Möckel Martin, Searle Julia, Hamm Christian, Slagman Anna, Blankenberg Stefan, Huber Kurt, Katus Hugo, Liebetrau Christoph, Müller Christian, Muller Reinhold, Peitsmeyer Philipp, von Recum Johannes, Tajsic Milos, Vollert Jörn O, Giannitsis Evangelos
Division of Emergency Medicine and CPU, Department of Cardiology, Campus Virchow-Klinikum and Campus Charité Mitte, Charité-University Medicine Berlin, Augustenburger Platz 1, Berlin 13353, Germany
Division of Emergency Medicine and CPU, Department of Cardiology, Campus Virchow-Klinikum and Campus Charité Mitte, Charité-University Medicine Berlin, Augustenburger Platz 1, Berlin 13353, Germany.
Eur Heart J. 2015 Feb 7;36(6):369-76. doi: 10.1093/eurheartj/ehu178. Epub 2014 Apr 30.
This randomized controlled trial (RCT) evaluated whether a process with single combined testing of copeptin and troponin at admission in patients with low-to-intermediate risk and suspected acute coronary syndrome (ACS) does not lead to a higher proportion of major adverse cardiac events (MACE) than the current standard process (non-inferiority design).
A total of 902 patients were randomly assigned to either standard care or the copeptin group where patients with negative troponin and copeptin values at admission were eligible for discharge after final clinical assessment. The proportion of MACE (death, survived sudden cardiac death, acute myocardial infarction (AMI), re-hospitalization for ACS, acute unplanned percutaneous coronary intervention, coronary artery bypass grafting, or documented life threatening arrhythmias) was assessed after 30 days. Intention to treat analysis showed a MACE proportion of 5.17% [95% confidence intervals (CI) 3.30-7.65%; 23/445] in the standard group and 5.19% (95% CI 3.32-7.69%; 23/443) in the copeptin group. In the per protocol analysis, the MACE proportion was 5.34% (95% CI 3.38-7.97%) in the standard group, and 3.01% (95% CI 1.51-5.33%) in the copeptin group. These results were also corroborated by sensitivity analyses. In the copeptin group, discharged copeptin negative patients had an event rate of 0.6% (2/362).
After clinical work-up and single combined testing of troponin and copeptin to rule-out AMI, early discharge of low- to intermediate risk patients with suspected ACS seems to be safe and has the potential to shorten length of stay in the ED. However, our results need to be confirmed in larger clinical trials or registries, before a clinical directive can be propagated.
本随机对照试验(RCT)评估了在低至中度风险且疑似急性冠状动脉综合征(ACS)的患者入院时进行 copeptin 和肌钙蛋白联合检测的流程,与当前标准流程相比,是否不会导致更高比例的主要不良心脏事件(MACE)(非劣效性设计)。
总共 902 名患者被随机分配至标准治疗组或 copeptin 组,入院时肌钙蛋白和 copeptin 值为阴性的患者在最终临床评估后可出院。30 天后评估 MACE(死亡、存活的心脏性猝死、急性心肌梗死(AMI)、因 ACS 再次住院、急性非计划性经皮冠状动脉介入治疗、冠状动脉旁路移植术或记录在案的危及生命的心律失常)的比例。意向性分析显示,标准组的 MACE 比例为 5.17%[95%置信区间(CI)3.30 - 7.65%;23/445],copeptin 组为 5.19%(95%CI 3.32 - 7.69%;23/443)。在符合方案分析中,标准组的 MACE 比例为 5.34%(95%CI 3.38 - 7.97%),copeptin 组为 3.01%(95%CI 1.51 - 5.33%)。敏感性分析也证实了这些结果。在 copeptin 组中,出院时 copeptin 为阴性的患者事件发生率为 0.6%(2/362)。
经过临床检查以及肌钙蛋白和 copeptin 的联合检测以排除 AMI 后,对低至中度风险的疑似 ACS 患者进行早期出院似乎是安全的,并且有可能缩短急诊室住院时间。然而,在能够推广临床指南之前,我们的结果需要在更大规模的临床试验或登记研究中得到证实。