Impact of geographic region on the COMMANDER-HF Trial

Ferreira, J. P. et al. (2021) Impact of geographic region on the COMMANDER-HF Trial. JACC: Heart Failure, 9(3), pp. 201-211. (doi: 10.1016/j.jchf.2020.11.007) (PMID:33549557)

[img] Text
226486.pdf - Accepted Version
Restricted to Repository staff only until 3 February 2022.
Available under License Creative Commons Attribution Non-commercial No Derivatives.

1MB
[img] Text
226486Sup.pdf - Supplemental Material
Restricted to Repository staff only until 3 February 2022.

485kB

Abstract

Objectives: This study sought to compare patient characteristics, outcomes, and treatment effects among regions in the COMMANDER-HF trial. Background: Globalization of cardiovascular trials increases generalizability. However, regional differences may also introduce heterogeneity in results. Methods: Incidence rates and interactions with treatment were recorded in pre-specified regions: Eastern Europe, Western Europe and South Africa, North America, Asia-Pacific, and Latin America. Results: Most patients (n = 3,224; 64.2%) were from Eastern Europe; 458 (9.1%) were from Western Europe and South Africa; 149 (3.0%) were from North America; 733 (14.6%) were from Asia-Pacific; and 458 (9.1%) were from Latin America. Compared with patients from Eastern Europe, patients from Western Europe and South Africa, North America, and Asia-Pacific were older and more likely to have coronary interventions and cardiac devices. Patients from Eastern Europe had the lowest event rates. For the primary outcome of myocardial infarction (MI), stroke, or all-cause death, event rates (100/year) in Eastern Europe were 11.6 (10.8 to 12.5); 19.5 (16.5 to 23.0) in Western Europe and South Africa; 14.2 (10.5 to 19.2) in North America; 17.7 (15.4 to 20.3) in Asia-Pacific; and 18.6 (15.6 to 22.1) in Latin America. There was a lower incidence of bleeding in Eastern Europe. Blood concentrations of rivaroxaban (Xarelto) at 4 weeks were undetectable in 21% patients from Eastern Europe (n = 128) compared to 5% in other regions (n = 42). There was no evidence of treatment-by-region heterogeneity for the primary outcome (interactionp = 0.14), but a favorable effect on the secondary outcome of MI, stroke, or cardiovascular death was observed in Western Europe and South Africa, North America, and Latin America but not in Eastern Europe and Asia-Pacific (interactionp = 0.017). Conclusions: In the COMMANDER-HF study, patients from Eastern Europe had a lower risk profile and fewer cardiovascular and bleeding events, possibly related to lower treatment adherence. Those differences might have influenced the effect of rivaroxaban therapy. (A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure [COMMANDER HF]; NCT01877915).

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Cleland, Professor John and Ferreira, Mr Joao Pedro
Authors: Ferreira, J. P., Cleland, J. G.F., Lam, C. S.P., van Veldhuisen, D., Byra, W. M., La Police, D. A., Anker, S. D., Mehra, M. R., Leroy, C., Eschwege, V., Toussaint-Hacquard, M., Rossignol, P., Greenberg, B., and Zannad, F.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
Journal Name:JACC: Heart Failure
Publisher:Elsevier
ISSN:2213-1779
ISSN (Online):2213-1787
Published Online:03 February 2021
Copyright Holders:Copyright © 2021 American College of Cardiology Foundation
First Published:First published in JACC: Heart Failure 9(3):201-211
Publisher Policy:Reproduced in accordance with the publisher copyright policy

University Staff: Request a correction | Enlighten Editors: Update this record