External validation of the 0/1h-algorithm and derivation of a 0/2h-algorithm using a new point-of-care Hs-cTnI assay - 18/01/24
, Jasper Boeddinghaus a, c, d, $, Pedro Lopez-Ayala a, c, Karin Wildi a, c, e, Thomas Nestelberger a, c, Desiree Wussler a, c, Caroline A. Guzman Tacla a, c, Timothy Holder a, Tamar Muench-Gerber a, c, Jonas Glaeser a, c, Ana Yufera Sanchez a, c, Òscar Miró c, f, F. Javier Martin-Sanchez c, g, Damian Kawecki c, h, Franz Buergler i, Andreas Buser j, Gabrielle Huré a, c, Maria Rubini Giménez a, k, Dagmar I. Keller l, Michael Christ m, Christian Mueller a, c, # for the
APACE investigators1
ABSTRACT |
Background |
The high-sensitivity cardiac troponin (hs-cTn) I point-of-care (POC) hs-cTnI-PATHFAST assay has recently become clinically available.
Methods |
We aimed to externally validate the hs-cTnI-PATHFAST 0/1h-algorithm recently developed for the early diagnosis of non-ST-segment-elevation myocardial infarction (NSTEMI) and derive and validate a 0/2-algorithm in patients presenting to the emergency department with acute chest discomfort included in a multicenter diagnostic study. Two independent cardiologists centrally adjudicated the final diagnoses using all the clinical and study-specific information available including serial measurements of hs-cTnI-Architect.
Results |
Among 1,532 patients (median age 60 years, 33% [n = 501] women), NSTEMI was the final diagnosis in 13%. External validation of the hs-cTnI-PATHFAST 0/1h-algorithm showed very high negative predictive value (NPV; 100% [95%CI, 99.5%-100%]) and sensitivity 100% (95%CI, 98.2%-100%) for rule-out of NSTEMI. Positive predictive value (PPV) and specificity for rule-in of NSTEMI were high (74.9% [95%CI, 68.3%-80.5%] and 96.4% [95%CI, 95.2%-97.3%], respectively). Among 1,207 patients (median age 61 years, 32% [n = 391] women) available for the derivation (n = 848) and validation (n = 359) of the hs-cTnI-PATHFAST 0/2h-algorithm, a 0h-concentration <3 ng/L or a 0h-concentration <4 ng/L with a 2h-delta <4ng/L ruled-out NSTEMI in 52% of patients with a NPV of 100% (95%CI, 98-100) and sensitivity of 100% (95%CI, 92.9%-100%) in the validation cohort. A 0h-concentration ≥90ng/L or a 2h-delta ≥ 55ng/L ruled-in 38 patients (11%): PPV 81.6% (95%CI, 66.6-90.8), specificity 97.7% (95%CI, 95.4-98.9%).
Conclusions |
The POC hs-cTnI-PATHFAST assay allows rapid and effective rule-out and rule-in of NSTEMI using both a 0/1h- and a 0/2h-algorithm with high NPV/sensitivity for rule-out and high PPV/specificity for rule-in.
Clinical trial registration |
: NCT00470587.
Il testo completo di questo articolo è disponibile in PDF.Graphical abstract |
NSTEMI – Non-ST-elevation myocardial infarction Created with biorender.com
Abbreviations : BACC, CI, cTn, ED, ECG, eGFR, ESC, hs-cTn, IQR, MACE, MI, NPV, NSTEMI, POC, PPV
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Vol 268
P. 104-113 - febbraio 2024 Ritorno al numero
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