Key result
An acute coronary syndrome regimen did not significantly reduce 30-day mortality compared to standard care in patients hospitalized with COVID-19 (11.5% vs 15%; OR 0.73; 95% CI 0.38-1.41; p=0.355).
Why the study?
Patients hospitalized with COVID-19 suffer thrombotic complications and share risk factors for poor outcomes with coronary artery disease, leading investigators to examine the efficacy of an ACS regimen.
Does an acute coronary syndrome regimen reduce 30-day mortality and bleeding in patients hospitalized with COVID-19 and coronary disease risk factors?
RCT (n=320)
Open-label
randomized
Yes
Does an acute coronary syndrome regimen reduce 30-day mortality and bleeding in patients hospitalized with COVID-19 and coronary disease risk factors?
Odds Ratio: 0.73 (95% CI 0.38–1.41)
Absolute Event Rate: 11.5% vs 15%
p-value: p=0.355
An acute coronary syndrome regimen added to standard care for COVID-19 patients did not significantly reduce 30-day mortality but was associated with a shorter hospital stay without excess major bleeding.
No support for ACS regimen in hospitalized COVID-19; confirms neutral 30-day mortality effect in RCT.
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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Kanagaratnam et al. (2023) conducted an RCT in COVID-19 and coronary disease risk factors (n=320). Acute coronary syndrome regimen (aspirin, clopidogrel, low-dose rivaroxaban, atorvastatin, and omeprazole) vs. standard care was evaluated on 30-day mortality (OR 0.73, 95% CI 0.38-1.41, p=0.355). An acute coronary syndrome regimen did not significantly reduce 30-day mortality compared to standard care in patients hospitalized with COVID-19 (11.5% vs 15%; OR 0.73; 95% CI 0.38-1.41; p=0.355).
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