Sivelestat helps mitigate ARDS risk in cardiovascular procedures

Treatment with sivelestat in patients undergoing cardiovascular procedures appears to lower the incidence of acute respiratory distress syndrome (ARDS) and all-cause mortality, as reported in a study.

The study included 424 consecutive patients scheduled to undergo coronary artery bypass grafting, valve surgery, ascending aortic reconstruction, combined procedures, congenital heart defect repairs, or cardiac tumour resection.

The patients were randomly assigned to treatment with continuous infusion of sivelestat (0.2 mg/kg/h) or volume-matched 0.9% sodium chloride placebo. In both groups, treatment was initiated immediately on ICU admission after the procedure and continued for up to 7 days or until ICU discharge.

ARDS was the primary outcome. Other outcomes included serial measurements of inflammatory biomarkers, including interleukin 6 and interleukin 8, tumour necrosis factor, systemic immune-inflammation index, and serum neutrophil elastase, on postoperative days 1, 3, 5, and 7. ARDS-related clinical outcomes such as death, pneumonia, and reintubation were also assessed.

A total of 382 patients completed the trial (mean age 62.9 years, 55 percent male). The incidence of adverse events did not significantly differ between the two treatment groups.

ARDS occurred less frequently in the sivelestat group than in the placebo group (16.8 percent vs 31.2 percent; p<0.001). At the same time, the sivelestat group had lower 90-day all-cause mortality (1.1 percent vs 5.2 percent; p=0.02).

Circulating levels of postoperative inflammatory biomarkers, including neutrophil elastase and interleukin 6, were significantly lower in the sivelestat vs the placebo group.