT00324766