Agreement between four high-sensitivity cardiac troponin assays and non-invasive testing, clinical and quality of care outcomes based on the 2020 ESC guidelines: results from the ROMICAT II trial

Abstract

Abstract Background Quality of care and safety of patients with suspected acute coronary syndrome (ACS) would greatly benefit if management was independent of which high-sensitivity cardiac troponin (hs-cTn) assay was used for risk stratification. Purpose To assess the agreement of 4 hs-cTn assays to risk stratify patients with suspected ACS using the ESC2020 Guidelines 0/2-hour algorithm, and to assess their associations with non-invasive diagnostic testing, clinical- and quality of care outcomes. Methods We analyzed blood samples obtained at emergency department (ED) presentation and 2 hours later from patients with suspected ACS enrolled in the ROMICAT (Rule Out Myocardial Infarction/Ischemia Using Computer Assisted Tomography) II trial, using 4 hs-cTn assays (Roche Diagnostics, Elecsys 2010; Abbott Diagnostics, ARCHITECT i2000SR; Siemens Diagnostics, HsVista; Beckman Coulter, ACCESS). We determined the agreement between the assays to assign patients to rule-out, observe, and rule-in management pathways according to the ESC2020 Guidelines. Further, we assessed assay association with non-invasive diagnostic test findings and adjudicated clinical- and quality of care outcomes. Finally, we compared observed conventional troponin management with predicted management per ESC2020 guidelines using hs-cTn assays. Results Overall, assignment to ESC2020 Guideline management pathways among 238 patients with suspected ACS (age 52.7±8.0 years; 40.3% [96/238] female) was concordant across all hs-Tn assays in 74% of patients but differed for rule-out rates (89.9% vs 76.5% vs 78.6% vs 86.6%, p<0.001) and observation rates (6.7% vs 20.6% vs 17.7% vs 9.2%, p<0.001), but not for rule-in (3.4% vs 2.9% vs 3.8% vs 4.2%, p=0.623). Among those whose management recommendation was rule-out, 19.1–21.6% had obstructive CAD defined as coronary stenosis ≥50% on coronary CT angiography or inducible myocardial ischemia on perfusion imaging and 3.3–4.2% were diagnosed with ACS as adjudicated by independent panel. Predicted ED discharge rates based on hs-cTn assays were higher than those observed with conventional troponin (80.3% to 90.8% vs. 21.0%, respectively p<0.001). As a result, predicted costs of care were significantly lower based on strategies utilizing hs-cTn assays than with conventional troponin ($2,578±2,896 to $2,894±4,371 vs $3,889±4,833, respectively, p<0.001) Conclusion In a quarter of patients presenting to the ED with suspected ACS ESC2020 Guideline-based management may be different, depending on the hs-cTn assay. As compared to conventional troponin, hs-cTn is predicted to significantly increase direct ED discharges and lower costs of care. Funding Acknowledgement Type of funding sources: None.