Van de Werf F, Topol E J, Lee K L, Woodlief L H, Granger C B, Armstrong P W, Barbash G I, Hampton J R, Guerci A, Simes R J
Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium.
JAMA. 1995;273(20):1586-91. doi: 10.1001/jama.273.20.1586.
To examine differences in outcomes and patient management between patients in the United States and outside the United States undergoing thrombolysis for acute myocardial infarction.
DESIGN, SETTING, AND PATIENTS: Patients in the United States (n = 23,105) and 14 other countries (n = 17,916) were randomized to receive streptokinase plus either subcutaneous or intravenous (IV) heparin, accelerated recombinant tissue-type plasminogen activator (rt-PA) plus IV heparin, or combined streptokinase and rt-PA plus IV heparin.
Differences in 30-day mortality and patient management were compared among treatments and between US and non-US patients. Treatment-by-country interactions were assessed by logistic regression analyses. Expected mortality of US and non-US patients was estimated using a predictive model and was compared with observed mortality.
Mortality reduction with accelerated rt-PA vs streptokinase was greater in the United States (1.2% absolute decrease vs 0.7% elsewhere), but the test for treatment-by-country interaction against streptokinase was not significant (P = .30). Benefits of accelerated rt-PA over combination therapy were observed in the United States, but not in other countries (P = .02). Despite differences in base-line characteristics and patient management, 30-day mortality was not significantly different: 6.8% in the United States vs 7.2% elsewhere (P = .09). After adjustment for baseline differences, observed vs predicted outcomes were slightly better in the United States (6.8% vs 7.0%) than elsewhere (7.2% vs 7.0%), indicating that enrollment in the United States was a marginally significant predictor of better survival (P = .047).
No significant evidence for a differentially greater benefit of accelerated rt-PA over streptokinase was found in US vs non-US patients. However, increased procedure and treatment use in the United States was associated with only a small decrease in short-term mortality. Long-term follow-up is required to clarify the relationship between survival and the more intensive US management approach.
研究在美国和美国以外地区接受急性心肌梗死溶栓治疗的患者在治疗结果和患者管理方面的差异。
设计、地点和患者：美国的患者（n = 23,105）和其他14个国家的患者（n = 17,916）被随机分配接受链激酶加皮下或静脉注射肝素、加速重组组织型纤溶酶原激活剂（rt-PA）加静脉注射肝素，或链激酶与rt-PA联合加静脉注射肝素。
比较各治疗组之间以及美国和非美国患者之间30天死亡率和患者管理方面的差异。通过逻辑回归分析评估治疗与国家之间的交互作用。使用预测模型估计美国和非美国患者的预期死亡率，并与观察到的死亡率进行比较。
在美国，加速rt-PA与链激酶相比，死亡率降低幅度更大（绝对降低1.2%，其他地区为0.7%），但针对链激酶的治疗与国家交互作用检验无显著差异（P = 0.30）。在美国观察到加速rt-PA优于联合治疗的益处，但在其他国家未观察到（P = 0.02）。尽管基线特征和患者管理存在差异，但30天死亡率无显著差异：美国为6.8%，其他地区为7.2%（P = 0.09）。在对基线差异进行调整后，美国观察到的与预测的结果略优于其他地区（6.8%对7.0%）（7.2%对7.0%），表明在美国入组是生存情况稍好的一个边缘显著预测因素（P = 0.047）。
未发现加速rt-PA在美国患者与非美国患者中相比具有明显更大益处的显著证据。然而，在美国增加的操作和治疗使用仅与短期死亡率的小幅降低相关。需要长期随访以阐明生存与美国更强化的管理方法之间的关系。
