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Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19.
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.
  • Stone GW; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • Farkouh ME; Peter Munk Cardiac Centre, University of Toronto, Toronto, Ontario, Canada.
  • Lala A; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • Tinuoye E; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • Dressler O; Cardiovascular Research Foundation, New York, New York, USA.
  • Moreno PR; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • Palacios IF; Massachusetts General Hospital, Boston, Massachusetts, USA.
  • Goodman SG; St Michael's Hospital, Unity Heath, University of Toronto, Toronto, Ontario, Canada; Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
  • Esper RB; Prevent Senior Institute, São Paulo, São Paulo, Brazil.
  • Abizaid A; Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil.
  • Varade D; BAJ RR Hospital, Mumbai, India.
  • Betancur JF; Clínica Medellín QuirónSalud, Medellín, Colombia.
  • Ricalde A; CITIC, Mexico City, Mexico.
  • Payro G; Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran, Mexico City, Mexico.
  • Castellano JM; Centro Integral de Enfermedades Cardiovasculares (CIEC), Hospital Universitario Monterpincipe, Grupo HM Hospitales, Madrid, Spain.
  • Hung IFN; The University of Hong Kong, Hong Kong.
  • Nadkarni GN; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; The Charles Bronfman Institute of Personalized Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Division of Data Driven and Digital Medicine, Icahn Sc
  • Giustino G; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • Godoy LC; Peter Munk Cardiac Centre, University of Toronto, Toronto, Ontario, Canada.
  • Feinman J; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • Camaj A; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • Bienstock SW; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • Furtado RHM; Brazilian Clinical Research Institute, São Paulo, Brazil.
  • Granada C; CogenTech Medical and Digital Innovation, Mahwah, New Jersey, USA.
  • Bustamante J; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • Peyra C; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • Contreras J; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • Owen R; London School of Hygiene and Tropical Medicine, London, United Kingdom.
  • Bhatt DL; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • Pocock SJ; London School of Hygiene and Tropical Medicine, London, United Kingdom.
  • Fuster V; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain. Electronic address: valentin.fuster@mountsinai.org.
J Am Coll Cardiol ; 81(18): 1747-1762, 2023 05 09.
Article in English | MEDLINE | ID: covidwho-2304226
ABSTRACT

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).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thromboembolism / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: J Am Coll Cardiol Year: 2023 Document Type: Article Affiliation country: J.jacc.2023.02.041

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thromboembolism / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: J Am Coll Cardiol Year: 2023 Document Type: Article Affiliation country: J.jacc.2023.02.041