Geographic differences in patients with acute myocardial infarction in the PARADISE‐MI trial

Butt, J. H. et al. (2023) Geographic differences in patients with acute myocardial infarction in the PARADISE‐MI trial. European Journal of Heart Failure, (doi: 10.1002/ejhf.2851) (PMID:37042062) (Early Online Publication)

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Introduction: The globalization of clinical trials has highlighted geographic differences in patient characteristics, treatments, and outcomes. We examined these differences in PARADISE-MI. Methods and results: 23.0% were randomized in Eastern Europe/Russia, 17.5% in Western Europe, 12.2% in Southern Europe, 10.1% in Northern Europe, 12.0% in Latin America (LA), 9.3% in North America (NA), 10.0% in East/South-East Asia and 5.8% in South Asia (SA). Those from Asia, particularly SA, were different from patients enrolled in the other regions, being younger and thinner. They also differed in terms of comorbidities (high prevalence of diabetes and low prevalence of AF), type of MI (more often STEMI), and treatment (low rate of primary PCI). By contrast, patients from LA did not differ meaningfully from those randomized in Europe or NA. Use of ACE-inhibitor/ARB (34.8%) and beta-blockers (65.5%) was low in SA, whereas MRA use was lowest in NA (22%) and highest in Eastern Europe/Russia (53%). Rates of the primary composite outcome of cardiovascular death or incident HF varied two-fold among regions, with the lowest rate in SA (4.6/100person-years) and the highest in LA (9.2/100person-years). Rates of incident HF varied almost six-fold among regions, with the lowest rate in SA (1.0/100person-years) and the highest in Northern Europe (5.9/100person-years). The effect of sacubitril/valsartan was not modified by region. Conclusion: In PARADISE-MI, there were substantial regional differences in patient characteristics, treatments and outcomes. Although the generalizability of these findings to a “real-world” unselected population may be limited, these findings underscore the importance of considering both regional and within-region differences when designing global clinical trials.

Item Type:Articles
Status:Early Online Publication
Glasgow Author(s) Enlighten ID:Butt, Mr Jawad and McMurray, Professor John and Kober, Professor Lars
Authors: Butt, J. H., Claggett, B. L., Miao, Z. M., Jering, K. S., Sim, D., van der Meer, P., Ntsekhe, M., Amir, O., Cho, M.‐C., Carrillo‐Calvillo, J., Núñez, J. E., Cadena, A., Kerkar, P., Maggioni, A. P., Steg, P. G., Granger, C. B., Mann, D. L., Merkely, B., Lewis, E. F., Solomon, S. D., Zhou, Y., Køber, L., Braunwald, E., McMurray, J. J.V., and Pfeffer, M. A.
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
Journal Name:European Journal of Heart Failure
ISSN (Online):1879-0844
Published Online:11 April 2023
Copyright Holders:Copyright © 2023 European Society of Cardiology
First Published:First published in European Journal of Heart Failure 2023
Publisher Policy:Reproduced in accordance with the publisher copyright policy

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
303944BHF Centre of ExcellenceColin BerryBritish Heart Foundation (BHF)RE/18/6/34217CAMS - Cardiovascular Science