Novel high-sensitivity cardiac troponin I assay in patients with suspected acute coronary syndrome

Abstract

BackgroundHigh-sensitivity cardiac troponin assays enable the early risk stratification of patients with suspected acute coronary syndrome to identify those at low risk of myocardial infarction or cardiac death. We evaluated the performance of a novel high-sensitivity cardiac troponin I assay in early rule out pathways.MethodsIn 1920 patients with suspected acute coronary syndrome, cardiac troponin was measured using the Siemens Atellica high-sensitivity cardiac troponin I assay (99th centile: 34 ng/L women, 53 ng/L men). We evaluated three pathways which use either low risk-stratification thresholds of cardiac troponin (High-SensitivityTroponin in the Evaluation of patients with Acute Coronary Syndrome (High-STEACS) and the European Society of Cardiology (ESC) 1 hour pathway) or the 99th centile diagnostic threshold (ESC 3 hour pathway) to rule out myocardial infarction.ResultsThe primary outcome of myocardial infarction or cardiac death at 30 days occurred in 14.4% (277/1920). The High-STEACS pathway ruled out 63% of patients (1218/1920), with five missed events for a negative predictive value (NPV) of 99.5% (95% CI (CI) 99.1% to 99.8%). Similar performance was observed for the ESC 1 hour pathway with an NPV of 99.0% (97.6% to 99.8%). In contrast, the ESC 3 hour pathway ruled out 65% of patients (1248/1920), but missed 25 events for an NPV of 98.0% (97.1% to 98.7%).ConclusionsA novel high-sensitivity cardiac troponin I assay can safely identify patients at low risk of myocardial infarction or cardiac death. Diagnostic pathways that use low cardiac troponin concentrations for risk stratification miss fewer events than those that rely on the 99th centile to rule out myocardial infarction.Trial registrationNCT1852123.

High-sensitivity cardiac troponin and the early rule out of myocardial infarction: time for action

“…For example, in patients with suspected acute coronary syndrome with a nonischaemic ECG and a high-sensitivity cardiac troponin I or T concentration <5 ng/L (measured using the Abbott ARCHI-TECT or Siemens Atelleca hs-cTnI, or the Roche Elecsys hs-cTnT assays), both negative predictive value and sensitivity are extremely high, missing as few as 1 in every 200 patients tested and stratifying between 30% and 50% of patients as low risk. [2][3][4] The High-Sensitivity Cardiac Troponin on Presentation to Rule-Out Myocardial Infarction (HiSTORIC) trial evaluated this approach in a stepped-wedge cluster randomised controlled trial, reporting at the European Society of Cardiology (ESC) Congress in 2019, demonstrating implementation of an early rule-out pathway for myocardial infarction reduced length of stay and hospital admission without increasing adverse cardiac events.…”

Four Different High-Sensitivity Cardiac Troponin Assays With Important Analytical Performance Differences

“…The proposed common cutoff of 5 ng/L for both highsensitivity cardiac troponin T (hs-cTnT) and high-sensitivity cardiac troponin I (hs-cTnI) assays to rule out myocardial infarction (MI) is supported by expert opinion and clinical studies. 1,2 Notwithstanding the ease of using a single cutoff for all high-sensitivity cardiac troponin (hs-cTn) assays, this may not be the most optimal approach. Moreover, this common threshold may confuse some clinicians.…”

Troponins and natriuretic peptides to detect cardiotoxicity: useful biomarkers or paradise lost?

“…Moreover, as also debated by the authors, conventional and hs‐cTn assays may generate different results: hs‐cTn could detect more patients at higher risk for developing cardiotoxicity than conventional assays, although this meta‐analysis could not validate this assumption. Compared to the conventional assays, the use of hs‐cTn increases the sensitivity of diagnosing early myocardial injury due to ACS by detecting much lower values . If we adopt the same logic in diagnosing myocardial damage due to cardiotoxicity, using hs‐cTn should more accurately uncover young women with high CV risk for developing cardiotoxicity.…”