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　　題目：ST段抬高心梗纖維蛋白溶解后早期經(jīng)皮冠狀介入vs 標準治療的評價(jià)：復合終點(diǎn)貢獻的加權（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：心血管臨床試驗的最佳終結點(diǎn)選擇始終具有挑戰性。本文在考慮個(gè)體事件嚴重程度情況下，研究了一系列試驗的一個(gè)替代性解釋。

　　方法和結果：本文使用加權復合方法，分析了纖維蛋白溶解后早期經(jīng)皮冠狀動(dòng)脈介入治療（PCI）的3項心梗（MI）試驗。該方法允許檢查復合終點(diǎn)方向和量值的異質(zhì)性，以及多重事件（vs第一個(gè)事件）。本文合并了最大研究中醫師對所有患者5項復合終點(diǎn)的嚴重程度的評估。急性心梗纖維蛋白溶解后增強再灌注的常規血管形成術(shù)和支架術(shù)實(shí)驗（TRANSFER-AMI）納入1059例ST段抬高心梗患者。傳統方法產(chǎn)生的無(wú)事件生存幾率，早期侵入性治療為0.89 [95% 置信區間（CI） 0.86~0.91]，標準治療為0.83 （95% CI 0.79-0.86）（P=0.004）。在考慮醫師-研究者-確定的加權后，早期侵入性治療的有效存活幾率為0.93 （95% CI 0.91~0.95），標準治療為0.93 （95% CI 0.90~0.95），二者無(wú)顯著(zhù)差異（P=0.54）。在一個(gè)使用4項復合終點(diǎn)的3項隊列試驗中也觀(guān)察到了同樣的特征，且無(wú)事件生存結局得到改善（P=0.01），而在考慮嚴重程度加權時(shí)，這種特征不再明顯（P=0.44）。

　　結論：該分析強調了在對臨床試驗的評估時(shí)，考慮相對嚴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