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 Table of Contents  
LANDMARK TRIALS
Year : 2019  |  Volume : 8  |  Issue : 3  |  Page : 142-152

The challenge of optimal evaluation of low and intermediate pretest probability stable chest pain: Insights from recent randomized clinical trials


1 Department of Cardiology, Medanta - Mediclinic, New Delhi, India
2 Division of Clinical and Preventive Cardiology, Medanta Heart Institute, Gurgaon, Haryana, India

Date of Web Publication31-Jul-2019

Correspondence Address:
Dr. Satyanarayana Upadhyayula
Consultant Cardiology, Medanta - Mediclinic, E-18 Defence Colony, New Delhi - 110 024
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JCPC.JCPC_25_19

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  Abstract 


Given the wide knowledge gaps in the evaluation of patients with low and intermediate pretest probability stable chest pain and the ubiquity of noninvasive imaging the below mentioned largest, most comprehensive and timely randomized clinical trials (RCTs), provide valuable insights into risk stratification, diagnosis, management, prognostication, and outcomes. Rapid clinical assessment of patients with low/intermediate-risk stable chest pain can identify high-risk individuals. However, about 33% of patients labeled as noncardiac chest pain die from cardiovascular disease or develop acute coronary syndrome (ACS) during 5 years' follow-up. About 1.5% of patients with ACS are missed even after extensive testing leading to potential medical, legal, and psychological sequelae. As a result, clinicians have a low threshold to admit even low risk patients for prolonged expensive observation and testing leading to unnecessary admissions, false-positive test results, and unnecessary invasive downstream investigations. This scenario gives a clarion call for improving the diagnostic accuracy, risk stratification, and prognostication in low/intermediate-risk stable chest pain patients. The most common clinical scenario most of us come across is a middle-aged patient with new onset/recurrent low/intermediate-risk stable chest pain attending the emergency department (ED). Issues which are head scratching and mindboggling about this scenario is the ability of the clinician to optimally utilize the appropriate tests from the available armamentarium of functional, anatomical and biochemical diagnostic strategies (exercise electrocardiogram, stress echocardiogram, nuclear stress test, computed tomographic coronary angiography, and circulating biomarkers) to arrive at accurate diagnosis for flawless management. One of the main purposes of the article is to avoid underdiagnosis, overdiagnosis, and misdiagnosis in patients with stable chest pain. We have cherry-picked four large recent landmark RCTs to help the clinician to sharpen his clinical skills, maximize diagnostic accuracy, speed up emergent interventions, assist in surgical planning, and optimize medical therapies. Unfortunately, physical examination for determining the cause of low/intermediate-risk stable chest pain is neither sensitive nor specific to identify obstructive coronary artery disease (CAD). The four recent RCTs are as follows: (1) PROspective Multicenter Imaging Study for Evaluation of Chest Pain trial; (2) Scottish COmputed Tomography of the History, Electrocardiogram, Age, Risk factors, and initial Troponin Trial; (3) Impact on Management of the HEART Risk Score in Chest Pain Patients trial; and (4) Randomized Investigation of Chest Pain Diagnostic Strategies, Shared Decision-Making in the ED: Chest Pain Choice trial.

Keywords: Circulating biomarkers, computed tomographic coronary angiography, exercise electrocardiogram, low and intermediate pretest probability stable chest pain, nuclear stress test, stress echocardiogram


How to cite this article:
Upadhyayula S, Kasliwal RR. The challenge of optimal evaluation of low and intermediate pretest probability stable chest pain: Insights from recent randomized clinical trials. J Clin Prev Cardiol 2019;8:142-52

How to cite this URL:
Upadhyayula S, Kasliwal RR. The challenge of optimal evaluation of low and intermediate pretest probability stable chest pain: Insights from recent randomized clinical trials. J Clin Prev Cardiol [serial online] 2019 [cited 2019 Oct 21];8:142-52. Available from: http://www.jcpconline.org/text.asp?2019/8/3/142/263831




  Official Title: Prospective Multicenter Imaging Study for Evaluation of Chest Pain-The Prospective Multicenter Imaging Study for Evaluation of Chest Pain Trial (Nct01174550) Top




Jang JJ, Bhapkar M, Coles A, Vemulapalli S, Fordyce CB, Lee KL, et al. Predictive model for high-risk coronary artery disease. Circ Cardiovasc Imaging 2019;12:e007940.




  Trial Summary Top




Introduction: The PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial investigators consisting of cardiologists, radiologists, anesthesiologists, primary care and urgent care physicians, randomized 10,003 participants in 193 US and Canadian centers for the study. It was an interventional, randomized, parallel assignment, open-label, diagnostic trial with two arms: (1) active comparator: functional diagnostic tests - stress echocardiogram, nuclear stress test, exercise electrocardiogram and (2) active comparator: anatomic diagnostic test-computed tomographic coronary angiography (CTCA).



Background: While 12% of low/intermediate-risk stable chest pain patients are inappropriately discharged, 25% are unnecessarily readmitted. Overall 30% of these patients diagnosed as noncardiac chest pain have a cardiac event within 1–2 years and subsequently die from cardiovascular (CV) disease or have an acute coronary syndrome (ACS) during 5 years. The analysis shows that this subgroup patients benefit from intervention. The objectives, hypothesis, questions, and issues mentioned addressed and answered by the arms and substudies of the PROMISE trial include the following:



Objectives: The objective of the study is to determine whether an initial noninvasive anatomic imaging strategy with CTCA will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease (CAD) relative to an initial functional testing (FT) strategy (usual care).



  1. To compare core laboratory interpretation (CLI) versus local site laboratory interpretation (SLI) for significant CAD and major adverse CV events (MACE)
  2. To compare and contrast the economics of anatomical versus functional diagnostic testing for obstructive CAD in patients with stable chest pain.


Hypotheses:



  1. Absolute concentration of high-sensitivity troponin I (hsTnI) may relate to the degree and extent of obstructive CAD
  2. Absolute hsTnI concentrations may be useful to triage downstream testing based on risk as opposed to the degree and extent of obstructive CAD.




Questions:



  1. What is the association between high-risk plaque (HRP) and MACE?
  2. What is the association between HRP and MACE independently of significant stenosis (SS) and CV risk factors?
  3. What is the association between HRP plus SS with MACE?
  4. What is the utility of HRP in risk stratification of patients with stable chest pain?
  5. What is the impact of diabetes mellitus (DM) on the evaluation of low/intermediate-risk stable chest pain in suspected CAD?
  6. What are the potential sociodemographic gaps in preventive medical therapy and healthy lifestyle practices among symptomatic patients with suspected CAD?
  7. What is the role of coronary artery calcium (CAC) by CTCA versus FT in the evaluation of low/intermediate-risk stable chest pain in suspected CAD?
  8. Anatomical versus FT modalities–which is safer?
  9. Prognostication by noninvasive testing; anatomical versus FT modality–which is superior?




Methods: Pragmatic randomized trial of the clinical effectiveness of diagnostic testing strategies for CA) was performed in outpatient settings including acute and primary care and cardiology offices. Qualifying patients presenting with new or worsening symptoms suspicious for clinically significant CAD who require diagnostic testing and have not been previously evaluated were randomized to an initial strategy of either anatomic or FT. The clinical care team was responsible for all decisions regarding additional testing, medications and/or procedures. Within the FT arm, the subject's care team selected the specific test to be performed (exercise electrocardiogram, stress nuclear, or stress echocardiogram) consistent with “usual care” in that practice setting.



Outcomes:



  1. Primary: Composite of death, myocardial infarction (MI), major complications from CV procedures or testing, and unstable angina (UA) hospitalization.
  2. Secondary:


    1. Death, MI, UA, and hospitalization
    2. Composite of death and MI
    3. Composite of major complications from CV procedures and testing (stroke, bleeding, anaphylaxis, and renal failure)
    4. Composite of death, MI, major complications from CV procedures or testing, UA hospitalization, and no CAD
    5. Percentage of invasive cardiac catheterization events without obstructive CAD within 90 days following participant randomization
    6. Assess and compare the total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative
    7. Participant score in quality of life (QOL) as measured by the Duke Activity Status Index
    8. Participant score QOL measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire
    9. Percentage of participants with improvement in QOL as measured by complete resolution of the symptoms that led to initial testing
    10. Cumulative radiation exposure from all CV diagnostic tests and procedures performed within 90 days after randomization.




Conclusion: There are many grey areas between cardiac and noncardiac chest pain clinically. Sometimes, the distinction is easy, sometimes difficult, and some other times almost impossible. About 2% and 12% of patients are discharged from hospital due to a missed diagnosis of CAD, and more than 25% benign noncardiac chest pain, patients are readmitted to the hospital due to over diagnosis of CAD. In patients, with low/intermediate-risk stable chest pain due to obstructive CAD, the results of CTCA can not only guide the judicious usage of invasive angiography, revascularization but also reduces MACE. Further studies are needed to determine if CTCA improves long-term outcomes.




  Clinical Perspective Top




What is already known: Utility of functional, anatomical, and biochemical diagnostic strategies (exercise electrocardiogram, stress echocardiogram, nuclear stress test, CTCA, and circulating biomarkers).



What is not known: There are no guidelines (from large outcome-based randomized trials) for the selection of diagnostic strategies from the available armamentarium for patients with low/intermediate-risk stable chest pain due to obstructive CAD with low and intermediate pretest probability.



Insights from PROMISE Trial:



  1. CTCA, by identifying patients at risk of obstructive CAD, provides better prognostic information than FT [Table 1]
  2. HRP found by CTCA was associated with a future MACE. It may help in risk stratification of patients with obstructive CAD, younger patients, and women [Table 2]
  3. Higher concentrations of hsTnI were associated with increasing presence and severity of coronary atherosclerosis [Table 3]
  4. The CLI classified 41% fewer patients as having significant CAD than the SLI [Table 4]
  5. Computed tomography (CT) angiography and functional diagnostic testing strategies in patients with suspected CAD have similar costs through 3 years of follow-up [Table 5]
  6. Low/intermediate-risk stable chest pain patients with and without DM have similar presentation and pretest likelihood of obstructive CAD [Table 6]
  7. Physicians perceive that patients with DM have a higher pretest likelihood of obstructive CAD [Table 6]
  8. Significant gaps exist in preventive care and lifestyle practices. High-risk patients sometimes had larger gaps. Differences by sex, age, race/ethnicity, socioeconomic status, and geography are modest [Table 7]
  9. In majority of low/intermediate-risk stable chest pain patients, CAC is measurable by CTCA. FT is abnormal in less than half of this patient subgroup. As the sensitivity of CTCA is more than FT and the specificity of FT is more than CTCA the overall discriminatory abilities of both tests were similar [Table 8]
  10. Complications were negligibly rare for both CTCA and FT. CTCA detected more incidental findings. CTCA radiation dose is less than nuclear stress testing and is independent of patient characteristics [Table 9].
Table 1: PROMISE trial: Prognostic value of noninvasive cardiovascular testing in patients with stable chest pain

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Table 2: PROMISE trial: High-risk plaque study - prespecified nested observational cohort study

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Table 3: PROMISE trial: High-sensitivity troponin and obstructive coronary artery disease

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Table 4: PROMISE trial: Site laboratory interpretation versus core laboratory interpretation

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Table 5: PROMISE trial: Economics of anatomical and functional imaging

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Table 6: PROMISE trial: Evaluation of chest pain in patients with and without diabetes mellitus

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Table 7: PROMISE trial: Quantifying potential gaps in preventive medical therapy and healthy lifestyle practices among suspected coronary artery disease patients

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Table 8: PROMISE trial: Prognostic value of coronary artery calcium

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Table 9: PROMISE trial: Safety of computed tomographic coronary angiography and functional testing for stable chest pain

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CTCA is superior to FT strategies in prognostication, risk stratification of stable chest pain patients with low/intermediate pretest probability for obstructive CAD. In addition, CTCA can estimate CAC as well as HRP. DM has a negligible effect on the pretest probability of obstructive CAD.



What is inferable is that the integration of SLI and CLI should improve the sensitivity and specificity of CTCA in the evaluation of stable chest pain with low and intermediate pretest probability for obstructive CAD. This can be achieved through seamless cooperation between the two laboratories by real-time sharing of imaging data. Interestingly, the same may be extrapolated to other functional imaging strategies (exercise electrocardiogram, stress echocardiogram, and nuclear stress test), and similar benefits may be expected.



In a nutshell, every diagnostic strategy has its own pros and cons. The modest exercise electrocardiogram, workhorse stress echocardiogram, erudite nuclear stress test, sophisticated CTCA, and naive circulating biomarkers all have a complementary and respectable role to play in risk stratification, management, and prognostication in stable chest pain with intermediate pretest probability for obstructive CAD. To this repertoire of functional, anatomical, and biochemical strategies, the addition of metabolic strategies in the form of positron-emission tomography (PET), PET with CT completes the ideal diagnostic armamentarium for stable chest pain syndromes with intermediate pretest probability for obstructive CAD.




  Official Title: Role of Multidetector Computed Tomography in the Diagnosis and Management of Patients Attending a Rapid Access Chest Pain Clinic (Nct01149590) Top




Williams MC, Moss AJ, Dweck M, Adamson PD, Alam S, Hunter A, et al. Coronary artery plaque characteristics associated with adverse outcomes in the SCOT-HEART study. J Am Coll Cardiol 2019;73:291-301.




  Trial Summary Top




Introduction: The magical utility of CTCA is that it performs two tests in one session-measure CAC scores and performs coronary angiography (CAG). CAC score is an independent risk factor for obstructive CAD. Even low-CAC scores correlate with the doubling of coronary events. The relative risk associated with CAC scores is greater than that associated with established factors, such as smoking, hypertension, and diabetes mellitus. Interestingly, the relative risk of smoking, hypertension, and DM for obstructive CAD is significantly less than that of CAC score. The presence of CAC can be used as a surrogate marker for atheromatous plaque disease and its progression as a marker for CV event rates. It cannot be used as a surrogate marker for soft plaque, presence of obstructive atheroma, measure of luminal stenosis, or patient's response to medical interventions.



Background: Very often patients with low/intermediate-risk stable chest pain with obstructive CAD are underdiagnosed, misdiagnosed, or overdiagnosed. Rapid access outpatient chest pain clinics are like “one-stop centers” for accurate diagnosis and risk stratification of such patients with stable chest pain. CTCA has a sensitivity of 89% and specificity of 96% for the detection of CAD with obesity, coronary calcification, or arrhythmia, radiation exposure being the limiting factors. Advances in scanning technology are paving way for improved spatial and temporal resolution with lower radiation doses.



Objectives:



  1. Does CAC score and computed tomography coronary angiogram alters the proportion of patients diagnosed with low/intermediate-risk stable chest pain due to obstructive CAD
  2. External validity of PROMISE minimal-risk tool within the context of the Scottish Computed Tomography of the History, Electrocardiogram, Age, Risk factors, and initial Troponin (SCOT-HEART) multicenter randomized controlled trial of patients with low/intermediate-risk stable chest pain due to obstructive CAD.




Hypothesis:



1. High-sensitivity cardiac troponin (cTn) I can improve the estimation of the pretest probability for obstructive CAD in patients with stable chest pain.



Questions:



  1. What are the prognostic implications the ability of CTCA to characterize subtypes of atherosclerotic plaque in patients with low/intermediate-risk stable chest pain due to obstructive CAD?
  2. What are the prognostic implications of adverse coronary plaque characteristics in patients with low/intermediate-risk stable chest pain due to obstructive CAD?
  3. What are the 5-year clinical outcomes of CTCA in the assessment of patients with low/intermediate-risk stable chest pain due to obstructive CAD?
  4. What are the diagnostic and prognostic benefits of CTCA using the 2016 National Institute for Health and Care Excellence (NICE) guidelines for the assessment of low/intermediate-risk stable chest pain due to obstructive CAD?
  5. Standard care versus standard care plus CTCA–which is superior?
  6. Does observer variability influence the assessment of CTCA and the subsequent diagnosis of low/intermediate-risk stable chest pain due to obstructive CAD?
  7. What are the effects of CTCA on the diagnosis, management, and outcome of patients referred to the cardiology clinic with low/intermediate-risk stable chest pain due to obstructive CAD?




Methods: The SCOT-HEART investigators randomized 4138 patients in an Interventional (Computed Tomography Angiography), Parallel Assignment, Open Label, Diagnostic study design. There were several experimental study arms including coronary artery plaque characteristics associated with MACE, CTCA and risk of acute MI (AMI), high-sensitivity troponin I (hsTnI) diagnosis of CAD in patients with stable chest pain, utility of PROMISE minimal-risk tool in the identification of patients with low/intermediate-risk stable chest pain deriving minimal value from CTCA, diagnostic and prognostic benefits of CTCA using NICE guidelines in stable chest pain, symptoms and QOL in low/intermediate-risk stable chest pain patients undergoing CTCA, utility of CTCA to guide management of patients with stable chest pain, interobserver variability in the assessment of CTCA and CAC score in low/intermediate-risk stable chest pain patients) to assess the added value of CTCA in diagnosing and treating patients with low/intermediate-risk stable chest pain due to obstructive CAD. For the study purposes CAD was classified as follows: (a) obstructive CAD: Defined as atherosclerotic plaque encompassing a luminal cross-sectional area of ≥70% in the left anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA); (b) nonobstructive CAD: defined as either atherosclerotic plaque encompassing a luminal cross-sectional area of <70% but >10% in LAD, LCX, RCA; and (c) minimal CAD: defined as significant plaque burden leading to >10% luminal cross-sectional area stenosis.



Inclusion Criteria: Patients between the ages of 18–75 years as well as those attending Rapid Access Chest Pain Clinics were included in the study. Exclusion Criteria: Morbid obesity, patient refusing to undergo CTCA or unable to give informed consent, serum creatinine >200 μmol/L, estimated glomerular filtration rate <30 mL/min, previous recruitment to the trial, allergy to iodinated contrast agent, pregnancy, recent ACS.



Results: The SCOT-HEART multicenter randomized controlled trial is a positive trial. Most of the results may be considered by standing committee members to be embedded into recommendations and guidelines.



Conclusion: In patients with low/intermediate-risk stable chest pain due to obstructive CAD, CTCA assists the diagnosis and leads to major additive value in planning further diagnostics and managing therapies leading to reduction in MACE. Further long-term randomized clinical trials (RCTs) are warranted to prove that these benefits are reflected in the long-term outcomes also.




  Clinical Perspective Top




What is already known: Rapid access chest pain clinics have facilitated the early diagnosis and management of patients with low/intermediate-risk stable chest pain and obstructive CAD. However, CAD continues to be under-diagnosed, misdiagnosed, and over diagnosed leading to patients being undertreated, maltreated, and overtreated, respectively.



What is not known: Implications for the management of low and intermediate pretest probability low/intermediate-risk stable chest pain patients due to outcome-focused systematic implementation of CTCA in the patient care pathway of rapid chest pain clinics.



Insights from SCOT-HEART Trial:



  1. Adverse coronary plaque characteristics and overall calcified plaque burden increase MACE [Table 10]
  2. The PROMISE minimal-risk tool outperforms the CAD Consortium model with regards to prognostic discrimination in patients with suspected stable angina and may assist clinicians in decisions regarding noninvasive testing [Table 11]
  3. High-sensitivity cTn I concentration is an independent predictor of obstructive CAD in patients with stable chest pain [Table 12]
  4. CTCA resulted in a significantly lower MACE (death from coronary heart disease or nonfatal MI) at 5 years than standard care alone, without resulting in a significantly higher rate of coronary angiography or coronary revascularization [Table 13]
  5. Multicenter multidetector CTCA has an excellent agreement in patients under investigation for in patients with low/intermediate-risk stable chest pain due to obstructive CAD [Table 14]
  6. CTCA is associated with a small attenuation of the improvements in symptoms and QOL due to the detection of moderate nonobstructive CAD [Table 15]
  7. NICE-guided patient selection maximizes the benefits of CTCA on diagnostic certainty, the use of invasive coronary angiography and reductions in MACE [Table 16]
  8. CTCA leads to more appropriate use of CAG and alterations in preventive therapies that were associated with a halving of MACE (fatal and nonfatal MI) [Table 17]
  9. CTCA enables not only in the diagnosis but also in planning interventions, investigations, and therapies and in the process reduces MACE [Table 18].
Table 10: Scottish COmputed Tomography-HEART Trial: Coronary artery plaque characteristics associated with major adverse cardiovascular events

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Table 11: Scottish COmputed Tomography- HEART Trial: Utility of PROMISE minimal-risk tool in the identification of patients with stable chest pain deriving minimal value from computed tomographic coronary angiography

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Table 12: Scottish COmputed Tomography - HEART Trial: hsTnI diagnosis of coronary artery disease in patients with suspected angina pectoris

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Table 13: Scottish COmputed Tomography-HEART Trial: Computed tomographic coronary angiography and risk of acute myocardial infarction

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Table 14: Scottish Computed Tomography- HEART Trial: Interobserver variability in the assessment of computed tomographic coronary angiography and coronary artery calcium score in stable chest pain patients

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Table 15: Scottish COmputed Tomography- HEART Trial: Symptoms and quality of life in stable chest pain patients undergoing computed tomographic coronary angiography

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Table 16: Scottish COmputed Tomography-HEART Trial: Diagnostic and prognostic benefits of Computed tomographic coronary angiography using National Institute for Health and Care Excellence guidelines in stable chest pain

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Table 17: Scottish COmputed Tomography -HEART trial: Utility of computed tomographic coronary angiography to guide management of patients with stable chest pain

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Table 18: Scottish COmputed Tomography-HEART trial: Utility of computed tomographic coronary angiography in the diagnosis, management, and outcome of patients with stable chest pains

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The above encouraging results have made way for the launching of a large randomized, clinical, and parallel assignment trial – “CTCA for the Prevention of MI (The SCOT-HEART 2 Trial) (NCT03920176)” – with an estimated enrolment of 6000 participants (Study start date: August 1, 2019; Primary completion date: October 1, 2023; and Study completion date: April 1, 2027).




  Official Title: Cost-Effectiveness Study of the Heart Score in the Management of Patients With Chest Pain Presenting in the Emergency Room (Nct01756846) Top




Poldervaart JM, Reitsma JB, Backus BE, Koffijberg H, Veldkamp RF, Ten Haaf ME, et al. Effect of using the HEART score in patients with chest pain in the emergency department: A Stepped-wedge, cluster randomized trial. Ann Intern Med 2017;166:689-97.




  Trial Summary Top




Objective: The objective is to quantify the impact of the use of the history, electrocardiogram, age, risk factors, and initial troponin risk score on patient outcomes, costs, in patients with chest pain presenting at the emergency room, as well as compare its performance with that of the thrombolysis in MI (TIMI) and Global Registry of Acute Coronary Events (GRACE) Scores.



Background: About 6.3% of patients visiting the emergency department (ED) with a complaint of chest pain. Rapid accurate diagnosis is envisaged. Inability to diagnose and manage ACS optimally can have a negative impact on their prognosis.



Hypothesis: The heart score is a useful tool to stratify patients with chest pain according to their short-term risk for MACE. Primary Endpoint: The occurrence of MACE (i.e., AMI, percutaneous coronary intervention, coronary artery bypass grafting, or death) within 6 weeks after presentation. Secondary Endpoint: QOL, costs of heart score, and cost-effectiveness of heart score as compared to usual care in different patient populations, pre-specified subgroup analyses were performed according to age (below and above 62 years of age), gender (men vs. women), disease (diabetics vs. non-diabetics), and ethnicity (caucasian vs. noncaucasian).



Methods: The HEART impact trial is a randomized, both parallel as well as crossover assignment, stepped wedge, cluster, and diagnostic purpose trial. Hospitals applied “usual care” or the HEART score to patients as per the trial protocol over a period of 14 months. Inclusion Criteria: All patients presenting with chest pain to the cardiac ED older than 18 years. Exclusion Criteria: Children (age <18 years), inability to fill in questionnaires, inability to give consent.



Results: There was no significant difference in the incidence of MACE in subgroup analyses according to age (below and above 62 years of age), gender (men vs. women), disease (diabetics vs. nondiabetics), and ethnicity (caucasian vs. noncaucasian).



Conclusions: The HEART impact trial proves that HEART score is superior to the GRACE and TIMI scores in risk stratification and prognostication. The HEART score stratified patients with and without MACE as well as identified the low-risk patients at more efficiently than the GRACE and TIMI scores at the same level of safety.




  Clinical Perspective Top




Unfortunately, even patients with low and intermediate pretest risk probability for ACS are hospitalized and extensively evaluated with noninvasive stress testing or an invasive coronary angiography. Early recognition of patients at low risk for ACS transmogrifies into diminished patient burden, diagnostic testing, length of stay, frequency of hospitalization, and associated expense.



What is known: The utility of TIMI score, GRACE score, HEART score in risk stratification of patients with low/intermediate-risk stable chest pain with low pretest probability of ACS.



What is not known: It is unclear which of the three risk scoring systems is superior and performs best in identifying patients at “low risk” of ACS, as these patients are candidates for early discharge from the ED.



Insights from HEART impact trial: Head-to-head comparison of the GRACE, HEART, and TIMI score was done in a large prospective cohort of chest pain patients. The HEART score performed best in discriminating between those with and without MACE. The HEART score identified the largest number of patients (40.5%) as low risk without compromising safety. The results justify the routine usage of HEART score in the risk stratification and prognostication of patients with low/intermediate-risk stable chest pain in the ED [Table 19] and [Table 20].
Table 19: HEART impact trial: Comparison of the Global Registry of Acute Coronary Events score, history, ECG, age, risk factors, and troponin score and thrombolysis in myocardial infarction score to predict major adverse cardiovascular events in chest pain patients

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Table 20: HEART impact trial: Effect of use of the history, ECG, age, risk factors, and troponin score on patient outcomes and use of health-care resources

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  Official Title: Shared Decision-Making in the Emergency Department: the Chest Pain Choice Trial (Nct01969240) Top




Hess EP, Hollander JE, Schaffer JT, Kline JA, Torres CA, Diercks DB, et al. Shared decision-making in patients with low-risk chest pain: Prospective randomized pragmatic trial. BMJ 2016;355:i6165.




  Trial Summary Top




Introduction:Chest pain is the second most common reason patients visit EDs. Even very low-risk patients are often admitted for prolonged observation and unnecessary advanced cardiac testing.



Hypothesis: The use of the decision aid will significantly increase patient knowledge, engagement, and satisfaction, and decrease the rate of testing that may have marginal benefit in the low-risk population with no increase in MACE.



Background: Decision-making, the patient education regarding their 45-day risk for ACS and management options, has the potential to safely decrease health-care utilization.



Objective: The objective is to test the effectiveness of the Chest Pain Choice (CPC) decision aid on health-care utilization within 30 days after enrolment to safely improve validate patient-centered outcome measures as well as promote evidence-based patient-centered evaluation in a pragmatic, parallel, and RCT.



Methods: CPC trial investigators randomized 898 patients in an interventional, parallel assignment, double-masked study. The clinician reviewed the decision aid, educated the patient regarding their individual risk for a heart attack or preheart attack as well as provided the patient with management options consistent with both the patient's values and preferences. Inclusion Criteria: Patients more than 18 years of age with chest pain were admitted to ED for cardiac testing. Exclusion criteria: Ischemic changes on the electrocardiogram, elevated cTn, potential ACS, cocaine use within the previous 72 h, pregnancy, patients undergoing medical clearance in a detox center, involuntary court or magistrate order, homelessness, out-of-town residence, patients in police custody, incarcerated individuals, major communication barriers that would compromise their ability to give written informed consent. Primary outcome: Test if CPC safely improves patient knowledge. Secondary outcome: Test if the decision aid has an effect on health care, safely improves patient engagement.



Results: Adverse coronary plaque characteristics, increased calcified plaque burden, and high-sensitivity cTn I concentration are independent predictors of obstructive CAD and lead to increased MACE. CTCA plus standard care resulted in lower MACE at 5 years than standard care alone without significant change in the number of CAG/coronary revascularization in the group.



Conclusion: Decision aid increases patient knowledge about their risk and safely decreases the rate of admissions. Patients can be engaged in optimally shared decision-making in a way that is acceptable to patients, clinicians, and policymakers [Table 20].




  Clinical Perspective Top




Shared decision-making, educating patients regarding their 45-day risk for ACS and management options, might safely decrease unnecessary health-care utilization.



What is known:



a. Utility of decision aid in health-care utilization.



What is not known:



  1. Effectiveness, safety, and acceptability of a shared decision-making approach to communicate risk to patients and engage them in decisions about testing and follow-up
  2. Decision aid versus usual care in further outpatient evaluation and management of patients with possible ACS
  3. Effectiveness of a decision aid on patient-centered outcomes and safety in low-risk chest pain patients from diverse geographic and ethnic backgrounds.




Insights from the CPC trial:



  1. Decision aid increases patient knowledge about their risk [Table 21]
  2. Decision aid increases patient involvement and safely decreases the rate of admissions [Table 21]
  3. Patients can be engaged in optimally shared decision-making in a way that is acceptable to patients, clinicians, and policymakers [Table 21].
Table 21: Chest pain choice trial: Effectiveness of shared decision-making in patients with low-risk chest pain

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Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.





 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12], [Table 13], [Table 14], [Table 15], [Table 16], [Table 17], [Table 18], [Table 19], [Table 20], [Table 21]



 

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