Reich Christoph, Yildirim Mustafa, Salbach Christian, Biener Moritz, Lopez-Ayala Pedro, Müller Christian, Frey Norbert, Giannitsis Evangelos
Department of Cardiology, Angiology and Pulmonology, University Hospital Heidelberg, Heidelberg, Germany.
Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, Basel, Switzerland.
Open Heart. 2025 Mar 28;12(1):e003047. doi: 10.1136/openhrt-2024-003047.
High-sensitivity cardiac troponin tests have enhanced early myocardial infarction diagnosis, yet many patients still land in the observe zone (OZ). Guidelines suggest a 3-hour troponin measurement for those in the European Society of Cardiology (ESC) 0/1 hour-algorithm's OZ, but evidence on extended troponin testing times and their impact on diagnostic accuracy and outcomes remains sparse.
Patients with suspected acute coronary syndrome were consecutively enrolled in a single-centre observational study. The triage protocol allowed an optional third troponin measurement at 3 hours or later to evaluate the performance and safety of two validated triage algorithms used to resolve the OZ.
Of the 4605 patients, 948 were triaged to the OZ (20.6%). The prevalence of non-ST-segment elevation myocardial infarction (NSTEMI) within the OZ was 7.2%. 212 patients (22.3% of OZ patients) had a third troponin measurement and were included in the comparative analysis. For diagnosing NSTEMI, the ESC 0/3-hour criteria showed lower sensitivity (69.4%) than the criteria defined in the Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) study (86.1%, p=0.053), with both having high negative predictive value (93.5% vs 87.5%, p=0.339). By definition, the ESC 0/3-hour algorithm categorises all patients into rule-in or rule-out, eliminating the need for an OZ, whereas 55.6% of patients remained in the OZ with the APACE criteria. Mortality rates in the OZ were similar across different timing protocols, with 30-day rates of 0.78% for third blood draws within 210 min (n=128) and 1.19% for those over 210 min (n=84); 3-year rates were 5.51% and 4.82%, confirming the safety of extended sampling.
Although the ESC 0/3-hour criteria have a lower sensitivity than the APACE criteria, it is by definition more effective because it does not leave patients in the OZ. Extending the timing for the third troponin measurement beyond 3 hours proves to be effective and safe, supporting its implementation in clinical practice.
NCT03111862.
高敏心肌肌钙蛋白检测提高了早期心肌梗死的诊断水平,但仍有许多患者处于观察区(OZ)。指南建议,对于欧洲心脏病学会(ESC)0/1小时算法观察区内的患者进行3小时肌钙蛋白检测,但关于延长肌钙蛋白检测时间及其对诊断准确性和预后影响的证据仍然很少。
连续纳入疑似急性冠状动脉综合征的患者进行单中心观察性研究。分诊方案允许在3小时或更晚进行可选的第三次肌钙蛋白检测,以评估用于解决观察区问题的两种有效分诊算法的性能和安全性。
4605例患者中,948例被分诊至观察区(20.6%)。观察区内非ST段抬高型心肌梗死(NSTEMI)的患病率为7.2%。212例患者(占观察区患者的22.3%)进行了第三次肌钙蛋白检测,并纳入比较分析。对于诊断NSTEMI,ESC 0/3小时标准的敏感性(69.4%)低于急性冠状动脉综合征评估优势预测指标(APACE)研究中定义的标准(86.1%,p=0.053),两者的阴性预测值均较高(93.5%对87.5%,p=0.339)。根据定义,ESC 0/3小时算法将所有患者分类为确诊或排除,无需观察区,而采用APACE标准时,55.6%的患者仍处于观察区。观察区内不同时间方案的死亡率相似,210分钟内第三次采血的30天死亡率为0.78%(n=128),210分钟以上的为1.19%(n=84);3年死亡率分别为5.51%和4.82%,证实了延长采样的安全性。
尽管ESC 0/3小时标准的敏感性低于APACE标准,但根据定义它更有效,因为它不会让患者留在观察区。将第三次肌钙蛋白检测时间延长至3小时以上被证明是有效和安全的,支持在临床实践中实施。
NCT03111862。