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

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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)

 

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

High-dose anticoagulation can reduce deaths by 30 percent and intubations by 25 percent in hospitalized COVID-19 patients who are not critically ill when compared to the standard treatment, which is low-dose anticoagulation. These are the significant findings from the large-scale international "FREEDOM" trial, led by Valentin Fuster, MD, Ph.D., President of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital, and General Director of the Spanish National Center for Cardiovascular Research (CNIC).

The study results were announced Monday, March 6, in a Late Breaking Clinical Trial presentation at the American College of Cardiology Scientific Sessions Together with World Congress of Cardiology (ACC.23/WCC) in New Orleans and simultaneously published in the Journal of the American College of Cardiology.

"This is an important study for patients with COVID-19 who are sick enough to require hospitalization but not so ill as to require ICU management. In this group of patients with radiologic evidence of ARDS, therapeutic dose anticoagulation prevents disease progression, especially the need for intubation, and saves lives. This is especially important as COVID-19 is not going away. Even in the United States, the current number of daily deaths, although much lower than at the peak of the pandemic, is twice that compared with just one year ago. And in other countries COVID-19 is raging," says co-Principal Investigator Gregg W. Stone