Direct comparison of the safety and efficacy of the ESC 0/1h-algorithm and the High-STEACS pathway for early rule-out of myocardial infarction

Abstract Background The optimal approach for early rule out of myocardial infarction (MI) is still uncertain. The European Society of Cardiology (ESC) 0/1h-algorithm and the High-Sensitivity Troponin in the Evaluation of Patients with Acute Coronary Syndrome (High-STEACS) pathway, have both been validated individually in large studies. However, as a direct comparison of both strategies has not been performed until now, it is largely unknown whether one is preferable to the other. Purpose To directly compare the safety and efficacy of the ESC 0/1h-algorithm with the High-STEACS pathway. Methods Patients presenting with acute chest discomfort to the emergency department were prospectively enrolled into an international multicenter diagnostic study. Final diagnoses were centrally adjudicated by two independent cardiologists applying the 4th universal definition of MI, based on complete cardiac work-up, cardiac imaging and serial hs-cTnI. Hs-cTnI (Architect) concentrations were measured at presentation, after 1h and 3h. The primary diagnostic endpoint was safety, assessed as the sensitivity and negative predictive value of ruling out index NSTEMI. The primary diagnostic endpoint was evaluated in prespecified subgroups stratified by sex, age, coronary artery disease, time of chest pain onset and glomerular filtration rate. Co-primary prognostic endpoint was 30- and 730- days all-cause mortality. Findings were externally validated in a large single center study. Results Among 5377 eligible patients, 1088 (20.2%) were finally adjudicated with the diagnosis of NSTEMI. Application of the ESC 0/1h-hs-cTnI-algorithm provided higher sensitivity (99.7 % [95% CI, 99.4-100]) compared to the High-STEACS pathway (99.0% [95% CI, 98.4 – 99.6], difference in sensitivity 0.7 [1.3-0.2], P-value for difference < 0.01), but left 846 patients (15.7%) without final triage towards rule-out or rule-in. Three patients with NSTEMI were missed by the ESC pathway compared to 11 patients missed by the High-STEACS algorithm (Figure). High safety and accuracy for the ESC pathway were confirmed in all subgroups and in the external validation cohort, whereas performance parameters for the High-STEACS pathway dropped considerably in the subgroup- and external validation analysis. Both strategies allowed reliable prediction of short and long-term mortality risk (log-rank test <0.001). Conclusion While the High-STEACS pathway identifies more patients at low-risk, the ESC 0/1h-algorithm provides higher sensitivity and NPV for rule-out of index NSTEMI.Performance of the ESC 0/1-h algorithmPerformance of the High-STEACS pathway