Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19
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Résumé
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 therapeutic-dose 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. (REMAP-CAP, ACTIV-4a, and ATTACC ClinicalTrials.gov numbers, NCT02735707, NCT04505774, NCT04359277, and NCT04372589.).
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La notice
- Revue
- New England Journal of Medicine
- Thématique
- COVID-19 Clinical Research Studies
- Domaine
- Medicine
- Établissements canadiens
- —
- Organismes subventionnaires
- Children's Hospital of PittsburghNational Center for Advancing Translational SciencesNational Health and Medical Research CouncilMedical Research CouncilUniversity of California, San DiegoMedical Center, University of PittsburghUniversity of California, Los AngelesSchool of Medicine, University of KansasUniversity of Illinois at Urbana-ChampaignNational Institutes of HealthFiona Stanley HospitalLarner College of Medicine, University of VermontUniversidade Federal de Mato Grosso do SulKing Abdullah International Medical Research CenterUniversitätsklinikum JenaRadboud Universitair Medisch CentrumNational Heart, Lung, and Blood InstituteCentre Hospitalier Universitaire de QuébecInstituto Mexicano del Seguro SocialNIHR Imperial Biomedical Research CentreEisaiFP7 HealthImperial College LondonUniversity of AlbertaUniversity of TorontoUniversiteit UtrechtQueen's UniversityFlinders UniversitySchool of Medicine, Stanford UniversityUniversity of AucklandHealth Research BoardUniversity of BristolMcMaster UniversityTranslational Breast Cancer Research ConsortiumUniversity of OxfordCleveland ClinicLondon School of Hygiene and Tropical MedicineYork UniversityWellcome TrustOchsner HealthEuropean CommissionInselspital, Universitätsspital BernUniversity of California, San FranciscoLifeArcNational Institute for Health and Care ResearchNHS Blood and TransplantMcGill UniversityUniversity College DublinUniversity College LondonKing Saud bin Abdulaziz University for Health ScienceResearch ManitobaImperial College Healthcare NHS TrustUniversité de SherbrookeUniversiteit van AmsterdamUniversity of VermontMassachusetts General HospitalQueen's University BelfastCanadian Institutes of Health ResearchUniversity Hospitals Bristol NHS Foundation TrustUniversiteit AntwerpenUniversity of ManitobaAix-Marseille UniversitéUniversity of BernNational Institute of General Medical SciencesMassachusetts Medical SocietyUniversity of ChicagoUniversity of OttawaHealth Research Council of New ZealandUniversity of PittsburghUniversity of CincinnatiMonash UniversityUniversité LavalBrigham and Women's HospitalUniversité de Versailles Saint-Quentin-en-YvelinesUniversity of MichiganUniversity of British ColumbiaRadboud UniversiteitMinderoo FoundationAmgen
- Mots-clés
- Interquartile rangeMedicineOdds ratioConfidence intervalRandomized controlled trialInternal medicineRegimenIntensive care unitIntensive care medicine
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