High-Sensitivity Cardiac Troponin and the Universal Definition of Myocardial Infarction

Background: The introduction of more sensitive cardiac troponin assays has led to increased recognition of myocardial injury in acute illnesses other than acute coronary syndrome. The Universal Definition of Myocardial Infarction recommends high-sensitivity cardiac troponin testing and classification of patients with myocardial injury based on pathogenesis, but the clinical implications of implementing this guideline are not well understood. Methods: In a stepped-wedge cluster randomized, controlled trial, we implemented a high-sensitivity cardiac troponin assay and the recommendations of the Universal Definition in 48 282 consecutive patients with suspected acute coronary syndrome. In a prespecified secondary analysis, we compared the primary outcome of myocardial infarction or cardiovascular death and secondary outcome of noncardiovascular death at 1 year across diagnostic categories. Results: Implementation increased the diagnosis of type 1 myocardial infarction by 11% (510/4471), type 2 myocardial infarction by 22% (205/916), and acute and chronic myocardial injury by 36% (443/1233) and 43% (389/898), respectively. Compared with those without myocardial injury, the rate of the primary outcome was highest in those with type 1 myocardial infarction (cause-specific hazard ratio [HR] 5.64 [95% CI, 5.12–6.22]), but was similar across diagnostic categories, whereas noncardiovascular deaths were highest in those with acute myocardial injury (cause specific HR 2.65 [95% CI, 2.33–3.01]). Despite modest increases in antiplatelet therapy and coronary revascularization after implementation in patients with type 1 myocardial infarction, the primary outcome was unchanged (cause specific HR 1.00 [95% CI, 0.82–1.21]). Increased recognition of type 2 myocardial infarction and myocardial injury did not lead to changes in investigation, treatment or outcomes. Conclusions: Implementation of high-sensitivity cardiac troponin assays and the recommendations of the Universal Definition of Myocardial Infarction identified patients at high-risk of cardiovascular and noncardiovascular events but was not associated with consistent increases in treatment or improved outcomes. Trials of secondary prevention are urgently required to determine whether this risk is modifiable in patients without type 1 myocardial infarction. Clinical Trial Registration: https://www.clinicaltrials.gov . Unique identifier: NCT01852123.

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249High-sensitivity cardiac troponin and the universal definition of myocardial infarction: a randomised controlled trial

European Heart Journal ◽

10.1093/eurheartj/ehz747.0066 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

A R Chapman ◽

P D Adamson ◽

A Anand ◽

A S V Shah ◽

K K Lee ◽

...

Keyword(s):

Myocardial Infarction ◽

Cardiac Troponin ◽

Myocardial Injury ◽

Primary Outcome ◽

Controlled Trial ◽

High Sensitivity ◽

Cardiovascular Death ◽

Acute Myocardial Injury ◽

Universal Definition

Abstract Background The Universal Definition of Myocardial Infarction recommends the 99th centile diagnostic threshold using a high-sensitivity cardiac troponin (hs-cTn) assay and the classification of patients by the etiology of myocardial injury. Whether implementation of this definition improves risk stratification, treatment or outcomes is unknown. Methods In a stepped-wedge cluster randomized controlled trial, we implemented a high-sensitivity troponin assay and the recommendations of the Universal Definition in 48,282 consecutive patients with suspected acute coronary syndrome across ten hospitals. In a pre-specified secondary analysis, we compared the primary outcome of myocardial infarction or cardiovascular death, and secondary outcome of non-cardiovascular death at one year across diagnostic categories as per the Fourth Universal Definition. We applied competing risks methodology in all analyses, using a cumulative incidence function and determining the cause-specific hazard ratio (csHR) for competing outcomes. Results Cardiac troponin concentrations were elevated in 21.5% (10,360/48,282) of all trial participants. Implementation increased the diagnosis of type 1 myocardial infarction by 11% (510/4,471), type 2 myocardial infarction by 22% (205/916), acute myocardial injury by 36% (443/1,233) and chronic myocardial injury by 43% (389/898). The risk and rate of the primary outcome was highest in those with type 1 myocardial infarction, whereas the risk and rate of non-cardiovascular death was highest in those with acute myocardial injury (Table, Figure). Despite increases in anti-platelet therapy and coronary revascularization after implementation, the primary outcome was unchanged in patients with type 1 myocardial infarction (csHR 1.00, 95% CI 0.82 to 1.21), or in any other category. Adjusted csHR for competing outcomes Myocardial infarction or cardiovascular death Non-cardiovascular death Adjusted csHR (95% CI) Adjusted csHR (95% CI) Type 1 myocardial infarction 5.64 (5.12 to 6.22) 0.83 (0.72 to 0.96) Type 2 myocardial infarction 3.50 (2.94 to 4.15) 1.72 (1.44 to 2.06) Acute myocardial injury 4.38 (3.80 to 5.05) 2.65 (2.33 to 3.00) Chronic myocardial injury 3.88 (3.31 to 4.55) 2.06 (1.77 to 2.40) Cox regression models adjusted for age, sex, diabetes, ischaemic heart disease, season, days since trial onset and site of recruitment (as a random effect). Cumulative incidence and number at risk Conclusions Implementation of the recommendations of the Universal Definition identified patients with different risks of future cardiovascular and non-cardiovascular events, but did not improve outcomes. Greater understanding of the underlying mechanisms and effective strategies for the investigation and treatment of patients with myocardial injury and infarction are required if we are to improve outcomes. Acknowledgement/Funding British Heart Foundation

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Abstract 350: Assessment of Clinicians’ Attitudes and Knowledge About Cardiac Troponin Testing

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/hcq.13.suppl_1.350 ◽

2020 ◽

Vol 13 (Suppl_1) ◽

Author(s):

Sandeep Jain ◽

Andrew Hammes ◽

Eric Rudofker ◽

Karen Ream ◽

Andrew E Levy

Keyword(s):

Myocardial Infarction ◽

Cardiac Troponin ◽

Myocardial Injury ◽

The United States ◽

Advanced Practice ◽

Attitudes And Knowledge ◽

Universal Definition ◽

Definition Of ◽

Attending Physicians

In the United States, the positive predictive value (PPV) of cardiac troponin for type 1 myocardial infarction is substantially lower than in Europe (15% vs. 50%). Further, even with publication of the 4 th Universal Definition of Myocardial Infarction, recent studies have shown that inaccurate classification of myocardial injury is common among clinicians in the United States. These findings are at least partly attributable to clinicians’ knowledge and attitudes about cardiac troponin testing; a survey of these parameters has never been conducted. Clinicians at the University of Colorado completed a brief 8-question multiple-choice survey related to troponin use, definitions of myocardial infarction and clinical assessment of elevated troponin levels. The survey was distributed via secure email and administered electronically using the Qualtrics™ platform. Responses were anonymous, completion was estimated to take 3 minutes and a lottery award system was used as an incentive for participation. Respondents included trainees, advanced practice providers and attending physicians from internal medicine, emergency medicine and medical subspecialties. We plan to obtain a total of 300 responses with descriptive findings of preliminary results included below. The survey was completed by 114 clinicians: 37 interns (32%), 45 residents (39%), 9 advanced practice providers (8%), 11 fellows (10%), and 12 attending physicians (11%). Regarding indications for troponin testing, 93% (106/114) indicated that they “usually” or “always” check troponin levels in patients with chest pain. More interestingly, 46% (52/112) reported checking troponin on “undifferentiated patients” at least half the time. For troponin interpretation, 97% (110/114) of participants identified that troponin levels alone cannot rule in or rule out coronary artery disease. In contrast, only 36% (41/114) and 55% (63/114), respectively, identified the NPV and PPV of a contemporary troponin assay for type 1 MI. Further, only 50% (57/114) of respondents identified that the likelihood of type 1 MI increases as troponin levels increase. Three brief clinical vignettes revealed that, while 78% (89/114) and 74% (45/61) of participants, respectively, identified type 1 MI and type 2 MI presentations, only 40% (21/53) of respondents correctly identified a vignette for non-ischemic myocardial injury. Concordant with this finding, 54% (61/114) of clinicians correctly identified the 4 th Universal Definition of Myocardial Infarction. These preliminary findings highlight important facets of clinician attitudes and knowledge about troponin testing that help explain the poor PPV for troponin and diagnostic misclassification observed among U.S. clinicians. These results could help guide curricular and clinical decision support interventions designed to improve the use and interpretation of cardiac troponin testing.

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Global Adoption of High-Sensitivity Cardiac Troponins and the Universal Definition of Myocardial Infarction

Clinical Chemistry ◽

10.1373/clinchem.2018.298059 ◽

2019 ◽

Vol 65 (3) ◽

pp. 484-489 ◽

Cited By ~ 21

Author(s):

Atul Anand ◽

Anoop S V Shah ◽

Agim Beshiri ◽

Allan S Jaffe ◽

Nicholas L Mills

Keyword(s):

Myocardial Infarction ◽

Cardiac Troponin ◽

Clinical Pathways ◽

High Sensitivity ◽

Diagnosis And Management ◽

Coronary Syndrome ◽

Diagnostic Threshold ◽

Serial Sampling ◽

Universal Definition ◽

Definition Of

Abstract BACKGROUND The universal definition of myocardial infarction (UDMI) standardizes the approach to the diagnosis and management of myocardial infarction. High-sensitivity cardiac troponin testing is recommended because these assays have improved precision at low concentrations, but concerns over specificity may have limited their implementation. METHODS We undertook a global survey of 1902 medical centers in 23 countries evenly distributed across 5 continents to assess adoption of key recommendations from the UDMI. Respondents involved in the diagnosis and management of patients with suspected acute coronary syndrome completed a structured telephone questionnaire detailing the primary biomarker, diagnostic thresholds, and clinical pathways used to identify myocardial infarction. RESULTS Cardiac troponin was the primary diagnostic biomarker at 96% of surveyed sites. Only 41% of centers had adopted high-sensitivity assays, with wide variation from 7% in North America to 60% in Europe. Sites using high-sensitivity troponin more frequently used serial sampling pathways (91% vs 78%) and the 99th percentile diagnostic threshold (74% vs 66%) than sites using previous-generation assays. Furthermore, high-sensitivity institutions more often used earlier serial sampling (≤3 h) and accelerated diagnostic pathways. Fewer than 1 in 5 high-sensitivity sites had adopted sex-specific thresholds (18%). CONCLUSIONS There has been global progress toward the recommendations of the UDMI, particularly in the use of the 99th percentile diagnostic threshold and serial sampling. However, high-sensitivity assays are still used by a minority of sites, and sex-specific thresholds by even fewer. Additional efforts are required to improve risk stratification and diagnosis of patients with myocardial infarction.

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Global Adoption of High-Sensitivity Cardiac Troponins and the Universal Definition of Myocardial Infarction

10.1101/371138 ◽

2018 ◽

Cited By ~ 1

Author(s):

Atul Anand ◽

Anoop SV Shah ◽

Agim Beshiri ◽

Allan S Jaffe ◽

Nicholas L Mills

Keyword(s):

Myocardial Infarction ◽

Cardiac Troponin ◽

High Sensitivity ◽

Diagnosis And Management ◽

Coronary Syndrome ◽

The Third ◽

Diagnostic Threshold ◽

Serial Sampling ◽

Universal Definition ◽

Definition Of

AbstractImportanceThe third Universal Definition of Myocardial Infarction aimed to standardize the approach to the diagnosis and management of myocardial infarction. High-sensitivity cardiac troponin testing was recommended, as these assays have improved precision at low concentrations, but concerns over specificity may have limited implementation.ObjectiveTo determine the global adoption of high-sensitivity cardiac troponin assays and key recommendations from the Universal Definition.Design, Setting and ParticipantsGlobal survey of 1,902 medical centers across 23 countries evenly distributed across all five continents. Included respondents were involved in the diagnosis and management of patients with suspected acute coronary syndrome at their institutions.Main Outcomes and MeasuresStructured questionnaire detailing the primary biomarker used for myocardial infarction, diagnostic thresholds and critical elements of clinical pathways for comparison to the third Universal Definition recommendations.ResultsCardiac troponin was the primary diagnostic biomarker for myocardial infarction at 96% of all sites surveyed. Only 41% of centers had adopted high-sensitivity cardiac troponin assays, with wide variation from 7% in North America to 60% in Europe. Sites using high-sensitivity assays more frequently employed serial sampling pathways (91% vs. 78%) and the 99th percentile diagnostic threshold (74% vs. 66%) when compared to sites using the previous generation of troponin assays. Furthermore, sites using high-sensitivity assays more often used earlier serial sampling (≤3 hours) and accelerated diagnostic pathways. However, fewer than 1 in 5 sites using high-sensitivity assays had adopted sex-specific thresholds (18%).Conclusions and RelevanceProgress has been made in adopting the recommendations of the Universal Definition of Myocardial Infarction, particularly in the use of the 99th percentile diagnostic threshold and serial sampling. However, high-sensitivity assays are used in a minority of sites and sex-specific thresholds in even fewer. These findings highlight regions where additional efforts are required to improve the risk stratification and diagnosis of patients with myocardial infarction.

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Diagnosis of Type 1 and Type 2 Myocardial Infarction Using a High-Sensitivity Cardiac Troponin I Assay with Sex-Specific 99th Percentiles Based on the Third Universal Definition of Myocardial Infarction Classification System

Clinical Chemistry ◽

10.1373/clinchem.2014.236638 ◽

2015 ◽

Vol 61 (4) ◽

pp. 657-663 ◽

Cited By ~ 45

Author(s):

Yader Sandoval ◽

Stephen W Smith ◽

Karen M Schulz ◽

MaryAnn M Murakami ◽

Sara A Love ◽

...

Keyword(s):

Myocardial Infarction ◽

Classification System ◽

Cardiac Troponin ◽

Troponin I ◽

High Sensitivity ◽

The Third ◽

Universal Definition ◽

Definition Of

Abstract BACKGROUND The frequency and characteristics of myocardial infarction (MI) subtypes per the Third Universal Definition of MI (TUDMI) classification system using high-sensitivity (hs) cardiac troponin assays with sex-specific cutoffs is not well known. We sought to describe the diagnostic characteristics of type 1 (T1MI) and type 2 (T2MI) MI using an hs–cardiac troponin I (hs-cTnI) assay with sex-specific cutoffs. METHODS A total of 310 consecutive patients with serial cTnI measurements obtained on clinical indication were studied with contemporary and hs-cTnI assays. Ninety-ninth percentile sex-specific upper reference limits (URLs) for the hs-cTnI assay were 16 ng/L for females and 34 ng/L for males. The TUDMI consensus recommendations were used to define and adjudicate MI based on each URL. RESULTS A total of 127 (41%) patients had at least 1 hs-cTnI exceeding the sex-specific 99th percentiles, whereas 183 (59%) had hs-cTnI within the reference interval. Females had more myocardial injury related to supply/demand ischemia than males (39% vs 18%, P = 0.01), whereas males had more multifactorial or indeterminate injury (52% vs 33%, P = 0.05). By hs-cTnI, there were 32 (10%) acute MIs, among which 10 (3%) were T1MI and 22 (7%) were T2MI. T2MI represented 69% (22 out of 32) of all acute MIs, whereas T1MI represented 31% (10 out of 32). Ninety-five patients (31%) had an increased hs-cTnI above the 99th percentile but did not meet criteria for acute MI. The most common triggers for T2MI were tachyarrhythmias, hypotension/shock, and hypertension. By contemporary cTnI, more MIs (14 T1MI and 29 T2MI) were diagnosed. By contemporary cTnI, there were 43 MIs, 14 T1MI, and 29 T2MI. CONCLUSIONS Fewer MI diagnoses were found with the hs-cTnI assay, contrary to the commonly accepted idea that hs-cTnI will lead to excessive false-positive diagnoses.

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P1578Outcomes in patients with renal impairment and myocardial injury or infarction identified by high-sensitivity cardiac troponin testing: a secondary analysis of the High-STEACS trial

European Heart Journal ◽

10.1093/eurheartj/ehz748.0338 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

P J Gallacher ◽

E Miller-Hodges ◽

A Shah ◽

A Anand ◽

K K Lee ◽

...

Keyword(s):

Myocardial Infarction ◽

Renal Function ◽

Renal Impairment ◽

Cardiac Troponin ◽

Myocardial Injury ◽

Primary Outcome ◽

Secondary Analysis ◽

High Sensitivity

Abstract Background Patients with renal impairment are at increased risk of myocardial infarction (MI), but the interpretation of cardiac troponin is challenging in this setting. The use of high-sensitivity cardiac troponin (hs-cTn) assays increases the detection of myocardial injury, yet may contribute to uncertainty in the diagnosis of MI in those with renal impairment. Purpose To describe the diagnosis and outcomes of patients with myocardial injury or infarction identified using a hs-cTnI assay, stratified by renal function. Methods In a pre-specified secondary analysis of a stepped-wedge cluster-randomised controlled trial, we identified consecutive patients with a hs-cTnI concentration greater than the sex-specific 99th centile between June 2013 and March 2016. The diagnoses of type 1 or type 2 MI were adjudicated and classified according to the 4th Universal Definition of Myocardial Infarction. Renal impairment was defined as an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2.The primary outcome of type 1 or type 4b MI or cardiovascular death was compared in patients with and without renal impairment at 1 year. Results A measure of renal function was available in 47,334 (98.0%) patients, of whom 7,933 (16.8%) had renal impairment (mean age 76±12 years; 54% female). Plasma hs-cTnI concentrations were >99th centile in 47.9% (3,800/7,933) of patients with renal impairment and 16.3% (6,439/39,401) of patients with normal renal function. In those with and without renal impairment, the adjudicated diagnosis was type 1 MI in 35.2% (1,336/3,800) and 55.8% (3,596/6,439) of patients, and type 2 MI in 12.6% (480/3,800) and 9.7% (626/6,439) of patients, respectively (P<0.001 for both). In patients with hs-cTnI concentrations >99th centile, the primary outcome occurred in 24.9% (945/3,800) of patients with renal impairment, compared to 12.1% (779/6,439) of patients with normal renal function (P<0.001). In patients with type 1 MI, the primary outcome occurred in 32.6% (436/1,336) of those with renal impairment and 11.7% (419/3,596) of those without (P<0.001). In patients with type 2 MI, the primary outcome occurred in 20.4% (98/480) and 9.9% (62/626) of patients with and without renal impairment, respectively (P<0.001). Conclusion Almost half of all patients with suspected acute coronary syndrome and renal impairment have hs-cTnI concentrations greater than the sex-specific 99th centile. Whilst only one in three had a diagnosis of type 1 MI, an elevated troponin concentration was associated with a poorer prognosis in those with concomitant renal impairment compared to those without, irrespective of the index diagnosis. Acknowledgement/Funding British Heart Foundation

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Abstract 19710: Causes for Increased Cardiac Troponin I Using Gender-Specific 99th Percentiles From a High Sensitivity Assay in a US Population

Circulation ◽

10.1161/circ.130.suppl_2.19710 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Yader Sandoval ◽

Stephen W Smith ◽

Karen M Schulz ◽

MaryAnn M Murakami ◽

Fred S Apple

Keyword(s):

Myocardial Ischemia ◽

Cardiac Troponin ◽

Myocardial Injury ◽

Troponin I ◽

Plaque Rupture ◽

High Sensitivity ◽

The United States ◽

Universal Definition ◽

Definition Of ◽

Gender Specific

Introduction: High-sensitivity cardiac troponin (hs-cTn) assays have not yet been FDA cleared for clinical use in the United States (US). Pending expected approval of hs-cTn assays, which will use gender-specific cutoffs (GSC), it is relevant to recognize the causes of cTn increases using hs-cTnI assays in a US population. Our purpose was to describe the frequency of distinct etiologies of hs-cTnI assay increases using GSC. Methods: Retrospective study of 310 patients with serial hs-cTnI (Abbott ARCHITECT, 99th percentiles: F:16 ng/L; M:34 ng/L) measurements. Patients with an increased hs-cTnI were adjudicated into categories according to the 3rd Universal Definition of MI. Categories included, A: primary myocardial ischemia (i.e. plaque rupture); B: injury secondary to supply/demand imbalance; C: injury not related to myocardial ischemia (i.e. cardiac contusion, ablation, shock, surgery); D: multifactorial or indeterminate myocardial injury (i.e. heart failure, critically ill, pulmonary HTN, sepsis, stroke, renal failure, pulmonary embolism); E: Unknown. Results: 127 (41%) had an increased hs-cTnI above the GSC 99th percentile, whereas 183 (59%) had a normal hs-cTnI. The most common causes of hs-cTnI increases were: a) multifactorial or indeterminate injury - 43% among all patients and 52% in males, and b) supply/demand imbalance - 39% in women (Table). Injury related to primary myocardial ischemia was present in 10% (n=13). Females had more injury related to supply/demand ischemia than males (39% vs. 18%, p=0.01), whereas males had more multifactorial or indeterminate injury (52% vs. 33%, p=0.05). Conclusions: Most increased hs-cTnI values were explained by non-plaque rupture conditions. Males tended to have hs-cTnI increases due to multifactorial/indeterminate causes, whereas in women supply/demand imbalance was the most common etiology. Investigations are needed to better understand if etiologies of myocardial injury have gender differences.

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P3593Improving the performance of high-sensitivity cardiac troponin for the diagnosis of myocardial infarction

European Heart Journal ◽

10.1093/eurheartj/ehz745.0453 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

A Anand ◽

A S V Shah ◽

F E Strachan ◽

K K Lee ◽

A R Chapman ◽

...

Keyword(s):

Myocardial Infarction ◽

Cardiac Troponin ◽

Diagnostic Performance ◽

Validation Cohort ◽

External Validation ◽

High Sensitivity ◽

Rate Of Change ◽

Coronary Syndrome ◽

Study Population

Abstract Background The Universal Definition of Myocardial Infarction (UDMI) mandates a rise and/or fall in high-sensitivity cardiac troponin (hs-cTn) concentration with at least one measure above the 99th centile of a healthy reference population. However, the 99th centile varies by age, sex, and prevalence of comorbid disease within reference populations, and the application of a single threshold may create diagnostic uncertainty in unselected patients attending the Emergency Department. Purpose To compare performance of hs-cTnI at the 99th centile with a model that includes additional clinical variables, for the diagnosis of type 1 myocardial infarction. Methods The High-Sensitivity Troponin in the Evaluation of patients with Acute Coronary Syndrome (High-STEACS trial) was a stepped wedge cluster randomised controlled trial of 48,282 consecutive patients across 10 hospitals in Scotland. We evaluated the positive predictive value (PPV) of a hs-cTnI >99th centile for a diagnosis of type 1 myocardial infarction. Patients with ST-segment elevation myocardial infarction (STEMI) were excluded, and all were adjudicated according to the 4th UDMI. The study population was randomly divided into derivation (80%) and internal validation (20%) cohorts. Using generalised additive modelling, we tested the effect of adding clinically relevant variables to hs-cTnI for the prediction of type 1 myocardial infarction in the derivation cohort, and assessed performance of the final model in the validation cohort. Results We included 47,101 consecutive patients (61±17 years, 47% female), of whom 9,057 (19%) had at least one hs-cTnI >99th centile (7,207 in derivation and 1,850 in validation cohorts). There were 4,087 (45%) patients with type 1 myocardial infarction, with 3239 (45%) and 848 (46%) in the derivation and validation cohorts, respectively. Across the study population, PPV for type 1 myocardial infarction reduced markedly with increasing age (Figure). Age, sex, chest pain, ischaemia on the electrocardiogram, creatinine and rate of change of hs-cTnI were included in the model. Comorbidities (ischaemic heart disease, diabetes, stroke and hyperlipidaemia) did not improve model performance. In the validation cohort, the area under the curve (AUC) for type 1 myocardial infarction using the 99th centile alone was 0.72 (95% CI 0.70–0.74), whereas the AUC for the optimised model was 0.84 (95% CI 0.82–0.85) (p<0.001 by DeLong's test for difference, see Figure). Figure 1 Conclusion The diagnostic performance of the 99th centile for type 1 myocardial infarction is poor, particularly in older populations. A simple model including readily available clinical features improves diagnostic performance and with further external validation could support more individualised treatment decisions. Acknowledgement/Funding British Heart Foundation

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247Safety and efficacy of high-sensitivity cardiac troponin for risk stratification in patients with suspected acute coronary syndrome

European Heart Journal ◽

10.1093/eurheartj/ehz747.0064 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

A Bularga ◽

A Anand ◽

F E Strachan ◽

K K Lee ◽

S Stewart ◽

...

Keyword(s):

Myocardial Infarction ◽

Acute Coronary Syndrome ◽

Risk Stratification ◽

Cardiac Troponin ◽

Cardiac Death ◽

Controlled Trial ◽

High Sensitivity ◽

Composite Outcome ◽

Coronary Syndrome

Abstract Background Guidelines acknowledge the emerging role of high-sensitivity cardiac troponin (hs-cTn) assays for the risk stratification and rapid rule-out of myocardial infarction, but multiple approaches have been described. We previously demonstrated the utility of a single hs-cTnI concentration <5 ng/L at presentation to risk stratify patients with suspected acute coronary syndrome (ACS). Purpose To assess the safety and efficacy of a hs-cTnI concentration <5 ng/L at presentation in consecutive patients included in the High-STEACS (High-SensitivityTroponin in the Evaluation of patients with Acute Coronary Syndrome) randomised controlled trial. Methods The High-STEACS trial was a stepped wedge cluster randomised controlled trial in ten hospitals across Scotland that included 48,282 patients in whom high-sensitivity cardiac troponin was requested by the attending clinician for evaluation of suspected ACS. Patients with ST-segment elevation myocardial infarction (STEMI) were excluded. We evaluated the negative predictive value (NPV) and sensitivity of a presentation hs-cTnI <5 ng/L for a composite outcome of type 1 myocardial infarction, or subsequent type 1 myocardial infarction or cardiac death at 30 days. To assess safety, we report the one-year risk of type 1 myocardial infarction or cardiac death. To assess efficacy, we report the proportion of patients with cardiac troponin <5 ng/L at presentation. Results We included 47,101 consecutive patients in the analysis (mean 61±17 years old, 47% female). Of these patients, 27,500 (58%) had a cardiac troponin <5 ng/L at presentation. Overall, 4,313/47,101 (9%) patients had a composite outcome at 30 days, but the event rate was only 0.4% in those with troponin <5 ng/L (98/27,500). The NPV for the composite outcome in those <5 ng/L was 99.7% (95% confidence intervals [CI] 99.6–99.7) and the sensitivity was 98.0% (95% CI 97.6–98.4). In those without evidence of myocardial injury at presentation (hs-cTnI <99thcentile), type 1 myocardial infarction or cardiac death at one year occurred in 197 (0.7%) patients with cardiac troponin <5 ng/L, compared to 647 (5.5%) of those ≥5 ng/L. The NPV was unchanged across all age groups, although efficacy fell as fewer older patients had hs-cTnI concentrations below the risk stratification threshold (see Figure). Conclusion A hs-cTnI concentration <5 ng/L at presentation identifies the majority of patients with suspected ACS as low-risk of early or late cardiac events. Although the proportion identified as low risk is reduced in older populations, the safety of this risk stratification approach is maintained across patients of all ages. Acknowledgement/Funding British Heart Foundation

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