Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction: contribution of weighting the composite endpoint
Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction: contribution of weighting the composite endpoint
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DOI：
10.1093/eurheartj/ehs438
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发表时间：
2013-03-21
影响因子：
39.3
通讯作者：
Armstrong, Paul W.
中科院分区：
文献类型：
--
作者：
Bakal, Jeffrey A.;Westerhout, Cynthia M.;Armstrong, Paul W.
心血管临床试验最佳终点的选择仍然具有挑战性。我们研究了一系列试验的另一种解释时，个别事件的严重程度considered.Methods和结果，我们分析了三个当代心肌梗死（MI）早期经皮冠状动脉介入治疗后纤溶试验，使用加权复合方法。该方法允许检查组分终点和多个事件（与首起事件相比）的方向和幅度的异质性。我们在最大的研究中纳入了医生评估的所有患者的五项复合终点的每个组分终点的严重程度，即纤溶后常规血管成形术和支架植入术以增强急性心肌梗死再灌注的试验（TRANSFER-AMI），该研究纳入了1059例ST段抬高型MI患者。传统方法得出早期侵入性治疗组的无事件生存概率为0.89 [95%置信区间（CI）0.86-0.91]，标准治疗组为0.83（95% CI 0.79-0.86）（P = 0.004）。在考虑了临床医生-研究者确定的权重后，早期侵入组的有效生存概率为0.93（95% CI 0.91-0.95），早期侵入组为0.93（95% CI 0.90-0.95），无显著差异（P = 0.54）。在三个试验队列中使用四项复合材料观察到相同的模式，观察到无事件生存结局的改善（P = 0.01），这是不再明显的严重程度权重后被认为（P = 0.44）。结论这种分析强调了在临床试验的评价中考虑相对严重程度和多个事件的重要性。
Aims The selection of optimal endpoints for cardiovascular clinical trials continues to be challenging. We examined an alternative interpretation of a series of trials when the individual event severity is considered.Methods and results We analysed three contemporary myocardial infarction (MI) trials of early percutaneous coronary intervention after fibrinolysis, using a weighted composite method. This method allows the examination of the heterogeneity in the direction and magnitude of component endpoints, and multiple events (vs. first event). We incorporated a physician-assessed severity of each component endpoint in all patients for the five-item composite in the largest study, Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI), which enrolled 1059 ST-elevation MI patients. The traditional approach yielded event-free survival probabilities of 0.89 [95% confidence interval (CI) 0.86-0.91] for the early invasive arm and 0.83 (95% CI 0.79-0.86) for the standard care arm (P = 0.004). After accounting for the clinician-investigator-determined weights, the effective survival probabilities were 0.93 (95% CI 0.91-0.95) for the early invasive arm and 0.93 (95% CI 0.90-0.95) with no significant difference (P = 0.54). The same pattern was observed in the three-trial cohort using a four-item composite with an observed improvement in event-free survival outcomes (P = 0.01), which was no longer apparent after the severity weights were considered (P = 0.44).Conclusion This analysis highlights the importance of considering the relative severity and multiple events in the evaluation of a clinical trial.