FREEDOM COVID: Therapeutic-Dose Anticoagulation Shows No Significant Composite Risk Reduction For Noncritical, Hospitalized COVID-19 Patients

Therapeutic-dose anticoagulation did not significantly reduce the combined risk of death from any cause, need of intensive care unit (ICU) treatment, a confirmed blood clot or stroke in noncritically ill patients hospitalized for COVID-19, but did lower rates of intubation and death, according to results from the FREEDOM COVID trial presented at ACC.23/WCC and simultaneously published in JACC.

Gregg W. Stone, MD, FACC, et al., enrolled 3,398 patients at 76 centers in 10 countries (average age 53 years, 60% male) hospitalized for COVID-19 but not requiring ICU care. Participants were randomized to receive prophylactic-dose enoxaparin (n=1,141), therapeutic-dose enoxaparin (n=1,136) or therapeutic-dose apixaban (n=1,121). The study's primary outcome was a 30-day composite of all-cause mortality, requirement for ICU level-of-care, systemic thromboembolism, or ischemic stroke comparing the therapeutic-dose groups to the prophylactic-dose group.

The primary endpoint was seen in 13.2% of prophylactic-dose patients and 11.3% in the therapeutic-dose groups (hazard ratio [HR], 0.85; 95% CI, 0.69-1.04; p=0.11), while all-cause mortality occurred in 7.0% vs. 4.9% of patients (HR, 0.70; 95% CI, 0.52-0.93; p=0.01) and intubation was required in 8.4% vs. 6.4% of patients respectively (HR, 0.75; 95% CI, 0.58-0.98; p=0.03).

Researchers noted that results were similar between the two therapeutic-dose groups while major bleeding in all groups was infrequent. Subgroup analyses also revealed that patients who showed early signs of COVID-19-related lung damage, like pulmonary infiltrates, in an admission X-ray or CT scan were less likely to die or experience another primary endpoint event if treated with the therapeutic-dose anticoagulant.

"Although our study did not reach its primary endpoint, it has shown that patients admitted to the hospital for COVID-19 who are not yet critically ill but who have early signs of lung damage caused by the virus appear to benefit from a higher dose of blood-thinning medication to stop disease progression, prevent the need for lung intubation and prevent death, without a significant increase in the risk of bleeding," said Valentin Fuster, MD, PhD, MACC, a co-author of the study.

Clinical Topics: Anticoagulation Management, COVID-19 Hub

Keywords: ACC Annual Scientific Session, ACC23, COVID-19, Blood Coagulation, Anticoagulants, Health Services

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