Abstract
ObjectiveTo evaluate the prognostic implications of longitudinal long-term changes beyond the biological variation of high-sensitivity cardiac troponin T (hs-cTnT) in outpatients with stable or asymptomatic cardiovascular disease (CV) and to assess possible differences in the prognostic value while using reference change value (RCV) and minimal important differences (MID) as metric for biological variation.MethodsHs-cTnT was measured at index visit and after 12 months in outpatients presenting for routine follow-up. The prognostic relevance of a concentration change of hs-cTnT values exceeding the biological variation defined by RCV and MID of a healthy population within the next 12 months following the stable initial period was determined regarding three endpoints: all-cause mortality (EP1), a composite of all-cause mortality, non-fatal myocardial infarction and stroke (EP2), and a composite of all-cause mortality, non-fatal myocardial infarction, stroke, hospitalization for acute coronary syndrome (ACS) or decompensated heart failure, and planned and unplanned percutaneous coronary interventions (PCI, EP3).ResultsChange in hs-cTnT values exceeding the biovariability defined by MID but not by RCV discriminated a group with a higher cardiovascular risk profile. Changes within MID were associated with uneventful course (NPV 91.6–99.7%) while changes exceeding MID were associated with a higher occurrence of all endpoints within the next 365 days indicating a 5.5-fold increased risk for EP 1 (p = 0.041) a 2.4-fold increased risk for EP 2 (p = 0.049) and a 1.9-fold increased risk for EP 3 (p < 0.0001).ConclusionsIn stable outpatients MID calculated from hs-cTnT changes measured 365 ± 120 days apart are helpful to predict an uneventful clinical course.Clinical trials identifierNCT01954303.Graphic abstract
Highlights
Cardiovascular (CV) disease remains worldwide leading cause of morbidity and mortality [1]
Higher high-sensitivity cardiac troponin T (hs-cTnT) values at index and follow-up visits, higher NT-proBNP values and lower eGFR values were observed in patients with minimal important differences (MID) values out of the reference range whereas lower hs-cTnT values and a higher eGFR was found in patients exceeding the reference change value (RCV) reference
The development of high-sensitivity troponin assays has allowed the detection of circulating troponin in patients with acute coronary syndromes, and in stable cardiovascular disease and even in healthy individuals [8,9,10]
Summary
Cardiovascular (CV) disease remains worldwide leading cause of morbidity and mortality [1]. Cardiac troponins are suggested as preferred biomarkers for the identification of myocardial infarction and indicate myocyte injury [4] Due to their high sensitivity, they allow to identify non-ST-segment elevation acute myocardial infarction (NSTEMI), and indicate myocardial injury due to non-coronary and non-cardiac diseases [6, 7]. In addition to their value as diagnostic biomarker, cardiac troponins can be used as prognostic biomarkers since they have proved to be indicative of future cardiovascular events including death irrespective of the underlying release mechanism [8,9,10]. Changes that exceed biological variation may be indicative of future cardiovascular events
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