Performance of Novel High-Sensitivity Cardiac Troponin I Assays for 0/1-Hour and 0/2-to 3-Hour Evaluations for Acute Myocardial Infarction: Results From the HIGH-US Study
Performance of Novel High-Sensitivity Cardiac Troponin I Assays for 0/1-Hour and 0/2-to 3-Hour Evaluations for Acute Myocardial Infarction: Results From the HIGH-US Study
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DOI：
10.1016/j.annemergmed.2019.12.008
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发表时间：
2020-07-01
影响因子：
6.2
通讯作者：
deFilippi, Christopher R.
中科院分区：
文献类型：
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作者：
Nowak, Richard M.;Christenson, Robert H.;deFilippi, Christopher R.
研究目的：我们确定的准确性，高灵敏度心肌肌钙蛋白I（超敏cTnI），欧洲衍生的，快速，急性心肌梗死，排除/规则的算法应用于美国急诊科（艾德）population.Methods：成人提出的艾德与疑似急性心肌梗死。在核心实验室使用Siemens Healthineers hs-cTnl检测试剂盒分析基线时以及40 - 90分钟和2 - 3小时后采集的血浆样本。独立裁定急性心肌梗死诊断。灵敏度，特异性，阴性和阳性预测值快速急性心肌梗死排除/规则，在使用欧洲算法和30天的outcomes reported.Results：从29个美国医疗中心，2,113名受试者的0/1小时算法分析的完整数据。使用Siemens Atellica免疫测定hs-cTnl值，1，065名患者排除率为50.4%，阴性预测值为99.7%，敏感性为98.7%（95%置信区间分别为99.2%至99.9%和96.3%至99.6%），而265例患者阳性预测值为69.4%，特异性为95.7%（95%可信区间分别为63.6%~ 74.7%和94.7%~ 96.5%）。其余783例患者（37.1%）被归类为继续评价，急性心肌梗死发生率为5.6%（95%置信区间为4.2%至7.5%）。排除组患者30天死亡或出院后急性心肌梗死的总体风险非常低，但其他组逐渐增加（排除组0.2%;继续评价组2.1%;纳入组4.8%）。在0/2- 3小时的分析中观察到了相同的结果，当两种算法都应用于高敏肌钙蛋白I ADVIA Centaur measurements.Conclusion：欧洲快速排除/规则在急性心肌梗死算法高敏肌钙蛋白I切割点可以与人口统计学和风险因素不同的美国艾德人口相协调。
Study objective: We determine the accuracy of high-sensitivity cardiac troponin I (hs-cTnl), European-derived, rapid, acute myocardial infarction, rule-out/rule-in algorithms applied to a US emergency department (ED) population.Methods: Adults presenting to the ED with suspected acute myocardial infarction were included. Plasma samples collected at baseline and between 40 and 90 minutes and 2 and 3 hours later were analyzed in core laboratories using the Siemens Healthineers hs-cTnl assays. Acute myocardial infarction diagnosis was independently adjudicated. The sensitivity, specificity, and negative and positive predictive values for rapid acute myocardial infarction rule-out/rule-in using European algorithms and 30 day outcomes are reported.Results: From 29 US medical centers, 2,113 subjects had complete data for the 0/1-hour algorithm analyses. With the Siemens Atellica Immunoassay hs-cTnl values, 1,065 patients (50.4%) were ruled out, with a negative predictive value of 99.7% and sensitivity of 98.7% (95% confidence interval 99.2% to 99.9% and 96.3% to 99.6%, respectively), whereas 265 patients (12.6%) were ruled in, having a positive predictive value of 69.4% and specificity of 95.7% (95% confidence interval 63.6% to 74.7% and 94.7% to 96.5%, respectively). The remaining 783 patients (37.1%) were classified as having continued evaluations, with an acute myocardial infarction incidence of 5.6% (95% confidence interval 4.2% to 7.5%). The overall 30-day risk of death or postdischarge acute myocardial infarction was very low in the ruled-out patients but was incrementally increased in the other groups (rule-out 0.2%; continued evaluations 2.1%; rule-in 4.8%). Equivalent results were observed in the 0/2- to 3-hour analyses and when both algorithms were applied to the hs-cTnl ADVIA Centaur measurements.Conclusion: The European rapid rule-out/rule-in acute myocardial infarction algorithm hs-cTnl cut points can be harmonized with a demographically and risk-factor diverse US ED population.