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即刻非选择性冠状动脉造影与无 ST 段抬高院外心脏骤停幸存者延迟分诊:TOMAHAWK 试验的设计和原理。

Immediate unselected coronary angiography versus delayed triage in survivors of out-of-hospital cardiac arrest without ST-segment elevation: Design and rationale of the TOMAHAWK trial.

机构信息

Universitäres Herzzentrum Lübeck, Lübeck, Germany; Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Berlin, Germany; Herzzentrum Leipzig-Universitätsklinik für Kardiologie, Leipzig, Germany.

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Berlin, Germany; Herzzentrum Leipzig-Universitätsklinik für Kardiologie, Leipzig, Germany.

出版信息

Am Heart J. 2019 Mar;209:20-28. doi: 10.1016/j.ahj.2018.12.005. Epub 2018 Dec 11.

Abstract

Patients experiencing out-of-hospital cardiac arrest (OHCA) without ST-segment elevation are a heterogenic group with a variety of underlying causes. Up to one-third of patients display a significant coronary lesion compatible with myocardial infarction as OHCA trigger. There are no randomized data on patient selection and timing of invasive coronary angiography after admission. METHODS AND RESULTS: The TOMAHAWK trial randomly assigns 558 patients with return of spontaneous circulation after OHCA with no obvious extracardiac origin of cardiac arrest and no ST-segment elevation/left bundle-branch block on postresuscitation electrocardiogram to either immediate coronary angiography or initial intensive care assessment with delayed/selective angiography in a 1:1 ratio. The primary end point is 30-day all-cause mortality. Secondary analyses will be performed with respect to initial rhythm, electrocardiographic patterns, myocardial infarction as underlying cause, neurological outcome, as well as clinical and laboratory markers. Clinical follow-up will be performed at 6 and 12 months. Safety end points include bleeding and stroke. CONCLUSION: The TOMAHAWK trial will address the unresolved issue of timing and general indication of angiography after OHCA without ST-segment elevation.

摘要

经历院外心脏骤停(OHCA)且无 ST 段抬高的患者是一组异质性群体,其潜在病因多种多样。多达三分之一的患者表现出与心肌梗死相符的明显冠状动脉病变,是 OHCA 的触发因素。目前尚无关于入院后侵入性冠状动脉造影的患者选择和时机的随机数据。

方法和结果

TOMAHAWK 试验随机分配 558 例 OHCA 患者,这些患者在 OHCA 后自主循环恢复,且无明显的心外原因导致心脏骤停,且在复苏后心电图上无 ST 段抬高/左束支传导阻滞,以 1:1 的比例随机分为立即行冠状动脉造影或初始强化治疗后延迟/选择性行冠状动脉造影。主要终点为 30 天全因死亡率。次要分析将针对初始节律、心电图模式、心肌梗死作为潜在病因、神经功能结局以及临床和实验室标志物进行。临床随访将在 6 个月和 12 个月进行。安全性终点包括出血和卒中。

结论

TOMAHAWK 试验将解决 OHCA 后无 ST 段抬高时血管造影的时机和一般适应证这一未解决的问题。

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