Abstract: BACKGROUND: The optimal approach for the early diagnosis of non-ST-segment elevation myocardial infarction (NSTEMI) remains uncertain, because no large trials have been performed. Accordingly, guideline recommendations differ and do not overall give a clear answer. OBJECTIVES: The authors aimed to directly compare the European Society of Cardiology 0/1-hour algorithm (ESC 0/1h-algorithm) and the high-sensitivity troponin in the evaluation of patients with acute coronary syndrome 0/2-hour or 0/3-hour pathway (High-STEACS 0/2h-0/3h-pathway) in patients presenting with acute chest discomfort. METHODS: This prospective, international, multicenter, diagnostic study enrolled patients presenting to the emergency department with acute chest discomfort. Final diagnoses were centrally adjudicated by 2 independent cardiologists. The primary diagnostic endpoint was NSTEMI type 1. Both algorithms were applied in parallel using 3 high-sensitivity cardiac troponin (hs-cTn) assays: hs-cTnI-Architect, hs-cTnI-Centaur/Atellica, and hs-cTnT-Elecsys. The findings were externally validated in an independent prospective diagnostic study. RESULTS: Among 4,663 eligible patients (median age: 61 years; 32% women), 663 (14.2%) had NSTEMI type 1. The ESC 0/1h-algorithm had higher sensitivity when using hs-cTnI-Architect (100% [95% CI: 99.4-100]) compared with the High-STEACS 0/2h-pathway (98.1% [95% CI: 96.7-99], P < 0.001), but the proportion of patients assigned to the rule-out group was lower (52% vs 72.5%, P < 0.001). Differences were similar but were less pronounced for hs-cTnI-Centaur/Atellica and absent for hs-cTnT-Elecsys. Specificity was consistently higher for the ESC 0/1h-algorithms vs the High-STEACS 0/2h-0/3h-pathways for all hs-cTnT/I-assays. These findings were confirmed when using High-STEACS 0/3h-pathways and in the external validation cohort (n = 2,485; median age: 64 years; 37% women). CONCLUSIONS: Overall, both algorithms exhibited comparable and excellent performance. When using hs-cTnI, the ESC-0/1h-algorithms showed higher sensitivity, whereas the High-STEACS 0/2h-0/3h-pathways demonstrated higher efficacy. Consistently, the ESC 0/1h-algorithms showed higher specificity for NSTEMI. These findings provide direct, validated evidence to guide hospitals in selecting an hs-cTn pathway aligned with their clinical and operational priorities. (Advantageous Predictors of Acute Coronary Syndromes Evaluation [APACE] Study [APACE], NCT00470587; Biomarkers in Acute Cardiac Care [BACC], NCT02355457).
Tags: (P400PM_180828) as well as speaker/consulting honoraria from Abbott, Ortho, *Acute Coronary Syndrome/diagnosis/blood, *Algorithms, *Myocardial Infarction/diagnosis/blood, *Non-ST Elevated Myocardial Infarction/diagnosis/blood, *Troponin I/blood, *Troponin T/blood, Aged, and he has, and research grants from the University of Basel, University Hospital of Basel,, as well as speaker honoraria from Roche Diagnostics, Abbott, and Siemens, paid to, AstraZeneca, Bayer, Boehringer Ingelheim, Inari, Medtronic, Merck, ReCor Medical,, Bangerter-Rhyner Foundation, and the "Freiwillige Akademische Gesellschaft Basel", Bayer, Ortho Clinical Diagnostics, and Orion Pharma, outside the submitted work., Biomarkers/blood, Clinical Diagnostics, Roche, and Siemens, outside the submitted work. Dr Wildi, co-founders and shareholders of the ART-EMIS Hamburg GmbH. Dr Mueller reports, Corporation, Novartis, Ortho Diagnostics, Quidel, Roche, Siemens, SpinChip,, Deutsche Forschungsgemeinschaft (SFB TRR219, Project-ID 322900939), and Deutsche, Division of Internal Medicine, Swiss Academy of Medical Sciences, Gottfried and, Dr Koechlin has received a research grant from the Swiss Heart Foundation,, ESC 0/1h-algorithm, Europe, external validation, Female, Foundation (FF20079, FF21103 and FF24149) and speaker's honoraria from Quidel,, Foundation (P400PM_191037/1), Prof Dr Max Cloetta Foundation, Margarete und, from the German Center of Cardiovascular Research (DZHK) and research support by, German Heart Research Foundation and an unrestricted grant from Roche. The, grants from the Swiss Heart Foundation and Swiss National Science Foundation, grants from the Swiss National Science Foundation, Swiss Heart Foundation,, has received research support from the University of Queensland (PhD, Heart Foundation and has received honoraria from Siemens, Roche Diagnostics,, Heart Foundation, University Hospital Basel, University of Basel, Abbott, Astra, Herzstiftung, his former employer (Saarland University) has received scientific, honoraria/consulting honoraria from Abbott, PHC, Roche, and Siemens. Drs, Humans, Idorsia, LSI Medience Corporation, Ortho Clinical Diagnostics, Quidel, Roche,, infarction (International Publication Number WO2022043229A1) as well as, Ingelheim, BMS, Idorsia, Novartis, Osler, Roche, SpinChip, and Sanofi, all paid, investigated hs-cTn assays were donated by the manufacturers (Roche, Abbott and, Julia Bangerter-Rhyner Foundation, Swiss National Science Foundation, and Swiss, Mahfoud has received research grants from Deutsche Gesellschaft fur Kardiologie,, Male, Middle Aged, myocardial infarction, National Science Foundation (grant no. P300PB_167803), Swiss Heart Foundation,, Nestelberger has received research support from the Swiss National Science, observe zone, Ortho Clinical Diagnostics, Quidel Corporation, and Beckman Coulter and travel, preparation of the manuscript, or decision to submit the manuscript for, Pronova Medical, Meril, Boston Scientific, Medtronic, Abbott, Beckman Coulter,, Prospective Studies, publication. Dr Lopez-Ayala has received research grants from the Swiss Heart, received speaker honoraria/consulting fees from Ablative Solutions, Amgen,, receiving research support from the Swiss National Science Foundation, Swiss, relationships relevant to the contents of this paper to disclose., Research, and German Research Foundation. Dr Rubini Gimenez has received research, Roche Diagnostics, and Polymedco in the last 36 months, all outside the submitted, rule-out, scholarship), Wesley Medical Research Foundation, and University of Basel. Dr, Servier, and Terumo. Dr Twerenbold reports research support from the Swiss, Siemens), who had no role in the design of the study, analysis of the data,, Siemens, Singulex, and SpinChip Diagnostics. The BACC study was supported by the, Siemens, Singulex, and Thermo Fisher. Dr Neumann reports speaker, Singulex, and Sphingotec, outside the submitted work, as well as, Societies, Medical, speaker/consulting honoraria from Abbott, Amgen, Astra Zeneca, Bayer, Boehringer, speaker/consulting honoraria from Abbott, Amgen, Astra Zeneca, Psyros, Roche,, speaker/consulting honoraria or research support from Edwards Lifesciences,, support from Ablative Solutions, Medtronic, and ReCor Medical, support from Medtronic and Vascularmedical, all outside the submitted work. Dr, Swiss Society of Cardiology, and Cardiovascular Research Foundation Basel and, the Faculty of Medicine, University of Hamburg, German Foundation for Heart, the institution and outside the submitted work. Dr Haller reports travel support, the use of a computing device to estimate the probability of myocardial, Time Factors, to the institution. All other authors have reported that they have no, troponin, Twerenbold and Neumann are listed as co-inventors of an international patent on, University Hospital Basel, University of Basel, Abbott, Beckman Coulter, Brahms,, University of Basel, Swiss Academy of Medical Sciences, Gottfried and Julia, Walter Lichtenstein-Stiftung (3MS1038), and University Hospital Basel as well as, work. Dr Boeddinghaus is supported by an Edinburgh Doctoral College Scholarship, Zeneca, Beckman Coulter, Boehringer Ingelheim, Brahms, Idorsia, LSI Medience.
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