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.
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Kanagaratnam Prapa, Francis Darrel P, Chamie Daniel, Coyle Clare, Marynina Alena, Katritsis George, Paiva Patricia, Szigeti Matyas, Cole Graham, de Andrade Nunes David, Howard James, Esper Rodrigo, Khan Masood, More Ranjit, Barreto Guilherme, Meneguz-Moreno Rafael, Arnold Ahran, Nowbar Alexandra, Kaura Amit, Mariveles Myril, March Katherine, Shah Jaymin, Nijjer Sukhjinder, Lip Gregory Y H, Mills Nicholas, Camm A John, Cooke Graham S, Corbett Simon J, Llewelyn Martin J, Ghanima Waleed, Toshner Mark, Peters Nicholas, Petraco Ricardo, Al-Lamee Rasha, Boshoff Ana Sousa Marcelino, Durkina Margarita, Malik Iqbal, Ruparelia Neil, Cornelius Victoria, Shun-Shin Matthew
Аннотация
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.