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Direct comparison of three 0/1h-algorithms for rapid rule-out and rule-in of acute myocardial infarction using one ultra-sensitive and two high-sensitivity cardiac troponin assays

Session Poster Session 1

Speaker Raphael Twerenbold

Event : ESC Congress 2018

  • Topic : coronary artery disease, acute coronary syndromes, acute cardiac care
  • Sub-topic : Acute Coronary Syndromes: Biomarkers
  • Session type : Poster Session

Authors : R Twerenbold (Basel,CH), J Boeddinghaus (Basel,CH), T Nestelberger (Basel,CH), M Rubini Gimenez (Basel,CH), P Badertscher (Basel,CH), C Puelacher (Basel,CH), J Du Fay De Lavallaz (Basel,CH), D Wussler (Basel,CH), N Kozhuharov (Basel,CH), O Miro (Barcelona,ES), FJ Martin-Sanchez (Madrid,ES), B Morawiec (Katowice,PL), D Keller (Zurich,CH), T Reichlin (Basel,CH), C Mueller (Basel,CH)

Authors:
R. Twerenbold1 , J. Boeddinghaus1 , T. Nestelberger1 , M. Rubini Gimenez1 , P. Badertscher1 , C. Puelacher1 , J. Du Fay De Lavallaz1 , D. Wussler1 , N. Kozhuharov1 , O. Miro2 , F.J. Martin-Sanchez3 , B. Morawiec4 , D. Keller5 , T. Reichlin1 , C. Mueller1 , 1University Hospital Basel - Basel - Switzerland , 2Hospital Clinic de Barcelona - Barcelona - Spain , 3Hospital Clinic San Carlos - Madrid - Spain , 4Medical University of Silesia, Cardiology department - Katowice - Poland , 5University Hospital Zurich - Zurich - Switzerland ,

Citation:
European Heart Journal ( 2018 ) 39 ( Supplement ), 147

Background: The European Society of Cardiology suggests the use of validated 0/1h-algorithms for rapid rule-out and rule-in of acute myocardial infarction (MI) based on high-sensitivity cardiac troponin (hs-cTn). We hypothesized that using a novel ultra-sensitive cTn (us-cTn) assay with more than ten-fold higher analytical sensitivity as compared to the best in-class hs-cTn assay, an even more effective 0/1h-algorithm can be derived.

Purpose: We aimed to directly compare the diagnostic performance of the 0/1h-algorithm using the us-cTn assay versus that of two hs-cTnT/I assays.

Methods: In a prospective international multicentre diagnostic study enrolling patients presenting with suspected MI to the ED, us-cTnI-Clarity, hs-cTnT-Elecsys and hs-cTnI-Architect were determined at presentation and after one hour. Patients presenting with ST-segment-elevation MI were excluded. Final diagnoses were centrally adjudicated by two independent cardiologists twice: first, using serial hs-cTnT-Elecsys (primary analysis) and second, using hs-cTnI-Architect (secondary analysis) measurements. Safety of rule-out was quantified by the negative predictive value (NPV) and sensitivity for MI, accuracy of rule-in by the positive predictive value (PPV) and specificity for MI and overall efficacy by the proportion of patients assigned to either rule-out or rule-in within one hour.

Results: Among 929 patients with available us-cTnI, hs-cTnT and hs-cTnI concentrations at presentation and after one hour, prevalence of MI was 17%. Using us-cTnI-Clarity, 55% of patients could be classified as “rule-out”, 16% as “rule-in”, and 29% as “observe”. Safety of rule-out was excellent with a NPV of 99.6% and a sensitivity of 98.8%. Direct rule-out was possible in 23% of patients. Similarly, accuracy of rule-in was high with a PPV of 79.9% and a specificity of 96.1% (Figure 1A). Using hs-cTnT-Elecsys, 60% of patients could be classified as “rule-out”, 17% as “rule-in”, and 23% as “observe”. Safety of rule-out was excellent with a NPV and a sensitivity of 100.0%. Direct rule-out was possible in 14% of patients. Similarly, accuracy of rule-in was high with a PPV of 83.4% and a specificity of 96.6% (Figure 1B). Using us-cTnI-Architect, 51% of patients could be classified as “rule-out”, 22% as “rule-in”, and 27% as “observe”. Safety of rule-out was excellent with a NPV of 99.6% and a sensitivity of 98.8%. Direct rule-out was possible in 10% of patients. Accuracy of rule-in was moderate with a PPV of 65.8% and a specificity of 90.8% (Figure 1C). Highly comparable findings were obtained when using the secondary adjudication including hs-cTnI-Architect.

Conclusion: The safety of the three investigated 0/1h-algorithms are very high and comparable among all three cTn-assays, while minor differences existed between accuracy of rule-in and overall efficacy. Of note, direct rule-out based on a single cTn concentration is almost doubled with us-cTnI as compared with hs-cTnT/I.

Figure 1

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