Department of Surgical Sciences/Anesthesiology and Intensive Care Medicine, Uppsala University, Sweden.
Department of Clinical Science and Education, Stockholm South General Hospital, Karolinska Institute, Sweden.
Am Heart J. 2018 Mar;197:53-61. doi: 10.1016/j.ahj.2017.11.009. Epub 2017 Dec 5.
Acute coronary syndrome is a common cause of out-of-hospital cardiac arrest (OHCA). In patients with OHCA presenting with ST elevation, immediate coronary angiography and potential percutaneous coronary intervention (PCI) after return of spontaneous circulation are recommended. However, the evidence for this invasive strategy in patients without ST elevation is limited. Observational studies have shown a culprit coronary artery occlusion in about 30% of these patients, indicating the electrocardiogram's (ECG's) limited sensitivity. The aim of this study is to determine whether immediate coronary angiography and subsequent PCI will provide outcome benefits in OHCA patients without ST elevation.
METHODS/DESIGN: We describe the design of the DIrect or Subacute Coronary angiography in Out-of-hospital cardiac arrest study (DISCO)-a pragmatic national, multicenter, randomized, clinical study. OHCA patients presenting with no ST elevation on their first recorded ECG will be randomized to a strategy of immediate coronary angiography or to standard of care with admission to intensive care and angiography after 3days at the earliest unless the patient shows signs of acute ischemia or hemodynamic instability. Primary end point is 30-day survival. An estimated 1,006 patients give 80% power (α = .05) to detect a 20% improved 30-day survival rate from 45% to 54%. Secondary outcomes include good neurologic recovery at 30days and 6months, and cognitive function and cardiac function at 6months.
This randomized clinical study will evaluate the effect of immediate coronary angiography after OHCA on 30-day survival in patients without ST elevation on their first recorded ECG.
急性冠状动脉综合征是院外心脏骤停(OHCA)的常见原因。对于出现 ST 段抬高的 OHCA 患者,建议在自主循环恢复后立即进行冠状动脉造影和潜在的经皮冠状动脉介入治疗(PCI)。然而,对于没有 ST 段抬高的患者,这种有创策略的证据有限。观察性研究表明,约 30%的这些患者存在罪犯性冠状动脉闭塞,表明心电图(ECG)的敏感性有限。本研究旨在确定在没有 ST 段抬高的 OHCA 患者中,立即进行冠状动脉造影和随后的 PCI 是否会带来预后获益。
方法/设计:我们描述了直接或亚急性冠状动脉造影在院外心脏骤停研究(DISCO)中的设计 - 这是一项实用的全国性、多中心、随机、临床研究。首次记录的 ECG 上没有 ST 段抬高的 OHCA 患者将被随机分为立即进行冠状动脉造影的策略组或标准治疗组,标准治疗组在患者出现急性缺血或血流动力学不稳定的情况下,将在重症监护病房入院,并在最早的 3 天后进行血管造影,否则将进行标准治疗。主要终点是 30 天生存率。预计将有 1006 例患者提供 80%的效力(α=0.05),以检测从 45%提高到 54%的 30 天生存率提高 20%。次要结局包括 30 天和 6 个月时的良好神经恢复,以及 6 个月时的认知功能和心脏功能。
这项随机临床研究将评估在首次记录的 ECG 上没有 ST 段抬高的 OHCA 患者中,立即进行冠状动脉造影对 30 天生存率的影响。