AspIrin does not reduce the risk of ARDS

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In a recent study, Dr Daryl J Kor, of the Mayo Clinic, Rochester, and colleagues evaluated the efficacy and safety of early aspirin administration for the prevention of acute respiratory distress syndrome (ARDS). The study is being released to coincide with its presentation at the American Thoracic Society International Conference.

Acute respiratory distress syndrome remains a life-threatening critical care syndrome. The median time to onset of ARDS is 2 days after hospital presentation. The period between hospital presentation and development of ARDS presents a brief window for possible prevention. ARDS is viewed as an inflammatory condition. Observational studies have suggested a potential preventive role for anti-platelet therapy in patients at high risk for ARDS.

Kor and colleagues randomly assigned patients at risk for ARDS (based on a lung injury prediction score) administration of aspirin (n = 195) or placebo (n = 195) within 24 hours of emergency department presentation and continued to hospital day 7, discharge, or death. The study was conducted at 16 US academic hospitals.

The researchers found that the administration of aspirin, compared with placebo, did not significantly reduce the incidence of ARDS at 7 days (20 patients [10.3%)] in the aspirin group vs 17 patients [8.7%] in the placebo group). No significant differences were seen in secondary outcomes or adverse events, such as ventilator-free days, hospital and intensive care unit length of stay, 28-day and 1-year survival.

“The findings of this phase 2b trial do not support continuation to a larger phase 3 trial,” the authors write.

Abstract
Importance: Management of acute respiratory distress syndrome (ARDS) remains largely supportive. Whether early intervention can prevent development of ARDS remains unclear.
Objective: To evaluate the efficacy and safety of early aspirin administration for the prevention of ARDS.
Design, Setting, and Participants: A multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 16 US academic hospitals. Between January 2, 2012, and November 17, 2014, 7673 patients at risk for ARDS (Lung Injury Prediction Score ≥4) in the emergency department were screened and 400 were randomized. Ten patients were excluded, leaving 390 in the final modified intention-to-treat analysis cohort.
Interventions: Administration of aspirin, 325-mg loading dose followed by 81 mg/d (n = 195) or placebo (n = 195) within 24 hours of emergency department presentation and continued to hospital day 7, discharge, or death.
Main Outcomes and Measures: The primary outcome was the development of ARDS by study day 7. Secondary measures included ventilator-free days, hospital and intensive care unit length of stay, 28-day and 1-year survival, and change in serum biomarkers associated with ARDS. A final α level of .0737 (α = .10 overall) was required for statistical significance of the primary outcome.
Results: Among 390 analyzed patients (median age, 57 years; 187 [48%] women), the median (IQR) hospital length of stay was 6 3-10) days. Administration of aspirin, compared with placebo, did not significantly reduce the incidence of ARDS at 7 days (10.3% vs 8.7%, respectively; odds ratio, 1.24 [92.6% CI, 0.67 to 2.31], P = .53). No significant differences were seen in secondary outcomes: ventilator-free to day 28, mean (SD), 24.9 (7.4) days vs 25.2 (7.0) days (mean [90% CI] difference, −0.26 [−1.46 to 0.94] days; P = .72); ICU length of stay, mean (SD), 5.2 (7.0) days vs 5.4 (7.0) days (mean [90% CI] difference, −0.16 [−1.75 to 1.43] days; P = .87); hospital length of stay, mean (SD), 8.8 (10.3) days vs 9.0 (9.9) days (mean [90% CI] difference, −0.27 [−1.96 to 1.42] days; P = .79); or 28-day survival, 90% vs 90% (hazard ratio [90% CI], 1.03 [0.60 to 1.79]; P = .92) or 1-year survival, 73% vs 75% (hazard ratio [90% CI] ,1.06 [0.75 to 1.50]; P = .79). Bleeding-related adverse events were infrequent in both groups (aspirin vs placebo, 5.6% vs 2.6%; odds ratio [90% CI], 2.27 [0.92 to 5.61]; P = .13).
Conclusions and Relevance: Among at-risk patients presenting to the ED, the use of aspirin compared with placebo did not reduce the risk of ARDS at 7 days. The findings of this phase 2b trial do not support continuation to a larger phase 3 trial.

JAMA material
JAMA abstract
JAMA editorial


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