Journal
NEW ENGLAND JOURNAL OF MEDICINE
Volume 385, Issue 9, Pages 777-789Publisher
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa2103417
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Funding
- European Union through FP7-HEALTH-2013-INNOVATION: the Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) consortium [602525]
- Horizon 2020 research and innovation program: the Rapid European Covid-19 Emergency Research response (RECOVER) consortium [101003589]
- Australian National Health and Medical Research Council [APP1101719, APP1116530]
- Health Research Council of New Zealand [16/631]
- Canadian Institutes of Health Research (Strategy for Patient-Oriented Research Innovative Clinical Trials Program) [158584]
- COVID-19 Rapid Research Operating Grant [447335]
- U.K. National Institute for Health Research (NIHR)
- NIHR Imperial Biomedical Research Centre
- Health Research Board of Ireland [CTN 2014-012]
- Translational Breast Cancer Research Consortium
- French Ministry of Health [PHRC-20-0147]
- Minderoo Foundation
- Amgen
- Global Coalition for Adaptive Research
- Wellcome Trust [215522]
- Canadian Institutes of Health Research [AR7162822]
- CancerCare Manitoba Foundation, Victoria General Hospital Foundation
- Ontario Ministry of Health
- Peter Munk Cardiac Centre
- National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) [OTA-20-011]
- NIH [1OT2HL156812-01]
- NIHR Research Professorship [RP-2015-06-18]
- Canada Research Chair-Tier 2
- Lyonel G. Israels Research Chair in Hematology (University of Manitoba)
- Health Research Board (HRB) [CTN-2014-012] Funding Source: Health Research Board (HRB)
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In critically ill patients with Covid-19, initial therapeutic-dose anticoagulation did not result in improved survival rates or fewer days requiring cardiovascular or respiratory organ support compared to usual-care pharmacologic thromboprophylaxis.
BACKGROUND Thrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19. METHODS In an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. RESULTS The trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeuticdose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio <1.2], 99.9%). The percentage of patients who survived to hospital discharge was similar in the two groups (62.7% and 64.5%, respectively; adjusted odds ratio, 0.84; 95% credible interval, 0.64 to 1.11). Major bleeding occurred in 3.8% of the patients assigned to therapeutic-dose anticoagulation and in 2.3% of those assigned to usual-care pharmacologic thromboprophylaxis. CONCLUSIONS In critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin did not result in a greater probability of survival to hospital discharge or a greater number of days free of cardiovascular or respiratory organ support than did usual-care pharmacologic thromboprophylaxis.
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