Levosimendan and postoperative NT-proBNP release in noncardiac surgery – a prospective, randomized, double-blinded, phase III trial

  1. Barbara Kabon
  2. Christian Reiterer
  3. Alexander Taschner
  4. Alexandra Graf
  5. Nikolas Adamowitsch
  6. Katharina Horvath
  7. David Emler
  8. Oliver Zotti
  9. Nicole Hantakova
  10. Beatrix Hochreiter
  11. Melanie Fraunschiel
  12. Theresa Clement
  13. Edith Fleischmann
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Abstract

Background: Postoperative elevated NT-proBNP concentrations are independently associated with cardiovascular complications and mortality after noncardiac surgery. Levosimendan significantly decreases the release of NT-proBNP, however, the effect in noncardiac surgical patients remains unknown. Thus, this study evaluates the effect of a perioperative levosimendan administration on postoperative maximum NT-proBNP. Methods: 230 cardiovascular risk patients undergoing moderate- to high-risk major noncardiac surgery were included in this prospective, double-blinded, parallel group, placebo-controlled, phase III trial, between October 2020 through November 2023. 115 patients were assigned to perioperative single-dose of 12.5mg starting with a rate of 0.2 mcg.kg -1 .min -1 of levosimendan and 115 patients were assigned to placebo. The primary outcome was postoperative maximum NT-proBNP concentration within the first three postoperative days. Secondary outcomes were MINS and maximum troponin T concentrations within the first three postoperative days. Results: Among 230 patients, 228 patients completed the trial. There was no significant difference in postoperative maximum NT-proBNP concentrations between the groups (effect estimate: -82.99ng.L -1 ; 95% CI -321.08 to 190.96; p=0.48). The incidence of MINS (p=0.063) and postoperative maximum troponin T (effect estimate: 0.45, 95% CI-1.66 to 3.41; p=0.728) concentrations within the first three postoperative days did not differ significantly between the groups. Conclusions: Levosimendan administration did not lead to a significantly lower release in postoperative NT-proBNP in cardiovascular risk patients undergoing major noncardiac surgery. There was no significant difference in MINS and postoperative Troponin T concentrations. The role of pre-emptive levosimendan as prophylactic treatment option in cardiovascular high-risk patients must be verified in large-scale trials.

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  1. Version published to 10.21203/rs.3.rs-5507267/v1 on Research Square