scholarly journals High-Sensitivity Troponin I in Stable Patients with Atherosclerotic Disease in the TRA 2°P - TIMI 50 Trial

2017 ◽  
Vol 63 (1) ◽  
pp. 307-315 ◽  
Author(s):  
Alon Eisen ◽  
Marc P Bonaca ◽  
Petr Jarolim ◽  
Benjamin M Scirica ◽  
Harvey D White ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Troponin I ◽  
Absolute Risk ◽  
High Sensitivity ◽  
Arterial Disease ◽  
Cardiovascular Death ◽  
Atherosclerotic Disease ◽  
Risk Indicators ◽  
Specific Reference ◽  
Reference Limit

Abstract BACKGROUND Cardiac troponin I, measured with a high-sensitivity assay (hs-TnI), is well-established for risk prediction in acute coronary syndromes. However, its prognostic role in stable atherosclerotic disease, particularly for future myocardial infarction (MI), is less well defined. METHODS We measured hs-TnI (Abbott ARCHITECT) in 15833 patients with prior MI, ischemic stroke, or peripheral arterial disease from the placebo-controlled Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P)–Thrombolysis in Myocardial Infarction (TIMI) 50 trial of the platelet inhibitor vorapaxar, excluding patients with recent MI (<30 days). hs-TnI was categorized into 5 groups based on the detection limit (1.9 ng/L), 99th percentile reference limit (26 ng/L), and tertiles in between (1.9–26 ng/L), as well as sex-specific reference limits. RESULTS Higher hs-TnI concentration was associated with older age, male sex, and increased atherosclerosis burden. hs-TnI identified a graded 3-year risk of cardiovascular death, MI, or stroke from 5.0% to 18.6% (P < 0.001), driven by cardiovascular death and MI (P < 0.001). This risk was independent of established clinical risk indicators, B-type natriuretic peptide and C-reactive protein [adjusted hazard ratio 2.70 (95% CI, 1.96–3.71), P < 0.001 for hs-TnI >26 ng/L vs <1.9 ng/L]. In patients with prior MI, there was a pattern of greater absolute benefit with vorapaxar in patients with an increased hs-TnI (absolute risk difference 1.9% with hs-TnI >26 ng/L vs 0.3% with hs-TnI <1.9 ng/L; P interaction = 0.82). CONCLUSIONS In stable patients with established atherosclerosis, hs-TnI concentrations effectively stratified the risk of new or recurrent cardiovascular (CV) events, in particular CV death and MI. High-risk patients with prior MI identified by increased hs-TnI had a substantial absolute improvement in net clinical outcome with vorapaxar.

Potential impact of a novel pathway for suspected myocardial infarction utilising a new high-sensitivity cardiac troponin I assay

2021 ◽  
pp. emermed-2020-210812
Author(s):  
Rob Meek ◽  
Louise Cullen ◽  
Zhong Xian Lu ◽  
Arthur Nasis ◽  
Lisa Kuhn ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
High Sensitivity ◽  
Routine Care ◽  
Primary Objective ◽  
Cardiac Troponin I ◽  
Post Discharge ◽  
Reference Limit

BackgroundHigh-sensitivity cardiac troponin I (hs-cTnI) assays promise high diagnostic accuracy for myocardial infarction (MI). In an ED where conventional cTnI was in use, we evaluated an assessment pathway using the new Access hsTnI assay.MethodsThis retrospective analysis recruited ED patients with suspected MI between June and September 2019. All patients received routine care with a conventional cTnI assay (AccuTnI +3: limit of detection (LoD) 10 ng/L, 99th centile upper reference limit (URL) 40 ng/L, abnormal elevation cut-point 80 ng/L). Arrival, then 90-minute or 360-minute cTnI levels for low and non-low risk patients, respectively (ED Assessment of Chest pain score) guided diagnosis and disposition which was at treating physician discretion. The same patients had arrival and 90-minute or 180-minute samples drawn for hs-cTnI levels (Access hsTnI: LoD 2 ng/L, 99th centile URL 10 ng/L (females) and 20 ng/L (males); abnormal elevation above the URL and delta >30%). Treating physicians were blinded to the hs-cTnI results. Using the hs-cTnI values, investigators retrospectively assigned likely diagnosis, disposition and likelihood of a 30-day major adverse cardiac event (MACE). Admission was recommended for significantly rising hs-cTnI elevations. The primary objective was to demonstrate an acceptable unexpected 30-day post-discharge MACE rate of <1%. cTnI elevation rates, diagnostic outcomes and ED disposition were also compared between pathways.ResultsFor the 935 patients, unexpected 30-day post-discharge MACE rates were 0/935 (0%, 95% CI 0% to 0.4%) with the conventional or novel pathway. For the high-sensitivity and conventional assays, respectively, abnormal elevation rates were 29% (95% CI 26% to 32%) and 19% (95% CI 17% to 22%), for MI were 9% (95% CI 8% to 11%) and 8% (95% CI 6% to 10%), and for hospital admission were 42% (95% CI 39% to 45%) and 43% (95% CI 40% to 47%).ConclusionThe novel pathway using the Access hsTnI assay has an acceptably low 30-day MACE rate.

scholarly journals Pilot project to study the association of troponin I with cardiovascular events in the population of Russian region

2021 ◽  
Vol 20 (5) ◽  
pp. 2980
Author(s):  
S. A. Shalnova ◽  
O. M. Drapkina ◽  
A. V. Kontsevaya ◽  
E. B. Yarovaya ◽  
V. A. Kutsenko ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Survival Analysis ◽  
High Risk ◽  
Cardiovascular Events ◽  
Troponin I ◽  
High Sensitivity ◽  
Cardiovascular Death ◽  
Russian Region ◽  
Composite Endpoints ◽  
Ctni Level

Aim. As part of a pilot study, to investigate the potential significance of cardiac troponin I (cTnI) in assessing the risk of cardiovascular diseases (CVD) in general population aged 35-64 years of one of the regions from the ESSE-RF study.Material and methods. The study is based on the ESSE-RF observational prospective study using a sample from one Russian region. The analysis included socio-demographic variables, risk factors, history of CVD. The cTnI level was measured from November to December 2021 in serum samples stored at -70° C using high sensitivity chemiluminescent microparticle immunoassay using Architect Stat High Sensitivity Troponin I (Abbott) reagents on an Architect i2000SR immunoassay analyzer (Abbott, Abbot Park IL USA). The endpoints were hard (cardiovascular death and myocardial infarction) and composite endpoints (cardiovascular death, new cases of myocardial infarction, stroke, coronary artery disease and revascularization). The median follow-up was 5,5 years. In total, the analysis included 1120 people aged 35-64 years.Results. Analysis of the associations between Systematic Coronary Risk Evaluation (SCORE) and cTnI showed a significant difference in risk stratification for these two parameters. In women from cTnI-related high-risk category for cardiovascular events (CVE), there were no endpoints at all. In men of moderate and high risk, the proportion of endpoints increases with increasing cTnI-related risk. The survival curves corresponding to first 3 quintiles of cTnI risk distribution did not diverge, and, therefore, the number of CVEs in these groups did not differ. At the same time, the curves corresponding to 4th and 5th quintiles significantly differed from the first 3 quintiles, which indicates a higher CVE risk in subjects from these groups (p<0,001). Considering that there were only 3 endpoints in cTnI-related high-risk group, a survival analysis was performed for low-risk versus moderate-high risk. The curves obtained diverge significantly (p=0.006). Cox proportional hazards models were analyzed to assess the relationship between the cTnI level and endpoints. It was shown that cTnI itself or its logarithm is significantly associated with hard and composite endpoints. The cTnI cut-off point of 12/10 pg/ml (males/females) was associated with hard endpoint, and 6/4 pg/ml — with composite one. It should be noted that the recommended cut-off point of 6/4 pg/ml is close to the upper quartile of cTnI distribution in the European population. For the Russian population, the upper quartile corresponds to cTnI level of 3,5/2,1 pg/ml, which indicates the need to reduce the critical cTnI values in Russia. To assess risk reclassification, Cox models were analyzed using the Net Reclassification Index (NRI), as well as NRIsurvival for survival analysis. For categorical variables, the NRIcategorial was used. Both methods of including cTnI in the model significantly improve the risk classification of severe endpoints in men.Conclusion. The results obtained confirm the need to lower the threshold values for predicting combined endpoints, in particular, in Russian men. cTnl has an independent effect on CVE risk and its addition to SCORE improves the prediction of CVEs among men. However, the data obtained are preliminary and require clarification sing larger sample. At the same time, it is obvious that the determination of cТnI level can play a significant role in cardiovascular risk assessment and be an unfavorable prognosis marker among Russian population.

Abstract 14870: Clinical Significance of Troponin Elevation in a Contemporary Hospitalized Population: Endotypes, Morbidity and In-hospital Mortality

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Michael Briscoe ◽  
Robert A Sykes ◽  
Thomas Krysztofiak ◽  
Kenneth Mangion ◽  
Oliver H Peck ◽  
...  
Keyword(s):  
Clinical Significance ◽  
Myocardial Injury ◽  
Troponin I ◽  
Coronary Revascularization ◽  
High Sensitivity ◽  
Hospitalized Patients ◽  
Troponin Elevation ◽  
Reference Limit ◽  
Upper Reference Limit

Introduction: Unplanned hospitalizations are commonly associated with a circulating troponin concentration >99 th percentile upper reference limit (URL). In order to better understand the clinical significance of troponin elevation, we evaluated outcomes in hospitalized patients according to cardiac endotype. Methods: We prospectively screened consecutive hospitalized patients with elevated high-sensitivity troponin-I (hs-TnI) concentrations (Abbott ARCHITECT troponin-I assay; sex-specific URL, 99 th centile: male: >34ng/L; female: >16ng/L) within a regional cardiac care network (population 650,000). A cardiology clinical team adjudicated individual patient records and assigned endotypes by consensus agreement according to the Fourth Universal Definition of Myocardial Infarction (MI). Endotypes were sub-classified into etiological category by inciting event(s). Characteristics and comorbidity were compared and outcomes recorded on virtual follow-up until June 2 nd 2020. Results: A total of 390 consecutive patients with ≥1 hs-TnI value >URL between March 1-April 15, 2020, were evaluated; 44 patients were excluded ( Duplicates: 2; Missing data: 41; Research patient: 1 ). Of 346 who qualified for inclusion, an index diagnosis of Type 1 MI (T1MI), T2MI and myocardial injury were assigned in 115 (33.2%), 79 (22.8%) and 152 (43.9%) patients, respectively. Compared with T1MI, patients with T2MI and myocardial injury had lower peak hs-TnI values (median [IQR]: 86 [250-697] vs 5020 [853-7774]ng/L; p< 0.01), lower estimated 10-year survival (40.2% vs 53.4%; p=0.002), less frequently underwent coronary revascularization (1.4% vs 45.2%; p<0.0005) and had longer inpatient stay (13.0 vs 6.1 days). Inpatient and overall mortality rates from admission to follow-up (median [range]: 71 [0-151] days) were higher among patients with T2MI and myocardial injury (19.9% vs 7.8%; p=0.004; and 26.0% vs 11.3%; Log rank (Mantel-Cox) X 2 = 1.927; p=0.003) independent of similar cardiovascular risk profiles. Conclusions: Despite lower peak circulating troponin concentrations, patients with T2MI and myocardial injury had higher inpatient mortality, lower estimated 10-year survival and longer in-hospital stay compared to those with T1MI.

High-sensitivity troponin assays: analytical and clinical aspects

2016 ◽  
Vol 51 (4) ◽  
pp. 315-320
Author(s):  
Magdalena Krintus
Keyword(s):  
Myocardial Infarction ◽  
Clinical Symptoms ◽  
High Sensitivity ◽  
Reference Population ◽  
Clinical Aspects ◽  
Analytical Sensitivity ◽  
Reference Limit ◽  
Highly Sensitive ◽  
Time Required ◽  
Highly Sensitive Troponin

Cardiac troponins are considered the most sensitive and specific biomarkers for the diagnosis of acute coronary syndromes (ACS). According to the Third Universal Definition of Acute Myocardial Infarction, the diagnosis requires a rise / or fall of troponin concentration with at least one value exceeding the 99th percentile upper reference limit (URL) in a reference population with the coexistence of clinical symptoms of ischemia. The introduction of highly sensitive assays has resulted in lower detection limits for the concentration of troponin, allowing for early diagnosis of, as well as the detection of quantifiable concentrations of this biomarker in healthy subjects. According to current guidelines, the use of high-sensitivity tests can shorten the time required to make clinical decisions from the current 3-6 hours to 1-2 hours. The use of highly sensitive troponin assays also carries other potential benefits associated with their predictive value, as well as challenges that include reduced specificity for myocardial infarction, lack of standardization or the presence of biological variability. Given the increasing availability of new, highly sensitive troponin assays we should be aware that their increased analytical sensitivity and precision is accompanied by accurate clinical assessment of the patient, and takes into account other non-cardiac causes of their increased concentrations.

scholarly journals Clinical Use of a New High-Sensitivity Cardiac Troponin I Assay in Patients with Suspected Myocardial Infarction

2019 ◽  
Vol 65 (11) ◽  
pp. 1426-1436 ◽  
Author(s):  
Jasper Boeddinghaus ◽  
Raphael Twerenbold ◽  
Thomas Nestelberger ◽  
Luca Koechlin ◽  
Desiree Wussler ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Diagnostic Accuracy ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Clinical Performance ◽  
High Sensitivity ◽  
Primary Objective ◽  
Cardiac Troponin I ◽  
Primary Analysis ◽  
Derivation Cohort

Abstract BACKGROUND We aimed to validate the clinical performance of the high-sensitivity cardiac troponin I [VITROS® Immunodiagnostic Products hs Troponin I (hs-cTnI-VITROS)] assay. METHODS We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists considering all clinical information, including cardiac imaging: first, using serial hs-cTnT-Elecsys (primary analysis) and, second, using hs-cTnI-Architect (secondary analysis) measurements in addition to the clinically used (hs)-cTn. hs-cTnI-VITROS was measured at presentation and at 1 h in a blinded fashion. The primary objective was direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI-VITROS vs hs-cTnT-Elecsys and hs-cTnI-Architect, and in a subgroup also hs-cTnI-Centaur and hs-cTnI-Access. Secondary objectives included the derivation and validation of an hs-cTnI-VITROS-0/1-h algorithm. RESULTS AMI was the adjudicated final diagnosis in 158 of 1231 (13%) patients. At presentation, the AUC for hs-cTnI-VITROS was 0.95 (95% CI, 0.93–0.96); for hs-cTnT-Elecsys, 0.94 (95% CI, 0.92–0.95); and for hs-cTnI-Architect, 0.92 (95% CI, 0.90–0.94). AUCs for hs-cTnI-Centaur and hs-cTnI-Access were 0.95 (95% CI, 0.94–0.97). Applying the derived hs-cTnI-VITROS-0/1-h algorithm (derivation cohort n = 519) to the validation cohort (n = 520), 53% of patients were ruled out [sensitivity, 100% (95% CI, 94.1–100)] and 14% of patients were ruled in [specificity, 95.6% (95% CI, 93.4–97.2)]. Patients ruled out by the 0/1-h algorithm had a survival rate of 99.8% at 30 days. Findings were confirmed in the secondary analyses using the adjudication including serial measurements of hs-cTnI-Architect. CONCLUSIONS The hs-cTnI-VITROS assay has at least comparable diagnostic accuracy with the currently best validated hs-cTnT and hs-cTnI assays. ClinicalTrials.gov Identifier NCT00470587.

scholarly journals P5595Clinical effect of sex-specific cutoff values of high-sensitivity cardiac troponin I in suspected myocardial infarction

2018 ◽  
Vol 39 (suppl_1) ◽  
Author(s):  
M Rubini Gimenez ◽  
P Badertscher ◽  
R Twerenbold ◽  
J Boeddinghaus ◽  
T Nestelberger ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Troponin ◽  
Troponin I ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Cutoff Values

scholarly journals High-sensitivity troponin I and all-cause mortality in patients with stable COPD: an analysis of the COSYCONET study

2019 ◽  
Vol 55 (2) ◽  
pp. 1901314 ◽  
Author(s):  
Benjamin Waschki ◽  
Peter Alter ◽  
Tanja Zeller ◽  
Christina Magnussen ◽  
Johannes T. Neumann ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cardiovascular Risk ◽  
Cardiovascular Diseases ◽  
Cardiovascular Risk Factors ◽  
Troponin I ◽  
High Sensitivity ◽  
Airflow Limitation ◽  
Reference Limit ◽  
High Sensitivity Troponin ◽  
All Cause Mortality

Chronic obstructive pulmonary disease (COPD) is a leading cause of death with a considerable part of the population dying from cardiovascular diseases. High-sensitivity troponin I (hs-TnI) might help to better identify COPD patients at high risk of mortality. We aimed to study the predictive value of hs-TnI for all-cause mortality beyond established COPD assessments, and after consideration of relevant cardiovascular risk factors and prevalent cardiovascular diseases, in a broad population with stable COPD.Circulating hs-TnI concentrations together with a wide range of respiratory and cardiovascular markers were evaluated in 2085 patients with stable COPD across all severity stages enrolled in the multicentre COSYCONET cohort study. The primary outcome was all-cause mortality over 3 years of follow-up.Hs-TnI was detectable in 2020 (96.9%) patients. The median hs-TnI concentration was 3.8 ng·L−1 (interquartile range 2.5–6.6 ng·L−1), with levels above the 99th percentile reference limit of 27 ng·L−1 observed in 1.8% of patients. In Cox regression analyses including adjustments for airflow limitation, dyspnoea grade, exercise capacity and history of severe exacerbations, as well as traditional cardiovascular risk factors, estimated glomerular filtration rate, ankle–brachial index, N-terminal pro-brain natriuretic peptides and prevalent cardiovascular diseases, hs-TnI was a significant predictor for all-cause mortality, both as a continuous variable (hazard ratio (HR) for log hs-TnI 1.28, 95% CI 1.01–1.62) and categorised according to the cut-off of 6 ng·L−1 (HR 1.63, 95% CI 1.10–2.42).In patients with stable COPD, hs-TnI is a strong predictor of all-cause mortality beyond established COPD mortality predictors, and independent of a broad range of cardiovascular risk factors and prevalent cardiovascular diseases. Hs-TnI concentrations well below the upper reference limit provide further prognostic value for all patients with COPD when added to established risk assessments.

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