Abstract

Introduction: The globalization of clinical trials has highlighted geographic differences in patient characteristics, treatments and outcomes, but there are few data on those with high-risk acute MI. We examined these differences in PARADISE-MI, the most globally representative trial in high-risk MI patients to date Methods: PARADISE-MI enrolled 5661 patients with an acute MI complicated by left ventricular dysfunction and/or pulmonary congestion; 23.0% were randomized in Eastern Europe/Russia (EER), 17.5% Western Europe, 12.2% Southern Europe, 10.1% Northern Europe (NE), 12.0% Latin America (LA), 9.3% North America (NA), 10.0% East/South-East Asia, 5.8% South Asia (SA) Results: Those from Asia, particularly SA, were notably different from patients enrolled in the other regions - they were younger, thinner and had a different pattern of comorbidities (high prevalence of diabetes despite lower BMI, and very low prevalence of AF), type of MI (more often STEMI) and treatment (low rate of primary PCI). By contrast, the characteristics of patients from LA did not differ meaningfully from those in Europe or NA. Use of ACEi/ARB (34.8%) and beta-blockers (65.5%) was remarkably low in SA, whereas MRA use was lowest in NA (21.8%) compared with the highest rate (53.0%) in EER. 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 / 100 person-years [PY]) and the highest in LA (9.2 / 100 PY). Strikingly, rates of incident HF varied almost six-fold among regions with the lowest rate in SA (1.0 /100 PY) and the highest in NE (5.9 /100 PY). Conversely, the rate of death from any cause varied about two-fold among regions (Figure) with the lowest rate in NA (2.4 /100 PY) and the highest in LA (5.3 / 100 PY) although the rate in the other six regions differed little (range 3.9 to 4.7 / 100 PY) Conclusion: In PARADISE-MI, there were substantial regional differences in patient characteristics, treatments and outcomes

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