The following is a summary of “Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19,” published in the May 2023 issue of Cardiology by Stone, et al.
Previous studies investigating the use of therapeutic-dose anticoagulation in patients with COVID-19 have produced conflicting results. For a study, researchers sought to assess the safety and effectiveness of therapeutic-dose anticoagulation in noncritically ill patients with COVID-19.
Noncritically ill patients hospitalized with COVID-19, who did not require intensive care unit (ICU) treatment, were enrolled in the randomized controlled trial. They were assigned to receive either prophylactic-dose enoxaparin, therapeutic-dose enoxaparin, or therapeutic-dose apixaban. The primary outcome measure was a composite of all-cause mortality, ICU-level care requirement, systemic thromboembolism, or ischemic stroke within 30 days, assessed in the combined therapeutic-dose groups compared to the prophylactic-dose group.
Between August 26, 2020, and September 19, 2022, 3,398 noncritically ill patients hospitalized with COVID-19 were randomized across 76 centers in 10 countries. Among them, 1,141 received prophylactic-dose enoxaparin, 1,136 therapeutic-dose enoxaparin, and 1,121 therapeutic-dose apixaban.
The primary composite outcome occurred in 13.2% of patients in the prophylactic-dose group and 11.3% in the combined therapeutic-dose groups (hazard ratio [HR]: 0.85; 95% CI: 0.69-1.04; P = 0.11). The incidence of all-cause mortality was 7.0% in the prophylactic-dose group compared to 4.9% in the therapeutic-dose anticoagulation group (HR: 0.70; 95% CI: 0.52-0.93; P = 0.01). Additionally, intubation was required in 8.4% of patients in the prophylactic-dose group compared to 6.4% in the therapeutic-dose anticoagulation group (HR: 0.75; 95% CI: 0.58-0.98; P = 0.03). The results were similar between the two therapeutic-dose groups, and major bleeding events were infrequent in all three groups.
In noncritically ill patients hospitalized with COVID-19, therapeutic-dose anticoagulation did not significantly reduce the primary composite outcome at 30 days compared to prophylactic-dose anticoagulation. However, fewer patients who received therapeutic-dose anticoagulation required intubation, and there was a lower incidence of mortality.
Source: jacc.org/doi/10.1016/j.jacc.2023.02.041
