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Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial.

ABSTRACT: Purpose To assess concordance and relative prognostic utility between central core laboratory and local site interpretation for significant coronary artery disease (CAD) and cardiovascular events. Materials and Methods In the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial, readers at 193 North American sites interpreted coronary computed tomographic (CT) angiography as part of the clinical evaluation of stable chest pain. Readers at a central core laboratory also interpreted CT angiography blinded to clinical data, site interpretation, and outcomes. Significant CAD was defined as stenosis greater than or equal to 50%; cardiovascular events were defined as a composite of cardiovascular death or myocardial infarction. Results In 4347 patients (51.8% women; mean age ± standard deviation, 60.4 years ± 8.2), core laboratory and site interpretations were discordant in 16% (683 of 4347), most commonly because of a finding of significant CAD by site but not by core laboratory interpretation (80%, 544 of 683). Overall, core laboratory interpretation resulted in 41% fewer patients being reported as having significant CAD (14%, 595 of 4347 vs 23%, 1000 of 4347; P < .001). Over a median follow-up period of 25 months, 1.3% (57 of 4347) sustained myocardial infarction or cardiovascular death. The C statistic for future myocardial infarction or cardiovascular death was 0.61 (95% confidence interval [CI]: 0.54, 0.68) for the core laboratory and 0.63 (95% CI: 0.56, 0.70) for the sites. Conclusion Compared with interpretation by readers at 193 North American sites, standardized core laboratory interpretation classified 41% fewer patients as having significant CAD. © RSNA, 2017 Online supplemental material is available for this article. Clinical trial registration no. NCT01174550.

SUBMITTER: Lu MT

PROVIDER: S-EPMC5881637 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial.

Lu Michael T MT Meyersohn Nandini M NM Mayrhofer Thomas T Bittner Daniel O DO Emami Hamed H Puchner Stefan B SB Foldyna Borek B Mueller Martin E ME Hearne Steven S Yang Clifford C Achenbach Stephan S Truong Quynh A QA Ghoshhajra Brian B BB Patel Manesh R MR Ferencik Maros M Douglas Pamela S PS Hoffmann Udo U

Radiology 20171127 1

Purpose To assess concordance and relative prognostic utility between central core laboratory and local site interpretation for significant coronary artery disease (CAD) and cardiovascular events. Materials and Methods In the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial, readers at 193 North American sites interpreted coronary computed tomographic (CT) angiography as part of the clinical evaluation of stable chest pain. Readers at a central core laboratory a ...[more]

PMID: 29178815

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Project description:OBJECTIVES:The purpose of this study was to determine whether noninvasive fractional flow reserve derived from computed tomography (FFRCT) predicts coronary revascularization and outcomes and whether its addition improves efficiency of referral to invasive coronary angiography (ICA) after coronary computed tomography angiography (CTA). BACKGROUND:FFRCT may improve the efficiency of an anatomic CTA strategy for stable chest pain. METHODS:This observational cohort study included patients with stable chest pain in the PROMISE (PROspective Multicenter Imaging Study for Evaluation of Chest Pain) trial referred to ICA within 90 days after CTA. FFRCT was measured at a blinded core laboratory, and FFRCT results were unavailable to caregivers. We determined the agreement of FFRCT (positive if ?0.80) with stenosis on CTA and ICA (positive if ?50% left main or ?70% other coronary artery), and predictive value for a composite of coronary revascularization or major adverse cardiac events (death, myocardial infarction, or unstable angina). We retrospectively assessed whether adding FFRCT ?0.80 as a gatekeeper could improve efficiency of referral to ICA, defined as decreased rate of ICA without ?50% stenosis and increased ICA leading to revascularization. RESULTS:FFRCT was calculated in 67% (181 of 271) of eligible patients (mean age 62 years; 36% women). FFRCT was discordant with stenosis in 31% (57 of 181) for CTA and 29% (52 of 181) for ICA. Most patients undergoing coronary revascularization had an FFRCT of ?0.80 (91%; 80 of 88). An FFRCT of ?0.80 was a significantly better predictor for revascularization or major adverse cardiac events than severe CTA stenosis (HR: 4.3 [95% confidence interval [CI]: 2.4 to 8.9] vs. 2.9 [95% CI: 1.8 to 5.1]; p = 0.033). Reserving ICA for patients with an FFRCT of ?0.80 could decrease ICA without ?50% stenosis by 44%, and increase the proportion of ICA leading to revascularization by 24%. CONCLUSIONS:In this hypothesis-generating study of patients with stable chest pain referred to ICA from CTA, an FFRCT of ?0.80 was a better predictor of revascularization or major adverse cardiac events than severe stenosis on CTA. Adding FFRCT may improve efficiency of referral to ICA from CTA alone.

Project description:PurposeTo determine the impact of low tube voltage coronary CT angiography on detection of subclinical atherosclerosis.Materials and methodsRetrospective sampling of an emergency department coronary CT angiography registry was performed. All patients in the registry underwent a noncontrast coronary artery calcium (CAC) scoring scan at 120 kV before coronary CT angiography. The study sample (n = 264) constituted patients with subclinical atherosclerosis (Coronary Artery Disease Reporting and Data System™ [CAD-RADS] 1 or 2) randomly mixed one-to-one with patients without atherosclerosis (CAD-RADS 0). The patients with coronary CT angiography performed at 70-90 kV were considered the low tube voltage group (n = 159) and patients with coronary CT angiography performed at 100-120 kV were considered the standard tube voltage group (n = 105). The number of coronary plaques and overall CAD-RADS classification (per patient) were evaluated twice: initially, by reading coronary CT angiography alone, and then, by coronary CT angiography in combination with a CAC scan. Considering the combined reading (CT angiography plus CAC scan) as the reference standard, the performance of coronary CT angiography alone was assessed for plaque detection and appropriate CAD-RADS (per patient) classification. The comparisons were made between the low tube voltage and standard tube voltage groups by using a Fisher exact test and χ2 test for proportions and a Mann-Whitney test and Kruskal-Wallis test for means.ResultsIn total, 455 plaques were identified in 118 patients (70 of 159 patients in the low tube voltage group; 48 of 105 in the standard tube voltage group). When reading coronary CT angiographic images alone, 97 of 455 (21%) plaques were missed that led to an incorrect CAD-RADS classification in 16 of 264 (6%) studies (interpreted as CAD-RADS 0 instead of CAD-RADS 1 or 2). Missed plaques were significantly more frequent in the low tube voltage group versus the standard tube voltage group (41% [85 of 206] vs 5% [12 of 249], respectively; P < .001). Incorrect CAD-RADS classification was also seen more commonly in the low tube voltage group (8.8% [14 of 159] vs 2% [two of 105]; P = .01), typically at low plaque burden (median CAC score, 1; range, 1-4). Calcified plaques that appeared isodense to luminal contrast material attenuation were seen more frequently in the low tube voltage group compared with the standard tube voltage group (20% [32 of 159] vs 7.6% [eight of 105], respectively; P = .005).ConclusionCoronary artery plaques may be missed at low tube voltage coronary CT angiographic examination performed without a concomitant CAC scan.© RSNA, 2019Supplemental material is available for this article.See also the commentary by Truong in this issue.

Project description:PurposeTo test whether the relationship between acute ischemic infarct size on concurrent computed tomographic (CT) angiography source images and diffusion-weighted (DW) magnetic resonance images is dependent on the parameters of CT angiography acquisition protocols.Materials and methodsThis retrospective study had institutional review board approval, and all records were HIPAA compliant. Data in 100 patients with anterior-circulation acute ischemic stroke and large vessel occlusion who underwent concurrent CT angiography and DW imaging within 9 hours of symptom onset were analyzed. Measured areas of hyperintensity at acute DW imaging were used as the standard of reference for infarct size. Information regarding lesion volumes and CT angiography protocol parameters was collected for each patient. For analysis, patients were divided into two groups on the basis of CT angiography protocol differences (patients in group 1 were imaged with the older, slower protocol). Intermethod agreement for infarct size was evaluated by using the Wilcoxon signed rank test, as well as by using Spearman correlation and Bland-Altman analysis. Multivariate analysis was performed to identify predictors of marked (?20%) overestimation of infarct size on CT angiography source images.ResultsIn group 1 (n=35), median hypoattenuation volumes on CT angiography source images were slightly underestimated compared with DW imaging hyperintensity volumes (33.0 vs 41.6 mL, P=.01; ratio=0.83), with high correlation (?=0.91). In group 2 (n=65), median volume on CT angiography source images was much larger than that on DW images (94.8 vs 17.8 mL, P<.0001; ratio=3.5), with poor correlation (?=0.49). This overestimation on CT angiography source images would have inappropriately excluded from reperfusion therapy 44.4% or 90.3% of patients eligible according to DW imaging criteria on the basis of a 100-mL absolute threshold or a 20% or greater mismatch threshold, respectively. Atrial fibrillation and shorter time from contrast material injection to image acquisition were independent predictors of marked (?20%) infarct size overestimation on CT angiography source images.ConclusionCT angiography protocol changes designed to speed imaging and optimize arterial opacification are associated with significant overestimation of infarct size on CT angiography source images.

Project description:ObjectiveBecause there is evidence for a clinical benefit of using coronary computed tomography (CT) angiography instead of invasive coronary angiography (ICA) in patients with suspected coronary artery disease (CAD), we ascertained if patient satisfaction could represent an important barrier to implementation of coronary CT in clinical practice.Materials and methodsA total of 329 patients with suspected CAD and clinical indication for ICA were randomly assigned to undergo either CT or ICA for guiding treatment. Satisfaction for both groups was assessed by patient questionnaire completed twice, ≥24 h after CT or ICA, and at follow-up after a median of 3.7 years. Assessment included preparation, concern, comfort, helplessness, pain, willingness to undergo tests again, overall satisfaction, and preference. Pearson's chi-square test and Wilcoxon rank-sum test were used.ResultsOverall, 91% of patients undergoing CT (152/167) and 86% undergoing ICA completed assessment (140/162, p = 0.19). Patients reported being significantly better prepared for CT, less concerned about the test, and felt less helpless than during ICA (all: p < 0.001). Subjective pain (horizontal nonmarked visual analogue scale) was significantly lower for CT (6.9 ± 14.7) than for ICA (17.1 ± 22.7; p < 0.001). At follow-up, significantly more patients in the CT group reported very good satisfaction with communication of findings compared with the ICA group (p < 0.001) and 92% would recommend the institution to someone referred for the same examination.ConclusionsResults from our single-center randomized study show very good satisfaction with coronary CT compared to ICA. Thus, superior acceptance of CT should be considered in shared decision-making.Clinical relevance statementThis evaluation of patient satisfaction in a randomized study shows that patients' preference is in line with the clinical benefit provided by CT and also suggests to prefer a CT-first strategy in suspected coronary artery disease.Key points• Subjective pain was significantly lower for coronary CT angiography than for invasive coronary angiography and patients felt better prepared and less concerned about CT. • Patients were overall more satisfied with coronary CT angiography than invasive coronary angiography in a randomized controlled trial. • After a median follow-up of 3.7 years, more patients in the CT group indicated very good satisfaction with the communication of findings and with the examination itself.

Dataset Information

Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial.

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Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial.

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