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首页> 外文期刊>The American Journal of Cardiology >Comparison of Site-Reported and Core Laboratory-Reported Creatine Kinase-MB Values in Non-ST-Segment Elevation Acute Coronary Syndrome (from the International Trial SYNERGY)
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Comparison of Site-Reported and Core Laboratory-Reported Creatine Kinase-MB Values in Non-ST-Segment Elevation Acute Coronary Syndrome (from the International Trial SYNERGY)

机译：非ST段抬高的急性冠状动脉综合征中现场报告的和核心实验室报告的肌酸激酶-MB值的比较（来自国际合作试验）

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The effect of nonstandardized creatine kinase (CK)-MB assays on the assessment of myocardial infarction (MI) end points in multicenter international trials has not been evaluated. We compared the site-reported and corresponding core laboratory CK-MB measures from 5 countries participating in the Superior Yield of the New Strategy of Enoxaparin, Revascularization, and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial. Samples for CK-MB were collected locally, with corresponding samples sent to a core laboratory at enrollment and after recurrent ischemic events, percutaneous coronary intervention, or coronary artery bypass grafting. The measured values were compared to the reported assay upper limits of normal (ULN) used at the site (or core laboratory for the core laboratory samples). The CK-MB results were available locally and from the core laboratory for 913 patients, constituting 4,693 time-matched laboratory values. The agreement between the core and site laboratory CK-MB/ULN ratio was moderate (concordance correlation coefficient 0.45) and varied considerably by geographic location and site. The CK-MB values were elevated (>=2 times the ULN) by the core laboratory but normal (<2 times the ULN) by local standards in 708 instances (15%). There were 162 MI end points according to the core laboratory values versus 91 MI end points using the site-reported CK-MB data (kappa statistic 0.48). Compared with patients with no MI by the core or site laboratory values, patients with MI, as determined by both the core and the site laboratories, had significantly lower unadjusted 1-year survival rates (80.6% vs 93.5%, p <0.0001). Patients with MI, as determined by the core laboratory but not by the site laboratory, showed a trend toward a lower 1-year survival rate (89.8% vs 93.5%, p = 0.20). In conclusion, a substantial variation in CK-MB ratios and MI outcomes between the site and core laboratory data was observed in the SYNERGY trial. More MI outcomes were identified by the core laboratory, and patients with MI as defined by core laboratory data had lower 1-year survival, making these events potentially clinically important.
机译：未评估多中心国际试验中非标准化肌酸激酶（CK）-MB检测对评估心肌梗死（MI）终点的影响。我们比较了来自5个国家的现场报道的和相应的核心实验室CK-MB措施，这些措施参加了依诺肝素，血运重建和糖蛋白IIb / IIIa抑制剂新战略（SYNERGY）的高产。 CK-MB的样品在当地收集，相应的样品在入组时以及复发性缺血事件，经皮冠状动脉介入治疗或冠状动脉搭桥术后送至核心实验室。将测量值与现场（或核心实验室样品的核心实验室）使用的报告测定上限（ULN）进行比较。 CK-MB结果可在本地或从核心实验室获得，用于913位患者，构成4,693个时间匹配的实验室值。核心实验室和现场实验室的CK-MB / ULN比率之间的一致性中等（一致性相关系数为0.45），并且随地理位置和场所的不同而有很大差异。核心实验室将CK-MB值提高了（> = ULN的2倍），但在708个实例中升高了（<2倍ULN）（15％）。根据核心实验室数据，有162个MI终点，而使用现场报告的CK-MB数据则有91个MI终点（kappa统计值为0.48）。与由核心实验室或现场实验室得出的无MI的患者相比，由核心实验室和现场实验室确定的MI患者的未调整1年生存率显着降低（80.6％比93.5％，p <0.0001）。由核心实验室而非现场实验室确定的MI患者显示出1年生存率较低的趋势（89.8％vs 93.5％，p = 0.20）。总之，在SYNERGY试验中，观察到站点和核心实验室数据之间CK-MB比率和MI结果存在很大差异。核心实验室确定了更多的MI结果，并且核心实验室数据定义的MI患者的1年生存期较低，因此这些事件可能具有重要的临床意义。

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