AUTHOR=Russo Vincenzo , Cardillo Giuseppe , Viggiano Giuseppe Vito , Mangiacapra Sara , Cavalli Antonella , Fontanella Andrea , Agrusta Federica , Bellizzi Annamaria , Amitrano Maria , Iannuzzo Mariateresa , Sacco Clara , Lodigiani Corrado , Castaldo Giampiero , Di Micco Pierpaolo 

TITLE=Thromboprofilaxys With Fondaparinux vs. Enoxaparin in Hospitalized COVID-19 Patients: A Multicenter Italian Observational Study

JOURNAL=Frontiers in Medicine

VOLUME=7

YEAR=2020

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2020.569567

DOI=10.3389/fmed.2020.569567

ISSN=2296-858X

ABSTRACT=<p><bold>Importance:</bold> The use of anticoagulant therapy with heparins decreased mortality in hospitalized patients with severe coronavirus disease 2019 (COVID-19). Even if enoxaparin and fondaparinux have the same clinical indication for venous thromboembolism (VTE) prevention; to date, there are no data about the use of fondaparinux in terms of safety, effectiveness, and impact on clinical prognosis among COVID-19 patients.</p><p><bold>Objective:</bold> To evaluate the safety, effectiveness, and clinical impact of VTE prophylaxis with fondaparinux and enoxaparin among COVID-19 patients hospitalized in internal medicine units.</p><p><bold>Design, Setting, and Participants:</bold> This was a retrospective multicenter observation study, including consecutive symptomatic patients with laboratory-proven COVID-19 admitted to internal medicine units of five Italian hospitals from 15th February to 15th March 2020.</p><p><bold>Main Outcomes and Measures:</bold> The primary safety outcome was the composite of major bleeding and clinically relevant non-major bleeding; the primary effectiveness outcome was the composite of all events classified as pulmonary embolism and deep venous thrombosis. The secondary effectiveness outcome included acute respiratory distress syndrome and all-cause death.</p><p><bold>Results:</bold> Among 120 COVID-19 patients enrolled in the study, 74 were taking enoxaparin (4,000 or 6,000 units/day) and 46 fondaparinux (2.5 units/day). No statistically significant difference in demographic and laboratory and clinical characteristics between the two groups has been shown. During a median follow-up of 32 (interquartile range: 14–51) days, the cumulative incidence rates of VTE and bleeding events on pharmacological thromboprophylaxis with heparins were 19% and 8%, respectively. The incidence of both VTE (6.5 vs. 13.5%; <italic>P</italic> = 0.36) and bleeding events (6.5 vs. 4.1%; <italic>P</italic> = 0.68) did not show a significant difference between COVID-19 patients on fondaparinux compared with those on enoxaparin therapy. The regression model for the risk of outcome events according to different VTE prophylaxis drugs did not show significant differences.</p><p><bold>Conclusions and Relevance:</bold> Although these results need confirmation by prospective studies including a larger population, our study provides preliminary evidence of a safe and efficacy use of fondaparinux for VTE prophylaxis in hospitalized COVID-19 patients.</p>