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

被引：40

作者：

Stone, Gregg W. ^{[1
]}

Farkouh, Michael E. ^{[2
]}

Lala, Anuradha ^{[1
]}

Tinuoye, Elizabeth ^{[1
]}

Dressler, Ovidiu ^{[3
]}

Moreno, Pedro R. ^{[1
]}

Palacios, Igor F. ^{[4
]}

Goodman, Shaun G. ^{[5
,6
]}

Esper, Rodrigo B. ^{[7
]}

Abizaid, Alexandre ^{[8
]}

Varade, Deepak ^{[9
]}

Betancur, Juan F. ^{[10
]}

Ricalde, Alejandro ^{[11
]}

Payro, Gerardo ^{[12
]}

Castellano, Jose Maria ^{[13
]}

Hung, Ivan F. N. ^{[14
]}

Nadkarni, Girish N. ^{[1
,15
,16
]}

Giustino, Gennaro ^{[1
]}

Godoy, Lucas C.

Feinman, Jason ^{[1
]}

Camaj, Anton ^{[1
]}

Bienstock, Solomon W. ^{[1
]}

Furtado, Remo H. M. ^{[17
]}

Granada, Carlos ^{[18
,19
]}

Bustamante, Jessica ^{[1
]}

Peyra, Carlos ^{[1
]}

Contreras, Johanna ^{[1
]}

Owen, Ruth ^{[19
]}

Bhatt, Deepak L. ^{[1
]}

Pocock, Stuart J. ^{[19
]}

Fuster, Valentin ^{[20
]}

机构：

[1] Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, New York, NY USA

[2] Univ Toronto, Peter Munk Cardiac Ctr, Toronto, ON, Canada

[3] Cardiovasc Res Fdn, New York, NY USA

[4] Massachusetts Gen Hosp, Boston, MA USA

[5] Univ Toronto, St Michaels Hosp, Unity Heath, Toronto, ON, Canada

[6] Univ Alberta, Canadian VIGOUR Ctr, Edmonton, AB, Canada

[7] Prevent Senior Inst, Sao Paulo, SP, Brazil

[8] Univ Sao Paulo, Heart Inst InCor, Med Sch, Sao Paulo, Brazil

[9] BAJ RR Hosp, Mumbai, India

[10] Clin Medellin QuironSalud, Medellin, Colombia

[11] CITIC, Mexico City, Mexico

[12] Inst Nacl Ciencias Med & Nutr Salvador Zubiran, Mexico City, Mexico

[13] Hosp Univ Monterpincipe, Grp HM Hosp, Ctr Integral Enfermedades Cardiovasc CIEC, Madrid, Spain

[14] Univ Hong Kong, Hong Kong, Peoples R China

[15] Icahn Sch Med Mt Sinai, Charles Bronfman Inst Personalized Med, New York, NY USA

[16] Icahn Sch Med Mt Sinai, Div Data Driven & Digital Med, New York, NY USA

[17] Brazilian Clin Res Inst, Sao Paulo, Brazil

[18] CogenTech Med & Digital Innovat, Mahwah, NJ USA

[19] London Sch Hyg & Trop Med, London, England

[20] Ctr Nacl Invest Cardiovasc CNIC, Madrid, Spain

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2023年 / 81卷 / 18期

基金：

加拿大健康研究院;

关键词：

apixaban; coronavirus disease 2019; enoxaparin; prognosis; severe acute respiratory syndrome coronavirus 2;

D O I：

10.1016/j.jacc.2023.02.041

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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-1 9 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) (J Am Coll Cardiol 2023;81:1747-1762) (c) 2023 by the American College of Cardiology Foundation.

引用

页码：1747 / 1762

页数：16

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