Zdroj: |
Kanagaratnam, P, Francis, D P, 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, G YH, Mills, N, Camm, A J, Cooke, G S, Corbett, S J, Llewelyn, M J, Ghanima, W, Toshner, M, Peters, N, Petraco, R, Al-Lamee, R, Boshoff, A S M, 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 ', Journal of Thrombosis and Haemostasis . https://doi.org/10.1016/j.jtha.2023.04.045 |
Popis: |
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. |