Dataset Information

Comparison of visual assessment of coronary stenosis with independent quantitative coronary angiography: Findings from the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial.

ABSTRACT: The outcomes in patients by visual assessment and quantitative coronary angiography (QCA) for obstructive coronary artery disease (CAD) are not known. Our objectives were to compare visual and QCA estimates of obstructive CAD and to assess their relationship to outcomes in stable patients with symptoms of CAD.The PROMISE trial randomized 10,003 patients with CAD symptoms to anatomical or functional testing. Site reports of invasive angiography detailing visual stenosis and independent, blinded QCA were performed for obstructive CAD (?50% stenosis). Disagreement between methods was determined and compared with outcomes (death, myocardial infarction, unstable angina hospitalization, or major procedural complications).Of 929 patients (9.3% of PROMISE cohort) with angiograms assessed by sites and QCA, 593 (64%) had obstructive CAD per site reports, whereas 428 (46%) had stenosis ?50% per QCA. Results differed in 177 patients (disagreement rate 19.1%, ?=0.63), of whom 171 had CAD per sites but not per QCA. One-year unadjusted Kaplan-Meier event rates were highest (5.1%) when QCA and visual assessment agreed for CAD, lowest (0.9%) when the 2 agreed for no obstructive CAD, and intermediate (3.1%) for patients who had CAD per visual assessment but not per QCA.Visual estimation of angiograms results in more frequent diagnosis of obstructive CAD as compared with QCA. Concordance of results for presence or absence of obstructive CAD was associated with high and low event rates, respectively. Disagreement was associated with intermediate event rates, suggesting that cardiologists integrated clinical information into routine visual assessment of angiograms.

SUBMITTER: Shah R

PROVIDER: S-EPMC5785086 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Comparison of visual assessment of coronary stenosis with independent quantitative coronary angiography: Findings from the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial.

Shah Rohan R Yow Eric E Jones William Schuyler WS Kohl Louis P LP Kosinski Andrzej S AS Hoffmann Udo U Lee Kerry L KL Fordyce Christopher B CB Mark Daniel B DB Lowe Alicia A Douglas Pamela S PS Patel Manesh R MR

American heart journal 20161026

<h4>Background</h4>The outcomes in patients by visual assessment and quantitative coronary angiography (QCA) for obstructive coronary artery disease (CAD) are not known. Our objectives were to compare visual and QCA estimates of obstructive CAD and to assess their relationship to outcomes in stable patients with symptoms of CAD.<h4>Methods</h4>The PROMISE trial randomized 10,003 patients with CAD symptoms to anatomical or functional testing. Site reports of invasive angiography detailing visual ...[more]

PMID: 27892881

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Project description:BackgroundIt is unclear whether an evaluation incorporating coronary computed tomographic angiography (CCTA) is more effective than standard evaluation in the emergency department in patients with symptoms suggestive of acute coronary syndromes.MethodsIn this multicenter trial, we randomly assigned patients 40 to 74 years of age with symptoms suggestive of acute coronary syndromes but without ischemic electrocardiographic changes or an initial positive troponin test to early CCTA or to standard evaluation in the emergency department on weekdays during daylight hours between April 2010 and January 2012. The primary end point was length of stay in the hospital. Secondary end points included rates of discharge from the emergency department, major adverse cardiovascular events at 28 days, and cumulative costs. Safety end points were undetected acute coronary syndromes.ResultsThe rate of acute coronary syndromes among 1000 patients with a mean (±SD) age of 54±8 years (47% women) was 8%. After early CCTA, as compared with standard evaluation, the mean length of stay in the hospital was reduced by 7.6 hours (P<0.001) and more patients were discharged directly from the emergency department (47% vs. 12%, P<0.001). There were no undetected acute coronary syndromes and no significant differences in major adverse cardiovascular events at 28 days. After CCTA, there was more downstream testing and higher radiation exposure. The cumulative mean cost of care was similar in the CCTA group and the standard-evaluation group ($4,289 and $4,060, respectively; P=0.65).ConclusionsIn patients in the emergency department with symptoms suggestive of acute coronary syndromes, incorporating CCTA into a triage strategy improved the efficiency of clinical decision making, as compared with a standard evaluation in the emergency department, but it resulted in an increase in downstream testing and radiation exposure with no decrease in the overall costs of care. (Funded by the National Heart, Lung, and Blood Institute; ROMICAT-II ClinicalTrials.gov number, NCT01084239.).

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:BackgroundIncreased inflammation and myocardial injury can be observed in the absence of myocardial infarction or obstructive coronary artery disease (CAD).ObjectivesThe authors determined whether biomarkers of inflammation and myocardial injury-interleukin (IL)-6 and high-sensitivity cardiac troponin (hs-cTn)-were associated with the presence and extent of CAD and were independent predictors of major adverse cardiovascular events (MACEs) in stable chest pain.MethodsUsing participants from the PROMISE trial, the authors measured hs-cTn I and IL-6 concentrations and analyzed computed tomography angiography (CTA) images in the core laboratory for CAD characteristics: significant stenosis (≥70%), high-risk plaque (HRP), Coronary Artery Disease Reporting and Data System (CAD-RADS) categories, segment involvement score (SIS), and coronary artery calcium (CAC) score. The primary endpoint was a composite MACE (death, myocardial infarction, or unstable angina).ResultsThe authors included 1,796 participants (age 60.2 ± 8.0 years; 47.5% men, median follow-up 25 months). In multivariable linear regression adjusted for atherosclerotic cardiovascular disease (ASCVD) risk, hs-cTn was associated with HRP, stenosis, CAD-RADS, and SIS. IL-6 was only associated with stenosis and CAD-RADS. hs-cTn above median (1.5 ng/L) was associated with MACEs in univariable analysis (HR: 2.1 [95% CI: 1.3-3.6]; P = 0.006), but not in multivariable analysis adjusted for ASCVD and CAD. IL-6 above median (1.8 ng/L) was associated with MACEs in multivariable analysis adjusted for ASCVD and HRP (HR: 1.9 [95% CI: 1.1-3.3]; P = 0.03), CAC (HR: 1.9 [95% CI: 1.0-3.4]; P = 0.04), and SIS (HR: 1.8 [95% CI: 1.0-3.2]; P = 0.04), but not for stenosis or CAD-RADS. In participants with nonobstructive CAD (stenosis 1%-69%), the presence of both hs-cTn and IL-6 above median was strongly associated with MACEs (HR: 2.5-2.7 after adjustment for CAD characteristics).ConclusionsConcentrations of hs-cTn and IL-6 were associated with CAD characteristics and MACEs, indicating that myocardial injury and inflammation may each contribute to pathways in CAD pathophysiology. This association was most pronounced among participants with nonobstructive CAD representing an opportunity to tailor treatment in this at-risk group. (PROspective Multicenter Imaging Study for Evaluation of Chest Pain [PROMISE]; NCT01174550).

Dataset Information

Comparison of visual assessment of coronary stenosis with independent quantitative coronary angiography: Findings from the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial.

Publications

Comparison of visual assessment of coronary stenosis with independent quantitative coronary angiography: Findings from the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial.

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