Allen Brandon R, Christenson Robert H, Cohen Scott A, Nowak Richard, Wilkerson R Gentry, Mumma Bryn, Madsen Troy, McCord James, Huis In't Veld Maite, Massoomi Michael, Stopyra Jason P, Montero Cindy, Weaver Michael T, Yang Kai, Mahler Simon A
Department of Emergency Medicine, College of Medicine (B.R.A., S.A.C., C.M.), University of Florida, Gainesville.
Departments of Pathology (R.H.C.), University of Maryland School of Medicine, Baltimore.
Circulation. 2021 Apr 27;143(17):1659-1672. doi: 10.1161/CIRCULATIONAHA.120.049298. Epub 2021 Jan 21.
European data support the use of low high-sensitivity troponin (hs-cTn) measurements or a 0/1-hour (0/1-h) algorithm for myocardial infarction to exclude major adverse cardiac events (MACEs) among patients in the emergency department with possible acute coronary syndrome. However, modest US data exist to validate these strategies. This study evaluated the diagnostic performance of an initial hs-cTnT measure below the limit of quantification (LOQ: 6 ng/L), a 0/1-h algorithm, and their combination with history, ECG, age, risk factors, and initial troponin (HEART) scores for excluding MACE in a multisite US cohort.
A prospective cohort study was conducted at 8 US sites, enrolling adult patients in the emergency department with symptoms suggestive of acute coronary syndrome and without ST-elevation on ECG. Baseline and 1-hour blood samples were collected, and hs-cTnT (Roche; Basel, Switzerland) was measured. Treating providers blinded to hs-cTnT results prospectively calculated HEART scores. MACE (cardiac death, myocardial infarction, and coronary revascularization) at 30 days was adjudicated. The proportion of patients with initial hs-cTnT measures below the LOQ and risk according to a 0/1-h algorithm was determined. The negative predictive value (NPV) was calculated for both strategies when used alone or with a HEART score.
Among 1462 participants with initial hs-cTnT measures, 46.4% (678 of 1462) were women and 37.1% (542 of 1462) were Black with an age of 57.6±12.9 (mean±SD) years. MACEs at 30 days occurred in 14.4% (210 of 1462) of participants. Initial hs-cTnT measures below the LOQ occurred in 32.8% (479 of 1462), yielding an NPV of 98.3% (95% CI, 96.7-99.3) for 30-day MACEs. A low-risk HEART score with an initial hs-cTnT below the LOQ occurred in 20.1% (294 of 1462), yielding an NPV of 99.0% (95% CI, 97.0-99.8) for 30-day MACEs. A 0/1-h algorithm was complete in 1430 patients, ruling out 57.8% (826 of 1430) with an NPV of 97.2% (95% CI, 95.9-98.2) for 30-day MACEs. Adding a low HEART score to the 0/1-h algorithm ruled out 30.8% (441 of 1430) with an NPV of 98.4% (95% CI, 96.8-99.4) for 30-day MACEs.
In a prospective multisite US cohort, an initial hs-cTnT below the LOQ combined with a low-risk HEART score has a 99% NPV for 30-day MACEs. The 0/1-h hs-cTnT algorithm did not achieve an NPV >99% for 30-day MACEs when used alone or with a HEART score. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02984436.
欧洲的数据支持使用低灵敏度肌钙蛋白（hs-cTn）检测或0/1小时（0/1-h）算法来诊断心肌梗死，以排除急诊科中可能患有急性冠状动脉综合征的患者发生主要不良心脏事件（MACE）。然而，美国用于验证这些策略的数据较少。本研究评估了初始hs-cTnT测量值低于定量下限（LOQ：6 ng/L）、0/1-h算法及其与病史、心电图、年龄、危险因素和初始肌钙蛋白（HEART）评分相结合，在一个多中心美国队列中排除MACE的诊断性能。
在美国8个地点进行了一项前瞻性队列研究，纳入急诊科有急性冠状动脉综合征症状且心电图无ST段抬高的成年患者。采集基线和1小时血样，检测hs-cTnT（罗氏公司；瑞士巴塞尔）。对hs-cTnT结果不知情的治疗提供者前瞻性计算HEART评分。判定30天时的MACE（心源性死亡、心肌梗死和冠状动脉血运重建）。确定初始hs-cTnT测量值低于LOQ的患者比例以及根据0/1-h算法的风险。单独使用或与HEART评分一起使用时，计算两种策略的阴性预测值（NPV）。
在1462例初始hs-cTnT测量的参与者中，46.4%（678/1462）为女性，37.1%（542/1462）为黑人，年龄为57.6±12.9（均值±标准差）岁。30天时14.4%（210/1462）的参与者发生了MACE。初始hs-cTnT测量值低于LOQ的情况占32.8%（479/1462），30天MACE的NPV为98.3%（95%CI，96.7 - 99.3）。初始hs-cTnT低于LOQ且HEART评分为低风险的情况占20.1%（294/1462），30天MACE的NPV为99.0%（95%CI，97.0 - 99.8）。1430例患者完成了0/1-h算法，排除了57.8%（826/1430），30天MACE的NPV为97.2%（95%CI，95.9 - 98.2）。在0/1-h算法中加入低HEART评分排除了30.8%（441/1430），30天MACE的NPV为98.4%（95%CI，96.8 - 99.4）。
在一项前瞻性多中心美国队列中，初始hs-cTnT低于LOQ并结合低风险HEART评分对30天MACE的NPV为99%。单独使用或与HEART评分一起使用时，0/1-h hs-cTnT算法对30天MACE的NPV未达到>99%。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT02984436。
