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.

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.

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interests P.K. receives research grants and consulting fees from Biosense-Webster, Abbott-Medical, Medtronic, and Boston Scientific. A patent for Ripple Mapping is licensed to Biosense-Webster, and royalties are paid to Imperial College. C.C. is the recipient of a British Heart Foundation Clinical Research Training Fellowship (number FS/20/14/34917). A.A. has had support to attend conferences from Bayer. A.N. received a research grant from the NIHR Academy. S.N. received payment or honoraria for speaker events/presentations from Bayer, Pfizer, and Philips and participates on an Advisory Board for Astra Zeneca. G.Y.H.L. is a consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, and Daiichi Sankyo. No fees are received personally. N.M. is supported by a Chair Award, Program Grant, and Research Excellence Award (CH/F/21/90010, RG/20/10/34966, and RE/18/5/34216, respectively) from the British Heart Foundation. A.J.C. reports personal fees/consulting fees from Bayer, Pfizer, BMS, Daiichi Sankyo, and Boehringer Ingelheim; reports royalties and/or editorial fees from Oxford University Press, Wiley, and Springer Verlag; and participates on DSMBs/Advisory Boards at Biotronik, Johnson and Johnson, and Allergan. G.S.C. receives grants from the NIHR, participates on DSMBs, and is a nonexecutive director at the MHRA. W.G. reports fees for participation in Advisory Board from Amgen, Novartis, Pfizer, Principia Biopharma Inc—a Sanofi Company, Sanofi, SOBI, Grifols, UCB, Argenx, Cellphire, and Hutchmed; lecture honoraria from Amgen, Novartis, Pfizer, Bristol Myers Squibb, SOBI, Grifols, and Sanofi; and research grants from Bayer and BMS/Pfizer. M.T. reports Scientific Advisory Board personal fees from MorphogenIX and personal fees/honoraria from J&J/Actelion. R.A.-L. receives speaker’s honoraria from Philips Volcano, Medtronic, and Menarini. M.S.-S. has received honoraria from Pfizer (<£500). D.P.F., D.C., A.M., G.K., P.P., M.S., G.C., D.d.A.N., J.H., R.E., M.K., R.M., G.B., R.M.M., A.K., M.M., K.M., J.S., S.J.C., M.J.L., N.P., R.P., A.S.M.B., M.D., I.M., N.P., V.C. have no competing interests to disclose.