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在美国多中心队列中,使用高敏心肌肌钙蛋白T的高STEACS早期排除途径在30天时的表现。

Performance of the High-STEACS Early Rule Out Pathway Using hs-cTnT at 30 Days in a Multisite US Cohort.

作者信息

Ashburn Nicklaus P, Snavely Anna C, Supples Michael W, Millard Marissa J, Allen Brandon R, Christenson Robert H, Madsen Troy, Mumma Bryn E, Hashemian Tara, Wilkerson R Gentry, Mahler Simon A

机构信息

Department of Emergency Medicine (N.P.A., A.C.S., M.W.S., M.J.M., T.H., S.A.M.), Wake Forest University School of Medicine, Winston-Salem, NC.

Department of Biostatistics and Data Science (A.C.S.), Wake Forest University School of Medicine, Winston-Salem, NC.

出版信息

Circ Cardiovasc Qual Outcomes. 2025 Feb;18(2):e011084. doi: 10.1161/CIRCOUTCOMES.124.011084. Epub 2025 Jan 9.

Abstract

BACKGROUND

The High-STEACS (High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome) pathway risk stratifies emergency department patients with possible acute coronary syndrome. This study aims to determine if the High-STEACS hs-cTnT (high-sensitivity cardiac troponin T) pathway can achieve the ≥99% negative predictive value (NPV) safety threshold for 30-day cardiac death or myocardial infarction (CDMI) in a multisite US cohort of patients with and without known coronary artery disease (CAD).

METHODS

A secondary analysis of the STOP-CP (High-Sensitivity Cardiac Troponin T [Gen 5 STAT Assay] to Optimize Chest Pain Risk Stratification) cohort, which enrolled adult emergency department patients with possible acute coronary syndrome at 8 US sites (January 25, 2017-September 6, 2018). Participants were classified into outpatient and admission dispositions using the High-STEACS hs-cTnT pathway. Known CAD was defined as prior MI, coronary revascularization, or ≥70% coronary stenosis. Outcomes included 30-day CDMI and efficacy, defined as the proportion identified for outpatient disposition. NPVs and negative likelihood ratios for 30-day CDMI were calculated. NPVs were compared between CAD subgroups using a Fisher exact test.

RESULTS

Among 1351 patients, 53.2% (719/1351) were male, 31.4% (424/1351) had known CAD, and the mean age was 57.4±12.8 years. At 30 days, CDMI occurred in 13.8% (187/1351). High-STEACS classified 63.4% (857/1351) to outpatient disposition, of which 2.0% (17/857) had 30-day CDMI, corresponding to an NPV of 98.0% (95% CI, 96.8-98.8) and negative likelihood ratio of 0.13 (95% CI, 0.08-0.20). In patients with CAD, 46.9% (199/424) were classified to outpatient disposition, of which 4.0% (8/199) had 30-day CDMI. Among patients without CAD, 71.0% (658/927) were classified to outpatient disposition with 1.4% (9/658) having 30-day CDMI. The NPV for 30-day CDMI was 96.0% (95% CI, 92.2-98.2) in patients with CAD versus 98.6% (95% CI, 97.4-99.4) among patients without CAD (=0.04). The negative likelihood ratio for 30-day CDMI among patients with CAD was 0.16 (95% CI, 0.08-0.31) and 0.12 (95% CI, 0.06-0.22) among patients without CAD.

CONCLUSIONS

The High-STEACS hs-cTnT pathway had high efficacy but was unable to achieve the ≥99% NPV safety threshold for 30-day CDMI.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT02984436.

摘要

背景

高敏肌钙蛋白在急性冠脉综合征患者评估中的应用(High-STEACS)路径可对急诊科疑似急性冠脉综合征患者进行风险分层。本研究旨在确定在美国一个包含有和没有已知冠状动脉疾病(CAD)患者的多中心队列中,High-STEACS高敏肌钙蛋白T(hs-cTnT)路径能否实现30天心脏死亡或心肌梗死(CDMI)的阴性预测值(NPV)≥99%的安全阈值。

方法

对优化胸痛风险分层的高敏肌钙蛋白T(第5代即时检测法)(STOP-CP)队列进行二次分析,该队列纳入了美国8个地点的成年急诊科疑似急性冠脉综合征患者(2017年1月25日至2018年9月6日)。使用High-STEACS hs-cTnT路径将参与者分为门诊和住院处置。已知CAD定义为既往心肌梗死、冠状动脉血运重建或冠状动脉狭窄≥70%。结局包括30天CDMI和有效性,有效性定义为确定为门诊处置的比例。计算30天CDMI的NPV和阴性似然比。使用Fisher精确检验比较CAD亚组之间的NPV。

结果

在1351例患者中,53.2%(719/1351)为男性,31.4%(424/1351)有已知CAD,平均年龄为57.4±12.8岁。在30天时,13.8%(187/1351)发生了CDMI。High-STEACS将63.4%(857/1351)分类为门诊处置,其中2.0%(17/857)发生了30天CDMI,对应的NPV为98.0%(95%CI,96.8-98.8),阴性似然比为0.13(95%CI,0.08-0.20)。在有CAD的患者中,46.9%(199/424)被分类为门诊处置,其中4.0%(8/199)发生了30天CDMI。在无CAD的患者中,71.0%(658/927)被分类为门诊处置,1.4%(9/658)发生了30天CDMI。有CAD患者30天CDMI的NPV为96.0%(95%CI,92.2-98.2),无CAD患者为98.6%(95%CI,97.4-99.4)(P=0.04)。有CAD患者30天CDMI的阴性似然比为0.16(95%CI,0.08-0.31),无CAD患者为0.12(95%CI,0.06-0.22)。

结论

High-STEACS hs-cTnT路径具有较高的有效性,但未能实现30天CDMI的NPV≥99%的安全阈值。

注册

网址:https://www.clinicaltrials.gov;唯一标识符:NCT02984436。

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