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Abstract
Objective We sought to validate the clinical performance of a rapid assessment pathway incorporating the Siemens Atellica IM high sensitivity cardiac troponin I (hs-cTnI) assay in patients presenting to the emergency department (ED) with suspected acute myocardial infarction (AMI).
Methods This was a multicentre prospective observational study of adult ED patients presenting to five Australian hospitals between November 2020 and September 2021. Participants included those with symptoms of suspected AMI (without ST-segment elevation MI on presentation ECG). The Siemen’s Atellica IM hs-cTnI laboratory-based assay was used to measure troponin concentrations at admission and after 2–3 hours and cardiologists adjudicated final diagnoses. The HighSTEACS diagnostic algorithm was evaluated, incorporating hs-cTnI concentrations at presentation and absolute changes within the first 2 to 3 hours. The primary outcome was index AMI, including type 1 or 2 non-ST segment elevation MI (NSTEMI) or ST-elevation MI (STEMI) following presentation. 30-day major adverse cardiac outcomes (including AMI, urgent revascularisation or cardiac death) were also reported. The trial was registered with the Australian and New Zealand Clinical Trials Registry.
Results 1994 patients were included. The average age was 56.2 years (SD=15.6), and 44.9% were women. 118 (5.9%) patients had confirmed index AMI. The 2-hour algorithm defined 61.3% of patients as low risk. Sensitivity was 99.1% (94.0%–99.9%) and negative predictive value was 99.9% (99.3%–100%). 24.4% of patients were deemed intermediate risk. When applying the parameters for high risk, 252 (14.3%) were identified, with a specificity of 91.5% (88.7%–93.6%) and a PPV of 42.0% (35.6–48.7%).
Conclusions A 2-hour algorithm based on the HighSTEACS strategy using the Siemens Atellica IM hs-cTnI laboratory-based assay enables safe and efficient risk assessment of emergency patients with suspected AMI.
Trial registration number ACTRN12621000053820.
- acute coronary syndrome
Data availability statement
Data are available upon reasonable request. Requests for further data should be directed to the corresponding author.
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Data availability statement
Data are available upon reasonable request. Requests for further data should be directed to the corresponding author.
Footnotes
Handling editor Richard Body
X @louiseacullen
Correction notice Since this article first published a change has been made to the discussion section. The sentence 'Translation of this modified HighSTEACS strategy incorporating the Siemens Atellica IM hs-cTnI assay for clinical use in the emergency setting should occur as this approach is accurate for the diagnosis of AMI and safe' has been updated so the term diagnosis of AMI and safe now reads '…the risk assessment for AMI and safe'.
Collaborators SAMIE Study Group 2022: Louise Cullen Jaimi Greenslade Laura Stephensen Isuru Ranasinghe Niranjan Gaikwad Maryam Khorramshahi Bayat Eshan Mahmoodi Martin Than Fred S. Apple William Parsonage Emily Brownlee Gavin Fincher Vinay Gangathimmaiah Emma Hall Christian Hamilton-Craig Rebecca Hancock Andrew Hobbins King Gerben Keijzers Ellyse McCormick Siegfried Perez Andrew Staib Anna Zournazi.
Contributors The authors confirm their contribution to the paper as follows: study conception and design: LC, JHG, LS, MT, FA and WP; data collection: LS, IR, NG, MKB and EM; analysis and interpretation of results: JHG, LC, MT, FA, WP; draft manuscript preparation: LC, JHG, FA, WP. All authors reviewed the results and approved the final version of the manuscript. LC is guarantor.
Funding This study was supported by an institutional grant to Pathology Queensland by Siemens Healthineers, including the provision of the assays, analysers, and QC material for the conduct of this study. The sponsors had no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication. Jaimi Greenslade was funded by a fellowship from Advance Queensland.
Competing interests LC has received institutional grants from Siemens, Beckman Coulter, Abbott Diagnostics, Roche, and Radiometer Pacific. She has received consulting fees from Siemens Healthineers, Abbott Diagnostics and Beckman Coulter. JHG received a fellowship from Advance Queensland. WP has received institutional grants from Siemens, Beckman Coulter, Abbott Diagnostics, Roche and Radiometer Pacific. He has received consulting fees from Pfizer, Abbott Diagnostics and institutional consultancy fees from Siemens Healthineers. MT has received funding for clinical research from Abbott, Alere, Beckman, Radiometer and Roche. Payment for speaking from Abbott, Alere and Roche, Consulting fees from Abbott, Roche and Siemens. Participation in Advisory boards of Abbott, Radiometer, Roche, and Siemens. Funding for education from Abbott, Alere and Beckman. FA: Board of Directors for HyTest Ltd; Associate Editor for Clinical Chemistry; Advisory Boards: Instrumentation Laboratory, Siemens Healthineers, Osler Diagnostics, Qorvo; Honorarium for Speaking at Industry Conferences: Siemens Healthineers, Abbott Diagnostics; principal investigator on Industry Funded Grants (non-salaried) on cardiac biomarkers through Hennepin Healthcare Research Institute: Abbott Diagnostics, Abbott POC, BD, Beckman Coulter, Ortho-Clinical Diagnostics, Roche Diagnostics, Siemens Healthcare, ET Healthcare, Qorvo.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer-reviewed.
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