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Direct comparison of safety and efficacy of 2 rule-out strategies for ami:undetectable levels at presentation vs. combination of 1h-algorithm and undetectable levels at presentation
Authors : M Rubini Gimenez (Basel,CH), R Twerenbold (Basel,CH), K Wildi (Basel,CH), M Wagener (Basel,CH), C Puelacher (Basel,CH), P Hillinger (Basel,CH), S Osswald (Basel,CH), C Mueller (Basel,CH)
M. Rubini Gimenez1
,
R. Twerenbold1
,
K. Wildi1
,
M. Wagener1
,
C. Puelacher1
,
P. Hillinger1
,
S. Osswald1
,
C. Mueller1
,
1University Hospital Basel, Department of Cardiology - Basel - Switzerland
,
Purpose: Addressing the increasingly recognized, yet unmet clinical need for rapid rule-out of acute myocardial infarction (AMI), several novel strategies have been developed. Due to the lack of direct comparisons in the same dataset, selection of the best strategy for clinical practice is challenging. We therefore aimed to directly compare the safety and efficacy of two previously defined strategies: LOD (Undetectable levels of high-sensitivity cardiac troponin (hs-cTn) at presentation) versus the combination of Hs-cTn 1h-algorithm and LOD.
Methods: In a prospective international multicentre diagnostic study enrolling 2213 patients presenting with suspected AMI to the emergency department, the final diagnosis of AMI was adjudicated by two independent cardiologists using all available clinical information including serial hs-cTnT concentrations. Safety was quantified as the negative predictive value (NPV) for AMI in the rule-out zone of the respective rule-out strategies. Efficacy was quantified as the percentage of the overall cohort assigned to the rule-out zone by the respective strategy. Both strategies were applied using the two best-validated hs-cTn assays (hs-cTnT Roche: LOD <5ng/L; 1h-algorithm 0h<12ng/l and Δ0–1h<3ng/l; and hs-cTnI Abbott: LOD <2ng/L; 1h-algorithm 0h <5ng/L and Δ0–1h<2ng/l) to ensure that findings are independent from the hs-cTn assay used. As both strategies should only be applied once ST-elevation MI (STEMI) has been excluded by the initial ECG, STEMI patients were excluded from the analysis.
Results: Acute myocardial infarction was the final diagnosis in 17% of patients. Using hs-cTnT, the safety was very high and comparable with both algorithms (LOD: NPV 99.8%, 95% CI 99.0–100% versus LOD+1h-Algorithm: NPV 99.9%, 95% CI 99.5–100%, p=ns).
Regarding efficacy, LOD allowed rule-out in 24% of patients versus 59% with 1h-algorithm +LOD (p<0.001). Using hs-cTnI, the safety was very high and comparable with both algorithms (LOD: NPV 100%, 95% CI 98.8–100% versus LOD+1h-algorithm: NPV 99.2% (95% CI 98.4–99.6, p=ns). Regarding efficacy, LOD allowed the rule-out in 16% of patients versus 53% with the 1h-algorithm (p<0.001).
Conclusion: Both investigated rule-out strategies allow a safe rule-out of AMI, irrespective of the underlying hs-cTn assay. While LOD has the obvious advantage of allowing rule-out already with the measurement at presentation, the combination of LOD and 1h-algorithm is much more effective and more than doubles the number of patients eligible for rule-out.
