Cardiac Troponin Assays With Improved Analytical Quality: A Trade-Off Between Enhanced Diagnostic Performance and Reduced Long-Term Prognostic Value

Abstract

Background Cardiac troponin (cTn) permits early rule‐out/rule‐in of patients admitted with possible non–ST‐segment–elevation myocardial infarction. In this study, we developed an admission and a 0/1 hour rule‐out/rule‐in algorithm for a troponin assay with measurable results in >99% of healthy individuals. We then compared its diagnostic and long‐term prognostic properties with other protocols.

Methods and Results Blood samples were collected at 0, 1, 3, and 8 to 12 hours from patients admitted with possible non–ST‐segment–elevation myocardial infarction. cTnT (Roche Diagnostics), cTnI(Abbott) (Abbott Diagnostics), and cTnI(sgx) (Singulex Clarity System) were measured in 971 admission and 465 1‐hour samples. An admission and a 0/1 hour rule‐out/rule‐in algorithm were developed for the cTnI(sgx) assay and its diagnostic properties were compared with cTnTESC (European Society of Cardiology), cTnI(Abbott)ESC, and 2 earlier cTnI(sgx) algorithms. The prognostic composite end point was all‐cause mortality and future nonfatal myocardial infarction during a median follow‐up of 723 days. non–ST‐segment–elevation myocardial infarction prevalence was 13%. The novel cTnI(sgx) algorithms showed similar performance regardless of time from symptom onset, and area under the curve was significantly better than comparators. The cTnI(sgx)0/1 hour algorithm classified 92% of patients to rule‐in or rule‐out compared with ≤78% of comparators. Patients allocated to rule‐out by the prior published 0/1 hour algorithms had significantly fewer long‐term events compared with the rule‐in and observation groups. The novel cTnI(sgx)0/1 hour algorithm used a higher troponin baseline concentration for rule‐out and did not allow for prognostication.

Conclusions Increasingly sensitive troponin assays may improve identification of non–ST‐segment–elevation myocardial infarction but could rule‐out patients with subclinical chronic myocardial injury. Separate protocols for diagnosis and risk prediction seem appropriate.