Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19
Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved..
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).
| Errataetall: |
CommentIn: J Am Coll Cardiol. 2023 May 9;81(18):1763-1765. - PMID 37137585 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:81 |
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| Enthalten in: |
Journal of the American College of Cardiology - 81(2023), 18 vom: 09. Mai, Seite 1747-1762 |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
Anticoagulants |
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| Anmerkungen: |
Date Completed 05.05.2023 Date Revised 17.08.2023 published: Print-Electronic ClinicalTrials.gov: NCT04512079 CommentIn: J Am Coll Cardiol. 2023 May 9;81(18):1763-1765. - PMID 37137585 Citation Status MEDLINE |
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| doi: |
10.1016/j.jacc.2023.02.041 |
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| PPN (Katalog-ID): |
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| 245 | 1 | 0 | |a Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19 |
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| 500 | |a Date Completed 05.05.2023 | ||
| 500 | |a Date Revised 17.08.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04512079 | ||
| 500 | |a CommentIn: J Am Coll Cardiol. 2023 May 9;81(18):1763-1765. - PMID 37137585 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: Prior studies of therapeutic-dose anticoagulation in patients with COVID-19 have reported conflicting results | ||
| 520 | |a OBJECTIVES: We sought to determine the safety and effectiveness of therapeutic-dose anticoagulation in noncritically ill patients with COVID-19 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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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| 650 | 4 | |a prognosis | |
| 650 | 4 | |a severe acute respiratory syndrome coronavirus 2 | |
| 650 | 7 | |a Enoxaparin |2 NLM | |
| 650 | 7 | |a Anticoagulants |2 NLM | |
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