Diagnostic Strategies for the Evaluation of Chest Pain: Clinical Implications From SCOT-HEART and PROMISE.
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ABSTRACT:
SUBMITTER: Fordyce CB
PROVIDER: S-EPMC4771619 | biostudies-literature | 2016 Feb
REPOSITORIES: biostudies-literature
Publications
Diagnostic Strategies for the Evaluation of Chest Pain: Clinical Implications From SCOT-HEART and PROMISE.
Fordyce Christopher B CB Newby David E DE Douglas Pamela S PS
Journal of the American College of Cardiology 20160201 7
SCOT-HEART (Scottish COmputed Tomography of the HEART) and PROMISE (PROspective Multicenter Imaging Study for Evaluation of chest pain) represent the 2 largest and most comprehensive cardiovascular imaging outcome trials in patients with stable chest pain and provide significant insights into patient diagnosis, management, and outcomes. These trials are particularly timely, given the well-recognized knowledge gaps and widespread use of noninvasive imaging. The overall goal of this review is to d ...[more]
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Project description:BACKGROUND:The impact of diabetes mellitus on the clinical presentation and noninvasive test (NIT) results among stable outpatients presenting with symptoms suggestive of coronary artery disease (CAD) has not been well described. METHODS AND RESULTS:The PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) trial enrolled 10 003 patients with known diabetic status, of whom 8966 were tested as randomized and had interpretable NIT results (1908 with diabetes mellitus, 21%). Differences in symptoms and NIT results were evaluated using logistic regression. Patients with diabetes mellitus (versus without) were similar in age (median 61 versus 60 years) and sex (female 54% versus 52%), had a greater burden of cardiovascular comorbidities, and had a similar likelihood of nonchest pain symptoms (29% versus 27%). The Diamond-Forrester/Coronary Artery Surgery Study score predicted that patients with diabetes mellitus (versus without) had similar likelihood of obstructive CAD (low 1.8% versus 2.7%; intermediate 92.3% versus 92.6%; high 5.9% versus 4.7%). Physicians estimated patients with diabetes mellitus to have a higher likelihood of obstructive CAD (low to very low: 28.3% versus 40.1%; intermediate 63.9% versus 55.9%; high to very high 7.8% versus 4.0%). Patients with diabetes mellitus (versus without) were more likely to have a positive NIT result (15% versus 11%; adjusted odds ratio, 1.23; P=0.01). CONCLUSIONS:Stable chest pain patients with and without diabetes mellitus have similar presentation and pretest likelihood of obstructive CAD; however, physicians perceive that patients with diabetes mellitus have a higher pretest likelihood of obstructive CAD, an assessment supported by increased risk of a positive NIT. Further evaluation of diabetes mellitus's influence on CAD assessment is required. CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01174550.
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Project description:PurposeTo determine lifetime cost-effectiveness of diagnostic evaluation strategies for individuals with stable chest pain and suspected coronary artery disease (CAD).MethodsExercise treadmill testing (ETT), stress echocardiography (SE), myocardial perfusion scintigraphy (MPS), coronary computed tomographic angiography (CCTA), and invasive coronary angiography (ICA) were assessed alone, or in succession to each other.ResultsInitial ETT followed by imaging wherein ETT was equivocal or unable to be performed appeared more cost-effective than any strategy employing initial testing by imaging.ConclusionAs pre-test likelihood of CAD varies, different modalities including SE, CCTA, and MPS result in improved costs and enhanced effectiveness.
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Project description:BackgroundSuspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients.MethodsThe PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina.ResultsMore than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites.ConclusionMultispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed.
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Project description:BackgroundOptimal management of patients with stable chest pain relies on the prognostic information provided by noninvasive cardiovascular testing, but there are limited data from randomized trials comparing anatomic with functional testing.MethodsIn the PROMISE trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain), patients with stable chest pain and intermediate pretest probability for obstructive coronary artery disease (CAD) were randomly assigned to functional testing (exercise electrocardiography, nuclear stress, or stress echocardiography) or coronary computed tomography angiography (CTA). Site-based diagnostic test reports were classified as normal or mildly, moderately, or severely abnormal. The primary end point was death, myocardial infarction, or unstable angina hospitalizations over a median follow-up of 26.1 months.ResultsBoth the prevalence of normal test results and incidence rate of events in these patients were significantly lower among 4500 patients randomly assigned to CTA in comparison with 4602 patients randomly assigned to functional testing (33.4% versus 78.0%, and 0.9% versus 2.1%, respectively; both P<0.001). In CTA, 54.0% of events (n=74/137) occurred in patients with nonobstructive CAD (1%-69% stenosis). Prevalence of obstructive CAD and myocardial ischemia was low (11.9% versus 12.7%, respectively), with both findings having similar prognostic value (hazard ratio, 3.74; 95% confidence interval [CI], 2.60-5.39; and 3.47; 95% CI, 2.42-4.99). When test findings were stratified as mildly, moderately, or severely abnormal, hazard ratios for events in comparison with normal tests increased proportionally for CTA (2.94, 7.67, 10.13; all P<0.001) but not for corresponding functional testing categories (0.94 [P=0.87], 2.65 [P=0.001], 3.88 [P<0.001]). The discriminatory ability of CTA in predicting events was significantly better than functional testing (c-index, 0.72; 95% CI, 0.68-0.76 versus 0.64; 95% CI, 0.59-0.69; P=0.04). If 2714 patients with at least an intermediate Framingham Risk Score (>10%) who had a normal functional test were reclassified as being mildly abnormal, the discriminatory capacity improved to 0.69 (95% CI, 0.64-0.74).ConclusionsCoronary CTA, by identifying patients at risk because of nonobstructive CAD, provides better prognostic information than functional testing in contemporary patients who have stable chest pain with a low burden of obstructive CAD, myocardial ischemia, and events.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01174550.
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Project description:Study objectiveThe HEART score is a risk stratification aid that may safely reduce chest pain admissions for emergency department patients. However, differences in interpretation of subjective components potentially alters the performance of the score. We compared agreement between HEART scores determined during clinical practice with research-generated scores and estimated their accuracy in predicting 30-day major adverse cardiac events.MethodsWe prospectively enrolled adult ED patients with symptoms concerning for acute coronary syndrome at a single tertiary center. ED clinicians submitted their clinical HEART scores during the patient encounter. Researchers then independently interviewed patients to generate a research HEART score. Patients were followed by phone and chart review for major adverse cardiac events. Weighted kappa; unweighted Cohen's kappa; prevalence-adjusted, bias-adjusted kappa (PABAK); and test probabilities were calculated.ResultsFrom November 2016 to June 2019, 336 patients were enrolled, 261 (77.7%) were admitted, and 30 (8.9%) had major adverse cardiac events. Dichotomized HEART score agreement was 78% (kappa 0.48, 95% confidence interval [CI] 0.37 to 0.58; PABAK 0.57, 95% CI 0.48 to 0.65) with the lowest agreement in the history (72%; WK 0.14, 95% CI 0.06 to 0.22) and electrocardiogram (85%; WK 0.4, 95% CI 0.3 to 0.49) components. Compared with researchers, clinicians had 100% sensitivity (95% CI 88.4% to 100%) (versus 86.7%, 95% CI 69.3% to 96.2%) and 27.8% specificity (95% CI 22.8% to 33.2%) (versus 34.6%, 95% CI 29.3% to 40.3%) for major adverse cardiac events. Four participants with low research HEART scores had major adverse cardiac events.ConclusionED clinicians had only moderate agreement with research HEART scores. Combined with uncertainties regarding accuracy in predicting major adverse cardiac events, we urge caution in the widespread use of the HEART score as the sole determinant of ED disposition.
| S-EPMC8324528 | biostudies-literature
Project description:ObjectivesThis study sought to compare the performance of major guidelines for the assessment of stable chest pain including risk-based (American College of Cardiology/American Heart Association and European Society of Cardiology) and symptom-focused (National Institute for Health and Care Excellence) strategies.BackgroundAlthough noninvasive testing is not recommended in low-risk individuals with stable chest pain, guidelines recommend differing approaches to defining low-risk patients.MethodsPatient-level data were obtained from the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) and SCOT-HEART (Scottish Computed Tomography of the Heart) trials. Pre-test probability was determined and patients dichotomized into low-risk and intermediate-high-risk groups according to each guideline's definitions. The primary endpoint was obstructive coronary artery disease on coronary computed tomography angiography. Secondary endpoints were coronary revascularization at 90 days and cardiovascular death or nonfatal myocardial infarction up to 3 years.ResultsIn total, 13,773 patients were included of whom 6,160 had coronary computed tomography angiography. The proportions of patients identified as low risk by the American College of Cardiology/American Heart Association, European Society of Cardiology, and National Institute for Health and Care Excellence guidelines, respectively, were 2.5%, 2.5%, and 10.0% within PROMISE, and 14.0%, 19.8%, and 38.4% within SCOT-HEART. All guidelines identified lower rates of obstructive coronary artery disease in low- versus intermediate-high-risk patients with a negative predictive value of ≥0.90. Compared with low-risk groups, all intermediate-high-risk groups had greater risks of coronary revascularization (odds ratio [OR]: 2.2 to 24.1) and clinical outcomes (OR: 1.84 to 5.8).ConclusionsCompared with risk-based guidelines, symptom-focused assessment identifies a larger group of low-risk chest pain patients potentially deriving limited benefit from noninvasive testing. (Scottish Computed Tomography of the Heart Trial [SCOT-HEART]; NCT01149590; Prospective Multicenter Imaging Study for Evaluation of Chest Pain [PROMISE]; NCT01174550).
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