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Noninvasive FFR Derived From Coronary CT Angiography: Management and Outcomes in the PROMISE Trial.

ABSTRACT: 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.

SUBMITTER: Lu MT

PROVIDER: S-EPMC5632098 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Noninvasive FFR Derived From Coronary CT Angiography: Management and Outcomes in the PROMISE Trial.

Lu Michael T MT Ferencik Maros M Roberts Rhonda S RS Lee Kerry L KL Ivanov Alexander A Adami Elizabeth E Mark Daniel B DB Jaffer Farouc A FA Leipsic Jonathon A JA Douglas Pamela S PS Hoffmann Udo U

JACC. Cardiovascular imaging 20170412 11

<h4>Objectives</h4>The purpose of this study was to determine whether noninvasive fractional flow reserve derived from computed tomography (FFR<sub>CT</sub>) predicts coronary revascularization and outcomes and whether its addition improves efficiency of referral to invasive coronary angiography (ICA) after coronary computed tomography angiography (CTA).<h4>Background</h4>FFR<sub>CT</sub> may improve the efficiency of an anatomic CTA strategy for stable chest pain.<h4>Methods</h4>This observatio ...[more]

PMID: 28412436

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Project description:ObjectivesThe addition of CT-derived fractional flow reserve (FFR-CT) increases the diagnostic accuracy of coronary CT angiography (CCTA). We assessed the impact of FFR-CT in routine clinical practice on clinical decision-making and patient prognosis in patients suspected of stable coronary artery disease (CAD).MethodsThis retrospective, single-center study compared a cohort that received CCTA with FFR-CT to a historical cohort that received CCTA before FFR-CT was available. We assessed the clinical management decisions after FFR-CT and CCTA and the rate of major adverse cardiac events (MACEs) during the 1-year follow-up using chi-square tests for independence. Kaplan-Meier curves were used to visualize the occurrence of safety outcomes over time.ResultsA total of 360 patients at low to intermediate risk of CAD were included, 224 in the CCTA only group, and 136 in the FFR-CT group. During follow-up, 13 MACE occurred in 12 patients, 9 (4.0%) in the CCTA group, and three (2.2%) in the FFR-CT group. Clinical management decisions differed significantly between both groups. After CCTA, 60 patients (26.5%) received optimal medical therapy (OMT) only, 115 (51.3%) invasive coronary angiography (ICA), and 49 (21.9%) single positron emission CT (SPECT). After FFR-CT, 106 patients (77.9%) received OMT only, 27 (19.9%) ICA, and three (2.2%) SPECT (p < 0.001 for all three options). The revascularization rate after ICA was similar between groups (p = 0.15). However, patients in the CCTA group more often underwent revascularization (p = 0.007).ConclusionAddition of FFR-CT to CCTA led to a reduction in (invasive) diagnostic testing and less revascularizations without observed difference in outcomes after 1 year.Key points• Previous studies have shown that computed tomography-derived fractional flow reserve improves the accuracy of coronary computed tomography angiography without changes in acquisition protocols. • This study shows that use of computed tomography-derived fractional flow reserve as gatekeeper to invasive coronary angiography in patients suspected of stable coronary artery disease leads to less invasive testing and revascularization without observed difference in outcomes after 1 year. • This could lead to a significant reduction in costs, complications and (retrospectively unnecessary) usage of diagnostic testing capacity, and a significant increase in patient satisfaction.

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.

Project description:BackgroundPatients evaluated for coronary artery disease have a range of symptoms and underlying risk. The relationships between patient-described symptoms, clinician conclusions, and subsequent clinical management and outcomes remain incompletely described.MethodsIn this secondary analysis, we examined the association between 4 types of presenting symptoms (substernal/left-sided chest pain, other chest/neck/arm pain, dyspnea, and other symptoms) and patient risk, noninvasive test results, clinical management, and outcomes for stable outpatients randomized in the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) trial. Multivariable regression models were used to evaluate differences in noninvasive test result, all-cause death/myocardial infarction/unstable angina hospitalization and cardiovascular death/myocardial infarction by symptom type.ResultsAmong 9996 patients, most presented with chest pain (47.2% substernal, 29.2% other), followed by dyspnea (14.9%), and other symptoms (8.7%). Patients with dyspnea were older (median age 63 versus 60, P≤0.02) with higher baseline risk (78.2% with atherosclerotic cardiovascular disease >7.5% versus 67.6%, P≤0.02). Using patients with substernal chest pain as a reference, there was no difference in noninvasive test positivity across symptom groups (all P>0.05), but test-positive patients with dyspnea (adjusted odds ratio, 0.66 [95% CI, 0.51-0.85]) or other symptoms (adjusted odds ratio, 0.65 [95% CI, 0.47-0.90]) were less likely to be referred for cardiac catheterization. While symptom type alone was not associated with outcomes, symptom presentation with chest pain or dyspnea did modify the association between a positive noninvasive test and clinical outcome (interaction P=0.025 for both all-cause death/myocardial infarction/unstable angina hospitalization and cardiovascular death/MI).ConclusionsAmong low-risk outpatients evaluated for coronary artery disease, typicality of symptoms was not closely associated with higher baseline risk but was related to differences in processes of care and the prognostic value of a positive test. Adverse events were not associated with clinician risk estimates or symptoms alone. These unexpected findings highlight the limitation of relying solely on symptom presentation or clinician risk estimation to evaluate patients for suspected coronary artery disease.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT01174550.

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Noninvasive FFR Derived From Coronary CT Angiography: Management and Outcomes in the PROMISE Trial.

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Noninvasive FFR Derived From Coronary CT Angiography: Management and Outcomes in the PROMISE Trial.

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