DIAGNOSTICS ASSESSMENT PROGRAMME

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1 DIAGNOSTICS ASSESSMENT PROGRAMME Evidence overview Early rule out or diagnosis of acute myocardial infarction: High-sensitivity troponin tests (Elecsys troponin T high-sensitive, ARCHITECT STAT highsensitivity troponin I and AccuTnI+3 assays) This overview summarises the key issues for the Diagnostics Advisory Committee s consideration. It includes a brief description of the topic, a description of the analytical structure and model, a discussion of the analytical difficulties, and a brief summary of the results. It is not a complete summary of the diagnostics assessment report, and it is assumed that the reader is familiar with that document. This overview contains sections from the original scope and the diagnostics assessment report, as well as referring to specific sections of these documents. 1 Background 1.1 Introduction The topic, 'Cardiac biomarkers to aid the diagnosis of acute myocardial ' was selected by the Medical Technologies Advisory Committee (MTAC) for the Diagnostics Assessment Programme to develop recommendations on the use of cardiac biomarkers in the NHS. During scoping, the cardiac biomarker, troponin (ctn), was identified as the marker that is currently most relevant for use in the NHS, and the use of high-sensitivity cardiac troponin (hs-ctn) tests was identified as being of particular interest. These tests were therefore defined as the technologies that Issue date: April 2014 Page 1 of 58

2 would be included in this assessment. Details of the CE marked hs-ctn tests identified during the scoping phase and included in the assessment are provided in section 2. The hs-ctn tests included in this scope were identified after consultation with stakeholders at the scoping workshop, and in addition, through information on test characteristics supplied by manufacturers and advice from clinical experts. For the purposes of this assessment, a hs-ctn test was defined as a test with a coefficient of variation (CV) of 10% or less at the 99th percentile upper limit of the reference population, and which is able to detect ctn in at least 50% of the reference population (see section 2 for further details). NICE is aware that there is currently a wide range of contemporary-sensitive troponin tests available to the NHS, with similar test characteristics to hs-ctn, but which fall outside the criteria applied for defining high-sensitivity in this assessment. The purpose of this assessment is to evaluate the clinical and cost effectiveness of using the Elecsys troponin T high-sensitive, ARCHITECT STAT high-sensitivity troponin I and the AccuTnI+3 assays for early rule out or diagnosis of acute myocardial infarction (without ST-segment elevation). In this assessment, the timing of testing will be within 4 hours of people presenting to an emergency department with acute chest pain. Provisional recommendations on the use of these technologies in the NHS will be formulated by the Diagnostics Advisory Committee at the Committee meeting on 15 April The Conditions Acute myocardial infarction Acute myocardial infarction (AMI) is part of a group of conditions collectively known as acute coronary syndrome (ACS), which includes both ST-segmentelevation myocardial infarction (STEMI) and non-st-segment-elevation myocardial infarction (NSTEMI) AMIs, and unstable angina. These conditions are associated with common symptoms but have different underlying Issue date: April 2014 Page 2 of 58

3 pathologies. Of the two types of AMI, STEMI is usually associated with a relatively large amount of damage to the myocardium (heart muscle) caused by a major blockage in the coronary artery, and can be detected with STelevation on electrocardiogram (ECG). By comparison, NSTEMI is associated with relatively less damage to myocardium caused by partial blockage of the coronary artery, and does not produce ST-elevation on ECG. Further details on these conditions can be found in the glossary. Acute coronary syndromes arise from an obstruction in the coronary arteries, usually caused by atherosclerosis and build-up of plaque. When blood flow to the heart is reduced or blocked for a significant length of time (around minutes) damage to cardiomyocytes (heart muscle cells) occurs, a pathological change which distinguishes an AMI from unstable angina. Patients with ACS generally present with chest pain, a symptom which is responsible for around 700,000 emergency department attendances per year in England and Wales (Goodacre et al, 2013) and 253,765 emergency admissions per year (Hospital Episode Statistics, 2011). During 2011/12, the Myocardial Ischaemia National Audit Project (MINAP) reported 79,433 admissions with AMI recorded in England and Wales, 32,439 (41%) of which were categorised as STEMI, and 46,994 (59%) were categorised as NSTEMI (MINAP, 2012). The incidence of acute myocardial infarction increases with age, with the average age of first STEMI being 65 years, and of first NSTEMI 70 years (MINAP, 2012). The incidence is also greater amongst men, with men being twice as likely to have an AMI as women (MINAP, 2012). 1.3 Patient issues and preferences Patients may prefer to receive an earlier diagnosis or rule out of NSTEMI, thereby reducing their length of stay in the emergency department and the anxiety associated with waiting for a diagnosis. The anxiety associated with waiting for a diagnosis may be of particular concern for patients as chest pain is widely associated with AMI and, as such, chest pain may be perceived to Issue date: April 2014 Page 3 of 58

4 be a symptom associated with serious consequences. The RATPAC study reported that patients who received the results of point-of care cardiac biomarker testing after 90 minutes were more likely to rate their care as excellent or very good, while patients who received usual care comprising standard laboratory ctn tests over a longer period of time were more likely to rate their care as good, fair or poor (Goodacre et al, 2011). 1.4 Diagnostic and care pathways Diagnosis People with an ACS often present with acute chest pain and other symptoms such as nausea, vomiting, dyspnoea, sweating and dyspepsia (Goodacre et al, 2011). These symptoms, including acute chest pain, are common to many other conditions such as anxiety, gastro-oesophageal reflux disease and muscle strain. The assessment of patients with a suspected ACS is described in NICE clinical guideline 95 (2010) Chest pain of recent onset: Assessment and diagnosis of recent onset chest pain or discomfort of suspected cardiac origin. Initial assessment comprises: Taking a resting 12-lead ECG along with a clinical history, a physical examination and biochemical marker analysis. Patients in whom a regional ST-segment elevation or presumed new left branch bundle block is observed on ECG should be managed according to NICE clinical guideline 167 (2013) The acute management of myocardial infarction with ST-segment elevation. People without persistent ST-elevation changes on ECG, are given a working diagnosis of a suspected non-st-segment- elevation acute coronary syndrome (NSTE-ACS), and require further workup with biochemical marker analysis in order to distinguish NSTEMI from unstable angina, conditions which require different treatment. NICE CG 95 makes the following recommendations on the use of biochemical markers: Issue date: April 2014 Page 4 of 58

5 Take a blood sample for cardiac troponin I (ctni) or cardiac troponin T (ctnt) on initial assessment in hospital. These are the preferred biochemical markers to diagnose AMI. Take a second blood sample for ctni or ctnt measurement hours after the onset of symptoms. Do not use biochemical markers such as natriuretic peptides and high sensitivity C-reactive protein to diagnose an ACS. Do not use biochemical markers of myocardial ischaemia (such as ischaemia modified albumin) as opposed to markers of necrosis when assessing people with acute chest pain. Take into account the clinical presentation, from the time of onset of symptoms and the resting 12-lead ECG findings when interpreting troponin measurements. Guidelines from the European Society of Cardiology on the management of people with a suspected NSTE-ACS acknowledge the use of high-sensitivity troponin assays and make recommendations on the use of a fast track rule out protocol. The guidelines state that hs-ctn assays have a negative predictive value (NPV) of greater 95% for AMI on admission; including a second sample of hs-ctn at 3 hours can increase this to 100% (Hamm et al, 2011). It is recommended that a diagnosis of NSTEMI should be made using the universal definition of myocardial infarction. The third universal definition of myocardial infarction (Thygesen et al, 2012b) defines AMI as The detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin) with at least one value above the 99th percentile upper reference limit and with at least one of the following: symptoms of ischaemia, new or presumed new significant ST-segment-T wave changes or new left branch bundle block, development of pathological Q waves in the ECG, imaging evidence of new loss of viable myocardium or new regional wall motion abnormality, or identification of an intracoronary thrombus by angiography or autopsy. Issue date: April 2014 Page 5 of 58

6 Management/treatment The management of patients with a suspected NSTEMI or unstable angina (NSTE-ACS) is described in NICE clinical guideline (CG 94) Unstable angina and NSTEMI: The early management of unstable angina and non-st-segment-elevation myocardial infarction. Initial treatment includes a combination of antiplatelet (aspirin, clopidogrel and glycoprotein IIb/IIIa inhibitors) and antithrombin therapy, taking into account contraindications, risk factors and the likelihood of percutaneous coronary intervention. People with a suspected NSTE-ACS are often transferred out of the emergency department into a range of clinical areas depending on the likelihood of complications and adverse outcomes. Established risk scores, such as the GRACE score or the TIMI risk score, that predict 6 month mortality can be used in combination with ECG findings and initial cardiac biomarker analysis to stratify patients with a suspected NSTE-ACS (Collinson et al, 2013). The care settings available vary between hospitals, but are likely to include coronary care, acute medical, chest pain and clinical decision units. People in whom an elevated ctn level is not observed may be discharged for further follow up according to clinical judgement and, in some cases, the results of ischaemia testing (SIGN 93, 2013). It is recommended that people who receive a diagnosis of NSTEMI, and who are assessed as being at low risk of future complications, receive conservative treatment with aspirin and/or clopidogrel, or aspirin in combination with ticagrelor. Ischaemia testing is also recommended to identify those who may need further intervention. In addition, people at a higher risk of future complications may also receive coronary angiography (within 96 hours of admission) with subsequent coronary revascularisation by percutaneous coronary intervention or coronary artery bypass grafting where indicated (NICE CG 94). Issue date: April 2014 Page 6 of 58

7 Longer term follow-up of people who have had an acute myocardial infarction (including both STEMI and NSTEMI) is described in full in NICE Clinical Guideline 172 (NICE CG 172) Secondary prevention in primary and secondary care for patients following a myocardial infarction. This includes recommendations on lifestyle changes, cardiac rehabilitation programmes, drug therapy (including a combination of ACE inhibitors, aspirin, beta-blockers and statins), and further cardiological assessment to determine whether coronary revascularisation is required. 1.5 The population The population covered in this assessment is people presenting to an emergency department with a suspected non-st-segment- elevation acute coronary syndrome (NSTE-ACS). 2 The technologies Cardiac troponin I (ctni) and cardiac troponin T (ctnt) are biological markers of cardiomyocyte necrosis, and together with cardiac troponin C, form the troponin-tropomyosin complex which is responsible for regulating cardiac muscle contraction. Both ctni and ctnt are specific to cardiac muscle and are released into the circulation when myocardial damage has occurred. ctni and ctnt are the recommended biomarkers for diagnosing myocardial infarction (NICE CG 95), where a rise and fall in troponin levels can signify that myocardial damage has occurred. The optimum sensitivity of standard ctn assays for AMI occurs during a period of hours after the onset of symptoms and for many people, this limitation results in the need for hospital admission and observation whilst serial troponin testing is carried out. In an attempt to overcome this limitation hs-ctn assays have been developed. These are able to detect lower levels of troponin in the blood. Use of these high-sensitivity assays enable the earlier detection of changes in ctn levels, and may permit NSTEMI to be ruled out within 4 hours, if test results are available within 3 hours of presentation to the emergency department. The Issue date: April 2014 Page 7 of 58

8 increased sensitivity of these assays could translate into a reduced length of stay for people without elevated levels of ctn, and earlier intervention for those with a confirmed NSTEMI. As with older ctn assays, the hs-ctn assays are intended to be used in conjunction with clinical history taking and ECG monitoring to diagnose NSTEMI as, despite being highly specific to cardiomyocyte necrosis, ctn may also be elevated in people who have conditions which may have direct or indirect effects on the heart muscle. Conditions which may cause troponin levels to be elevated include myocarditis, congestive heart failure, severe infections, and renal disease. European guidelines recommend that in order to be classified as highsensitivity, ctn assays should have a coefficient of variation (CV) of 10% or less at the 99th percentile upper limit of the reference population, and in addition it is suggested that they should be able to detect ctn in at least 50% of disease free individuals (Thygesen et al, 2012a). Apple and Collinson (2012) discuss the characteristics of hs-ctn tests further, and state that assays should be able to detect ctn in 50% of the reference population, at a concentration value that is above the assay s limit of detection. The analytical characteristics of high-sensitivity assays increase their ability to detect changes in ctn levels at an earlier time point than older ctn assays, leading to increased early sensitivity for the detection of AMI. Although there is no universal consensus on the composition of a reference population, and populations vary between assay validation studies (Apple et al, 2012), in the context of NSTE-ACS the term reference population refers to a healthy population who would not be expected to have elevated ctn levels. 2.1 Elecsys troponin T high-sensitive assay The Elecsys troponin T high-sensitive assay (Roche Diagnostics) is designed for use in a laboratory setting and can be used on the Roche Elecsys 2010 analyser and the cobas Modular Analytics e series immunoassay analysers. The Elecsys test is a sandwich electrochemiluminescence immunoassay (ECLIA), and is intended for the in vitro quantitative determination of ctnt in Issue date: April 2014 Page 8 of 58

9 serum and plasma samples. The Elecsys troponin T high-sensitive assay has an estimated turnaround time of 18 minutes. The manufacturer states that the Elecsys assay can detect ctnt in 61% of the reference population and has a recommended 99th percentile cut off of 14ng/L with a CV of less than 10%. The assay is CE marked and available to the NHS. The Elecsys troponin T high sensitive assay is also available as a STAT version, which has a shorter turnaround time of 9 minutes. 2.2 AccuTnI+3 troponin I assay The AccuTnI+3 troponin I assay (Beckman Coulter) is designed for use in a laboratory setting with the Beckman Coulter Access II and UniCel DxI analysers. The AccuTnI+3 assay is a paramagnetic particle chemiluminescent immunoassay, and is intended for the in vitro quantitative determination of ctni in serum and plasma samples. The assay is designed to be run as a STAT test and results are available within 13 minutes. The manufacturer states that the AccuTnI+3 troponin I assay has a recommended 99th percentile cut-off of 40ng/L with a CV of 10%; when used with the Access II analyser the assay can detect ctni in *** of the reference population, and in *** when used with the UniCel DxI analyser. The assay is CE marked and available to the NHS. 2.3 ARCHITECT STAT high-sensitivity troponin I assay The ARCHITECT STAT high-sensitivity troponin I assay (Abbott Diagnostics) is designed for use in a laboratory setting and can be used with the Abbott ARCHITECT i2000sr and i1000sr analysers. The assay is a chemiluminescent microparticle immunoassay (CMIA) and is intended for the in vitro quantitative determination of ctni in serum and plasma samples. Results are available within 16 minutes. The manufacturer states that the ARCHITECT STAT high-sensitivity troponin I assay can detect ctni in 96% of the reference population, and has a recommended 99th percentile cut-off of 26.2ng/L with a CV of 4%. The assay is CE marked and available to the NHS. Issue date: April 2014 Page 9 of 58

10 2.4 The comparator The comparator used in this assessment is standard ctn testing over hours. 3 The evidence This section summarises data from the diagnostics assessment report compiled by the External Assessment Group (EAG). 3.1 Clinical Effectiveness The External Assessment Group conducted a systematic review of the evidence on the clinical effectiveness of hs-ctn for the early rule out or diagnosis of acute myocardial infarction within 4 hours of people presenting with acute chest pain at an emergency department. Details of the systematic review can be found starting on page 27 of the diagnostics assessment report (DAR). Studies were considered for inclusion based on criteria developed for each of the clinical effectiveness questions defined in the review protocol (see Table 1). Issue date: April 2014 Page 10 of 58

11 Table 1 Inclusion criteria Question Participants: Setting: Interventions (index test): What is the accuracy of hs-ctn assays (used singly or in series, such that results are available within 3 hours of presentation) for the diagnosis of AMI in adults with acute chest pain? What is the effectiveness of hs-ctn assays (used singly or in series) compared with conventional diagnostic assessment, for achieving successful early discharge of adults with acute chest pain within 4 hours of presentation? Adults ( 18 yrs) presenting with acute pain, discomfort or pressure in the chest, epigastrium, neck, jaw, or upper limb without an apparent noncardiac source (Anderson et al, 2007) due to a suspected, but not proven, AMI Secondary or tertiary care Any hs-ctnt or hs-ctni test *, listed as an intervention, hs-ctn assays (used singly or in series **, such that results were available within 3 hours of presentation) Comparators: Any other hs-ctn test, as specified above, or no comparator Troponin T or I measurement on presentation and hours after the onset of symptoms Reference standard: Outcomes$$: Universal definition of AMI, including measurement of troponin T or I (using any method not defined as a hs-ctn test) on presentation and hours after the onset of symptoms in 80% of the population $ or occurrence of MACE (any definition used in identified studies) during 30 day follow-up Test accuracy (the numbers of true positive, false negative, false positive and true negative test results) Not applicable Early discharge ( 4 hrs after initial presentation) without MACE during follow-up, incidence of MACE during follow-up, re-attendance at or re-admission to hospital during follow-up, time to discharge, patient satisfaction or health-related quality of life (HRQoL) measures Study design: Diagnostic cohort studies Randomised controlled trials (RCTs) (controlled clinical trials (CCTs) will be considered if no RCTs are identified) * A high sensitivity assay is defined as one which has a CV 10% at the 99th percentile value for the healthy reference population, and where the LoD allows measurable concentrations to be attained for at least 50% of healthy individuals ** For serial Tn assays, both data on change in Tn levels and peak Tn values will be considered $ Studies that used only new diagnostic ECG changes or outcome-based MACE (cardiac death, non-fatal AMI, revascularisation, or hospitalisation for myocardial ischemia) alongside a Tn-based reference standard will be included (Goodacre et al, 2013) $$ Any estimates of the relative accuracy/effectiveness of different hs-ctnt or hs-ctni tests, or will be derived from direct, within study comparisons Issue date: April 2014 Page 11 of 58

12 In total, 18 studies, reported in 38 publications were included in the review. 15 studies (reported in 34 publications) reported accuracy data for the Elecsys troponin T high-sensitive assay, 4 studies (reported in 5 publications) reported accuracy data for the ARCHITECT STAT high-sensitivity troponin I assay and 2 studies (reported in 3 publications) reported accuracy data for the AccuTnI+3 troponin I assay. All 18 studies were classed as diagnostic cohort studies; no randomised controlled trials or clinical controlled trials were identified. Of the 18 identified studies, 13 were conducted in Europe (of which 2 were UK based), 4 were conducted in Australia and New Zealand and 1 was conducted in the USA. A summary of the main characteristics of the 18 included studies can be found starting on page 161 of the DAR. Critical appraisal of the identified studies was undertaken using the QUADAS-2 tool. Full details of the critical appraisal can be found starting on page 35 of the DAR, in summary the main potential sources of bias in the included studies related to patient spectrum and patient flow, which were of particular concern in studies which excluded patients presenting out of hours or which ceased recruitment during periods of high work load. There were also concerns regarding applicability of the patient population and reference standard; 7 studies excluded people with STEMI and 1 study reported data separately for people in whom STEMI was excluded. The remaining studies included in this assessment reported data from a mixed population, that is people with either NSTEMI or STEMI (any AMI). Evidence on intermediate outcomes Diagnostic accuracy Full details of the methods and analysis used in the clinical effectiveness review can be found starting on page 31 of the DAR. For meta-analyses including 4 or more studies, the bivariate/hierarchical summary receiver operator characteristic (HSROC) model was used to estimate summary sensitivity and specificity estimates with 95% confidence intervals and prediction regions, and to derive HSROC curves. For meta-analyses involving Issue date: April 2014 Page 12 of 58

13 fewer than 4 studies, separate pooled estimates of sensitivity and specificity were derived using random-effects logistic regression. Analyses were performed separately for each hs-ctn assay, and were stratified according to whether the study reported the prediction of AMI or MACE, timing of the collection of the blood sample for ctn testing, and the threshold used to derive a positive hs-ctn result. Where possible, data were reported for all studies, studies excluding people with STEMI and studies where the target condition was any AMI. The EAG presented the results of their analyses according to whether the studies reported results from samples taken at the time the patient presented to the emergency department (presentation samples), samples taken between 1 and 3 hours after the patient presented to the emergency department (subsequent samples) and diagnostic strategies which involved multiple samples (multiple samples). Diagnostic accuracy of the Elecsys troponin T high-sensitive assay Of the15 diagnostic cohort studies reporting data on the Elecsys troponin T high-sensitive assay, 14 assessed the accuracy of the assay for the detection of AMI. Complete results from the Elecsys troponin T high-sensitive assay analyses can be found in Table 4, starting on page 47 of the DAR. Presentation samples All 14 studies reporting accuracy for the detection of AMI reported data on single samples taken at presentation. Full details of this analysis can be found starting on page 38 of the DAR. Of these 14 studies, 13 reported data on presentation samples using the 99 th percentile as the diagnostic threshold, providing a summary estimate of sensitivity of 89% (95%CI 85-92%) and for specificity of 82% (95%CI 77 86%). The positive likelihood ratio (LR+) was 4.96 (95%CI ) and the negative likelihood ratio (LR-) was 0.14 (95%CI ). When this analysis was restricted to studies which excluded participants with STEMI (6 studies), similar summary estimates were Issue date: April 2014 Page 13 of 58

14 obtained; sensitivity 88% (95%CI 78 93%), specificity 84% (95%CI 74 90%), LR (95%CI ) and LR ( ), see figure 1. Figure 1 Summary ROC curve for the Elecsys troponin T high-sensitive assay presentation samples using the 99 th percentile as the diagnostic threshold in a population with NSTEMI Sensitivity Study estimate Summary point HSROC curve 95% confidence region 95% prediction region Specificity.2 0 The EAG also repeated this analysis restricted to studies with a mixed population, that is any AMI (8 studies), and again similar summary estimates were obtained; sensitivity 89% (95%CI 86% - 91%), specificity 81% (95%CI 76% - 85%), LR (95%CI ) and LR (95%CI ). Summary ROC curves for each of the presentation samples with 99 th percentile diagnostic threshold analyses can be found on pages 39 and 40 of the DAR. As the analysis which excluded patients with STEMI (shown in figure 1) was the most applicable to the population defined in the scope, it was used to inform the cost effectiveness analysis reported in section 3.2. Data on presentation samples using diagnostic thresholds equivalent to the limit of detection (5ng/L) or limit of blank (3ng/L) was reported in 5 studies. 3 studies reported data for the limit of detection, 1 of which was excluded from Issue date: April 2014 Page 14 of 58

15 analyses as the limit of detection data was only reported for people over 70 years of age. The summary estimates for presentation samples at the limit of detection were sensitivity 95% (95%CI 92 97%), specificity 54% (95%CI 51 58%), LR ( ) and LR (95%CI ). 1 study reported this data excluding patients with STEMI; sensitivity 93% (95%CI 89 96%), specificity 58% (95%CI 55 62%), LR (95%CI ) and LR (95%CI ). 3 studies reported data for the limit of blank; summary estimates were sensitivity 98% (95%CI 95-99%), specificity 40% (95%CI 38-43%), LR (95%CI ) and LR (95%CI ). One study reported the limit of blank in a population which excluded people with STEMI and was used to inform the cost effectiveness modelling; sensitivity 95% (95%CI 92 98%), specificity 48% (95%CI 44 51%), LR (95%CI ) and LR (95%CI ). The EAG identified limited data on clinically relevant subgroups, including age >70 years compared with 70 years, no pre-existing coronary artery disease compared with pre-existing coronary artery disease, and high pre-test probability compared with low to moderate pre-test probability. All of the studies that reported subgroup data were in a mixed population, and did not exclude people with STEMI. The results of subgroup analyses suggest that hs-ctnt testing, using the 99 th percentile diagnostic threshold on a sample taken at presentation, could be adequate for rule out of AMI in people aged 70 years or older, people who do not have pre-existing coronary artery disease and people who are classified as having a high pre-test probability of AMI. Full details of these analyses can be found on pages 41 and 42 of the DAR. The EAG noted that the time between onset of chest pain and presentation at the emergency department was inconsistently reported in the included studies. In studies which did report time from chest pain onset, the median time ranged from hours. Two studies, conducted in a mixed population, stratified participants as presenting either before or after 3 hours since the onset of chest pain, and in addition, either before or after 6 hours Issue date: April 2014 Page 15 of 58

16 since the onset of chest pain. The results of this analysis suggested that the Elecsys high-sensitive troponin T assay with the 99 th percentile as the diagnostic threshold on a sample taken at presentation had a higher sensitivity (94% [95%CI 92 96%) and lower specificity (77% [95%CI 75 79%]) for any AMI in people presenting more than 3 hours after the onset of chest pain compared with people presenting within 3 hours; sensitivity 78% (95%CI 71 83%) and specificity 84% (95%CI 81 86%). When the analysis was repeated using 6 hours as the threshold similar results were obtained. Full details of this analysis can be found on pages 42 and 43 of the DAR. Subsequent samples Of the 14 studies reporting accuracy for the detection of AMI, 2 reported data on samples taken 1 to 3 hours after presentation. Both studies used the 99 th percentile as the diagnostic threshold and excluded people with STEMI. Summary estimates were sensitivity 95% (95%CI 92% - 97%), specificity 80% (95%CI 77% - 82%), LR (95%CI ) and LR (95%CI ). Multiple samples Of the 14 studies reporting accuracy for the detection of AMI, 6 reported data on the performance of diagnostic strategies involving multiple samples. The most commonly reported strategies were those involving a combination of a peak hs-ctnt value above the 99 th percentile diagnostic threshold and a 20% change in hs-ctnt over 2 3 hours after presentation; 1 study reported these data in a population which excluded people with STEMI, and consequently was used in the cost effectiveness modelling. The results of this analysis indicates that a test strategy which defines a positive result as a peak value above the 99 th percentile diagnostic threshold and a delta change of greater than 20% over 2 hours provided the optimal rule in performance, with a LR+ of 8.42 (95%CI ), whilst a test strategy which defines a negative result as no value above the 99 th percentile diagnostic threshold and a delta Issue date: April 2014 Page 16 of 58

17 change of less than 20% over 2 hours provided the optimal rule-out performance, with a LR (95%CI ). Combining the results of tests over two hours also creates a third category, in addition to the optimal rule in and rule out categories, which includes people with either a peak value above the 99 th percentile diagnostic threshold or a delta change of greater than 20% who require further investigations to determine whether they are experiencing an AMI. Full details of this analysis can be found on pages 44 to 46 of the DAR. Test pathways used in economic modelling (based on results restricted to a NSTEMI population) The EAG constructed an optimal test pathway for multiple sampling on which the cost-effectiveness modelling (reported in section 3.2) was based. This test pathway was based on the optimal diagnostic accuracy reported in the EAG s clinical effectiveness analysis, and included data only from studies which excluded people with STEMI. For the Elecsys troponin T high-sensitive assay this test pathway comprised a presentation sample with the limit of blank (3ng/L) as the diagnostic threshold, followed by a second sample at 2 hours with the 99 th percentile as the diagnostic threshold, and a combination of peak values plus delta change of more or less than 20%. To construct the test pathway used in the economic modelling the EAG assumed that the diagnostic performance of the second sample taken at 2 hours is the same for people in whom NSTEMI is not ruled out by the presentation sample reported at the limit of blank, as for the initial population presenting to the emergency department. The test pathway is shown in Figure 2. When this test pathway is applied to a hypothetical cohort of 1000 people presenting with a suspected NSTE-ACS with an estimated prevalence of NSTEMI of 17% (based on data from three studies which exclude people with STEMI), the first step of the strategy would discharge 407 (40.7%) people, 9 (0.9%) of whom would have been erroneously discharged. The second stage of the strategy would lead to the Issue date: April 2014 Page 17 of 58

18 discharge of a further 286 (28.6%) people, 5 (0.5%) of whom would have been erroneously discharged. The EAG also applied the hypothetical cohort to the Elecsys troponin T high-sensitive 99 th percentile presentation sample test strategy, and the number of people who would be erroneously discharged is 20 (2%). Issue date: April 2014 Page 18 of 58

19 Figure 2 The Elecsys troponin T high-sensitive assay test pathway used in the economic model Issue date: April 2014 Page 19 of 58

20 Diagnostic accuracy of the ARCHITECT STAT high-sensitivity troponin I assay Of the 4 diagnostic cohort studies reporting data on the ARCHITECT STAT high-sensitivity troponin I assay, 3 assessed the accuracy of the assay for the detection of AMI. All 3 studies were conducted in a mixed population (any AMI), and did not exclude people with STEMI. Presentation samples All 3 studies reporting accuracy for the detection of AMI reported data on single samples taken at presentation. Full details of this analysis can be found on page 51 of the DAR. Summary estimates based on the 99 th percentile as the diagnostic threshold were 80% (95%CI 77% - 83%), specificity 93% (95%CI 92% - 94%), LR (95%CI ) and LR (95%CI ). No studies reported any clinical subgroup data, or information of the timing of the test with regards to the onset of symptoms. One study also reported accuracy based on the limit of detection as the diagnostic threshold; the results were sensitivity 100% (95%CI 98% - 100%), specificity 35% (95%CI 32% - 38%), LR (95%CI ) and LR (95%CI ). Subsequent samples Of the 3 studies reporting accuracy for the detection of AMI, 1 reported data on samples taken 3 hours after presentation. The study reported accuracy based on the 99 th percentile as the diagnostic threshold; the results were sensitivity 98% (95%CI 96% - 99%), specificity 90% (95%CI 88% - 92%), LR (95%CI ), LR ( ). Multiple samples Of the 3 studies reporting accuracy for the detection of AMI, 2 reported data on the performance of diagnostic strategies involving multiple samples. One study reported the accuracy of a sample taken at presentation and at 2-3 Issue date: April 2014 Page 20 of 58

21 hours with a peak hs-ctni value over the 99 th percentile and the second study reported the accuracy of a sample taken on admission with the limit of detection as the threshold and a delta change of 20% at 3 hours; and the accuracy of sample taken on presentation, and at 3 hours, with a delta change of 20%. The results from these studies are shown in Table 2. Table 2 Results of the ARCHITECT STAT high-sensitivity troponin I assay multiple sample analysis Multiple samples Sample at presentation and 2-3 hours; peak value over 99th percentile Sample on admission with LoD and delta change 20% at 3 hours Sample taken on presentation, and at 3 hours with delta change 20% N (studies) Sensitivity (95%CI) 1 91% (81% - 96%) 1 82% (78% - 86%) 1 77% (72% - 82%) Specificity (95%CI) 93% (91% - 95%) 52% (49% - 55%) 26% (23% - 29%) LR+ (95%CI) ( ) 1.73 ( ) 1.04 ( ) LR- (95%CI) 0.09 ( ) 0.34 ( ) 0.87 ( ) Test pathways used in economic modelling (based on mixed population results) The EAG constructed an optimal test pathway for multiple sampling on which the cost-effectiveness modelling (reported in section 3.2) was based. This test pathway was derived from the results of the EAG s clinical effectiveness review, and includes estimates taken from studies reporting diagnostic accuracy in a mixed population, For the ARCHITECT STAT high-sensitivity troponin I assay this test pathway comprised a presentation sample with the limit of detection as the diagnostic threshold, followed by a second sample at 3hours with the 99 th percentile as the diagnostic threshold. To construct the test pathway used in the economic modelling the EAG assumed that the diagnostic performance of the second sample taken at 3 hours is the same for people in whom NSTEMI is not ruled out by the presentation sample reported Issue date: April 2014 Page 21 of 58

22 at the limit of blank, as for the initial population presenting to the emergency department. The test pathway is shown in Figure 3. When this test pathway is applied to a hypothetical cohort of 1,000 people presenting with a suspected NSTE-ACS and an estimated prevalence of NSTEMI of 17%, the first step of the strategy would discharge 291(29.1%) people, none of whom would have been erroneously discharged. The second stage of the strategy would lead to the discharge of a further 489 (48.9%) people, 3 (0.3%) of whom would have been erroneously discharged. This cohort was also applied to the ARCHITECT STAT high-sensitivity troponin I 99 th percentile presentation test strategy and 34 (3.4%) people would be erroneously discharged. Issue date: April 2014 Page 22 of 58

23 Figure 3 The ARCHITECT STAT high-sensitivity troponin I assay test pathway used in the economic model Issue date: April 2014 Page 23 of 58

24 Diagnostic accuracy of the AccuTnI+3 troponin I assay Both of the diagnostic cohort studies reporting data on the AccuTnI+3 assay assessed the accuracy of the assay for the detection of AMI. Both studies were conducted in a mixed population (any AMI), and did not exclude people with STEMI. It should be noted that both studies report the performance of a pre-commercial version of the assay, with test characteristics which differ from those provided by the manufacturer for the AccuTnI+3 assay. Presentation samples Both studies reporting accuracy for the detection of AMI reported data on single samples taken at presentation. Full details of this analysis can be found on page 56 of the DAR. One study reported the diagnostic accuracy of a sample taken on presentation using the 99 th percentile as the diagnostic threshold (note that this was 9 ng/l for the assay used in this study, described as an investigational prototype). The results of the study were sensitivity 92% (95%CI 88% - 95%), specificity 75% (95%CI 72% - 78%), LR (95%CI ) and LR (95%CI ). When the results of this study were combined with the second study, which reported presentation samples at a diagnostic threshold of 18ng/L the summary estimates of accuracy were sensitivity 92% (95%CI 88% - 95%), specificity 75% (95%CI 72% - 77%), LR (95%CI ) and LR (95%CI ). No studies reported any clinical subgroup data, or information of the timing of the test with regards to the onset of symptoms. Subsequent samples None of the studies reporting data on the AccuTnI+3 troponin I assay provided information on subsequent samples. Multiple samples Of the 2 studies reporting accuracy for the detection of AMI, 1 reported data on the diagnostic performance of a >27% change in hs-ctni from presentation Issue date: April 2014 Page 24 of 58

25 to 1 hour. The results were sensitivity 63% (95%CI 53% - 71%), specificity 66% (95%CI 63% - 69%), LR (95%CI ) and LR (95%CI ). Test pathway used in economic modelling (based on mixed population results) The EAG constructed a test pathway on which the cost-effectiveness modelling (reported in section 3.2) was based. For the AccuTnI+3 troponin I assay this test pathway comprised a presentation sample with the 99 th percentile (9 ng/l) as the diagnostic threshold, and is based on a study which did not exclude people with STEMI. When this test pathway is applied to a hypothetical cohort of 1,000 people presenting with a suspected NSTE-ACS and an estimated prevalence of NSTEMI of 17%, the number of people with AMI who would be erroneously discharged on the basis of a negative hs-ctni result is 14 (1.4%). The test pathway for the AccuTnI+3 assay does not include a second sample because of the limited data available on this assay. Comparative accuracy of the high-sensitivity troponin assays Summary estimates from analyses with common time points and cut-off thresholds were tabulated to compare the accuracy of the hs-ctn assays. In addition, 1 study provided a direct comparison of all three assays in the same population. This study reported data on presentation samples using the 99 th percentile as the diagnostic threshold. The results of both the indirect and direct comparisons of test accuracy are shown in Table 3. Data on the AccuTnI+3 assay relates to a pre-commercial version of the assay. Full details of this analysis can be found on page 59 of the DAR. As comparative data are only available from one study, and only for presentation samples reported using the 99 th percentile diagnostic threshold, there is uncertainty as to how the hs-ctn tests compare at different time points and different diagnostic thresholds. It is also not known how the optimum test strategies compare directly in terms of accuracy. Issue date: April 2014 Page 25 of 58

26 Table 3 Comparative accuracy of the high-sensitivity troponin assays with a 99 th percentile threshold at presentation Assay Indirect comparison Direct comparison AccuTnI+3 hs-ctni ARCHITECT hs-ctni Elecsys hs-ctnt Number of studies Sensitivity (95% CI) 2 92% (88 95%) 3 80% (77 83%) 15 88% (85 91%) Specificity (95% CI) 75% (72 77%) 93% (92 94%) 82% (78 86%) LR+ (95% CI) 3.32 ( ) ( ) 5.02 ( ) LR- (95% CI) 0.11 ( ) 0.21 ( ) 0.14 ( ) Sensitivity (95% CI) 92% (88 98%) 77% (72 82%) 90% (86-92%) Specificity (95% CI) 75% (72 78%) 93% (91 94%) 78% (76 79%) LR+ (95% CI) 3.68 ( ) ( ) 4.02 ( ) LR- (95% CI) 0.11 ( ) 0.25 ( ) 0.13 ( ) Issue date: April 2014 Page 26 of 58

27 Evidence on clinical outcomes Prognostic accuracy of the Elecsys troponin T high-sensitive assay Of the 15 diagnostic cohort studies reporting data on the Elecsys troponin T high-sensitive assay, 1 assessed the accuracy of the assay for the prediction of major cardiac adverse events (MACE) within 30 days of presentation. The final scope for this assessment defined MACE as death, non-fatal AMI, revascularisation or hospitalisation for myocardial ischaemia. The study, which excluded people with STEMI, reported the prognostic accuracy of a presentation sample using the limit of blank (3ng/L) as the threshold. The study reported a sensitivity of 85% (95%CI 74%-92%), specificity 46% (95%CI 41% - 51%), LR (95%CI ) and LR ( ). Prognostic accuracy of the ARCHITECT STAT high-sensitivity troponin I assay Of the 3 diagnostic cohort studies reporting data on the ARCHITECT STAT high-sensitivity troponin I assay, 1 assessed the accuracy of the assay for the prediction of MACE within 30 days of presentation. The study, in a mixed population, reported the prognostic accuracy of a presentation sample using the 99 th percentile as the threshold. The study reported a sensitivity of 88% (95%CI 85% - 91%), specificity 93% (95%CI 91% - 94%), LR (95%CI ) and LR (95%CI ). Prognostic accuracy of the AccuTnI+3 troponin I assay Neither of the 2 diagnostic cohort studies reporting data on the AccuTnI+3 troponin I assay assessed the accuracy of the assay for the prediction of MACE within 30 days of presentation. Evidence on patient reported outcomes None of the identified studies included data on patient reported outcomes. 3.2 Costs and cost effectiveness The EAG conducted a systematic review to identify existing studies investigating the cost effectiveness of diagnostic strategies incorporating hs- Issue date: April 2014 Page 27 of 58

28 ctn testing. The EAG also constructed a de novo economic model designed to assess the cost-effectiveness of the Elecsys troponin T high-sensitive assay, the ARCHITECT STAT high-sensitivity troponin I assay and the AccuTnI+3 troponin I assay, used singly or in series up to 4 hours from the onset of chest pain or presentation to an emergency department. Systematic review of cost effectiveness evidence Studies reporting a full economic analysis relating to the cost effectiveness of either hs-ctn or ctn testing, which included survival or quality adjusted life years (QALYs) as an outcome measure were eligible for inclusion. Critical appraisal of the included studies was conducted using the Drummond checklist. Full details of the systematic review can be found starting on page 60 of the DAR. The systematic review identified 5 studies, reported in 7 publications. Tabulated summaries of the included studies can be found starting on page 69 of the DAR. The included studies evaluated a range of diagnostic strategies for AMI, including the use of both hs-ctn and ctn. The diagnostic strategies included using hs-ctn alone, combining hs-ctn with heart-fatty acid binding protein, panels of cardiac biomarkers and point of care cardiac biomarker panel testing. The timing of tests varied both within and between the included studies. Of the 5 included studies, 3 adopted the perspective of the NHS, 1 adopted the perspective of a publicly funded healthcare system and 1 stated that the perspective was that of a healthcare system. The results of the studies included in the systematic review varied widely, and the EAG concluded that the review demonstrated uncertainty regarding the cost effectiveness of diagnostic strategies incorporating hs-ctn. One of the included studies, conducted in Europe and reported as a conference abstract only, concluded that hs-ctnt is a cost effective option compared to standard ctn testing and reported an ICER of 3,748 euros per QALY. Another study, which investigated a number of diagnostic strategies for AMI and adopted the perspective of the NHS, concluded that the optimal diagnostic strategy in all Issue date: April 2014 Page 28 of 58

29 but one of the scenarios modelled was a single hs-ctn test at presentation, with people receiving a negative result being discharged and those receiving a positive result being admitted for a second ctn test at 10 hours. The remaining three studies, including two taking the perspective of the NHS, reported substantially higher ICERs and greater uncertainty. The EAG noted that the key drivers of cost effectiveness in the included studies were the accuracy of hs-ctn assays, and the efficiency of decision-making once test results were available. It should also be noted that tests defined as hs-ctn in the published economic evaluations may differ from those included in the scope of this assessment because of the definition of high-sensitivity applied to the hs-ctn assays. Economic analysis The EAG developed a de novo economic model designed to assess the cost effectiveness of 5 hs-ctn testing strategies using 3 high-sensitivity assays: the Elecsys troponin T high-sensitive assay, the ARCHITECT STAT highsensitivity troponin I assay and the AccuTnI+3 troponin I assay. The population included in the economic model is people presenting to the emergency department with a suspected NSTE-ACS (with STEMI ruled out), who have no major co-morbidities requiring hospital admission, such as heart failure or arrhythmia. Expected costs, life years and QALYs were calculated for each of the diagnostic strategies included in the model; discount rates of 3.5% and a half-cycle correction were applied for both costs and effects. The following hs-ctn test strategies were included in the model: Single test strategies Elecsys troponin T high-sensitive assay presentation sample with the 99 th percentile as the diagnostic threshold ARCHITECT STAT high-sensitivity troponin I assay presentation sample with the 99 th percentile as the diagnostic threshold Issue date: April 2014 Page 29 of 58

30 AccuTnI+3 troponin I presentation sample with the 99 th percentile (9ng/L) as the diagnostic threshold Multiple test strategies Elecsys troponin T high-sensitive assay optimal test pathway (shown in figure 2) ARCHITECT STAT high-sensitivity troponin I assay optimal test pathway (shown in figure 3) Model structure The model structure is based upon a previous cost-effectiveness model reported in Goodacre et al (2013). The model produced by Goodacre and colleagues was adapted to fit the scope of this assessment. Full details of the model structure can be found on page 77 of the DAR. The model comprised a decision tree (shown in figure 4) to model the short term (30 days) outcomes after presentation and a long term Markov model (shown in figure 5). The decision tree models the results of hs-ctn or ctn testing and the resulting treatment decision, that is hospital admission and AMI treatment or discharge from the emergency department. The outcomes included in the short term model were no ACS or unstable angina (UA), UA, untreated non-fatal AMI, treated non-fatal AMI and death. The long term outcomes, based on a 60 year lifetime time horizon, were estimated using a Markov cohort model with a one year cycle time. The following health states were included in the model: No ACS and no UA, UA, Post AMI (treated and untreated), post AMI with re-infarction and death. People enter the Markov model based on their short term outcome from the decision tree; consequently, in the first cycle, the model makes a distinction between treated and untreated AMI. Issue date: April 2014 Page 30 of 58

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