Sivelestat may reduce the risk of acute respiratory distress syndrome in adults undergoing cardiac surgery

1. Sivelestat significantly reduced the incidence of postoperative acute respiratory distress syndrome (ARDS) compared to placebo in adult patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB).

Evidence Rating Level: 1 (Excellent)

ARDS is a common postoperative complication after cardiac surgery with CPB, with very high mortality rates. Neutrophil elastase (NE) is a key amplifier of pulmonary inflammation and has been implicated in the pathophysiology of ARDS. Sivelestat sodium, a selective NE inhibitor, is effective in treating ARDS. However, its role in reducing the risk of ARDS among patients after cardiovascular surgery requiring CPB is unknown. This randomized, placebo-controlled clinical trial evaluated the efficacy and safety of sivelestat. 382 patients aged 50-80 years scheduled for elective cardiac surgery requiring CPB were randomized to receive sivelestat (n = 190; mean [SD] age, 62.5 [6.0] years; 47.9% female) or placebo (n = 192; mean [SD] age, 63.3 [6.4] years; 42.2% female). The sivelestat group had significantly lower rates of ARDS (16.8% [32 of 190] vs 31.2% [60 of 192]; P < .001), and 90-day mortality (1.1% [2 of 190] vs 5.2% [10 of 192]; P = .02). There were significant reductions in multiple inflammatory markers across postoperative days 1 to 7 (systemic immune-inflammation index (SII; P = .009) (A), interleukin 6 (IL-6; P = .001) (B), neutrophil elastase (NE; P < .001) (C), interleukin 8 (IL-8; P = .012) (D), tumor necrosis factor (TNF; P = .03) (E), and procalcitonin (PCT; P = .001)). Furthermore, adverse events did not significantly differ between groups. Overall, sivelestat is effective at reducing the risk of ARDS and 90-day all-cause mortality.

Click here to read the study in JAMA Network Open

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