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多中心横断面观察性登记研究,以监测 copeptin 和肌钙蛋白排除急性心肌梗死后早期出院的安全性:Pro-Core 登记研究。

Multicentre cross-sectional observational registry to monitor the safety of early discharge after rule-out of acute myocardial infarction by copeptin and troponin: the Pro-Core registry.

机构信息

Cardiology, University of Heidelberg, Heidelberg, Germany.

Buckinghamshire Healthcare NHS Trust, Amersham, UK.

出版信息

BMJ Open. 2019 Jul 23;9(7):e028311. doi: 10.1136/bmjopen-2018-028311.

Abstract

OBJECTIVES

There is sparse information on the safety of early primary discharge from the emergency department (ED) after rule-out of myocardial infarction in suspected acute coronary syndrome (ACS). This prospective registry aimed to confirm randomised study results in patients at low-to-intermediate risk, with a broader spectrum of symptoms, across different institutional standards and with a range of local troponin assays including high-sensitivity cTn (hs-cTn), cardiac troponin (cTn) and point-of-care troponin (POC Tn).

DESIGN

Prospective, multicentre European registry.

SETTING

18 emergency departments in nine European countries (Germany, Austria, Switzerland, France, Spain, UK, Turkey, Lithuania and Hungary) PARTICIPANTS: The final study cohort consisted of 2294 patients (57.2% males, median age 57 years) with suspected ACS.

INTERVENTIONS

Using the new dual markers strategy, 1477 patients were eligible for direct discharge, which was realised in 974 (42.5%) of patients.

MAIN OUTCOME MEASURES

The primary endpoint was all-cause mortality at 30 days.

RESULTS

Compared with conventional workup after dual marker measurement, the median length of ED stay was 60 min shorter (228 min, 95% CI: 219 to 239 min vs 288 min, 95% CI: 279 to 300 min) in the primary dual marker strategy (DMS) discharge group. All-cause mortality was 0.1% (95% CI: 0% to 0.6%) in the primary DMS discharge group versus 1.1% (95% CI: 0.6% to 1.8%) in the conventional workup group after dual marker measurement. Conventional workup instead of discharge despite negative DMS biomarkers was observed in 503 patients (21.9%) and associated with higher prevalence of ACS (17.1% vs 0.9%, p<0.001), cardiac diagnoses (55.2% vs 23.5%, p<0.001) and risk factors (p<0.01), but with a similar all-cause mortality of 0.2% (95% CI: 0% to 1.1%) versus primary DMS discharge (p=0.64).

CONCLUSIONS

Copeptin on top of cardiac troponin supports safe discharge in patients with chest pain or other symptoms suggestive of ACS under routine conditions with the use of a broad spectrum of local standard POC, conventional and high-sensitivity troponin assays.

TRIAL REGISTRATION NUMBER

NCT02490969.

摘要

目的

在疑似急性冠状动脉综合征(ACS)的患者中,排除心肌梗死并早期初级出院的安全性方面信息匮乏。本前瞻性登记研究旨在确认随机研究结果在低至中度风险患者中的适用性,这些患者具有更广泛的症状谱,符合不同机构标准,并采用多种当地肌钙蛋白检测方法,包括高敏肌钙蛋白(hs-cTn)、心脏肌钙蛋白(cTn)和即时检测肌钙蛋白(POC Tn)。

设计

前瞻性、多中心欧洲登记研究。

地点

欧洲 9 个国家的 18 个急诊室(德国、奥地利、瑞士、法国、西班牙、英国、土耳其、立陶宛和匈牙利)。

参与者

最终研究队列纳入了 2294 名疑似 ACS 的患者(57.2%为男性,中位年龄 57 岁)。

干预措施

使用新的双重标志物策略,1477 名患者有资格直接出院,其中 974 名(42.5%)患者实际出院。

主要结局测量

主要终点为 30 天全因死亡率。

结果

与双重标志物测量后常规检查相比,主要双重标志物策略(DMS)出院组的急诊室中位留观时间缩短 60 分钟(228 分钟,95%CI:219 至 239 分钟比 288 分钟,95%CI:279 至 300 分钟)。主要 DMS 出院组的全因死亡率为 0.1%(95%CI:0%至 0.6%),而双重标志物测量后常规检查组的全因死亡率为 1.1%(95%CI:0.6%至 1.8%)。尽管 DMS 生物标志物为阴性,但仍对 503 名患者进行了常规检查而非出院,这与 ACS 患病率较高(17.1%比 0.9%,p<0.001)、心脏诊断(55.2%比 23.5%,p<0.001)和风险因素(p<0.01)相关,但全因死亡率相似(0.2%,95%CI:0%至 1.1%),与主要 DMS 出院相比(p=0.64)无差异。

结论

在常规条件下,使用广泛的当地标准即时检测、常规和高敏肌钙蛋白检测方法,在胸痛或其他疑似 ACS 症状的患者中,心脏肽素联合心脏肌钙蛋白可安全出院。

试验注册

NCT02490969。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22f4/6661885/03fef3ba544c/bmjopen-2018-028311f01.jpg

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