在一项镁治疗急性心肌梗死的国际试验中,患者特征、治疗和结果的地理差异

Michael Domanski , Elliott M. Antman , Sonja McKinlay , Sergei Varshavsky , Pyotr Platonov , Susan F. Assmann , James Norman
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引用次数: 20

摘要

背景:在解释旨在减轻全球冠状动脉疾病负担的临床试验和努力时,必须考虑到地区差异。本研究考察了ST段抬高型心肌梗死(STEMI)患者的基线特征、治疗和结局的地区差异,这些患者进入了冠状动脉镁(MAGIC)试验。方法和结果smagic将6213例患者随机分为安慰剂输注组和硫酸镁静脉输注组。两组之间的死亡率没有差异。为了进行这项分析,确定了三个地理区域(区域1=美国和加拿大;区域2:保加利亚、格鲁吉亚和俄罗斯;区域3=奥地利、比利时、智利、匈牙利、以色列、荷兰、新西兰和委内瑞拉),并在基线特征、治疗和30天死亡率方面进行比较。2区患者入院时不良危险因素患病率最高,包括既往心肌梗死、心力衰竭、中风和高血压病史;急性心肌梗死前位;并在就诊时出现肺充血。此外,与1区患者相比,2区患者很少接受再灌注治疗。第3区在这方面处于中间地位。2区死亡率最高,1区最低,3区处于中等水平。结论:地理位置,特别是东欧部分地区,与STEMI后的死亡率存在强烈且独立的相关性。这种死亡率的地理差异证实了先前的报告,尽管充分的解释仍然难以捉摸,并且超出了这项大型简单试验的范围。未来的国际试验必须在设计、分析和解释中认识到这种差异。
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Geographic variability in patient characteristics, treatment and outcome in an international trial of magnesium in acute myocardial infarction

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.

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Editorial Board On the generation and ownership of alpha in medical studies Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels Geographic variability in patient characteristics, treatment and outcome in an international trial of magnesium in acute myocardial infarction Analyzing bronchodilation with emphasis on disease type, age and sex
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