TY - JOUR
T1 - Geographic differences in patients with acute myocardial infarction in the PARADISE-MI trial
AU - Butt, Jawad H.
AU - Claggett, Brian L.
AU - Miao, Zi M.
AU - Jering, Karola S.
AU - Sim, David
AU - van der Meer, Peter
AU - Ntsekhe, Mpiko
AU - Amir, Offer
AU - Cho, Myeong Chan
AU - Carrillo-Calvillo, Jorge
AU - Núñez, Julio E.
AU - Cadena, Alberto
AU - Kerkar, Prafulla
AU - Maggioni, Aldo P.
AU - Steg, Philippe G.
AU - Granger, Christopher B.
AU - Mann, Douglas L.
AU - Merkely, Béla
AU - Lewis, Eldrin F.
AU - Solomon, Scott D.
AU - Zhou, Yinong
AU - Køber, Lars
AU - Braunwald, Eugene
AU - McMurray, John J.V.
AU - Pfeffer, Marc A.
N1 - Publisher Copyright:
© 2023 European Society of Cardiology.
PY - 2023/8
Y1 - 2023/8
N2 - Aim: 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: Overall, 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 atrial fibrillation), type of myocardial infarction (more often ST-elevation myocardial infarction), and treatment (low rate of primary percutaneous coronary intervention). By contrast, patients from LA did not differ meaningfully from those randomized in Europe or NA. Use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (34.8%) and beta-blockers (65.5%) was low in SA, whereas mineralocorticoid receptor antagonist use was lowest in NA (22%) and highest in Eastern Europe/Russia (53%). Rates of the primary composite outcome of cardiovascular death or incident heart failure varied two-fold among regions, with the lowest rate in SA (4.6/100 person-years) and the highest in LA (9.2/100 person-years). Rates of incident heart failure varied almost six-fold among regions, with the lowest rate in SA (1.0/100 person-years) and the highest in Northern Europe (5.9/100 person-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.
AB - Aim: 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: Overall, 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 atrial fibrillation), type of myocardial infarction (more often ST-elevation myocardial infarction), and treatment (low rate of primary percutaneous coronary intervention). By contrast, patients from LA did not differ meaningfully from those randomized in Europe or NA. Use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (34.8%) and beta-blockers (65.5%) was low in SA, whereas mineralocorticoid receptor antagonist use was lowest in NA (22%) and highest in Eastern Europe/Russia (53%). Rates of the primary composite outcome of cardiovascular death or incident heart failure varied two-fold among regions, with the lowest rate in SA (4.6/100 person-years) and the highest in LA (9.2/100 person-years). Rates of incident heart failure varied almost six-fold among regions, with the lowest rate in SA (1.0/100 person-years) and the highest in Northern Europe (5.9/100 person-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.
KW - Angiotensin receptor–neprilysin inhibitor
KW - Clinical trial
KW - Geographic region
KW - Heart failure
KW - Myocardial infarction
UR - http://www.scopus.com/inward/record.url?scp=85156213345&partnerID=8YFLogxK
U2 - 10.1002/ejhf.2851
DO - 10.1002/ejhf.2851
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C2 - 37042062
AN - SCOPUS:85156213345
SN - 1388-9842
VL - 25
SP - 1228
EP - 1242
JO - European Journal of Heart Failure
JF - European Journal of Heart Failure
IS - 8
ER -
