Domanski Michael, Antman Elliott M, McKinlay Sonja, Varshavsky Sergei, Platonov Pyotr, Assmann Susan F, Norman James
The Clinical Trials Group, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892, USA.
Control Clin Trials. 2004 Dec;25(6):553-62. doi: 10.1016/j.cct.2004.08.005.
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.
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.
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.
对临床试验的解读以及为减轻全球冠心病负担所做的努力必须考虑到地区差异。本研究调查了参与“冠状动脉疾病中的镁”(MAGIC)试验的ST段抬高型心肌梗死(STEMI)患者在基线特征、治疗及结局方面的地区差异。
MAGIC试验将6213例患者随机分为接受安慰剂输注或静脉输注硫酸镁的标准治疗组。两组死亡率无差异。在本次分析中,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),并比较了它们在基线特征、治疗及30天死亡率方面的情况。区域2的患者入院时不良风险因素的患病率最高,包括既往心肌梗死病史、心力衰竭、中风和高血压;首次急性心肌梗死的前壁位置;以及就诊时存在肺淤血。此外,与区域1的患者相比,区域2的患者很少接受再灌注治疗。区域3在这方面处于中间水平。区域2的死亡率最高,区域1最低,区域3居中。
地理位置,特别是东欧部分地区,与STEMI后的死亡率密切且独立相关。这种死亡率的地理差异证实了先前的报道,尽管充分的解释仍然难以捉摸,且超出了这项大型简单试验的范围。未来的国际试验在设计、分析和解读时必须认识到这种差异。