Anticoagulation Strategies in Non-Critically Ill Patients Hospitalized with COVID-19: A Randomized Clinical Trial, 2023, Stone et al

Anticoagulation Strategies in Non-Critically Ill Patients Hospitalized with COVID-19: A Randomized Clinical Trial
Gregg W. Stone ... Mercedes Villareal Garcia Lomas

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.


Link (Paywalled, Journal of the American College of Cardiology)

 

Discussed in High-dose anticoagulation can reduce intubations and improve survival for hospitalized COVID-19 patients