European society of cardiology 0-hour/1-hour high-sensitivity troponin algorithm performance in a United States cohort

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Conference Proceeding

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Academic emergency medicine


Background and Objectives: The European Society of Cardiology 0/1-hour algorithm (ESC 0/1-h) is a high sensitivity cardiac troponin (hs-cTn) accelerated diagnostic protocol (ADP) that was derived and validated in Europe and is endorsed by the ESC guidelines. Based largely on European data demonstrating a negative predictive value (NPV) >99%, the ESC 0/1-h is being adopted at US hospitals, but evidence of its diagnostic performance in the US is limited. The objective of this study is to validate the ESC 0/1-h in a multisite US cohort.

Methods: A prospective observational cohort study was conducted at 8 US sites. Adult Emergency Department patients with symptoms suggestive of acute coronary syndrome and without ST-segment elevation myocardial infarction on ECG were enrolled. Serial blood samples were collected from participants and hscTnT concentrations were measured in a central laboratory using the Roche (Basel, Switzerland) hs-cTnT assay. Treating providers were blinded to hs-cTnT results. Adjudicated outcomes included MACE (the composite of cardiac death, myocardial infarction [MI], and coronary revascularization) at 30-days and cardiac death or MI at 30-days. Risk based on the ESC 0/1-h was determined for each participant and its diagnostic performance (NPV and positive predictive value [PPV] with exact 95% confidence intervals) was calculated.

Results: Among 1,462 patients enrolled, 1,430 patients had 0 and 1 hour hs-cTnT measures; 45.8% (655/1430) were women and 36.6% (524/1430) were African American with a mean age of 57.6 (SD±12.8) years. MACE at 30-days occurred in 14.2% (203/1,430). The ESC 0/1-h ADP stratified 59.6% (853/ 1,430) of patients to the Rule-Out zone, with a NPV for 30-day MACE of 97.2% (95%CI: 95.8-98.2%) and 98.4% (95%CI: 97.3-99.1%) for 30-day cardiac death and MI. The Rule-In criteria were met by 12.2% (175/1,430) with a PPV of 62.9% (95%CI 55.2-70.0%) for 30-day MACE and 62.9% (95%CI 55.2- 70.0%) for 30-day cardiac death and MI. The remaining 28.1% (402/1,430) were stratified to the observation zone. Among observation zone patients, 17.2% (69/402) had 30-day MACE.

Conclusion: In a multisite prospective US cohort, the ESC 0/1-h hs-cTnT ADP stratified a large proportion of patients to the Rule-Out zone, but was unable to achieve a sufficiently high NPV to safely exclude 30-day MACE or 30-day cardiovascular death and MI.



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