학술논문
Enoxaparin for thromboprophylaxis in hospitalized COVID-19 patients: The X-COVID-19 Randomized Trial.
Document Type
Academic Journal
Author
Morici N; Intensive Coronary Care Unit, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.; Podda G; Unità di Medicina 2, ASST Santi Paolo e Carlo, Milan, Italy.; Dipartimento di Scienze della Salute, Università Degli Studi di Milano, Milan, Italy.; Birocchi S; Unità di Medicina 2, ASST Santi Paolo e Carlo, Milan, Italy.; Bonacchini L; Emergency Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.; Merli M; Divisione di Malattie Infettive, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.; Trezzi M; Struttura Operativa Complessa (SOC) Malattie Infettive II, AUSL Toscana Centro, Ospedale San Jacopo, Pistoia, Italy.; Massaini G; Struttura Operativa Semplice (SOS) Chirurgia vascolare, AUSL Toscana Centro, Ospedale San Jacopo, Pistoia, Italy.; Agostinis M; Emergency Department, Ospedale San Carlo Borromeo, ASST Santi Paolo e Carlo, Milano, Italy.; Carioti G; Emergency Department, Ospedale San Carlo Borromeo, ASST Santi Paolo e Carlo, Milano, Italy.; Saverio Serino F; ASL 4 Veneto, Covid Hospital, Jesolo, Italy.; Gazzaniga G; Postgraduate School of Clinical Pharmacology and Toxicology, Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.; Barberis D; Intensive Coronary Care Unit, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.; Antolini L; Center of Bioinformatics, Biostatistics and Bioimaging, School of Medicine and Surgery, University of Milano Bicocca, Monza, Italy.; Grazia Valsecchi M; Center of Bioinformatics, Biostatistics and Bioimaging, School of Medicine and Surgery, University of Milano Bicocca, Monza, Italy.; Cattaneo M; Unità di Medicina 2, ASST Santi Paolo e Carlo, Milan, Italy.; Dipartimento di Scienze della Salute, Università Degli Studi di Milano, Milan, Italy.
Source
Publisher: Wiley Country of Publication: England NLM ID: 0245331 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2362 (Electronic) Linking ISSN: 00142972 NLM ISO Abbreviation: Eur J Clin Invest Subsets: MEDLINE
Subject
Language
English
Abstract
Background: It is uncertain whether higher doses of anticoagulants than recommended for thromboprophylaxis are necessary in COVID-19 patients hospitalized in general wards METHODS: This is a multicentre, open-label, randomized trial performed in 9 Italian centres, comparing 40 mg b.i.d. versus 40 mg o.d. enoxaparin in COVID-19 patients, between April 30 2020 and April 25 2021. Primary efficacy outcome was in-hospital incidence of venous thromboembolism (VTE): asymptomatic or symptomatic proximal deep vein thrombosis (DVT) diagnosed by serial compression ultrasonography (CUS), and/or symptomatic pulmonary embolism (PE) diagnosed by computed tomography angiography (CTA). Secondary endpoints included each individual component of the primary efficacy outcome and a composite of death, VTE, mechanical ventilation, stroke, myocardial infarction, admission to ICU. Safety outcomes included major bleeding.
Results: The study was interrupted prematurely due to slow recruitment. We included 183 (96%) of the 189 enrolled patients in the primary analysis (91 in b.i.d., 92 in o.d.). Primary efficacy outcome occurred in 6 patients (6.5%, 0 DVT, 6 PE) in the o.d. group and 0 in the b.id. group (ARR 6.5, 95% CI: 1.5-11.6). The absence of concomitant DVT and imaging characteristics suggests that most pulmonary artery occlusions were actually caused by local thrombi rather than PE. Statistically nonsignificant differences in secondary and safety endpoints were observed, with two major bleeding events in each arm.
Conclusions: No DVT developed in COVID-19 patients hospitalized in general wards, independently of enoxaparin dosing used for thromboprophylaxis. Pulmonary artery occlusions developed only in the o.d. group. Our trial is underpowered and with few events.
(© 2021 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.)
Results: The study was interrupted prematurely due to slow recruitment. We included 183 (96%) of the 189 enrolled patients in the primary analysis (91 in b.i.d., 92 in o.d.). Primary efficacy outcome occurred in 6 patients (6.5%, 0 DVT, 6 PE) in the o.d. group and 0 in the b.id. group (ARR 6.5, 95% CI: 1.5-11.6). The absence of concomitant DVT and imaging characteristics suggests that most pulmonary artery occlusions were actually caused by local thrombi rather than PE. Statistically nonsignificant differences in secondary and safety endpoints were observed, with two major bleeding events in each arm.
Conclusions: No DVT developed in COVID-19 patients hospitalized in general wards, independently of enoxaparin dosing used for thromboprophylaxis. Pulmonary artery occlusions developed only in the o.d. group. Our trial is underpowered and with few events.
(© 2021 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.)