Kanagaratnam, P;
Francis, DP;
Chamie, D;
Coyle, C;
Marynina, A;
Katritsis, G;
Paiva, P;
Szigeti, M;
Cole, G;
de Andrade Nunes, D;
et al.
Kanagaratnam, P; Francis, DP; Chamie, D; Coyle, C; Marynina, A; Katritsis, G; Paiva, P; Szigeti, M; Cole, G; de Andrade Nunes, D; Howard, J; Esper, R; Khan, M; More, R; Barreto, G; Meneguz-Moreno, R; Arnold, A; Nowbar, A; Kaura, A; Mariveles, M; March, K; Shah, J; Nijjer, S; Lip, GYH; Mills, N; Camm, AJ; Cooke, GS; Corbett, SJ; Llewelyn, MJ; Ghanima, W; Toshner, M; Peters, N; Petraco, R; Al-Lamee, R; Boshoff, ASM; Durkina, M; Malik, I; Ruparelia, N; Cornelius, V; Shun-Shin, M
(2023)
A randomized controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalized with COVID-19: the COVID-19 Acute Coronary Syndrome trial.
J Thromb Haemost, 21 (8).
pp. 2213-2222.
ISSN 1538-7836
https://doi.org/10.1016/j.jtha.2023.04.045
SGUL Authors: Camm, Alan John
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Abstract
BACKGROUND: Patients hospitalized with COVID-19 suffer thrombotic complications. Risk factors for poor outcomes are shared with coronary artery disease. OBJECTIVES: To investigate the efficacy of an acute coronary syndrome regimen in patients hospitalized with COVID-19 and coronary disease risk factors. METHODS: A randomized controlled, open-label trial across acute hospitals (United Kingdom and Brazil) added aspirin, clopidogrel, low-dose rivaroxaban, atorvastatin, and omeprazole to standard care for 28 days. Primary efficacy and safety outcomes were 30-day mortality and bleeding. The key secondary outcome was a daily clinical status (at home, in hospital, on intensive therapy unit admission, or death). RESULTS: Three hundred twenty patients from 9 centers were randomized. The trial terminated early due to low recruitment. At 30 days, there was no significant difference in mortality (intervention vs control, 11.5% vs 15%; unadjusted odds ratio [OR], 0.73; 95% CI, 0.38-1.41; p = .355). Significant bleeds were infrequent and were not significantly different between the arms (intervention vs control, 1.9% vs 1.9%; p > .999). Using a Bayesian Markov longitudinal ordinal model, it was 93% probable that intervention arm participants were more likely to transition to a better clinical state each day (OR, 1.46; 95% credible interval [CrI], 0.88-2.37; Pr [beta > 0], 93%; adjusted OR, 1.50; 95% CrI, 0.91-2.45; Pr [beta > 0], 95%) and median time to discharge to home was 2 days shorter (95% CrI, -4 to 0; 2% probability that it was worse). CONCLUSION: Acute coronary syndrome treatment regimen was associated with a reduction in the length of hospital stay without an excess in major bleeding. A larger trial is needed to evaluate mortality.
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