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Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery.

Publication ,  Journal Article
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 ...
Published in: N Engl J Med
May 25, 2017

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 .).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 25, 2017

Volume

376

Issue

21

Start / End Page

2032 / 2042

Location

United States

Related Subject Headings

  • Ventricular Dysfunction, Left
  • Treatment Failure
  • Stroke Volume
  • Simendan
  • Renal Replacement Therapy
  • Pyridazines
  • Postoperative Complications
  • Perioperative Period
  • Myocardial Infarction
  • Mortality
 

Citation

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Mehta, R. H., Leimberger, J. D., van Diepen, S., Meza, J., Wang, A., Jankowich, R., … LEVO-CTS Investigators, . (2017). Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery. N Engl J Med, 376(21), 2032–2042. https://doi.org/10.1056/NEJMoa1616218
Mehta, Rajendra H., Jeffrey D. Leimberger, Sean van Diepen, James Meza, Alice Wang, Rachael Jankowich, Robert W. Harrison, et al. “Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery.N Engl J Med 376, no. 21 (May 25, 2017): 2032–42. https://doi.org/10.1056/NEJMoa1616218.
Mehta RH, Leimberger JD, van Diepen S, Meza J, Wang A, Jankowich R, et al. Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery. N Engl J Med. 2017 May 25;376(21):2032–42.
Mehta, Rajendra H., et al. “Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery.N Engl J Med, vol. 376, no. 21, May 2017, pp. 2032–42. Pubmed, doi:10.1056/NEJMoa1616218.
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. N Engl J Med. 2017 May 25;376(21):2032–2042.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 25, 2017

Volume

376

Issue

21

Start / End Page

2032 / 2042

Location

United States

Related Subject Headings

  • Ventricular Dysfunction, Left
  • Treatment Failure
  • Stroke Volume
  • Simendan
  • Renal Replacement Therapy
  • Pyridazines
  • Postoperative Complications
  • Perioperative Period
  • Myocardial Infarction
  • Mortality