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肌钙蛋白释放策略与常规治疗的检测限:随机对照试验。

Limit of detection of troponin discharge strategy versus usual care: randomised controlled trial.

作者信息

Carlton Edward Watts, Ingram Jenny, Taylor Hazel, Glynn Joel, Kandiyali Rebecca, Campbell Sarah, Beasant Lucy, Aziz Shahid, Beresford Peter, Kendall Jason, Reuben Adam, Smith Jason E, Chapman Rebecca, Creanor Siobhan, Benger Jonathan Richard

机构信息

Emergency Department, North Bristol NHS Trust, Bristol, UK

Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

出版信息

Heart. 2020 Oct;106(20):1586-1594. doi: 10.1136/heartjnl-2020-316692. Epub 2020 May 5.

Abstract

INTRODUCTION

The clinical effectiveness of a 'rule-out' acute coronary syndrome (ACS) strategy for emergency department patients with chest pain, incorporating a single undetectable high-sensitivity cardiac troponin (hs-cTn) taken at presentation, together with a non-ischaemic ECG, remains unknown.

METHODS

A randomised controlled trial, across eight hospitals in the UK, aimed to establish the clinical effectiveness of an undetectable hs-cTn and ECG (limit of detection and ECG discharge (LoDED)) discharge strategy. Eligible adult patients presented with chest pain; the treating clinician intended to perform investigations to rule out an ACS; the initial ECG was non-ischaemic; and peak symptoms occurred <6 hours previously. Participants were randomised 1:1 to either the LoDED strategy or the usual rule-out strategy. The primary outcome was discharge from the hospital within 4 hours of arrival, without a major adverse cardiac event (MACE) within 30 days.

RESULTS

Between June 2018 and March 2019, 632 patients were randomised; 3 were later withdrawn. Of 629 patients (age 53.8 (SD 16.1) years, 41% women), 7% had a MACE within 30 days. For the LoDED strategy, 141 of 309 (46%) patients were discharged within 4 hours, without MACE within 30 days, and for usual care, 114 of 311 (37%); pooled adjusted OR 1.58 (95% CI 0.84 to 2.98). No patient with an initial undetectable hs-cTn had a MACE within 30 days.

CONCLUSION

The LoDED strategy facilitates safe early discharge in >40% of patients with chest pain. Clinical effectiveness is variable when compared with existing rule-out strategies and influenced by wider system factors.

TRIAL REGISTRATION NUMBER

ISRCTN86184521.

摘要

引言

对于急诊科胸痛患者,采用“排除”急性冠状动脉综合征(ACS)策略的临床有效性尚不清楚,该策略包括就诊时单次检测不到的高敏心肌肌钙蛋白(hs-cTn)以及非缺血性心电图。

方法

在英国的八家医院进行了一项随机对照试验,旨在确定检测不到的hs-cTn和心电图(检测限和心电图出院(LoDED))出院策略的临床有效性。符合条件的成年患者出现胸痛;主治医生打算进行检查以排除ACS;初始心电图为非缺血性;且峰值症状出现在6小时内。参与者按1:1随机分为LoDED策略组或常规排除策略组。主要结局是到达医院后4小时内出院,且30天内无重大不良心脏事件(MACE)。

结果

2018年6月至2019年3月期间,632例患者被随机分组;3例后来退出。在629例患者(年龄53.8(标准差16.1)岁,41%为女性)中,7%在30天内发生了MACE。对于LoDED策略,309例患者中有141例(46%)在4小时内出院,30天内无MACE,对于常规治疗,311例患者中有114例(37%);合并调整后的比值比为1.58(95%置信区间0.84至2.98)。初始hs-cTn检测不到的患者在30天内均未发生MACE。

结论

LoDED策略有助于40%以上的胸痛患者安全早期出院。与现有的排除策略相比,临床有效性存在差异,并受更广泛的系统因素影响。

试验注册号

ISRCTN86184521。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f214/7525793/22afc2322178/heartjnl-2020-316692f01.jpg

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