Original Article
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

https://doi.org/10.1016/j.jtha.2023.04.045Get rights and content
Under a Creative Commons license
open access

Essentials

  • Thrombosis is often found in patients hospitalized with COVID-19, and risk factors for poor prognosis are shared with coronary artery disease.

  • In a multinational randomized controlled trial, we tested if the addition of standard acute coronary syndrome therapy in 320 hospitalized patients with COVID-19 and cardiovascular risk factors improved clinical outcomes.

  • No significant reduction in mortality was found with therapy.

  • There was modest evidence of a reduction in the length of hospital stay without an increase in major bleeding.

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.

Keywords

anticoagulant agent
antiplatelet agent
COVID-19 infection
ischemic heart disease
randomized controlled trial
thrombosis

Cited by (0)

Funding information Coronary Flow Charitable Trust and Imperial College COVID-19 fund.

Manuscript handled by: Jean Connors

Final decision: Jean Connors, 01 May 2023