BACKGROUND: The interpretation of clinical trials and efforts directed at reducing the worldwide burden of coronary disease must take regional differences into account. This study examined the regional differences in baseline characteristics, treatment, and outcome in patients presenting with ST elevation myocardial infarction (STEMI) who were entered into the Magnesium in Coronaries (MAGIC) trial. METHODS AND RESULTS: MAGIC randomized 6213 patients to standard care with eitherplacebo infusion or infusion of intravenous magnesium sulphate. There was no difference in mortality between these groups. For this analysis, three geographic regions were identified (Region 1=United States and Canada; Region 2=Bulgaria, Georgia, and Russia; Region 3=Austria, Belgium, Chile, Hungary, Israel, the Netherlands, New Zealand, and Venezuela) and compared with respect to baseline characteristics, treatment, and 30-day mortality. Patients in Region 2 had the highest prevalence of adverse risk factors at entry, including history of prior myocardial infarction, heart failure, stroke, and hypertension; anterior location of index acute myocardial infarction; and presence of pulmonary congestion at presentation. Furthermore, Region 2 patients infrequently received reperfusion therapy compared with those in Region 1. Region 3 was intermediate in this regard. Mortality was highest in Region 2, least in Region 1, and intermediate in Region 3. CONCLUSION: Geographic location, particularly, parts of Eastern Europe, is strongly and independently associated with mortality following STEMI. This geographic variation in mortality confirms prior reports, although adequate explanations continue to be elusive and are beyond the scope of this large simple trial. Future international trials must recognize this variation in design, analysis, and interpretation.
RCT Entities:
BACKGROUND: The interpretation of clinical trials and efforts directed at reducing the worldwide burden of coronary disease must take regional differences into account. This study examined the regional differences in baseline characteristics, treatment, and outcome in patients presenting with ST elevation myocardial infarction (STEMI) who were entered into the Magnesium in Coronaries (MAGIC) trial. METHODS AND RESULTS: MAGIC randomized 6213 patients to standard care with either placebo infusion or infusion of intravenous magnesium sulphate. There was no difference in mortality between these groups. For this analysis, three geographic regions were identified (Region 1=United States and Canada; Region 2=Bulgaria, Georgia, and Russia; Region 3=Austria, Belgium, Chile, Hungary, Israel, the Netherlands, New Zealand, and Venezuela) and compared with respect to baseline characteristics, treatment, and 30-day mortality. Patients in Region 2 had the highest prevalence of adverse risk factors at entry, including history of prior myocardial infarction, heart failure, stroke, and hypertension; anterior location of index acute myocardial infarction; and presence of pulmonary congestion at presentation. Furthermore, Region 2 patients infrequently received reperfusion therapy compared with those in Region 1. Region 3 was intermediate in this regard. Mortality was highest in Region 2, least in Region 1, and intermediate in Region 3. CONCLUSION: Geographic location, particularly, parts of Eastern Europe, is strongly and independently associated with mortality following STEMI. This geographic variation in mortality confirms prior reports, although adequate explanations continue to be elusive and are beyond the scope of this large simple trial. Future international trials must recognize this variation in design, analysis, and interpretation.
Authors: Timothy A Reistetter; Amol M Karmarkar; James E Graham; Karl Eschbach; Yong-Fang Kuo; Carl V Granger; Jean Freeman; Kenneth J Ottenbacher Journal: Arch Phys Med Rehabil Date: 2013-08-03 Impact factor: 3.966
Authors: Oscar Peñuelas; Alfonso Muriel; Victor Abraira; Fernando Frutos-Vivar; Jordi Mancebo; Konstantinos Raymondos; Bin Du; Arnaud W Thille; Fernando Ríos; Marco González; Lorenzo Del-Sorbo; Niall D Ferguson; Maria Del Carmen Marín; Bruno Valle Pinheiro; Marco Antonio Soares; Nicolas Nin; Salvatore M Maggiore; Andrew Bersten; Pravin Amin; Nahit Cakar; Gee Young Suh; Fekri Abroug; Manuel Jibaja; Dimitros Matamis; Amine Ali Zeggwagh; Yuda Sutherasan; Antonio Anzueto; Andrés Esteban Journal: Intensive Care Med Date: 2020-01-07 Impact factor: 41.787