Key result
Preoperative levosimendan did not significantly reduce 90-day mortality compared to placebo in a mixed surgical population with LV dysfunction (HR 0.73; 95% CI 0.41-1.28; P=0.27).
Why the study?
The effect of preoperative levosimendan on mortality in patients with LVEF ≤ 40% undergoing isolated CABG versus combined CABG and valve surgery was uncertain.
Does preoperative prophylactic levosimendan reduce mortality at day 90 in patients with LVEF ≤ 40% undergoing CABG?
Meta-Analysis (n=1,084)
Yes
Does preoperative prophylactic levosimendan reduce mortality at day 90 in patients with LVEF ≤ 40% undergoing CABG?
Preoperative levosimendan does not reduce 90-day mortality in a mixed surgical population with LV dysfunction, but may offer a survival benefit in patients undergoing isolated CABG.
OBJECTIVES: To assess the effect of preoperative levosimendan on mortality at day 90 in patients with left ventricular ejection fraction (LVEF) ≤ 40%, and to investigate a possible differential effect between patients undergoing isolated coronary artery bypass grafting (CABG) versus CABG combined with valve replacement surgery. DESIGN: Pooled analysis of two multicentre randomised controlled trials (RCT) investigating prophylactic levosimendan versus placebo prior to CABG surgery on mortality at day 90 in patients with LVEF ≤ 40%. A meta-analysis of all RCT investigating the same issue was also conducted. RESULTS: A cohort of 1084 patients (809 isolated CABG, and 275 combined surgery) resulted from the merging of LEVO-CTS and LICORN databases. Seventy-two patients were dead at day 90. The mortality at day 90 was not different between levosimendan and placebo (Hazard Ratio (HR): 0.73, 95% CI: 0.41-1.28, p = 0.27). However, there was a significant interaction between the type of surgery and the study drug (p = 0.004). We observed a decrease in mortality at day 90 in the isolated CABG subgroup (HR: 0.39, 95% CI: 0.19-0.82, p = 0.013), but not in the combined surgery subgroup (HR: 1.73, 95% CI: 0.77-3.92, p = 0.19). The meta-analysis of 6 RCT involving 1441 patients confirmed the differential effect on mortality at day 30 between the 2 subgroups. CONCLUSIONS: Preoperative levosimendan did not reduce mortality in a mixed surgical population with LV dysfunction. However, the subgroup of patients undergoing isolated CABG had a reduction in mortality at day 90, whereas there was no significant effect in combined surgery patients. This finding requires confirmation with a specific prospective trial.
No takes yet. Share an insight, caveat, or question.
Caruba et al. (2022) conducted a meta-analysis in Left ventricular ejection fraction ≤ 40% undergoing coronary artery bypass grafting (n=1,084). Prophylactic levosimendan vs. Placebo was evaluated on Mortality at day 90 (HR 0.73, 95% CI 0.41-1.28, p=0.27). Preoperative levosimendan did not significantly reduce 90-day mortality compared to placebo in a mixed surgical population with LV dysfunction (HR 0.73; 95% CI 0.41-1.28; P=0.27).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: