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Direct Comparison of the 0/1h- and 0/2h-Algorithms in Patients With Prior Coronary Artery Bypass Grafting
Luca Koechlin1,2,3,4, Jasper Boeddinghaus1,3, Pedro Lopez-Ayala1,3
1Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology University Hospital Basel Switzerland.
Insights
The 0/2h high-sensitivity troponin algorithm improves myocardial infarction diagnosis in patients with prior coronary artery bypass grafting compared to the 0/1h algorithm. This enhanced diagnostic efficacy aids in better patient triage for myocardial infarction.
Area of Science:
- Cardiology
- Biomarkers
- Diagnostic Accuracy
Background:
- The European Society of Cardiology (ESC) 0/1h-high-sensitivity cardiac troponin (hs-cTn) algorithms show reduced efficacy in patients with prior coronary artery bypass grafting (CABG).
- Patients with prior CABG represent a high-risk group for myocardial infarction (MI).
Purpose of the Study:
- To test the hypothesis that the ESC 0/2h-hs-cTn algorithm increases diagnostic efficacy in patients with prior CABG compared to the ESC 0/1h-hs-cTn algorithm.
- To evaluate the safety and efficacy of both algorithms in this specific patient population.
Main Methods:
- A prospective international multicenter diagnostic study involving patients with acute chest discomfort.
- Central adjudication of final diagnoses based on the Universal Definition of Myocardial Infarction.
- Direct comparison of ESC 0/1h- and 0/2h-hs-cTn algorithms using assay-specific cut-offs, with external validation.
Main Results:
- The ESC 0/2h-hs-cTnT-Elecsys algorithm showed high sensitivity (99.1%) and specificity (98.4%) for NSTEMI rule-in/out.
- Efficacy was higher for the 0/2h algorithm (58.4%) compared to the 0/1h algorithm (50.6%), a difference of 7.9%.
- These findings were confirmed with hs-cTnI assays and in an external validation cohort, showing consistently higher efficacy for the 0/2h algorithm.
Conclusions:
- The ESC 0/2h-hs-cTn algorithms demonstrate superior efficacy compared to the ESC 0/1h-hs-cTn algorithms in patients with prior CABG.
- The 0/2h algorithm offers comparable safety to the 0/1h algorithm in this high-risk group.
Background:
The European Society of Cardiology (ESC) 0/1h-high-sensitivity cardiac troponin (hs-cTn)T/I-algorithms have lower efficacy in patients with prior coronary artery bypass grafting. We hypothesized that in these high-risk patients, the longer time to the second blood draw within the ESC 0/2h-hs-cTn-algorithms would increase efficacy, defined as the proportion of patients triaged to rule-in/out of myocardial infarction, versus the ESC-0/1h-hs-cTn-algorithms.
Methods:
In a prospective international multicenter diagnostic study including patients presenting to the emergency department with acute chest discomfort, final diagnoses were centrally adjudicated according to the Universal Definition of Myocardial Infarction. Safety and efficacy of the guideline-recommended ESC 0/1h- and 0/2h-hs-cTn-algorithms using assay-specific use-optimized cut-offs were directly compared in patients with prior coronary artery bypass grafting. Findings were externally validated in an independent prospective US multicenter study.
Results:
Among 356 patients (median [interquartile range] age 73 [64-80] years, prevalence of non-ST-segment-elevation myocardial infarction [NSTEMI]: 31% [n=112]), sensitivity for rule-out of NSTEMI was high for the ESC 0/1h- and 0/2h-hs-cTnT-Elecsys-algorithms (0/1h: 100% [95% CI 96.7-100]; 0/2h: Sensitivity: 99.1% [95% CI 95.1-99.8]). Specificity for rule-in of NSTEMI was also high (0/1h: 97.1% [95% CI 94.2-98.6]; 0/2h 98.4% [95% CI 95.9-99.4]). Efficacy was 50.6% for 0/1h and 58.4% for 0/2h (difference: 7.9% [95% CI 4.2-11.5]). Findings with higher efficacy for 0/2h versus 0/1h were confirmed using hs-cTnI-Architect (difference in efficacy 3.1% [95% CI 0.1-6.1]) and using hs-cTnI-Atellica in the external validation cohort (n=178; difference in efficacy 9% [95% CI 4.5-13.5]).
Conclusions:
The ESC 0/2h-hs-cTn-algorithms have higher efficacy and comparable safety versus the ESC 0/1h-hs-cTn-algorithms in patients with prior coronary artery bypass grafting.
Registration:
URL: https://www.clinicaltrials.gov; Unique Identifier: NCT00470587.
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