Only 56.2% of patients had concordant 0h/1h ESC guideline classification across four hs-cTn assays, showing poor agreement affecting ACS diagnosis.
Does the choice of high-sensitivity cardiac troponin assay affect single-sample diagnostic classification for acute coronary syndrome according to ESC guidelines?
There is poor agreement between different high-sensitivity cardiac troponin assays when applying ESC single-sample diagnostic criteria, which can substantially affect patient triage.
Tasa de eventos absoluta: 0% vs 0%
Abstract Background Analysis of high-sensitivity cardiac troponin T and I subunits (hs-cTnT and hs-cTnI, respectively) is integral to the 4th Universal Definition of Myocardial Infarction (MI). However, fundamental differences between the cTnT and cTnI subunits, as well as lack of analytical standardisation of hs-cTnI assays, complicates clinical decision making. Purpose To investigate the concordance between single-sample classification according to the 2023 European Society of Cardiology (ESC) guideline for the management of acute coronary syndromes (ACS) between hs-cTnT and hs-cTnI assays from four manufacturers (three central laboratory and one point-of-care) within the Mersey Acute Coronary syndrome Rule Out Study (MACROS2) patient cohort. Methods Inclusion criteria were concurrent data from Abbott Alinity hs-cTnI, Quidel TriageTrue point-of-care hs-cTnI (in whole blood and plasma matrices), Roche Elecsys hs-cTnT and Siemens Atellica hs-cTnI. Baseline results were classified as single-sample rule-out (SSRO), single-sample rule-in (SSRI) or additional sample required (ASR) according to assay-specific rule-in and rule-out thresholds from the 2023 ESC guideline for the management of ACS (0h/1h algorithm). Weighted Cohen’s Kappa values (R Studio) were used for pairwise comparison of classification by each assay against the Abbott Alinity hs-cTnI (the gold-standard in MACROS2, clinicaltrials.gov: NCT05322395). Kappa values of 0.41-0.60 were deemed moderate and 0.61-0.80 substantial. Concordance of classification across all assays was also considered. Results The population investigated comprised 3251 individuals (53.1% male, 46.9% female) with an observed MI incidence of 6.3% (n=206). Table 1 summarises agreement in SSRO, SSRI and ASR classification for each assay. Both Roche Elecsys and Siemens Atellica methods ruled-out fewer patients on a single sample with a greater proportion requiring an additional sample to make a 2023 ESC ACS guideline diagnosis than Abbott Alinity and Quidel TriageTrue POC methods. Notably, only 56.2% of individuals (n=1828) were allocated to the same SSRO, SSRI or ASR category by all assays. Conclusions Cardiac subunit differences between hs-cTnT and hs-cTnI, as well as method-related differences in hs-cTnI result in poor agreement between assays and considerably influences classification to ESC SSRO, SSRI or ASR groups on the baseline sample. The choice of hs-cTn can substantially affect the diagnostic journey for a patient.
Davies et al. (Sat,) reported a other. Only 56.2% of patients had concordant 0h/1h ESC guideline classification across four hs-cTn assays, showing poor agreement affecting ACS diagnosis.