Performance of the European Society of Cardiology 0/1-hour algorithm with high-sensitivity cardiac troponin T at 90 days among patients with known coronary artery disease.

Background: The European Society of Cardiology (ESC) 0/1-h high sensitivity troponin T (hs-cTnT) algorithm does not differentiate risk based on known coronary artery disease (CAD: prior myocardial infarction [MI], coronary revascularization, or ≥ 70% coronary stenosis). We recently evaluated its performance among patients with known CAD at 30-days, but little is known about its longer-term risk prediction. The objective of this study is to determine and compare the performance of the algorithm at 90-days among patients with and without known CAD.
Methods: We performed a pre-planned subgroup analysis of the STOP-CP cohort, which prospectively enrolled ED patients ≥21 years old with symptoms suggestive of ACS without ST-elevation on initial ECG across 8 US sites (1/25/2017-9/6/2018). Participants with 0- and 1-h hs-cTnT measures (Roche, Basel, Switzerland) were stratified into rule-out, observe, and rule-in groups using the ESC 0/1-h algorithm. Algorithm performance was tested among patients with or without known CAD, as determined by the treating provider. The primary outcome was cardiac death or MI at 90-days. Fisher's exact tests were used to compare 90-day event and rule-out rates between patients with and without known CAD. Negative predictive values (NPVs) for 90-day cardiac death or MI with exact 95% confidence intervals were calculated and compared using Fisher's exact test.
Results: The STOP-CP study accrued 1430 patients, of which 31.4% (449/1430) had known CAD. Cardiac death or MI at 90 days was more common in patients with known CAD than in those without [21.2% (95/449) vs. 10.0% (98/981); p < 0.001]. Using the ESC 0/1-h algorithm, 39.6% (178/449) of patients with known CAD and 66.1% (648/981) of patients without known CAD were ruled-out (p < 0.001). Among rule-out patients, 90-day cardiac death or MI occurred in 3.4% (6/178) of patients with known CAD and 1.2% (8/648) without known CAD (p = 0.09). NPV for 90-day cardiac death or MI was 96.6% (95%CI 92.8-98.8) among patients with known CAD and 98.8% (95%CI 97.6-99.5) in patients without known CAD (p = 0.09).
Conclusion: Patients with known CAD who were ruled-out using the ESC 0/1-h hs-cTnT algorithm had a high rate of missed 90-day cardiac events, suggesting that the ESC 0/1-h hs-cTnT algorithm may not be safe for use among patients with known CAD.
Trial Registration: High-Sensitivity Cardiac Troponin T to Optimize Chest Pain Risk Stratification (STOP-CP; ClinicalTrials.gov: NCT02984436; https://clinicaltrials.gov/ct2/show/NCT02984436).
Competing Interests: Declaration of competing interest Dr. Ashburn receives funding from AHRQ (R01HS029017). Dr. Snavely receives funding from Abbott, HRSA (1H2ARH399760100), and AHRQ (R01HS029017). Dr. Stopyra receives research funding from HRSA (H2ARH39976–01-00), AHRQ (R01HS029017), AHRQ (1R21HS029234-01A1), The Duke Endowment, Roche Diagnostics, Abbott Laboratories, Pathfast, Genetesis, Cytovale, Forest Devices, Vifor Pharma, and Chiesi Farmaceutici. Dr. Mahler receives funding/support from Roche Diagnostics, Abbott Laboratories, QuidelOrtho, Siemens, Grifols, Pathfast, Beckman Coulter, Genetesis, Cytovale, The Duke Endowment, Brainbox, HRSA (1H2ARH399760100), and AHRQ (R01HS029017). He is a consultant for Roche, Quidel, Abbott, Siemens, Inflammatix, and Radiometer and is the Chief Medical Officer for Impathiq Inc. Dr. Allen receives research funding/support from RocheDiagnostics, Siemens, and Beckman Coulter. He is a consultant for Roche Diagnostics and Beckman Coulter. Dr. Mumma has research support from the NIH (5K08HL130546) and Roche Diagnostics. Dr. McCord receives research funding/support from Beckman Coulter, Roche Diagnostics, Abbott Laboratories, and Siemens. He is a consultant for Beckman Coulter, Roche Diagnostics, and Siemens. Dr. Wilkerson received research funding from Regeneron Pharmaceuticals, Inc., Lilly USA, LLC, BioAge Labs, Inc., Roche Diagnostics, Global Blood Therapeutics, Inc., Novartis Pharmaceuticals, Egetis Therapeutics AB, EndPoint Health, Inc., Blade Therapeutics, Janssen R&D LLC, ProvePharma, Beckton, Dickinson and Company, and Pfizer Inc. He has received research funding from CoapTech, LLC through an NIH/NIDDK grant (R44DK115325). He has received research support in the form of equipment and supplies from Cepheid and Eldon Biologicals A/S. He is an uncompensated advisor to CSL Behring. Dr. Christenson is a consultant for and receives funding/support from Roche Diagnostics, Siemens Healthineers, Beckman Coulter Diagnostics, Beckton Dickinson and Company, Quidel Corp., and Sphingotec GMBH. The other authors report no conflicts.
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