LO56: External validation of a 1-hour rapid diagnostic algorithm for ruling out acute myocardial infarction in emergency department patients with chest pain using a high-sensitivity troponin-T assay

Abstract

Introduction: Ruling out acute myocardial infarction (AMI) using serial troponin testing is central to the care of many emergency department (ED) patients with chest pain. While diagnostic strategies using conventional troponin assays require repeat sampling over many hours to avoid missed diagnoses, serial high-sensitivity troponin (hs-cTn) assays may be able to exclude AMI in most patients within 1 or 2 hours. However, many of the initial studies deriving and validating these rapid diagnostic algorithms had all hs-cTn samples analyzed in a central core lab likely representing optimal assay performance. This objective of this study is to validate a 1-hour rapid diagnostic algorithm to exclude AMI in ED chest pain patients using an hs-cTn assay in real world practice. Methods: This prospective cohort study was conducted at a single urban tertiary center and regional percutaneous coronary intervention site in Calgary, Alberta. Patients were eligible for enrolment if they presented to the ED with chest pain, were 25-years or older and required biomarker testing to rule out AMI at the discretion of the attending emergency physician. Patients were excluded if they had clear acute ischemic ECG changes, new arrhythmia or renal failure requiring hemodialysis. A high-sensitivity troponin result (Roche Elecsys hs-cTnT) was obtained in all patients at ED presentation and 1-hour later. The primary outcome was AMI on the index visit. Secondary outcomes included 30-day AMI and 30-day major adverse cardiac events (MACE - including AMI, revascularization or cardiac death). Electronic medical records were reviewed and telephone follow-up was obtained for all patients at 30-days to ensure relevant events were captured. Two physician adjudication (board-certified emergency physician and cardiologist) was obtained for all outcomes. The study was REB approved. Results: A total of 350 patients were enrolled from August 2014 September 2016 with 1-hour serial hs-cTnT results, of which 219 (62.6%) met the 1-hour rapid diagnostic algorithm low risk criteria (time 0h hs-cTnT <12ng/L and delta 1h <3ng/L). The sensitivity of the 1-hour low risk criteria for index AMI was 97.2% (95% CI 85.5%-99.9%) and for 30-day AMI was 97.3% (95% CI 85.8-99.9%). The sensitivity of the low risk criteria for 30-day MACE was lower 80.9% (95% CI 66.7-90.9%) but maintained a high negative predictive value, 95.9% (95% CI 92.3-98.1%). Conclusion: A 1-hour rapid diagnostic algorithm using an hs-cTnT assay was highly sensitive for AMI on the index visit and successfully identified patients at low risk of 30-day AMI; however, sensitivity for 30-day MACE was much lower. Of note, the 1-hour algorithm appears to be less sensitive for both AMI and 30-day MACE than a 2-hour algorithm validated in the same population.