Enoxaparin for symptomatic COVID-19 managed in the ambulatory setting : an individual patient level analysis of the OVID and ETHIC trials / Stefano Barco, Saverio Virdone, Andrea Götschi, Walter Ageno, Juan I. Arcelus, Roland Bingisser, Giuseppe Colucci, Frank Cools, Daniel Duerschmied, Harry Gibbs, Riccardo M. Fumagalli, Bernhard Gerber, Sylvia Haas, Jelle C.L. Himmelreich, Richard Hobbs, Lukas Hobohm, Barry Jacobson, Gloria Kayani, Renato D. Lopes, Peter MacCallum, Evy Micieli, Marc Righini, Helia Robert-Ebadi, Ana Thereza Rocha, Thomas Rosemann, Jitendra Sawhney, Sebastian Schellong, Tim Sebastian, David Spirk, Stefan Stortecky, Alexander G. G. Turpie, Davide Voci, Nils Kucher, Karen Pieper, Ulrike Held, Ajay K. Kakkar, on behalf of the OVID and ETHIC investigators
Background - Antithrombotic treatment may improve the disease course in non-critically ill, symptomatic COVID-19 outpatients. - Methods - We performed an individual patient-level analysis of the OVID and ETHIC randomized controlled trials, which compared enoxaparin thromboprophylaxis for either 14 (OVID) or 21 days (ETHIC) vs. no thromboprophylaxis for outpatients with symptomatic COVID-19 and at least one additional risk factor. The primary efficacy outcome included all-cause hospitalization and all-cause death within 30 days from randomization. Both studies were prematurely stopped for futility. Secondary efficacy outcomes were major symptomatic venous thromboembolic events, arterial cardiovascular events, or their composite occurring within 30 days from randomization. The same outcomes were assessed over a 90-day follow-up. The primary safety outcome was major bleeding (ISTH criteria). - Results - A total of 691 patients were randomized: 339 to receive enoxaparin and 352 to the control group. Over 30-day follow-up, the primary efficacy outcome occurred in 6.0 % of patients in the enoxaparin group vs. 5.8 % of controls for a risk ratio (RR) of 1.05 (95%CI 0.57-1.92). The incidence of major symptomatic venous thromboembolic events and arterial cardiovascular events was 0.9 % vs. 1.8 %, respectively (RR 0.52; 95%CI 0.13-2.06). Most cardiovascular thromboembolic events were represented by symptomatic venous thromboembolic events, occurring in 0.6 % vs. 1.5 % of patients, respectively. A similar distribution of outcomes between the treatment groups was observed over 90 days. No major bleeding occurred in the enoxaparin group vs. one (0.3 %) in the control group. - Conclusions - We found no evidence for the clinical benefit of early administration of enoxaparin thromboprophylaxis in outpatients with symptomatic COVID-19. These results should be interpreted taking into consideration the relatively low occurrence of events..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
October 2023 2023 |
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| Erschienen: |
October 2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:230 |
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| Enthalten in: |
Thrombosis research - 230(2023) vom: Okt., Seite 27-32 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Barco, Stefano [VerfasserIn] |
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| Anmerkungen: |
Online verfügbar: 18. August 2023, Artikelversion: 23. August 2023 Gesehen am 15.11.2023 |
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| Umfang: |
Illustrationen 6 |
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| doi: |
10.1016/j.thromres.2023.08.009 |
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| 245 | 1 | 0 | |a Enoxaparin for symptomatic COVID-19 managed in the ambulatory setting |b an individual patient level analysis of the OVID and ETHIC trials |c Stefano Barco, Saverio Virdone, Andrea Götschi, Walter Ageno, Juan I. Arcelus, Roland Bingisser, Giuseppe Colucci, Frank Cools, Daniel Duerschmied, Harry Gibbs, Riccardo M. Fumagalli, Bernhard Gerber, Sylvia Haas, Jelle C.L. Himmelreich, Richard Hobbs, Lukas Hobohm, Barry Jacobson, Gloria Kayani, Renato D. Lopes, Peter MacCallum, Evy Micieli, Marc Righini, Helia Robert-Ebadi, Ana Thereza Rocha, Thomas Rosemann, Jitendra Sawhney, Sebastian Schellong, Tim Sebastian, David Spirk, Stefan Stortecky, Alexander G. G. Turpie, Davide Voci, Nils Kucher, Karen Pieper, Ulrike Held, Ajay K. Kakkar, on behalf of the OVID and ETHIC investigators |
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| 520 | |a Background - Antithrombotic treatment may improve the disease course in non-critically ill, symptomatic COVID-19 outpatients. - Methods - We performed an individual patient-level analysis of the OVID and ETHIC randomized controlled trials, which compared enoxaparin thromboprophylaxis for either 14 (OVID) or 21 days (ETHIC) vs. no thromboprophylaxis for outpatients with symptomatic COVID-19 and at least one additional risk factor. The primary efficacy outcome included all-cause hospitalization and all-cause death within 30 days from randomization. Both studies were prematurely stopped for futility. Secondary efficacy outcomes were major symptomatic venous thromboembolic events, arterial cardiovascular events, or their composite occurring within 30 days from randomization. The same outcomes were assessed over a 90-day follow-up. The primary safety outcome was major bleeding (ISTH criteria). - Results - A total of 691 patients were randomized: 339 to receive enoxaparin and 352 to the control group. Over 30-day follow-up, the primary efficacy outcome occurred in 6.0 % of patients in the enoxaparin group vs. 5.8 % of controls for a risk ratio (RR) of 1.05 (95%CI 0.57-1.92). The incidence of major symptomatic venous thromboembolic events and arterial cardiovascular events was 0.9 % vs. 1.8 %, respectively (RR 0.52; 95%CI 0.13-2.06). Most cardiovascular thromboembolic events were represented by symptomatic venous thromboembolic events, occurring in 0.6 % vs. 1.5 % of patients, respectively. A similar distribution of outcomes between the treatment groups was observed over 90 days. No major bleeding occurred in the enoxaparin group vs. one (0.3 %) in the control group. - Conclusions - We found no evidence for the clinical benefit of early administration of enoxaparin thromboprophylaxis in outpatients with symptomatic COVID-19. These results should be interpreted taking into consideration the relatively low occurrence of events. | ||
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