Low-molecular-weight heparin for the prevention of clinical worsening in severe non-critically ill COVID-19 patients: a joint analysis of two randomized controlled trials.

Autor: Wu MA; Division of Internal Medicine, Department of Biomedical and Clinical Sciences, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy. maddalena.ale.wu@gmail.com., Del GIovane C; Department of Medical and Surgical Sciences for Children and Adults, University-Hospital of Modena and Reggio Emilia, Modena, Italy.; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.; Unità di Supporto Statistico Metodologico per la Ricerca Clinica Azienda Ospedaliero-Universitaria di Modena, Modena, Italy., Colombo R; Division of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy., Dolci G; Infectious Diseases Unit, University of Modena and Reggio Emilia, Modena, Italy., Arquati M; Columbus Center Clinic, Milan, Italy., Vicini R; Unità di Supporto Statistico Metodologico per la Ricerca Clinica Azienda Ospedaliero-Universitaria di Modena, Modena, Italy., Russo U; Division of Haematology, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy., Ruggiero D; Division of Cardiology, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy., Coluccio V; Hematology Unit, Azienda Ospedaliero-Universitaria, Modena, Italy., Taino A; Division of Internal Medicine, Department of Biomedical and Clinical Sciences, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy., Franceschini E; Infectious Diseases Unit, University of Modena and Reggio Emilia, Modena, Italy., Facchinetti P; Division of Internal Medicine, Department of Biomedical and Clinical Sciences, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy., Mighali P; Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy., Trombetta L; Division of Internal Medicine, Department of Biomedical and Clinical Sciences, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy., Tonelli F; Division of Internal Medicine, Department of Biomedical and Clinical Sciences, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy., Gabiati C; Division of Internal Medicine, Department of Biomedical and Clinical Sciences, ASST Fatebenefratelli Sacco, Fatebenefratelli Hospital, University of Milan, Milan, Italy., Cogliati C; Division of Internal Medicine, Department of Biomedical and Clinical Sciences, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy., D'Amico R; Department of Medical and Surgical Sciences for Children and Adults, University-Hospital of Modena and Reggio Emilia, Modena, Italy.; Unità di Supporto Statistico Metodologico per la Ricerca Clinica Azienda Ospedaliero-Universitaria di Modena, Modena, Italy., Marietta M; Hematology Unit, Azienda Ospedaliero-Universitaria, Modena, Italy.
Jazyk: angličtina
Zdroj: Internal and emergency medicine [Intern Emerg Med] 2024 Jan; Vol. 19 (1), pp. 71-79. Date of Electronic Publication: 2023 Oct 04.
DOI: 10.1007/s11739-023-03439-w
Abstrakt: Coronavirus disease 2019 (COVID-19) carries a high risk of vascular thrombosis. However, whether a specific anticoagulation intensity strategy may prevent clinical worsening in severe COVID-19 patients is still debated. We conducted a joint analysis of two randomized controlled trials, COVID-19 HD (NCT044082359) and EMOS-COVID (NCT04646655), to assess the efficacy and safety of two anticoagulant regimens in hospitalized severe COVID-19 patients. Subjects with COVID-19-associated respiratory compromise and/or coagulopathy were randomly assigned to low (4000 IU qd) or high (70 IU Kg -1 every 12 h) enoxaparin dose. The primary efficacy endpoint was clinical worsening within 30 days, defined as the occurrence of at least one of the following events, whichever came first: in-hospital death, evidence of arterial or venous thromboembolism, acute myocardial infarction, need for either continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) in patients receiving standard oxygen therapy or none at randomization, and need for mechanical ventilation in any patient. The safety endpoint was major bleeding. We estimated the relative risk (RR) and its 95% confidence interval (CI) for the outcomes. Among 283 patients included in the study (144 in the low-dose and 139 in the high-dose group), 118 (41.7%) were on NIV or CPAP at randomization. 23/139 (16.5%) patients in the high-dose group reached the primary endpoint compared to 33/144 (22.9%) in the low-dose group (RR 0.72, 95% CI 0.45-1.17). No major bleeding was observed. No significant differences were found in the clinical worsening of hospitalized COVID-19 patients treated with high versus low doses of enoxaparin.
(© 2023. The Author(s), under exclusive licence to Società Italiana di Medicina Interna (SIMI).)
Databáze: MEDLINE
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