Kleijnen Systematic Reviews Ltd, Escrick, York, UK.
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, the Netherlands.
Clin Chem. 2021 Jan 8;67(1):237-244. doi: 10.1093/clinchem/hvaa280.
We assessed the accuracy and clinical effectiveness of high-sensitivity cardiac troponin (hs-cTn) assays for early rule-out of non-ST-segment elevation myocardial infarction (NSTEMI) in adults presenting with acute chest pain.
Sixteen databases were searched to September 2019. Review methods followed published guidelines. The bivariate model was used to estimate summary sensitivity and specificity with 95% confidence intervals for meta-analyses involving 4 or more studies, otherwise random-effects logistic regression was used.
Thirty-seven studies (124 publications) were included in the review. The hs-cTn test strategies evaluated in the included studies were defined by the combination of 4 factors (assay, number of tests, timing of tests, and threshold concentration or change in concentration between tests). Clinical opinion indicated a minimum acceptable sensitivity of 97%. A single test at presentation using a threshold at or near the assay limit of detection could reliably rule-out NSTEMI for a range of hs-cTn assays. Serial testing strategies, which include an immediate rule-out step, increased the proportion ruled out without loss of sensitivity. Finally, serial testing strategies without an immediate rule-out step had excellent sensitivity and specificity, but at the expense of the option for immediate patient discharge.
Test strategies that comprise an initial rule-out step, based on low hs-cTn concentrations at presentation and a minimum symptom duration, and a second step for those not ruled-out that incorporates a small absolute change in hs-cTn at 1, 2, or 3 hours, produce the highest rule-out rates with a very low risk of missed NSTEMI.
CRD42019154716.
我们评估了高敏心肌肌钙蛋白(hs-cTn)检测在急性胸痛成人中排除非 ST 段抬高型心肌梗死(NSTEMI)的准确性和临床有效性。
我们检索了 16 个数据库,检索截至 2019 年 9 月。综述方法遵循已发表的指南。对于包含 4 项或更多研究的荟萃分析,使用双变量模型来估计汇总敏感性和特异性,置信区间为 95%;否则,使用随机效应逻辑回归。
共纳入 37 项研究(124 篇文献)。纳入研究中 hs-cTn 检测策略是通过 4 个因素(检测方法、检测次数、检测时间、检测阈值或检测间浓度变化)的组合来定义的。临床意见表明,最低可接受的敏感性为 97%。单次就诊时采用检测方法的检测限或接近检测限的阈值,对于一系列 hs-cTn 检测方法,可以可靠地排除 NSTEMI。包括立即排除步骤的连续检测策略可增加排除的比例而不损失敏感性。最后,不包括立即排除步骤的连续检测策略具有极好的敏感性和特异性,但以丧失立即患者出院的选择为代价。
包含初始排除步骤的检测策略基于就诊时的低 hs-cTn 浓度和最低症状持续时间,如果未排除,则采用在 1、2 或 3 小时时 hs-cTn 浓度有小的绝对变化的第二步,可产生最高的排除率,同时发生漏诊 NSTEMI 的风险非常低。
PROSPERO 注册号:CRD42019154716。