Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19

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 noncritically ill patients with COVID-19. METHODS: Patients hospitalized w...

Descripción completa

Detalles Bibliográficos
Autores principales: Stone, Gregg W., Farkouh, Michael E., Lala, Anuradha, Tinuoye, Elizabeth, Dressler, Ovidiu, Moreno, Pedro R., Palacios, Igor F., Goodman, Shaun G., Esper, Rodrigo B., Abizaid, Alexandre, Varade, Deepak, Betancur, Juan F., Ricalde, Alejandro, Payro, Gerardo, Castellano, José María, Hung, Ivan F.N., Nadkarni, Girish N., Giustino, Gennaro, Godoy, Lucas C., Feinman, Jason, Camaj, Anton, Bienstock, Solomon W., Furtado, Remo H.M., Granada, Carlos, Bustamante, Jessica, Peyra, Carlos, Contreras, Johanna, Owen, Ruth, Bhatt, Deepak L., Pocock, Stuart J., Fuster, Valentin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: by the American College of Cardiology Foundation. Published by Elsevier. 2023
Materias:
Original Investigation
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9987252/
https://www.ncbi.nlm.nih.gov/pubmed/36889611
http://dx.doi.org/10.1016/j.jacc.2023.02.041
Descripción
Sumario: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 noncritically ill patients with COVID-19. METHODS: Patients hospitalized with COVID-19 not requiring intensive care unit 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 intensive care unit–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, 3,398 noncritically ill patients hospitalized with COVID-19 were randomized to prophylactic-dose enoxaparin (n = 1,141), therapeutic-dose enoxaparin (n = 1,136), or therapeutic-dose apixaban (n = 1,121) 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: 0.69-1.04; 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: 0.52-0.93; 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). Results were similar in the 2 therapeutic-dose groups, and major bleeding in all 3 groups was infrequent. CONCLUSIONS: Among noncritically 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 and fewer died (FREEDOM COVID [FREEDOM COVID Anticoagulation Strategy]; NCT04512079)

Ejemplares similares