Enoxaparin for symptomatic COVID-19 managed in the ambulatory setting: An individual patient level analysis of the OVID and ETHIC trials.
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Barco Stefano, Virdone Saverio, Götschi Andrea, Ageno Walter, Arcelus Juan I, Bingisser Roland, Colucci Giuseppe, Cools Frank, Duerschmied Daniel, Gibbs Harry, Fumagalli Riccardo M, Gerber Bernhard, Haas Sylvia, Himmelreich Jelle C L, Hobbs Richard, Hobohm Lukas, Jacobson Barry, Kayani Gloria, Lopes Renato D, MacCallum Peter, Micieli Evy, Righini Marc, Robert-Ebadi Helia, Rocha Ana Thereza, Rosemann Thomas, Sawhney Jitendra, Schellong Sebastian, Sebastian Tim, Spirk David, Stortecky Stefan, Turpie Alexander G G, Voci Davide, Kucher Nils, Pieper Karen, Held Ulrike, Kakkar Ajay K, OVID and ETHIC Investigators
Аннотация
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.