Nuccia Morici1, GianMarco Podda2,3, Simone Birocchi2, Luca Bonacchini4, Marco Merli5, Michele Trezzi6, Gianluca Massaini7, Marco Agostinis8, Giulia Carioti8, Francesco Saverio Serino9, Gianluca Gazzaniga10, Daniela Barberis1, Laura Antolini11, Maria Grazia Valsecchi11, Marco Cattaneo2,3. 1. Intensive Coronary Care Unit, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy. 2. Unità di Medicina 2, ASST Santi Paolo e Carlo, Milan, Italy. 3. Dipartimento di Scienze della Salute, Università Degli Studi di Milano, Milan, Italy. 4. Emergency Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy. 5. Divisione di Malattie Infettive, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy. 6. Struttura Operativa Complessa (SOC) Malattie Infettive II, AUSL Toscana Centro, Ospedale San Jacopo, Pistoia, Italy. 7. Struttura Operativa Semplice (SOS) Chirurgia vascolare, AUSL Toscana Centro, Ospedale San Jacopo, Pistoia, Italy. 8. Emergency Department, Ospedale San Carlo Borromeo, ASST Santi Paolo e Carlo, Milano, Italy. 9. ASL 4 Veneto, Covid Hospital, Jesolo, Italy. 10. Postgraduate School of Clinical Pharmacology and Toxicology, Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy. 11. Center of Bioinformatics, Biostatistics and Bioimaging, School of Medicine and Surgery, University of Milano Bicocca, Monza, Italy.
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.
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.
Authors: Francesco Poletto; Luca Spiezia; Chiara Simion; Elena Campello; Fabio Dalla Valle; Daniela Tormene; Giuseppe Camporese; Paolo Simioni Journal: Viruses Date: 2022-03-31 Impact factor: 5.818
Authors: Marc Blondon; Sara Cereghetti; Jérôme Pugin; Christophe Marti; Pauline Darbellay Farhoumand; Jean-Luc Reny; Alexandra Calmy; Christophe Combescure; Lucia Mazzolai; Olivier Pantet; Zied Ltaief; Marie Méan; Sara Manzocchi Besson; Séverin Jeanneret; Hans Stricker; Helia Robert-Ebadi; Pierre Fontana; Marc Righini; Alessandro Casini Journal: Res Pract Thromb Haemost Date: 2022-05-18
Authors: Sam Schulman; Michelle Sholzberg; Alex C Spyropoulos; Ryan Zarychanski; Helaine E Resnick; Charlotte A Bradbury; Lisa Broxmeyer; Jean Marie Connors; Anna Falanga; Toshiaki Iba; Scott Kaatz; Jerrold H Levy; Saskia Middeldorp; Tracy Minichiello; Eduardo Ramacciotti; Charles Marc Samama; Jecko Thachil Journal: J Thromb Haemost Date: 2022-07-29 Impact factor: 16.036