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高敏心肌肌钙蛋白 I 与疑似急性冠状动脉综合征患者的临床风险评分。

High-Sensitivity Cardiac Troponin I and Clinical Risk Scores in Patients With Suspected Acute Coronary Syndrome.

机构信息

British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (A.R.C., K.H., J.A., K.K.L., A.A., A.S.V.S., D.S., A.V.F., J.J., S.P., S.S., L.M., F.E.S., D.E.N., N.L.M.).

Department of Emergency Medicine (A.G.), Royal Infirmary of Edinburgh, United Kingdom.

出版信息

Circulation. 2018 Oct 16;138(16):1654-1665. doi: 10.1161/CIRCULATIONAHA.118.036426.

Abstract

BACKGROUND

High-sensitivity cardiac troponin assays can help to identify patients who are at low risk of myocardial infarction in the emergency department. We aimed to determine whether the addition of clinical risk scores would improve the safety of early rule-out pathways for myocardial infarction.

METHODS

In 1935 patients with suspected acute coronary syndrome, we evaluated the safety and efficacy of 2 rule-out pathways alone or in conjunction with low-risk TIMI (Thrombolysis In Myocardial Infarction) (0 or 1), GRACE (Global Registry of Acute Coronary Events) (≤108), EDACS (Emergency Department Assessment of Chest Pain Score) (<16), or HEART (History, ECG, Age, Risk factors, Troponin) (≤3) scores. The European Society of Cardiology 3-hour pathway uses a single diagnostic threshold (99th percentile), whereas the High-STEACS (High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome) pathway applies different thresholds to rule out (<5 ng/L) and rule in (>99th percentile) myocardial infarction.

RESULTS

Myocardial infarction or cardiac death during the index presentation or at 30 days occurred in 14.3% of patients (276/1935). The European Society of Cardiology pathway ruled out 70%, with 27 missed events giving a negative predictive value of 97.9% (95% CI, 97.1-98.6). The addition of a HEART score ≤3 reduced the proportion ruled out by the European Society of Cardiology pathway to 25% but improved the negative predictive value to 99.7% (95% CI, 99.0-100; P<0.001). The High-STEACS pathway ruled out 65%, with 3 missed events for a negative predictive value of 99.7% (95% CI, 99.4-99.9). No risk score improved the negative predictive value of the High-STEACS pathways, but all reduced the proportion ruled out (24% to 47%; P<0.001 for all).

CONCLUSIONS

Clinical risk scores significantly improved the safety of the European Society of Cardiology 3-hour pathway, which relies on a single cardiac troponin threshold at the 99th percentile to rule in and rule out myocardial infarction. Where lower thresholds are used to rule out myocardial infarction, as applied in the High-STEACS pathway, risk scores halve the proportion of patients ruled out without improving safety.

CLINICAL TRIAL REGISTRATION

URL: https://www.clinicaltrials.gov . Unique identifier: NCT01852123.

摘要

背景

高敏肌钙蛋白检测有助于在急诊科确定心肌梗死风险较低的患者。本研究旨在评估临床风险评分的加入是否能提高心肌梗死早期排除路径的安全性。

方法

在 1935 例疑似急性冠脉综合征患者中,我们评估了单独应用或联合应用低危 TIMI(血栓形成溶栓治疗)评分(0 或 1)、GRACE(全球急性冠脉事件注册)评分(≤108)、EDACS(急诊科胸痛评估评分)评分(<16)或 HEART(病史、心电图、年龄、危险因素、肌钙蛋白)评分(≤3)的两种排除路径的安全性和有效性。欧洲心脏病学会 3 小时路径采用单一诊断界值(99 百分位值),而高敏性肌钙蛋白在急性冠脉综合征患者评估中的应用(High-STEACS)路径则应用不同的界值来排除(<5ng/L)和确诊(>99 百分位值)心肌梗死。

结果

在指数期就诊或 30 天内,心肌梗死或心源性死亡发生于 14.3%(276/1935)的患者中。欧洲心脏病学会路径排除了 70%的患者,但有 27 例漏诊事件,阴性预测值为 97.9%(95%CI,97.1%~98.6%)。添加 HEART 评分≤3 可将欧洲心脏病学会路径排除的比例降至 25%,但阴性预测值提高至 99.7%(95%CI,99.0%~100%;P<0.001)。高敏性肌钙蛋白在急性冠脉综合征患者评估中的应用路径排除了 65%的患者,漏诊 3 例,阴性预测值为 99.7%(95%CI,99.4%~99.9%)。没有风险评分能提高高敏性肌钙蛋白在急性冠脉综合征患者评估中的应用路径的阴性预测值,但所有评分都降低了排除的比例(24%~47%;所有 P<0.001)。

结论

临床风险评分显著提高了欧洲心脏病学会 3 小时路径的安全性,该路径依赖于第 99 百分位值的单一肌钙蛋白界值来确诊和排除心肌梗死。而在应用高敏性肌钙蛋白在急性冠脉综合征患者评估中的应用路径时,为了排除心肌梗死采用更低的界值,所有风险评分都将排除的患者比例降低了一半,而不提高安全性。

临床试验注册

网址:https://www.clinicaltrials.gov。唯一识别码:NCT01852123。

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