题目：ST段抬高心梗纤维蛋白溶解后早期经皮冠状介入vs 标准治疗的评价：复合终点贡献的加权（Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction： contribution of weighting the composite endpoint）

　　目的：心血管临床试验的最佳终结点选择始终具有挑战性。本文在考虑个体事件严重程度情况下，研究了一系列试验的一个替代性解释。

　　方法和结果：本文使用加权复合方法，分析了纤维蛋白溶解后早期经皮冠状动脉介入治疗（PCI）的3项心梗（MI）试验。该方法允许检查复合终点方向和量值的异质性，以及多重事件（vs第一个事件）。本文合并了最大研究中医师对所有患者5项复合终点的严重程度的评估。急性心梗纤维蛋白溶解后增强再灌注的常规血管形成术和支架术实验（TRANSFER-AMI）纳入1059例ST段抬高心梗患者。传统方法产生的无事件生存几率，早期侵入性治疗为0.89 [95% 置信区间（CI） 0.86~0.91]，标准治疗为0.83 （95% CI 0.79-0.86）（P=0.004）。在考虑医师-研究者-确定的加权后，早期侵入性治疗的有效存活几率为0.93 （95% CI 0.91~0.95），标准治疗为0.93 （95% CI 0.90~0.95），二者无显著差异（P=0.54）。在一个使用4项复合终点的3项队列试验中也观察到了同样的特征，且无事件生存结局得到改善（P=0.01），而在考虑严重程度加权时，这种特征不再明显（P=0.44）。

　　结论：该分析强调了在对临床试验的评估时，考虑相对严重程度和多重事件的重要性。

　　Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction： contribution of weighting the composite endpoint.

　　Bakal JA， Westerhout CM， Cantor WJ， Fernández-Avilés F， Welsh RC， Fitchett D， Goodman SG， Armstrong PW.

　　SourceDivision of Cardiology， 2-132 Li Ka Shing Centre for Health Research Innovation， University of Alberta， Edmonton， Alberta， Canada T6G 2E1.

　　Abstract

　　AimsThe 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 resultsWe 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).ConclusionThis analysis highlights the importance of considering the relative severity and multiple events in the evaluation of a clinical trial.

　　查看原文：http://www.ncbi.nlm.nih.gov/pubmed/22963114