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在心肌损伤和 2 型心肌梗死(ACT-2)中进行冠状动脉检查的适宜性:一项随机试验设计。

The appropriateness of coronary investigation in myocardial injury and type 2 myocardial infarction (ACT-2): A randomized trial design.

机构信息

Department of Cardiology, Flinders Medical Centre, Adelaide, Australia.

School of Medicine, University of New South Wales, Sydney, Australia.

出版信息

Am Heart J. 2019 Feb;208:11-20. doi: 10.1016/j.ahj.2018.09.016. Epub 2018 Oct 25.

DOI:10.1016/j.ahj.2018.09.016
PMID:30522086
Abstract

BACKGROUND

Elevated troponin level findings among patients presenting with suspected acute coronary syndrome (ACS) or another intercurrent illness undeniably identifies patients at increased risk of mortality. Whilst enhancing our capacity to discriminate risk, the use of high-sensitivity troponin assays frequently identifies patients with myocardial injury (i.e. troponin rise without acute signs of myocardial ischemia) or type 2 myocardial infarction (T2MI; oxygen supply-demand imbalance). This leads to the clinically challenging task of distinguishing type 1 myocardial infarction (T1MI; coronary plaque rupture) from myocardial injury and T2MI in the context of concurrent acute illness. Diagnostic discernment in this context is crucial because MI classification has implications for further investigation and care. Early invasive management is of well-established benefit among patients with T1MI. However, the appropriateness of this investigation in the heterogeneous context of T2MI, where there is high competing mortality risk, remains unknown. Although coronary angiography in T2MI is advocated by some, there is insufficient evidence in existing literature to support this opinion as highlighted by current national guidelines.

OBJECTIVE

The objective is to evaluate the clinical and economic impact of early invasive management with coronary angiography in T2MI in terms of all-cause mortality and cost effectiveness.

DESIGN

This prospective, pragmatic, multicenter, randomized trial among patients with suspected supply demand ischemia leading to troponin elevation (n=1,800; T2MI [1,500], chronic myocardial injury [300]) compares the impact of invasive angiography (or computed tomography angiography as per local preference) within 5 days of randomization versus conservative management (with or without functional testing at clinician discretion) on all-cause mortality by 2 years. Randomized treatment allocation will be stratified by baseline estimated risk of mortality using the Acute Physiology, Age, and Chronic Health Evaluation (APACHE) III risk score. Cost-effectiveness will be evaluated by follow-up on clinical events, quality of life, and resource utilization over 24 months.

SUMMARY

Ascertaining the most appropriate first-line investigative strategy for these commonly encountered high-risk T2MI patients in a randomized comparative study will be pivotal in informing evidence-based guidelines that lead to better patient and health care outcomes.

摘要

背景

在表现出疑似急性冠脉综合征(ACS)或其他并发疾病的患者中,升高的肌钙蛋白水平无疑确定了具有更高死亡率风险的患者。虽然提高了我们区分风险的能力,但高敏肌钙蛋白检测的应用经常会识别出心肌损伤(即肌钙蛋白升高但没有急性心肌缺血迹象)或 2 型心肌梗死(T2MI;氧供需失衡)的患者。这导致了在并发急性疾病的情况下,区分 1 型心肌梗死(T1MI;斑块破裂)与心肌损伤和 T2MI 的临床挑战性任务。在这种情况下进行诊断区分至关重要,因为 MI 分类对进一步的检查和治疗有影响。对于 T1MI 患者,早期有创性治疗已得到充分证实有益。然而,在 T2MI 这种异质性背景下,这种检查的适当性,其中存在高竞争死亡率风险,仍然未知。虽然一些人主张在 T2MI 中进行冠状动脉造影,但现有文献中的证据不足以支持这一观点,正如当前的国家指南所强调的那样。

目的

目的是评估早期有创性管理(包括冠状动脉造影)对 T2MI 患者全因死亡率和成本效益的临床和经济影响。

设计

这是一项在疑似供需缺血导致肌钙蛋白升高的患者中进行的前瞻性、实用、多中心、随机试验(n=1800;T2MI [1500],慢性心肌损伤 [300]),比较了在随机分组后 5 天内进行有创血管造影(或根据当地偏好进行计算机断层血管造影)与保守管理(根据临床医生的判断,包括或不包括功能检查)对 2 年内全因死亡率的影响。随机治疗分配将根据基线估计死亡率使用急性生理学、年龄和慢性健康评估(APACHE)III 风险评分进行分层。通过 24 个月的临床事件、生活质量和资源利用随访评估成本效益。

总结

在随机对照研究中确定这些常见的高风险 T2MI 患者最适当的一线调查策略至关重要,这将为循证指南提供信息,从而改善患者和医疗保健结果。

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