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SHR Neuro Cancer Cardio Lipid Metab Microb
Mehta, RH; Leimberger, JD; van Diepen, S; Meza, J; Wang, A; Jankowich, R; Harrison, RW; Hay, D; Fremes, S; Duncan, A; Soltesz, EG; Luber, J; Park, S; Argenziano, M; Murphy, E; Marcel, R; Kalavrouziotis, D; Nagpal, D; Bozinovski, J; Toller, W; Heringlake, M; Goodman, SG; Levy, JH; Harrington, RA; Anstrom, KJ; Alexander, JH; LEVO-CTS Investigators.
Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery.
NEW ENGL J MED. 2017; 376(21): 2032-2042.
Doi: 10.1056/NEJMoa1616218
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- Toller Wolfgang
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- Abstract:
- Levosimendan is an inotropic agent that has been shown in small studies to prevent or treat the low cardiac output syndrome after cardiac surgery. 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. 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. 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 .).
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Cardiac Output, Low - drug therapy
- Cardiac Surgical Procedures -
- Cardiotonic Agents - adverse effects
- Cardiotonic Agents - therapeutic use
- Double-Blind Method -
- Female -
- Heart-Assist Devices - statistics & numerical data
- Humans -
- Hydrazones - adverse effects
- Hydrazones - therapeutic use
- Infusions, Intravenous -
- Male -
- Middle Aged -
- Mortality -
- Myocardial Infarction - epidemiology
- Perioperative Period -
- Postoperative Complications - drug therapy
- Pyridazines - adverse effects
- Pyridazines - therapeutic use
- Renal Replacement Therapy - statistics & numerical data
- Stroke Volume - drug effects
- Treatment Failure -
- Ventricular Dysfunction, Left - drug therapy