Department of Medicine, Sarver Heart Center (K.B.K., K.S.L., K.L., R.J.), University of Arizona, Tucson.
Center for Intensive Internal Medicine, University Medical Center Ljubljana, Faculty of Medicine, University of Ljubljana, Slovenia (P.R., M.N.).
Circulation. 2020 Nov 24;142(21):2002-2012. doi: 10.1161/CIRCULATIONAHA.120.049569. Epub 2020 Sep 28.
The benefit of emergency coronary angiography after resuscitation from out-of-hospital cardiac arrest is uncertain for patients without ST-segment elevation. The aim of this randomized trial was to evaluate the efficacy and safety of early coronary angiography and to determine the prevalence of acute coronary occlusion in resuscitated patients with out-of-hospital cardiac arrest without ST-segment elevation.
Adult (>18 years) comatose survivors without ST-segment elevation after resuscitation from out-of-hospital cardiac arrest were prospectively randomized in a 1:1 fashion under exception to informed consent regulations to early coronary angiography versus no early coronary angiography in this multicenter study. Early angiography was defined as ≤120 minutes from arrival at the percutaneous coronary intervention-capable facility. The primary end point was a composite of efficacy and safety measures, including efficacy measures of survival to discharge, favorable neurologic status at discharge (Cerebral Performance Category score ≤2), echocardiographic measures of left ventricular ejection fraction >50%, and a normal regional wall motion score of 16 within 24 hours of admission. Adverse events included rearrest, pulmonary edema on chest x-ray, acute renal dysfunction, bleeding requiring transfusion or intervention, hypotension (systolic arterial pressure ≤90 mm Hg), and pneumonia. Secondary end points included the incidence of culprit vessels with acute occlusion.
The study was terminated prematurely before enrolling the target number of patients. A total of 99 patients were enrolled from 2015 to 2018, including 75 with initially shockable rhythms. Forty-nine patients were randomized to early coronary angiography. The primary end point of efficacy and safety was not different between the 2 groups (55.1% versus 46.0%; =0.64). Early coronary angiography was not associated with any significant increase in survival (55.1% versus 48.0%; =0.55) or adverse events (26.5% versus 26.0%; =1.00). Early coronary angiography revealed a culprit vessel in 47%, with a total of 14% of patients undergoing early coronary angiography having an acutely occluded culprit coronary artery.
This underpowered study, when considered together with previous clinical trials, does not support early coronary angiography for comatose survivors of cardiac arrest without ST elevation. Whether early detection of occluded potential culprit arteries leads to interventions that improve outcomes requires additional study.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02387398.
对于无 ST 段抬高的院外心脏骤停后复苏患者，急诊冠状动脉造影的获益尚不确定。本随机试验的目的是评估早期冠状动脉造影的疗效和安全性，并确定无 ST 段抬高的院外心脏骤停复苏患者中急性冠状动脉闭塞的发生率。
本多中心研究前瞻性地将无 ST 段抬高的院外心脏骤停复苏后昏迷的成年（>18 岁）患者按 1:1 的比例随机分组，根据知情同意豁免规定，接受早期冠状动脉造影与不接受早期冠状动脉造影。早期血管造影定义为从到达有经皮冠状动脉介入能力的机构到开始血管造影的时间不超过 120 分钟。主要终点是疗效和安全性措施的复合终点，包括出院时的生存、出院时的良好神经状态（脑功能表现分类评分≤2）、超声心动图左心室射血分数>50%和入院后 24 小时内正常的 16 节段室壁运动评分。不良事件包括再次骤停、胸片上的肺水肿、急性肾功能障碍、需要输血或介入治疗的出血、低血压（收缩压≤90mmHg）和肺炎。次要终点包括罪犯血管急性闭塞的发生率。
在纳入目标患者数量之前，该研究提前终止。2015 年至 2018 年共纳入 99 例患者，其中 75 例初始节律为可电击节律。49 例患者被随机分为早期冠状动脉造影组。两组间疗效和安全性的主要终点无差异（55.1%比 46.0%；=0.64）。早期冠状动脉造影并未增加生存率（55.1%比 48.0%；=0.55）或不良事件（26.5%比 26.0%；=1.00）。早期冠状动脉造影显示 47%的罪犯血管，共有 14%的接受早期冠状动脉造影的患者存在急性闭塞的罪犯冠状动脉。
这项效力不足的研究，与之前的临床试验一起考虑，不支持对无 ST 抬高的心脏骤停昏迷幸存者进行早期冠状动脉造影。早期发现闭塞的潜在罪犯动脉是否会导致改善预后的干预措施还需要进一步研究。
