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Direct comparison of the safety and efficacy of two rule-out strategies for acute myocardial infarction: undetectable levels of troponin at presentation versus 2-hour accelerated diagnostic protocol

Session Poster session 1

Speaker Raphael Twerenbold

Event : ESC Congress 2015

  • Topic : coronary artery disease, acute coronary syndromes, acute cardiac care
  • Sub-topic : Non-ST-Elevation Myocardial Infarction (NSTEMI)
  • Session type : Poster Session

Authors : R Twerenbold (Basel,CH), K Wildi (Basel,CH), M Rubini Gimenez (Basel,CH), T Reichlin (Basel,CH), C Puelacher (Basel,CH), J Boeddinghaus (Basel,CH), K Grimm (Basel,CH), M Wagener (Basel,CH), S Osswald (Basel,CH), C Mueller (Basel,CH)

Authors:
R. Twerenbold1 , K. Wildi1 , M. Rubini Gimenez1 , T. Reichlin1 , C. Puelacher1 , J. Boeddinghaus1 , K. Grimm1 , M. Wagener1 , S. Osswald1 , C. Mueller1 , 1University Hospital Basel - Basel - Switzerland ,

Citation:
European Heart Journal ( 2015 ) 36 ( Abstract Supplement ), 59-60

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 (1h-algorithm versus 2h accelerated diagnostic protocol (2h-ADP)).

Methods: In a prospective international multicentre diagnostic study enrolling 1697 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 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: 1h-algorithm 0h<12ng/l and Δ0–1h<3ng/l; 2h-ADP 0h and 2h ≤14ng/l, TIMI-score≤1 and no ischaemic ECG changes; and hs-cTnI Abbott: 1h-algorithm 0h <5ng/L and Δ0–1h<2ng/l; 2h-ADP 0h and 2h ≤26.2ng/l, TIMI-score≤1 and no ischaemic ECG changes) 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 16% of patients. Using hs-cTnT, the safety was very high and comparable with both algorithms (1h-algorithm: NPV 99.9%, 95% CI 99.5–100% versus 2h-ADP: NPV 100%, 95% CI 99.4–100%, p=ns). Regarding efficacy, 1h-algorithm allowed rule-out in 60% of patients versus 37% with the 2h-ADP (p<0.001). Using hs-cTnI, the safety was very high and comparable with both algorithms (1h-algorithm: NPV 99.4%, 95% CI 98.6–99.9% versus 2h-ADP: NPV 100% (95% CI 99.2–100%, p=ns). Regarding efficacy, 1h-algorithm allowed the rule-out in 53% of patients versus 35% with the 2h-ADP (p<0.001).

Conclusion: Both investigated rule-out strategies allow a safe rule-out of AMI, irrespective of the underlying hs-cTn assay. Regarding efficacy, the 1h-algorithm requires retesting of hs-cTn after only 1h as compared to 2h with the 2h-ADP and is much more effective by nearly doubling the number of patients eligible for rule-out.

Trial Registration: ClinicalTrials.gov number, NCT00470587

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