European society of cardiology 0-hour/1-hour high-sensitivity troponin algorithm performance in a United States cohort
Allen B, Christenson R, Cohen SA, Nowak RM, Wilkerson RG, Mumma BE, Madsen T, McCord J, T'Veld MH, Massoomi M, Stopyra JP, Montero C, Weaver M, Yang K, and Mahler SA. European society of cardiology 0-hour/1-hour high-sensitivity troponin algorithm performance in a United States cohort. Academic Emergency Medicine 2020; 27:S48.
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.