NHMRC Clinical Trials Center, University of Sydney, Sydney, Australia.
Am Heart J. 2010 Jun;159(6):988-97. doi: 10.1016/j.ahj.2009.12.044.
Despite advances in therapy, global mortality due to acute myocardial infarction remains high. The international Hirulog and Early Reperfusion or Occlusion (HERO-2) trial of 17,073 patients with ST-segment elevation myocardial infarction provided the opportunity to explore international differences in outcomes.
Patient characteristics, treatment, and outcomes were compared across 5 diverse regions: Western countries, Latin America, Eastern Europe, Russia, and Asia. In addition, a representative sample of 1,743 screened patients was compared with enrolled patients.
Larger percentages of eligible patients were randomized in Eastern Europe, Russia, and Asia than Western countries. These regions enrolled more patients with anterior myocardial infarction, Killip class III or IV, and late presentation (>4 hours). More patients aged >75 years were enrolled from Western countries. Overall risk levels were similar. Eastern Europe and Russia had lower rates than Western countries of coronary revascularization (2% vs 18%) and longer hospital stays (median 18 vs 7 days). Thirty-day mortality was lower in Western countries; 6.7% versus 10.2% to 13.2% elsewhere, whereas reinfarction was more frequent (3.2% vs 1.5% to 3.0%; each, P < .001). Regional mortality differences persisted after adjustment for baseline risk factors, treatments, or national health and economic statistics (each P < .001).
The variation in mortality and other clinical outcomes across geographic regions was not adequately explained by risk factors, patterns of care, or national health statistics. Nevertheless, large international trials are a better way to assess potential new treatments across many countries than the alternative of separate smaller trials in each region.
尽管治疗方法有所进步，但全球急性心肌梗死的死亡率仍然很高。在 17073 例 ST 段抬高型心肌梗死患者中进行的国际 Hirulog 和早期再灌注或闭塞（HERO-2）试验为探索国际间结果差异提供了机会。
对来自 5 个不同地区（西方国家、拉丁美洲、东欧、俄罗斯和亚洲）的患者特征、治疗和结局进行比较。此外，还比较了筛查患者的代表性样本（1743 例）和入选患者。
东欧、俄罗斯和亚洲符合条件的患者被随机分配的比例高于西方国家。这些地区纳入了更多前壁心肌梗死、Killip 分级 III 或 IV 级和晚期就诊（>4 小时）的患者。更多年龄>75 岁的患者来自西方国家。总体风险水平相似。东欧和俄罗斯的血运重建率（2%比 18%）和住院时间（中位数 18 天比 7 天）低于西方国家。西方国家的 30 天死亡率较低（6.7%比 10.2%到 13.2%），但再梗死率较高（3.2%比 1.5%到 3.0%；每处，P<.001）。调整基线风险因素、治疗方法或国家卫生和经济统计数据后，区域死亡率差异仍然存在（每处，P<.001）。
死亡率和其他临床结局的地理区域差异不能仅用风险因素、治疗模式或国家卫生统计数据来充分解释。然而，与在每个地区分别进行较小规模试验的替代方法相比，大型国际试验是在许多国家评估潜在新疗法的更好方法。
