Diagnostic performance of a novel high-sensitivity cardiac troponin T assay in the ESC 0/1-hour algorithm for the early diagnosis of NSTEMI
A N Nguyen, D U N G Dao, T H A N H Pham, T H A N H Vo, D A N Pham, L I E U Tran, N H A T Tran, D U Y Nguyen, T R I Nguyen, K H U E NguyenAbstract
Background
The European Society of Cardiology (ESC) 0/1-hour algorithm is recommended for the rapid triage of patients with suspected non-ST-elevation myocardial infarction (NSTEMI). While this strategy is well-established for the reference high-sensitivity cardiac troponin T (hs-cTnT) assay, the algorithm is assay-dependent, and clinical data defining specific 0/1-hour cut-offs for alternative platforms are currently lacking.
Purpose
This study evaluated the diagnostic performance and safety of a novel hs-cTnT assay within this clinical protocol.
Methods
In this prospective, single-center study at a general hospital, 397 adult patients presenting with symptoms suggestive of acute coronary syndrome were enrolled. The final diagnosis of NSTEMI was adjudicated by two independent cardiologists based on ESC guidelines. We assessed the correlation between the novel hs-cTnT assay and the established reference assay and derived optimal cut-offs for a 0/1h algorithm.
Results
NSTEMI was diagnosed in 11.6% of the population. The novel assay showed an excellent correlation with the reference assay (R2=0.995). At presentation (0h), the AUC-ROC for NSTEMI diagnosis was 0.94 (95% CI: 0.90–0.98). The derived 0/1h rule-out criteria (0h < 5 ng/L if onset > 3h, or 0h < 12 ng/L and 1h-delta < 2 ng/L) triaged 41.7% of patients with a Negative Predictive Value (NPV) of 99.4% and sensitivity of 97.0%. The rule-in criteria (0h ≥ 57 ng/L or 1h-delta ≥ 7 ng/L) identified 17.1% of patients with a Positive Predictive Value (PPV) of 56.0% and specificity of 92.1%. The 30-day all-cause mortality in the rule-out group was 0.9%, and the MACE rate was 0.96%.
Conclusions
The novel hs-cTnT assay is safe and effective for use in the ESC 0/1-hour algorithm. It successfully meets the ESC safety requirement (NPV > 99%) for rapid rule-out, making it a viable and promising platform for emergency department triage of suspected NSTEMI.