copeptin 联合非高敏或高敏心肌肌钙蛋白即时排除疑似非 ST 段抬高型心肌梗死。
Copeptin combined with either non-high sensitivity or high sensitivity cardiac troponin for instant rule-out of suspected non-ST segment elevation myocardial infarction.
机构信息
Department of Cardiology, Angiology and Pulmology, Medizinische Klinik III, University Hospital of Heidelberg, Heidelberg, Germany.
Division of Emergency Medicine and Chest Pain Units, Campus Virchow and Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.
出版信息
Biomarkers. 2020 Dec;25(8):649-658. doi: 10.1080/1354750X.2020.1833084. Epub 2020 Oct 31.
BACKGROUND
Whether Copeptin combined with high sensitivity troponin below the respective decision cut-offs improves rule-out of NSTEMI and may predict all-cause death at 30-day is under debate.
METHODS
Data on 10,329 patients from 5 trials were pooled to evaluate the diagnostic and prognostic performance of an initial Copeptin below decision cut-off in combination with a (hs)-cTn below the uppler limit of normal (ULN) compared to a) the initial (hs)-cTn alone in the standard serial sampling strategy based on the 99th percentile and b) a single marker strategy (SMS) based on hs-cTn < limit of detection. Endpoints were sensitivities and negative predictive values (NPV) for rule-out of NSTEMI, 30-day all-cause mortality and rates of eligibility for DMS or SMS.
RESULTS
NPV for NSTEMI was higher for DMS than for the initial cTn, regardless assay sensitivity. The highest NPVs were observed with DMS vs. hs-cTn (99.4% [95% CI: 99.0%-99.6%] vs. 98.8% [98.4%-99.1%],) , and improved performance was consistent across all important subgroups including presentation <3 h, again irrespective of assay sensitivity. The point estimate of all NPVs for all-cause death exceeded 99.75%. In the label populations, DMS versus SMS demonstrated comparably high NPVs for rule-out of NSTEMI (99.4% [99.0%-99.6%] vs. 99.9% [99.2%-100.0%]), very low mortality after rule-out (0.1% [0.0%-0.4% vs. 0.0% [0.0%-1.2%]), but eligibility for rule-out was 2.4-fold higher (61.4% [59.9%-62.9%] vs. 25.3% [23.7%-26.9%]) with DMS than SMS.
CONCLUSION
Findings from a large pooled cohort corroborate the safety of the dual marker strategy for instant rule-out of NSTEMI, extending evidence to hs-cTn. Copeptin below cut-off in combination with hs-cTn below ULN may be used in more than 2.4-times more patients presenting with suspected ACS than a single marker strategy based on very low hs-cTn, without the need to exclude very early presenters or other important subgroups.
背景
在各自决策截止值以下的 Copeptin 与高敏肌钙蛋白联合使用是否能排除 NSTEMI，并且可能预测 30 天全因死亡率，目前仍存在争议。
方法
对 5 项试验的 10329 例患者的数据进行了汇总，以评估初始 Copeptin 在低于决策截止值时与 a) 初始（高敏）肌钙蛋白（hs-cTn）在基于第 99 百分位的标准连续采样策略中的表现相比，以及 b) 基于 hs-cTn <检测限的单一标志物策略（SMS）在联合使用时，对排除 NSTEMI 的诊断和预后性能。终点为排除 NSTEMI 的敏感性和阴性预测值（NPV）、30 天全因死亡率和符合 DMS 或 SMS 条件的比例。
结果
无论检测方法的敏感性如何，DMS 对 NSTEMI 的 NPV 均高于初始 cTn。最高的 NPV 是 DMS 与 hs-cTn 相比（99.4% [95% CI：99.0%-99.6%] vs. 98.8% [98.4%-99.1%]），并且在所有重要亚组中观察到的性能改善情况一致，包括就诊时间<3 小时，同样与检测方法的敏感性无关。所有全因死亡率的 NPV 的点估计值均超过 99.75%。在标签人群中，DMS 与 SMS 相比，排除 NSTEMI 的 NPV 相当高（99.4% [99.0%-99.6%] vs. 99.9% [99.2%-100.0%]），排除后死亡率极低（0.1% [0.0%-0.4%] vs. 0.0% [0.0%-1.2%]），但 DMS 比 SMS 更适合排除规则（61.4% [59.9%-62.9%] vs. 25.3% [23.7%-26.9%]）。
结论
来自大型汇总队列的研究结果证实了双重标志物策略即时排除 NSTEMI 的安全性，将证据扩展到高敏肌钙蛋白。在低于截止值的 Copeptin 与低于正常值上限的 hs-cTn 联合使用时，与基于非常低 hs-cTn 的单一标志物策略相比，可能适用于超过 2.4 倍的疑似 ACS 患者，而无需排除非常早出现的患者或其他重要亚组。
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