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Direct Comparison of the Safety and Efficacy of two Rule-out Strategies for Acute Myocardial Infarction: 1h-Algorithm versus Combination of 1h-Algorithm and Undetectable Levels at Presentation

Session Knowing more about STEMI and non-STEMI

Speaker Raphael Twerenbold

Event : ESC Congress 2015

  • Topic : coronary artery disease, acute coronary syndromes, acute cardiac care
  • Sub-topic : Unstable Angina
  • Session type : Moderated Posters

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

R. Twerenbold1 , K. Wildi1 , M. Rubini Gimenez1 , C. Puelacher1 , P. Hillinger1 , J. Boeddinghaus1 , K. Grimm1 , M. Wagener1 , S. Osswald1 , C. Mueller1 , 1University Hospital Basel - Basel - Switzerland ,

European Heart Journal ( 2015 ) 36 ( Abstract Supplement ), 173

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 based on high-sensitivity cardiac troponin (hs-cTn) at presentation and its change within 1h versus the combination of the 1h-algorithm with undetectable levels of hs-cTn at presentation (1h-algorithm+LOD).

Methods: In a prospective international multicentre diagnostic study enrolling 2213 patients presenting with suspected AMI to the ED, 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; 1h-algorithm+LOD 0h<5ng OR (0h<12ng/l and Δ0–1h<3ng/l); and hs-cTnI Abbott: 1h-algorithm 0h <5ng/L and Δ0–1h<2ng/l; 1h-algorithm+LOD 0h<2ng/l OR (0h <5ng/L and Δ0–1h<2ng/l)) to ensure that findings are independent from the hs-cTn assay used. Patients presenting with STEMI were excluded.

Results: AMI was the final diagnosis in 17% of patients. Using hs-cTnT, the safety was very high and comparable with both algorithms (1h-algorithm: NPV 99.9%, 95% CI 99.6–100% versus 1h-algorithm+LOD: NPV 99.9%, 95% CI 99.5–100%, p=ns). Regarding efficacy, 1h-algorithm allowed rule-out in 59% of patients after 1h versus 59% with the 1h-algorithm+LOD (41% at presentation and 59% after 1h). Using hs-cTnI, the safety was very high and comparable with both algorithms (1h-algorithm: NPV 99.2%, 95% CI 98.4–99.6% versus 1h-algorithm+LOD: NPV 99.2% (95% CI 98.4–99.6, p=ns). The 1h-algorithm allowed the rule-out in 53% of patients after 1h versus 53% with the 1h-algorithm+LOD (31% at presentation and 69% after 1h).

Conclusion: Both investigated rule-out strategies allow a safe and comparable rule-out of AMI, irrespective of the underlying hs-cTn assay. While the 1h-algorithm requires retesting of hs-cTn after 1h in all patients, the 1h-algorithm+LOD allows the safe rule-out of AMI in about every fifth patient already at presentation.

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