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ESC-TROP(欧洲心脏病学会 0h/1h 肌钙蛋白排除试验)试验的有效性和安全性。

Effectiveness and Safety of the ESC-TROP (European Society of Cardiology 0h/1h Troponin Rule-Out Protocol) Trial.

机构信息

Department of Cardiology Lund University, Skåne University Hospital Lund Sweden.

Department of Emergency Medicine Helsingborg Hospital Helsingborg Sweden.

出版信息

J Am Heart Assoc. 2024 Nov 5;13(21):e036307. doi: 10.1161/JAHA.124.036307. Epub 2024 Oct 29.

DOI:10.1161/JAHA.124.036307
PMID:39470043
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11935679/
Abstract

BACKGROUND

European guidelines recommend the use of a 0h/1h hs-cTn (high-sensitivity cardiac troponin) protocol in patients with acute chest pain. We aimed to determine the performance of this protocol in routine care when supplemented with patient history and ECG and a recommendation to refrain from noninvasive testing in low-risk patients.

METHODS AND RESULTS

This was a pre- and postimplementation study with concurrent controls. Patients with chest pain were enrolled at 5 Swedish emergency departments (EDs) during a 10-month period in both 2017 and 2018. All hospitals used a 0h/3h hs-cTnT protocol in 2017 and 3 EDs implemented a 0h/1h hs-cTnT protocol during 10 months in 2018. The 2 coprimary outcomes were the incidence of acute myocardial infarction and all-cause death within 30 days and ED length of stay. The study included 26 040 consecutive patients. In the intervention hospitals, 21 (0.40%) of the discharged patients had an acute myocardial infarction/death event during the control period (0h/3h testing) and 22 (0.45%) in the intervention period (0h/1h testing), which met the criteria for noninferiority. There was no significant difference in ED length of stay (ratio 0.99, =0.48) or ED discharge rate between the periods in the intervention versus the control hospitals. A total of 3142 patients met low-risk 0h/1h hs-cTnT criteria and were discharged, of whom 2 had an acute myocardial infarction/death event.

CONCLUSIONS

A 0h/1h hs-cTnT protocol incorporating patient history and ECG was as safe as using a 0h/3h protocol but did not reduce ED length of stay or increase the discharge rate. Refraining from noninvasive testing in patients identified as low risk was safe.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03421873.

摘要

背景

欧洲指南建议在急性胸痛患者中使用 0h/1h hs-cTn(高敏心肌肌钙蛋白)方案。我们旨在确定当该方案结合病史和心电图,并建议低危患者避免进行无创检查时,在常规护理中的表现。

方法和结果

这是一项在 2017 年和 2018 年期间,在瑞典的 5 家急诊部门(EDs)进行的前瞻性和实施后对照研究。所有医院在 2017 年都使用了 0h/3h hs-cTnT 方案,在 2018 年的 10 个月中,有 3 家 ED 实施了 0h/1h hs-cTnT 方案。主要转归指标为 30 天内急性心肌梗死和全因死亡的发生率以及 ED 住院时间。该研究纳入了 26040 例连续患者。在干预医院,在对照组(0h/3h 检测)期间出院的 21 例(0.40%)患者和干预组(0h/1h 检测)期间出院的 22 例(0.45%)患者发生急性心肌梗死/死亡事件,符合非劣效性标准。在干预与对照组 ED 住院时间(比值 0.99,=0.48)或 ED 出院率方面无显著差异。共有 3142 例患者符合低危 0h/1h hs-cTnT 标准并出院,其中 2 例发生急性心肌梗死/死亡事件。

结论

结合病史和心电图的 0h/1h hs-cTnT 方案与使用 0h/3h 方案一样安全,但并未降低 ED 住院时间或增加出院率。对于被确定为低危的患者,避免进行无创检查是安全的。

注册信息

网址:https://www.clinicaltrials.gov;唯一标识符:NCT03421873。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4248/11935679/5841feb034ec/JAH3-13-e036307-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4248/11935679/9a8242ae6d6c/JAH3-13-e036307-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4248/11935679/5841feb034ec/JAH3-13-e036307-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4248/11935679/9a8242ae6d6c/JAH3-13-e036307-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4248/11935679/5841feb034ec/JAH3-13-e036307-g001.jpg

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2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR 胸痛评估与诊断指南:美国心脏病学会/美国心脏协会联合临床实践指南委员会的报告。
Circulation. 2021 Nov 30;144(22):e368-e454. doi: 10.1161/CIR.0000000000001029. Epub 2021 Oct 28.
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High-Sensitivity Cardiac Troponin on Presentation to Rule Out Myocardial Infarction: A Stepped-Wedge Cluster Randomized Controlled Trial.就诊时采用高敏心肌肌钙蛋白排除心肌梗死:一项递进式楔形集群随机对照试验。
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