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Diagnostic accuracy of sensitive or high-sensitive troponin on presentation for myocardial infarction: a meta-analysis and systematic review.

ABSTRACT: BACKGROUND: Recently, high-sensitive troponin (hsTrop) assays consistent with professional societies' recommendations became available. We aimed to summarize the evidence on the diagnostic accuracy of hsTrop on presentation. METHODS: We searched electronic databases for studies evaluating the diagnostic accuracy of hsTrop in suspected acute coronary syndrome (ACS) patients. Random effect meta-analyses and meta-regression were performed. Primary and secondary analyses were restricted to studies using conventional Trop and hsTrop in the reference standard, respectively. RESULTS: Fifteen studies with a total of 8,628 patients met the inclusion criteria for the primary analysis. hsTrop T (Hoffman-La Roche Ltd) and hsTrop I (Siemens) had sensitivities of 0.89 (95% confidence interval [CI]: 0.86-0.91) and 0.90 (95% CI: 0.87-0.92) and specificities of 0.79 (95% CI: 0.77-0.80) and 0.89 (95% CI: 0.87-0.90), respectively. There was no statistically significant difference in the area under the curve between hsTrop (95% CI: 0.920) and conventional Trop (95% CI: 0.929) at the 99th percentile (P=0.62). hsTrop at the level of detection had a sensitivity of 0.97 (95% CI: 0.96-0.98) and a specificity of 0.41 (95% CI: 0.40-0.42). The studies using a cut-off at coefficient of variance <10% as opposed to the 99th percentile for the conventional assay used for diagnosis reported higher diagnostic accuracy (relative diagnostic odds ratio =2.13, P=0.02). Five studies were included in the secondary analysis; hsTrop T (Hoffman-La Roche Ltd) had a sensitivity of 0.91 (95% CI: 0.89-0.93) and a specificity of 0.67 (95% CI: 0.63-0.70). There was significant heterogeneity among the studies. CONCLUSION: hsTrop have excellent diagnostic accuracy for myocardial infarction on presentation, but may not outperform conventional Trop assays. The variation among the studies can be explained, in part, by the cut-off used for conventional Trop assays.

SUBMITTER: Sethi A

PROVIDER: S-EPMC4115590 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Diagnostic accuracy of sensitive or high-sensitive troponin on presentation for myocardial infarction: a meta-analysis and systematic review.

Sethi Ankur A Bajaj Anurag A Malhotra Gurveen G Arora Rohit R RR Khosla Sandeep S

Vascular health and risk management 20140721

<h4>Background</h4>Recently, high-sensitive troponin (hsTrop) assays consistent with professional societies' recommendations became available. We aimed to summarize the evidence on the diagnostic accuracy of hsTrop on presentation.<h4>Methods</h4>We searched electronic databases for studies evaluating the diagnostic accuracy of hsTrop in suspected acute coronary syndrome (ACS) patients. Random effect meta-analyses and meta-regression were performed. Primary and secondary analyses were restricted ...[more]

PMID: 25092986

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Project description:ObjectiveTo obtain summary estimates of the accuracy of a single baseline measurement of the Elecsys Troponin T high-sensitive assay (Roche Diagnostics) for the diagnosis of acute myocardial infarction in patients presenting to the emergency department.DesignSystematic review and meta-analysis of diagnostic test accuracy studies.Data sourcesMedline, Embase, and other relevant electronic databases were searched for papers published between January 2006 and December 2013.Study selectionStudies were included if they evaluated the diagnostic accuracy of a single baseline measurement of Elecsys Troponin T high-sensitive assay for the diagnosis of acute myocardial infarction in patients presenting to the emergency department with suspected acute coronary syndrome.Study appraisal and data synthesisThe first author screened all titles and abstracts identified through the searches and selected all potentially relevant papers. The screening of the full texts, the data extraction, and the methodological quality assessment, using the adapted QUADAS-2 tool, were conducted independently by two reviewers with disagreements being resolved through discussion or arbitration. If appropriate, meta-analysis was conducted using the hierarchical bivariate model.ResultsTwenty three studies reported the performance of the evaluated assay at presentation. The results for 14 ng/L and 3-5 ng/L cut-off values were pooled separately. At 14 ng/L (20 papers), the summary sensitivity was 89.5% (95% confidence interval 86.3% to 92.1%) and the summary specificity was 77.1% (68.7% to 83.7%). At 3-5 ng/L (six papers), the summary sensitivity was 97.4% (94.9% to 98.7%) and the summary specificity was 42.4% (31.2% to 54.5%). This means that if 21 of 100 consecutive patients have the target condition (21%, the median prevalence across the studies), 2 (95% confidence interval 2 to 3) of 21 patients with acute myocardial infarction will be missed (false negatives) if 14 ng/L is used as a cut-off value and 18 (13 to 25) of 79 patients without acute myocardial infarction will test positive (false positives). If the 3-5 ng/L cut-off value is used, <1 (0 to 1) patient with acute myocardial infarction will be missed and 46 (36 to 54) patients without acute myocardial infarction will test positive.ConclusionsThe results indicate that a single baseline measurement of the Elecsys Troponin T high-sensitive assay could be used to rule out acute myocardial infarction if lower cut-off values such as 3 ng/L or 5 ng/L are used. However, this method should be part of a comprehensive triage strategy and may not be appropriate for patients who present less than three hours after symptom onset. Care must also be exercised because of the higher imprecision of the evaluated assay and the greater effect of lot-to-lot reagent variation at low troponin concentrations.Systematic review registrationPROSPERO registration number CRD42013003926.

Project description:BackgroundHigh-sensitivity cardiac troponin assays enable myocardial infarction to be ruled out earlier, but the safety and efficacy of this approach is uncertain. We investigated whether an early rule-out pathway is safe and effective for patients with suspected acute coronary syndrome.MethodsWe performed a stepped-wedge cluster randomized controlled trial in the emergency departments of 7 acute care hospitals in Scotland. Consecutive patients presenting with suspected acute coronary syndrome between December 2014 and December 2016 were included. Sites were randomized to implement an early rule-out pathway where myocardial infarction was excluded if high-sensitivity cardiac troponin I concentrations were <5 ng/L at presentation. During a previous validation phase, myocardial infarction was ruled out when troponin concentrations were <99th percentile at 6 to 12 hours after symptom onset. The coprimary outcome was length of stay (efficacy) and myocardial infarction or cardiac death after discharge at 30 days (safety). Patients were followed for 1 year to evaluate safety and other secondary outcomes.ResultsWe enrolled 31 492 patients (59±17 years of age [mean±SD]; 45% women) with troponin concentrations <99th percentile at presentation. Length of stay was reduced from 10.1±4.1 to 6.8±3.9 hours (adjusted geometric mean ratio, 0.78 [95% CI, 0.73-0.83]; P<0.001) after implementation and the proportion of patients discharged increased from 50% to 71% (adjusted odds ratio, 1.59 [95% CI, 1.45-1.75]). Noninferiority was not demonstrated for the 30-day safety outcome (upper limit of 1-sided 95% CI for adjusted risk difference, 0.70% [noninferiority margin 0.50%]; P=0.068), but the observed differences favored the early rule-out pathway (0.4% [57/14 700] versus 0.3% [56/16 792]). At 1 year, the safety outcome occurred in 2.7% (396/14 700) and 1.8% (307/16 792) of patients before and after implementation (adjusted odds ratio, 1.02 [95% CI, 0.74-1.40]; P=0.894), and there were no differences in hospital reattendance or all-cause mortality.ConclusionsImplementation of an early rule-out pathway for myocardial infarction reduced length of stay and hospital admission. Although noninferiority for the safety outcome was not demonstrated at 30 days, there was no increase in cardiac events at 1 year. Adoption of this pathway would have major benefits for patients and health care providers. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03005158.

Project description:BackgroundThe instant, single-sampling rule-out of acute myocardial infarction (AMI) is still an unmet clinical need. We aimed at testing and comparing diagnostic performance and prognostic value of two different single-sampling biomarker strategies for the instant rule-out of AMI.MethodsFrom the Biomarkers in Acute Cardiac Care (BACC) cohort, we recruited consecutive patients with acute chest pain and suspected AMI presenting to the Emergency Department of the University Medical Center Hamburg-Eppendorf, Hamburg, Germany. We compared safety, effectiveness and 12-month incidence of the composite endpoint of all-cause death and myocardial infarction between (i) a single-sampling, dual-marker pathway combining high-sensitivity cardiac troponin I (hs-cTnI) and ultra-sensitive copeptin (us-Cop) at presentation (hs-cTnI ≤ 27 ng/L, us-Cop < 10 pmol/L and low-risk ECG) and (ii) a single-sampling pathway based on one-off hs-cTnI determination at presentation (hs-cTnI < 5 ng/L and low-risk ECG). As a comparator, we used the European Society of Cardiology (ESC) 0/1-h dual-sampling algorithm.ResultsWe enrolled 1,136 patients (male gender 65%) with median age of 64 years (interquartile range, 51-75). Overall, 228 (20%) patients received a final diagnosis of AMI. The two single-sampling instant rule-out pathways yielded similar negative predictive value (NPV): 97.4% (95%CI: 95.4-98.7) and 98.7% (95%CI: 96.9-99.6) for dual-marker and single hs-cTnI algorithms, respectively (P = 0.11). Both strategies were comparably safe as the ESC 0/1-h dual-sampling algorithm and this was consistent across subgroups of early-comers, low-intermediate risk (GRACE-score < 140) and renal dysfunction. Despite a numerically higher rate of false-negative results, the dual-marker strategy ruled-out a slightly but significantly higher percentage of patients compared with single hs-cTnI determination (37.4% versus 32.9%; P < 0.001). There were no significant between-group differences in 12-month composite outcome.ConclusionsInstant rule-out pathways based on one-off determination of hs-cTnI alone or in combination with us-Cop are comparably safe as the ESC 0/1 h algorithm for the instant rule-out of AMI, yielding similar prognostic information. Instant rule-out strategies are safe alternatives to the ESC 0/1 h algorithm and allow the rapid and effective triage of suspected AMI in patients with low-risk ECG. However, adding copeptin to hs-cTn does not improve the safety of instant rule-out compared with the single rule-out hs-cTn at very low cut-off concentrations.

Dataset Information

Diagnostic accuracy of sensitive or high-sensitive troponin on presentation for myocardial infarction: a meta-analysis and systematic review.

Publications

Diagnostic accuracy of sensitive or high-sensitive troponin on presentation for myocardial infarction: a meta-analysis and systematic review.

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