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Impact of Diabetes Mellitus on the Evaluation of Stable Chest Pain Patients: Insights From the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) Trial.

ABSTRACT: 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.

SUBMITTER: Sharma A

PROVIDER: S-EPMC5721780 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Impact of Diabetes Mellitus on the Evaluation of Stable Chest Pain Patients: Insights From the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) Trial.

Sharma Abhinav A Sekaran Nishant K NK Coles Adrian A Pagidipati Neha J NJ Hoffmann Udo U Mark Daniel B DB Lee Kerry L KL Al-Khalidi Hussein R HR Lu Michael T MT Pellikka Patricia A PA Truong Quynh A QA Douglas Pamela S PS

Journal of the American Heart Association 20171031 11

<h4>Background</h4>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.<h4>Methods and results</h4>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 me ...[more]

PMID: 29089344

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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.

Project description:ImportanceAlthough cardiovascular (CV) disease represents the leading cause of morbidity and mortality that increases with age, the best noninvasive test to identify older patients at risk for CV events remains unknown.ObjectiveTo determine whether the prognostic utility of anatomic vs functional testing varies based on patient age.Design, setting, and participantsPrespecified analysis of the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) study, which used a pragmatic comparative effectiveness design. Participants were enrolled from 193 sites across North America and comprised outpatients without known coronary artery disease (CAD) but with symptoms suggestive of CAD. Data were analyzed between October 2018 and April 2019.InterventionsRandomization to noninvasive testing with coronary computed tomographic angiography or functional testing.Main outcomes and measuresThe composite of CV death/myocardial infarction (MI) over a median follow-up of 25 months.ResultsAmong 10 003 PROMISE patients, we included the 8966 who received the noninvasive test to which they were randomized and had interpretable results; 6378 (71.1%) were younger than 65 years, 2062 (23.0%) were between ages 65 and 74 years, and 526 (5.9%) were 75 years and older. More than half of participants were women (4720 of 8966 [52.6%]). Only a minority of patients were of nonwhite race/ethnicity, a proportion that was lower among the older age groups (1071 of 6378 [16.8%] for <65 years; 258 of 2062 [12.5%] for age 65-74 years; 41 of 526 [7.8%] for ≥75 years). Compared with patients younger than 65 years, older patients were more likely to have a positive test result (age 65-74 years: odds ratio, 1.65; 95% CI, 1.42-1.91; age ≥75 years: odds ratio, 2.32; 95% CI, 1.83-2.95), regardless of noninvasive test completed. A positive functional test result was not associated with CV death/MI in patients younger than 65 years (hazard ratio [HR], 1.09; 95% CI, 0.43-2.82) but it was among older patients (age 65-74 years: HR, 3.18; 95% CI, 1.44-7.01; age ≥75 years: HR, 6.55; 95% CI, 1.46-29.35). Conversely, a positive anatomic test result was associated with CV death/MI among patients younger than 65 years (HR, 3.04; 95% CI, 1.46-6.34) but not among older patients (age, 65-74 years: HR, 0.67; 95% CI, 0.15-2.94; age ≥75 years: HR, 1.07; 95% CI, 0.22-5.34; P for interaction = .01). An elevated coronary artery calcium score was predictive of events in patients younger than 65 years (HR, 2.73; 95% CI, 1.31-5.69) but not for older patients (age 65-74 years: HR, 0.44; 95% CI, 0.14-1.42; age ≥75 years: HR, 1.31; 95% CI, 0.25-6.88).Conclusions and relevanceOlder patients with stable symptoms suggestive of CAD are more likely to have a positive noninvasive test result and more coronary artery calcium. However, only a positive functional test result was associated with risk of CV death/MI. Age-specific approaches to noninvasive evaluation of CAD should be further examined.Trial registrationClinicalTrials.gov identifier: NCT01174550.

Project description:BACKGROUND:Coronary artery calcium (CAC) is an established predictor of future major adverse atherosclerotic cardiovascular events in asymptomatic individuals. However, limited data exist as to how CAC compares with functional testing (FT) in estimating prognosis in symptomatic patients. METHODS:In the PROMISE trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain), patients with stable chest pain (or dyspnea) and intermediate pretest probability for obstructive coronary artery disease were randomized to FT (exercise electrocardiography, nuclear stress, or stress echocardiography) or anatomic testing. We evaluated those who underwent CAC testing as part of the anatomic evaluation (n=4209) and compared that with results of FT (n=4602). We stratified CAC and FT results as normal or mildly, moderately, or severely abnormal (for CAC: 0, 1-99 Agatston score [AS], 100-400 AS, and >400 AS, respectively; for FT: normal, mild=late positive treadmill, moderate=early positive treadmill or single-vessel ischemia, and severe=large ischemic region abnormality). The primary end point was all-cause death, myocardial infarction, or unstable angina hospitalization over a median follow-up of 26.1 months. Cox regression models were used to calculate hazard ratios (HRs) and C statistics to determine predictive and discriminatory values. RESULTS:Overall, the distribution of normal or mildly, moderately, or severely abnormal test results was significantly different between FT and CAC (FT: normal, n=3588 [78.0%]; mild, n=432 [9.4%]; moderate, n=217 [4.7%]; severe, n=365 [7.9%]; CAC: normal, n=1457 [34.6%]; mild, n=1340 [31.8%]; moderate, n=772 [18.3%]; severe, n=640 [15.2%]; P<0.0001). Moderate and severe abnormalities in both arms robustly predicted events (moderate: CAC: HR, 3.14; 95% confidence interval, 1.81-5.44; and FT: HR, 2.65; 95% confidence interval, 1.46-4.83; severe: CAC: HR, 3.56; 95% confidence interval, 1.99-6.36; and FT: HR, 3.88; 95% confidence interval, 2.58-5.85). In the CAC arm, the majority of events (n=112 of 133, 84%) occurred in patients with any positive CAC test (score >0), whereas fewer than half of events occurred in patients with mildly, moderately, or severely abnormal FT (n=57 of 132, 43%; P<0.001). In contrast, any abnormality on FT was significantly more specific for predicting events (78.6% for FT versus 35.2% for CAC; P<0.001). Overall discriminatory ability in predicting the primary end point of mortality, nonfatal myocardial infarction, and unstable angina hospitalization was similar and fair for both CAC and FT (C statistic, 0.67 versus 0.64). Coronary computed tomographic angiography provided significantly better prognostic information compared with FT and CAC testing (C index, 0.72). CONCLUSIONS:Among stable outpatients presenting with suspected coronary artery disease, most patients experiencing clinical events have measurable CAC at baseline, and fewer than half have any abnormalities on FT. However, an abnormal FT was more specific for cardiovascular events, leading to overall similarly modest discriminatory abilities of both tests. CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01174550.

Project description:OBJECTIVES:This study sought to externally validate prediction models for the presence of obstructive coronary artery disease (CAD). BACKGROUND:A better assessment of the probability of CAD may improve the identification of patients who benefit from noninvasive testing. METHODS:Stable chest pain patients from the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) trial with computed tomography angiography (CTA) or invasive coronary angiography (ICA) were included. The authors assumed that patients with CTA showing 0% stenosis and a coronary artery calcium (CAC) score of 0 were free of obstructive CAD (?50% stenosis) on ICA, and they multiply imputed missing ICA results based on clinical variables and CTA results. Predicted CAD probabilities were calculated using published coefficients for 3 models: basic model (age, sex, chest pain type), clinical model (basic model + diabetes, hypertension, dyslipidemia, and smoking), and clinical + CAC score model. The authors assessed discrimination and calibration, and compared published effects with observed predictor effects. RESULTS:In 3,468 patients (1,805 women; mean 60 years of age; 779 [23%] with obstructive CAD on CTA), the models demonstrated moderate-good discrimination, with C-statistics of 0.69 (95% confidence interval [CI]: 0.67 to 0.72), 0.72 (95% CI: 0.69 to 0.74), and 0.86 (95% CI: 0.85 to 0.88) for the basic, clinical, and clinical + CAC score models, respectively. Calibration was satisfactory although typical chest pain and diabetes were less predictive and CAC score was more predictive than was suggested by the models. Among the 31% of patients for whom the clinical model predicted a low (?10%) probability of CAD, actual prevalence was 7%; among the 48% for whom the clinical + CAC score model predicted a low probability the observed prevalence was 2%. In 2 sensitivity analyses excluding imputed data, similar results were obtained using CTA as the outcome, whereas in those who underwent ICA the models significantly underestimated CAD probability. CONCLUSIONS:Existing clinical prediction models can identify patients with a low probability of obstructive CAD. Obstructive CAD on ICA was imputed for 61% of patients; hence, further validation is necessary.

Project description:BackgroundPatients from racial and ethnic minority groups presenting to the Emergency Department (ED) with chest pain experience lower odds of receiving stress testing compared with nonminorities. Studies have demonstrated that care pathways administered within the ED can reduce health disparities, but this has yet to be studied as a strategy to increase stress testing equity.MethodsA secondary analysis from 3 randomized clinical trials involving ED patients with acute chest pain was performed to determine whether a care pathway, ACES (Accelerated Chest pain Evaluation with Stress imaging), reduces the racial disparity in index visit cardiac testing between African American (AA) and White patients. Three hundred thirty-four participants with symptoms and findings indicating intermediate to high risk for acute coronary syndrome were enrolled in 3 clinical trials. Major exclusions were ST-segment elevation, initial troponin elevation, and hemodynamic instability. Participants were randomly assigned to receive usual inpatient care, or ACES. The ACES care pathway includes placement in observation for serial cardiac markers, with an expectation for stress imaging. The primary outcome was index visit objective cardiac testing, compared among AA and White participants.ResultsAA participants represented 111/329 (34%) of the study population, 80/220 (36%) of the ACES group and 31/109 (28%) of the usual care group. In usual care, objective testing occurred less frequently among AA (22/31, 71%) than among White (69/78, 88%, P = 0.027) participants, primarily driven by cardiac catheterization (3% vs. 24%; P = 0.012). In ACES, testing rates did not differ by race [AA 78/80 (98%) vs. White 138/140 (99%); P = 0.623]. At 90 days, death, MI, and revascularization did not differ in either group between AA and White participants.ConclusionsA care pathway with the expectation for stress imaging eliminates the racial disparity among AA and White participants with chest pain in the acquisition of index-visit cardiovascular testing.

Dataset Information

Impact of Diabetes Mellitus on the Evaluation of Stable Chest Pain Patients: Insights From the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) Trial.

Publications

Impact of Diabetes Mellitus on the Evaluation of Stable Chest Pain Patients: Insights From the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) Trial.

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