The novel TnT hs Gen 6 assay demonstrated excellent discrimination for myocardial infarction with an admission AUC of 0.87 (95% CI 0.84-0.90) and a 99.5% negative predictive value for rule-out.
Observational (n=1,415)
Does a novel high-sensitivity cardiac troponin T assay accurately diagnose myocardial infarction and predict 1-year mortality and MACE in patients presenting with suspected NSTEMI?
The novel high-sensitivity cardiac troponin T assay provides excellent diagnostic accuracy for the rapid rule-out and rule-in of NSTEMI, while also offering significant prognostic value for 1-year mortality and MACE.
Effect estimate: AUC 0.87 (95% CI 0.84-0.90)
Abstract Aims High-sensitivity cardiac troponin (hs-cTn) assays are integral to evaluating suspected myocardial infarction (MI). A recently developed hs-cTnT assay requires diagnostic and prognostic evaluation. Methods and results Patients presenting to the emergency department with suspected non-ST-elevation MI were prospectively evaluated. Discrimination was tested using the area under the curve (AUC). Diagnostic performance was assessed with previously derived cut-off concentrations and ESC 0/1 h algorithm. Head-to-head comparisons between the new and established assays were performed. Prognostic performance of hs-cTnT for 1-year mortality and major adverse cardiac events (MACE) was analysed using adjusted Cox regression. In 1415 patients, mean age 64 years and 64.2% male, MI was diagnosed in 12.1%. The novel TnT hs Gen 6 assay demonstrated excellent discrimination with an AUC on admission of 0.87 (95% CI: 0.84, 0.90) and 0.91 (95% CI: 0.89, 0.93) after 1 h. Using a 0 h cut-off 8 ng/L or 18 ng/L and Δ 0/1 h of 2 ng/L enabled rule-out in 54.3% (95% CI: 51.7%, 57.0%), with a NPV of 99.5% (95% CI: 98.7%, 99.9%); sensitivity was 97.7% (95% CI: 94.1%, 99.4%). For rule-in, a 0 h cut-off ≥112 ng/L or a Δ 0/1 h ≥ 10 ng/L yielded a PPV of 58.5% (95% CI: 51.9%, 64.9%) and specificity of 92.2% (95% CI: 90.6%, 93.6%) with rule-in of 16.5% (95% CI: 14.6%, 18.6%). Hs-cTnT was associated with 1-year mortality hazard ratio (HR) 1.39 (95% CI: 1.28, 1.51) and MACE HR 1.22 (95% CI: 1.15, 1.29). Conclusion The novel hs-cTnT assay demonstrates high diagnostic accuracy to rule-out or diagnose MI and offers valuable prognostic information regarding 1-year mortality and MACE. Trial Registration: clinicaltrials.gov (NCT02355457)
Völschow et al. (Wed,) conducted a observational in Suspected non-ST-elevation myocardial infarction (n=1,415). Novel high-sensitivity cardiac troponin T (TnT hs Gen 6) assay vs. Established assays was evaluated on Discrimination for myocardial infarction (AUC on admission) (AUC 0.87, 95% CI 0.84-0.90). The novel TnT hs Gen 6 assay demonstrated excellent discrimination for myocardial infarction with an admission AUC of 0.87 (95% CI 0.84-0.90) and a 99.5% negative predictive value for rule-out.