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. 2021 Aug:46:170-175.
doi: 10.1016/j.ajem.2020.06.072. Epub 2020 Jul 18.

Ideal high sensitivity troponin baseline cutoff for patients with renal dysfunction

Alexander T Limkakeng Jr  1 , Julian Hertz  2 , Reginald Lerebours  3 , Maragatha Kuchibhatla  4 , James McCord  5 , Adam J Singer  6 , Fred S Apple  7 , William F Peacock  8 , Robert H Christenson  9 , Richard M Nowak  10
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Ideal high sensitivity troponin baseline cutoff for patients with renal dysfunction

Alexander T Limkakeng Jr et al. Am J Emerg Med. 2021 Aug.

Abstract

Objective: High-sensitivity cardiac troponin assays (hs-cTn) aid in diagnosis of myocardial infarction (MI). These assays have lower specificity for non-ST Elevation MI (NSTEMI) in patients with renal disease. Our objective was to determine an optimized cutoff for patients with renal disease.

Methods: We conducted an a priori secondary analysis of a prospective FDA study in adults with suspected MI presenting to 29 academic urban EDs between 4/2015 and 4/2016. Blood was drawn 0, 1, 2-3, and 6-9 h after ED arrival. We recorded cTn and estimated glomerular filtrate rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration equation. The primary endpoint was NSTEMI (Third Universal Definition of MI), adjudicated by physicians blinded to hs-cTn results. We generated an adjusted hscTn rule-in cutoff to increase specificity.

Results: 2505 subjects were enrolled; 234 were excluded. Patients were mostly male (55.7%) and white (57.2%), median age was 56 years 472 patients [20.8%] had an eGFR <60 mL/min/1.73 m2. In patients with eGFR <15 mL/min/1.73 m2, a baseline rule-in cutoff of 120 ng/L led to a specificity of 85.0% and Positive Predictive Value (PPV) of 62.5% with 774 patients requiring further observation. Increasing the cutoff to 600 ng/L increased specificity and PPV overall and in every eGFR subgroup (specificity and PPV 93.3% and 78.9%, respectively for eGFR <15 mL/min/1.73m2), while increasing the number (79) of patients requiring observation.

Conclusions: An eGFR-adjusted baseline rule-in threshold for the Siemens Atellica hs-cTnI improves specificity with identical sensitivity. Further study in a prospective cohort with higher rates of renal disease is warranted.

Keywords: Acute coronary syndrome; Acute myocardial infarction; High-sensitivity troponin assays; Renal disease.

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Conflict of interest statement

Declaration of Competing Interest Dr. Limkakeng reports receiving grant funding from Roche Diagnostics, Abbott Laboratories, Siemens Healthineers, Bristol-Myers Squibb, Ischemia Care, LTD, and GE AstraZeneca; and serving as a consultant for BioMérieux and ZS Pharma. Dr. Hertz has received research support from Roche Diagnostics and Abbott Laboratories. Dr. McCord has received research support from Roche, Siemens Healthineers, Abbott, and Beckman Coulter and has served as a consultant for Roche and Siemens Healthineers. Dr. Singer reports serving as a consultant for Jansen, Pfizer, BNS, and AstraZeneca. Dr. Apple reports serving on the board of directors for HyTest Ltd. and the advisory board for Siemens Healthcare and Instrumentation Laboratory. He reports serving as a consultant for LumiraDx; he has served as a nonsalaried principle investigator through Hennepin Healthcare Research Institute for Abbott Diagnostics, Abbott Point of Care, Roche Diagnostics, Siemens Healthcare, Quidel/Alere, Ortho Clinical Diagnostics, and Beckman Coulter. He reports serving as an associate editor for Clinical Chemistry. Dr. Peacock reports receiving research grants from Abbott, BrainCheck, ImmunArray, Janssen, Ortho Clinical Diagnostics, Relypsa, and Roche; serving as a consultant for Abbott, AstraZeneca, Bayer, Beckman, Boehringer Ingelheim, Ischemia Care, Dx, ImmunArray, Instrument Labs, Janssen, Nabriva Therapeutics, Ortho Clinical Diagnostics, Relypsa, Roche, Quidel, and Siemens Healthineers; and providing expert testimony for Johnson & Johnson. He also reports stock/ownership interests in AseptiScope Inc., Brainbox Inc., Comprehensive Research Association LLC, Emergencies in Medicine LLC, and Ischemia DC LLC. Dr. Christenson has received fees from Siemens Healthineers for consultancy work on design and conduct of high-sensitivity cardiac troponin I clinical trials and is a consultant for Siemens Healthineers, Roche Diagnostics, Quidel Diagnostics, and Beckman Coulter. Dr. Nowak has received fees from Siemens Healthineers as a consultant for the design and conduct of this trial. He has been or is a consultant for Siemens Healthineers, Roche Diagnostics, Beckman Coulter, Ortho Clinical Diagnostics, and Abbott.

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