Anticoagulation Strategies in Non-Critically Ill Patients Hospitalized with COVID-19: A Randomized Clinical Trial

Link to article at PubMed

J Am Coll Cardiol. 2023 Feb 27:S0735-1097(23)04527-8. doi: 10.1016/j.jacc.2023.02.041. Online ahead of print.


BACKGROUND: Prior studies of therapeutic-dose anticoagulation in patients with COVID-19 have reported conflicting results.

OBJECTIVES: We sought to determine the safety and effectiveness of therapeutic-dose anticoagulation in non-critically ill patients with COVID-19.

METHODS: Patients hospitalized with COVID-19 not requiring intensive care unit (ICU) treatment were randomized to prophylactic-dose enoxaparin, therapeutic-dose enoxaparin, or therapeutic-dose apixaban. The primary outcome was the 30-day composite of all-cause mortality, requirement for ICU level-of-care, systemic thromboembolism, or ischemic stroke assessed in the combined therapeutic-dose groups compared with the prophylactic-dose group.

RESULTS: Between August 26, 2020, and September 19, 2022, 3398 non-critically ill patients hospitalized with COVID-19 were randomized to prophylactic-dose enoxaparin (n=1141), therapeutic-dose enoxaparin (n=1136) or therapeutic-dose apixaban (n=1121) at 76 centers in 10 countries. The 30-day primary outcome occurred in 13.2% of patients in the prophylactic-dose group and 11.3% of patients in the combined therapeutic-dose groups (HR 0.85; 95% CI 0.69 to 1.04; p=0.11). All-cause mortality occurred in 7.0% of patients treated with prophylactic-dose enoxaparin and 4.9% of patients treated with therapeutic-dose anticoagulation (HR 0.70; 95% CI 0.52 to 0.93; p=0.01), and intubation was required in 8.4% vs. 6.4% of patients respectively (HR 0.75; 95% CI 0.58 to 0.98; p=0.03). Results were similar in the two therapeutic-dose groups, and major bleeding in all three groups was infrequent.

CONCLUSIONS: Among non-critically ill patients hospitalized with COVID-19, the 30-day primary composite outcome was not significantly reduced with therapeutic-dose anticoagulation compared with prophylactic-dose anticoagulation. However, fewer patients who were treated with therapeutic-dose anticoagulation required intubation or died.

PMID:36889611 | PMC:PMC9987252 | DOI:10.1016/j.jacc.2023.02.041

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