External validation of a rapid algorithm using high-sensitivity troponin assay results for evaluating patients with suspected acute myocardial infarction

Abstract

ObjectiveWe 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).MethodsThis 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.Results1994 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%).ConclusionsA 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 numberACTRN12621000053820.