{"id":"ea022c8fa416","type":"article","url":"https://hartvaat.nl/2017/05/25/levosimendan-bij-lv-disfunctie-voor-hartchirurgie-nejm-levo-cts/","title":"Levosimendan bij LV-disfunctie voor hartchirurgie: NEJM LEVO-CTS","title_en":"Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1616218","source_url":"https://doi.org/10.1056/NEJMoa1616218","authors":["Rajendra H Mehta","Jeffrey D Leimberger","Sean van Diepen","James Meza","Alice Wang","Rachael Jankowich","Robert W Harrison","Douglas Hay","Stephen Fremes","Andra Duncan","Edward G Soltesz","John Luber","Soon Park","Michael Argenziano","Edward Murphy","Randy Marcel","Dimitri Kalavrouziotis","Dave Nagpal","John Bozinovski","Wolfgang Toller","Matthias Heringlake","Shaun G Goodman","Jerrold H Levy","Robert A Harrington","Kevin J Anstrom","John H Alexander"],"significance":8,"published":"2017-05-25","source_date":"2017-05-25","image":"","kennis":[],"congress":"","summary_en":"The LEVO-CTS trial showed that preoperative levosimendan did not improve outcomes in patients with left ventricular dysfunction undergoing cardiac surgery, with no reduction in the composite of death, renal failure, perioperative MI, or mechanical circulatory support use.","created":"2026-07-03T10:26:43Z","updated":"2026-07-03T13:26:02Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM LEVO-CTS-trial die preoperatief levosimendan onderzocht bij patiënten met LV-disfunctie die hartchirurgie ondergaan. Geen verbetering van klinische uitkomsten.","abstract_original":"BACKGROUND: Levosimendan is an inotropic agent that has been shown in small studies to prevent or treat the low cardiac output syndrome after cardiac surgery. METHODS: In a multicenter, randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of levosimendan in patients with a left ventricular ejection fraction of 35% or less who were undergoing cardiac surgery with the use of cardiopulmonary bypass. Patients were randomly assigned to receive either intravenous levosimendan (at a dose of 0.2 μg per kilogram of body weight per minute for 1 hour, followed by a dose of 0.1 μg per kilogram per minute for 23 hours) or placebo, with the infusion started before surgery. The two primary end points were a four-component composite of death through day 30, renal-replacement therapy through day 30, perioperative myocardial infarction through day 5, or use of a mechanical cardiac assist device through day 5; and a two-component composite of death through day 30 or use of a mechanical cardiac assist device through day 5. RESULTS: A total of 882 patients underwent randomization, 849 of whom received levosimendan or placebo and were included in the modified intention-to-treat population. The four-component primary end point occurred in 105 of 428 patients (24.5%) assigned to receive levosimendan and in 103 of 421 (24.5%) assigned to receive placebo (adjusted odds ratio, 1.00; 99% confidence interval [CI], 0.66 to 1.54; P=0.98). The two-component primary end point occurred in 56 patients (13.1%) assigned to receive levosimendan and in 48 (11.4%) assigned to receive placebo (adjusted odds ratio, 1.18; 96% CI, 0.76 to 1.82; P=0.45). The rate of adverse events did not differ significantly between the two groups. CONCLUSIONS: Prophylactic levosimendan did not result in a rate of the short-term composite end point of death, renal-replacement therapy, perioperative myocardial infarction, or use of a mechanical cardiac assist device that was lower than the rate with placebo among patients with a reduced left ventricular ejection fraction who were undergoing cardiac surgery with the use of cardiopulmonary bypass. (Funded by Tenax Therapeutics; LEVO-CTS ClinicalTrials.gov number, NCT02025621 .)."}