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. 2023 Apr 1;8(4):347-356.
doi: 10.1001/jamacardio.2023.0031.

Performance of the European Society of Cardiology 0/1-Hour Algorithm With High-Sensitivity Cardiac Troponin T Among Patients With Known Coronary Artery Disease

Nicklaus P Ashburn  1   2 , Anna C Snavely  1   3 , James C O'Neill  1 , Brandon R Allen  4 , Robert H Christenson  5 , Troy Madsen  6 , Michael R Massoomi  7 , James K McCord  8 , Bryn E Mumma  9 , Richard Nowak  10 , Jason P Stopyra  1 , Maite Huis In't Veld  11 , R Gentry Wilkerson  11 , Simon A Mahler  1   12   13
Affiliations

Performance of the European Society of Cardiology 0/1-Hour Algorithm With High-Sensitivity Cardiac Troponin T Among Patients With Known Coronary Artery Disease

Nicklaus P Ashburn et al. JAMA Cardiol. .

Abstract

Importance: The European Society of Cardiology (ESC) 0/1-hour algorithm is a validated high-sensitivity cardiac troponin (hs-cTn) protocol for emergency department patients with possible acute coronary syndrome. However, limited data exist regarding its performance in patients with known coronary artery disease (CAD; prior myocardial infarction [MI], coronary revascularization, or ≥70% coronary stenosis).

Objective: To evaluate and compare the diagnostic performance of the ESC 0/1-hour algorithm for 30-day cardiac death or MI among patients with and without known CAD and determine if the algorithm could achieve the negative predictive value rule-out threshold of 99% or higher.

Design, setting, and participants: This was a preplanned subgroup analysis of the STOP-CP prospective multisite cohort study, which was conducted from January 25, 2017, through September 6, 2018, at 8 emergency departments in the US. Patients 21 years or older with symptoms suggestive of acute coronary syndrome without ST-segment elevation on initial electrocardiogram were included. Analysis took place between February and December 2022.

Interventions/exposures: Participants with 0- and 1-hour high-sensitivity cardiac troponin T (hs-cTnT) measures were stratified into rule-out, observation, and rule-in zones using the ESC 0/1-hour hs-cTnT algorithm.

Main outcomes and measures: Cardiac death or MI at 30 days determined by expert adjudicators.

Results: During the study period, 1430 patients were accrued. In the cohort, 775 individuals (54.2%) were male, 826 (57.8%) were White, and the mean (SD) age was 57.6 (12.8) years. At 30 days, cardiac death or MI occurred in 183 participants (12.8%). Known CAD was present in 449 (31.4%). Among patients with known CAD, the ESC 0/1-hour algorithm classified 178 of 449 (39.6%) into the rule-out zone compared with 648 of 981 (66.1%) without CAD (P < .001). Among rule-out zone patients, 30-day cardiac death or MI occurred in 6 of 178 patients (3.4%) with known CAD and 7 of 648 (1.1%) without CAD (P < .001). The negative predictive value for 30-day cardiac death or MI was 96.6% (95% CI, 92.8-98.8) among patients with known CAD and 98.9% (95% CI, 97.8-99.6) in patients without known CAD (P = .04).

Conclusions and relevance: Among patients with known CAD, the ESC 0/1-hour hs-cTnT algorithm was unable to safely exclude 30-day cardiac death or MI. This suggests that clinicians should be cautious if using the algorithm in patients with known CAD. The negative predictive value was significantly higher in patients without a history of CAD but remained less than 99%.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Ashburn reported grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Snavely reported grants from Roche Diagnostics during the conduct of the study; grants from Abbott and Health Resources and Services Administration outside the submitted work; and had a patent for US 63/401335 pending. Dr O'Neill reported funding from Cytovale, National Center for Advancing Translational Sciences, and Wake Forest Clinical and Translational Science Institute outside the submitted work. Dr Allen reported grants from Roche Diagnostics during the conduct of the study, personal fees from Roche Diagnostics, and grants from Siemens and Beckman Coulter outside the submitted work. Dr Christenson reported receiving part of their salary paid by the American Association for Clinical Chemistry for being editor in chief of the Journal of Applied Laboratory Medicine and is a consultant for and receives funding/support from Roche Diagnostics, Siemens Healthineers, Beckman Coulter Diagnostics, Becton Dickinson, Quidel Corp, and Sphingotec GMBH. Dr Madsen reported grants from University of Florida during the conduct of the study and grants from the National Institutes of Health outside the submitted work. Dr McCord receives research funding/support from Beckman Coulter, Roche Diagnostics, Abbott Laboratories, and Siemens. Dr Mumma reported grants from Alpha Phi Foundation Heart to Heart Award outside the submitted work and research support from the National Institutes of Health and Roche Diagnostics. Dr Nowak receives research funding/support from and consults for Roche Diagnostics, Beckmann Coulter, Siemens, Abbott Diagnostics, and Ortho Clinical Diagnostics. Dr Stopyra reported grants from Roche during the conduct of the study; research support from Abbott, Pathfast, Genetesis, Forest Devices, Vifor Pharma, and Chiesi Farmaceutici; adjudication fee from CytoVale; and grants from Health Resources and Services Administration and National Center for Advancing Translational Sciences outside the submitted work. Dr Wilkerson reported grants from Roche during the conduct of the study; research funding from Regeneron Pharmaceuticals, Eli Lilly and Company, BioAge Labs, Roche Diagnostics, Global Blood Therapeutics, Novartis Pharmaceuticals, Egetis Therapeutics AB, EndPoint Health, Blade Therapeutics, Janssen R&D, ProvePharma, Pfizer; and CoapTech through a National Institute of Diabetes and Digestive and Kidney Diseases grant; research support in the form of equipment and supplies from Cepheid and Eldon Biologicals A/S; and is an uncompensated advisor to CSL Behring. Dr Mahler reported grants from Roche Diagnostics during the conduct of the study; personal fees from Roche Diagnostics, Abbott Laboratories, Quidel, Genetesis, Inflammatix, Radiometer, and Amgen; grants from Abbott Laboratories, Orthor Clinical Diagnostics, Siemens, Grifols, Pathfast, Quidel, Roche Diagnostics, Genetesis, Cytovale, and Health Resources and Services Administration; is a consultant for Roche, Quidel, Abbott, Genetesis, Inflammatix, Radiometer, and Amgen; has stock ownership and is on the board of directors of Impathiq; and had a patent for 63/401335 pending with Abbott Laboratories outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. The European Society of Cardiology 0/1-Hour Algorithm Among Patients With and Without Known Coronary Artery Disease (CAD) for Index Cardiac Death or Myocardial Infarction (MI), 30-Day Cardiac Death or MI, and 30-Day Major Adverse Cardiovascular Event (MACE)
Abbreviations: −LR, negative likelihood ratio, +LR, positive likelihood ratio; ACS, acute coronary syndrome; ED, emergency department; hs-cTnT, high-sensitivity cardiac troponin T; NPV, negative predictive value; PPV, positive predictive value.
Figure 2.
Figure 2.. Interaction Between European Society of Cardiology (ESC) 0/1-Hour Algorithm Classification and Known Coronary Artery Disease (CAD) With Adjusted Odds Ratios (aOR)
aOR was adjusted for age, sex, race, hypertension, diabetes, hyperlipidemia, obesity, current smoking, prior stroke, peripheral vascular disease, and end-stage kidney disease as well as the interaction between ESC 0/1-hour classification and known CAD. hs-cTnT indicates high-sensitivity cardiac troponin T; MACE, major adverse cardiovascular event.
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