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European Heart Journal Advance Access published online on January 12, 2006
European Heart Journal, doi:10.1093/eurheartj/ehi701
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European Heart Journal © The European Society of Cardiology 2006; all rights reserved
Received February 7, 2005
Revised November 22, 2005
Accepted December 1, 2005

Clinical research

Outcomes of patients in clinical trials with ST-segment elevation myocardial infarction among countries with different gross national incomes

Andrés Orlandini 1 *, Rafael Díaz 1, Daniel Wojdyla 1, Karen Pieper 2, Frans Van de Werf 3, Christopher B. Granger 2, Robert A. Harrington 2, Éric Boersma 4, Robert M. Califf 2, Paul Armstrong 5, Harvey White 6, John Simes 7, and Ernesto Paolasso 1

1 Estudios Clínicos Latino America (ECLA) Collaborative Group, Jujuy 1415, Rosario 2000, Argentina
2 Duke University Medical Center, Durham, NC, USA
3 Gasthuisberg University Hospital, Leuven, Belgium
4 Erasmus MC, Rotterdam, The Netherlands
5 University of Alberta, Edmonton, Alberta, Canada
6 Green Lane Hospital, Auckland, New Zealand
7 NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia

* To whom correspondence should be addressed.
Andrés Orlandini, E-mail: aorlandinimd{at}ecla.org.ar


  Abstract

Aims To evaluate whether there is an association between 30-day mortality in patients with ST-segment elevation myocardial infarction (STEMI) included in clinical trials and country gross national income (GNI).

Methods and results A retrospective analysis of the databases of five randomized trials including 50 310 patients with STEMI (COBALT 7169, GIK-2 2931, HERO-2 17 089, ASSENT-2 17 005, and ASSENT-3 6116 patients) from 53 countries was performed. Countries were divided into three groups according to their GNI based on the World Bank data: low (less than US$ 2900), medium (between US$ 2900 and 9000), and high GNI (more than US$ 9000 per capita). Baseline characteristics, in-hospital management variables, and 30-day outcomes were evaluated. A previously defined logistic regression model was used to adjust for differences in baseline characteristics and to predict mortality. The observed mortality was higher than the predicted mortality in the low (12.1 vs. 11.8%) and in the medium income groups (9.4 vs. 7.9%), whereas it was lower in the high income group (4.9 vs. 5.6%).

Conclusion An inverse relationship between mortality and GNI was observed in STEMI clinical trials. Most of the variability in mortality can be explained by differences in baseline characteristics; however, after adjustment, lower income countries have higher mortality than the expected.

Keywords: Regional differences; Outcomes; ST-elevation myocardial infarction; Clinical trials; Gross national income.
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