Publications by authors named "Campbell Rogers"

79 Publications

Acute Stent-Induced Endothelial Denudation: Biomechanical Predictors of Vascular Injury.

Front Cardiovasc Med 2021 15;8:733605. Epub 2021 Oct 15.

Institute for Medical Engineering and Science, Massachusetts Institute of Technology (MIT), Cambridge, MA, United States.

Recent concern for local drug delivery and withdrawal of the first Food and Drug Administration-approved bioresorbable scaffold emphasizes the need to optimize the relationships between stent design and drug release with imposed arterial injury and observed pharmacodynamics. In this study, we examine the hypothesis that vascular injury is predictable from stent design and that the expanding force of stent deployment results in increased circumferential stress in the arterial tissue, which may explain acute injury poststent deployment. Using both numerical simulations and experiments on three different stent designs (slotted tube, corrugated ring, and delta wing), arterial injury due to device deployment was examined. Furthermore, using numerical simulations, the consequence of changing stent strut radial thickness on arterial wall shear stress and arterial circumferential stress distributions was examined. Regions with predicted arterial circumferential stress exceeding a threshold of 49.5 kPa compared favorably with observed endothelial denudation for the three considered stent designs. In addition, increasing strut thickness was predicted to result in more areas of denudation and larger areas exposed to low wall shear stress. We conclude that the acute arterial injury, observed immediately following stent expansion, is caused by high circumferential hoop stresses in the interstrut region, and denuded area profiles are dependent on unit cell geometric features. Such findings when coupled with where drugs move might explain the drug-device interactions.
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http://dx.doi.org/10.3389/fcvm.2021.733605DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8553954PMC
October 2021

Prognostic value of coronary computed tomography angiographic derived fractional flow reserve: a systematic review and meta-analysis.

Heart 2021 Oct 22. Epub 2021 Oct 22.

Cardiology, Glostrup University Hospital, Glostrup, Denmark.

Objectives: To obtain more powerful assessment of the prognostic value of fractional flow reserve testing we performed a systematic literature review and collaborative meta-analysis of studies that assessed clinical outcomes of CT-derived calculation of FFR (FFR) (HeartFlow) analysis in patients with stable coronary artery disease (CAD).

Methods: We searched PubMed and Web of Science electronic databases for published studies that evaluated clinical outcomes following fractional flow reserve testing between 1 January 2010 and 31 December 2020. The primary endpoint was defined as 'all-cause mortality (ACM) or myocardial infarction (MI)' at 12-month follow-up. Exploratory analyses were performed using major adverse cardiovascular events (MACEs, ACM+MI+unplanned revascularisation), ACM, MI, spontaneous MI or unplanned (>3 months) revascularisation as the endpoint.

Results: Five studies were identified including a total of 5460 patients eligible for meta-analyses. The primary endpoint occurred in 60 (1.1%) patients, 0.6% (13/2126) with FFR>0.80% and 1.4% (47/3334) with FFR ≤0.80 (relative risk (RR) 2.31 (95% CI 1.29 to 4.13), p=0.005). Likewise, MACE, MI, spontaneous MI or unplanned revascularisation occurred more frequently in patients with FFR ≤0.80 versus patients with FFR >0.80. Each 0.10-unit FFR reduction was associated with a greater risk of the primary endpoint (RR 1.67 (95% CI 1.47 to 1.87), p<0.001).

Conclusions: The 12-month outcomes in patients with stable CAD show low rates of events in those with a negative FFR result, and lower risk of an unfavourable outcome in patients with a negative test result compared with patients with a positive test result. Moreover, the FFR numerical value was inversely associated with outcomes.
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http://dx.doi.org/10.1136/heartjnl-2021-319773DOI Listing
October 2021

Trans-lesional fractional flow reserve gradient as derived from coronary CT improves patient management: ADVANCE registry.

J Cardiovasc Comput Tomogr 2021 Sep 2. Epub 2021 Sep 2.

Department of Radiology, St. Paul's Hospital and University of British Columbia, Vancouver, British Columbia, Canada; Department of Cardiology, Fiona Stanley Hospital, Harry Perkins Institute of Medical Research, University of Western Australia, Perth, Australia.

Background: The role of change in fractional flow reserve derived from CT (FFR) across coronary stenoses (ΔFFR) in guiding downstream testing in patients with stable coronary artery disease (CAD) is unknown.

Objectives: To investigate the incremental value of ΔFFR in predicting early revascularization and improving efficiency of catheter laboratory utilization.

Materials: Patients with CAD on coronary CT angiography (CCTA) were enrolled in an international multicenter registry. Stenosis severity was assessed as per CAD-Reporting and Data System (CAD-RADS), and lesion-specific FFR was measured 2 ​cm distal to stenosis. ΔFFR was manually measured as the difference of FFR across visible stenosis.

Results: Of 4730 patients (66 ​± ​10 years; 34% female), 42.7% underwent ICA and 24.7% underwent early revascularization. ΔFFR remained an independent predictor for early revascularization (odds ratio per 0.05 increase [95% confidence interval], 1.31 [1.26-1.35]; p ​< ​0.001) after adjusting for risk factors, stenosis features, and lesion-specific FFR. Among the 3 models (model 1: risk factors ​+ ​stenosis type and location ​+ ​CAD-RADS; model 2: model 1 ​+ ​FFR; model 3: model 2 ​+ ​ΔFFR), model 3 improved discrimination compared to model 2 (area under the curve, 0.87 [0.86-0.88] vs 0.85 [0.84-0.86]; p ​< ​0.001), with the greatest incremental value for FFR 0.71-0.80. ΔFFR of 0.13 was the optimal cut-off as determined by the Youden index. In patients with CAD-RADS ≥3 and lesion-specific FFR ≤0.8, a diagnostic strategy incorporating ΔFFR >0.13, would potentially reduce ICA by 32.2% (1638-1110, p ​< ​0.001) and improve the revascularization to ICA ratio from 65.2% to 73.1%.

Conclusions: ΔFFR improves the discrimination of patients who underwent early revascularization compared to a standard diagnostic strategy of CCTA with FFR, particularly for those with FFR 0.71-0.80. ΔFFR has the potential to aid decision-making for ICA referral and improve efficiency of catheter laboratory utilization.
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http://dx.doi.org/10.1016/j.jcct.2021.08.003DOI Listing
September 2021

Predictors for carotid and femoral artery intima-media thickness in a non-diabetic sleep clinic cohort.

PLoS One 2021 4;16(6):e0252569. Epub 2021 Jun 4.

Ludwig Engel Centre for Respiratory Research, The Westmead Institute for Medical Research, Westmead, Sydney, New South Wales, Australia.

Introduction: The impact of sleep disordered breathing (SDB) on arterial intima-media thickness (IMT), a surrogate measure for cardiovascular disease, remains uncertain, in part because of the potential for non-SDB vascular risk factor interactions. In the present study, we determined predictors for common carotid (CCA) and femoral (CFA) artery IMT in an adult, sleep clinic cohort where non-SDB vascular risk factors (particularly diabetes) were eliminated or controlled.

Methods: We recruited 296 participants for polysomnography (standard SDB severity metrics) and CCA/CFA ultrasound examinations, followed by a 12 month vascular risk factor minimisation (RFM) and continuous positive pressure (CPAP) intervention for participants with a range of SDB severity (RFM Sub-Group, n = 157; apnea hyponea index [AHI]: 14.7 (7.2-33.2), median [IQR]). Univariable and multivariable linear regression models determined independent predictors for IMT. Linear mixed effects modelling determined independent predictors for IMT change across the intervention study. P<0.05 was considered significant.

Results: Age, systolic blood pressure and waist:hip ratio were identified as non-SDB predictive factors for CCA IMT and age, weight and total cholesterol:HDL ratio for CFA IMT. No SDB severity metric emerged as an independent predictor for either CCA or CFA IMT, except in the RFM Sub-Group, where a 2-fold increase in AHI predicted a 2.4% increase in CFA IMT. Across the intervention study, CCA IMT decreased in those who lost weight, but there was no CPAP use interaction. CFA IMT, however, decreased by 12.9% (95%CI 6.8, 18.7%, p = 0.001) in those participants who both lost weight and used CPAP > = 4hours/night.

Conclusion: We conclude that SDB severity has little impact on CCA IMT values when non-SDB vascular risk factors are minimised or not present. This is the first study, however, to suggest a potential linkage between SDB severity and CFA IMT values.

Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12611000250932 and ACTRN12620000694910.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0252569PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8177540PMC
November 2021

Effect of Coronary Computed Tomography Angiography-Derived Fractional Flow Reserve on Physicians' Clinical Behavior - Differences Between Sites With and Without Appropriate Use Criteria as Designated by the Japanese Reimbursement System.

Circ Rep 2020 Jun 5;2(7):364-371. Epub 2020 Jun 5.

Department of Cardiovascular Medicine, Wakayama Medical University Wakayama Japan.

Coronary computed tomography angiography (CCTA)-derived fractional flow reserve (FFR) is an established tool for identifying lesion-specific ischemia that is now approved for use by the Japanese insurance system. However, current clinical reimbursement is strictly limited to institutions with designated appropriate use criteria (AUC). This study assessed differences in physicians' behavior (e.g., use and interpretation of FFR, final management) according to Japanese AUC and non-AUC site designation. Of 5,083 patients in the ADVANCE Registry, 1,829 from Japan were enrolled in this study. Physicians' behavior after interrogating CCTA and FFR was analyzed separately according to AUC and non-AUC site designation. Compared with AUC sites, patients referred for FFR from non-AUC sites had a higher rate of negative FFR, less severe anatomic stenosis, and a slightly lower rate of management plan reclassification (51.2% vs. 61.3%), with near-identical utility in both groups. Actual care corresponded equally well to post-FFR plans in both groups. The likelihood of revascularization for positive or negative FFR was similar between the 2 groups. Importantly, AUC and non-AUC sites were equally unlikely to revascularize patients with negative FFR and stenosis >50% or patients with positive FFR and stenosis <50%. Compared with AUC sites, non-AUC sites had lower disease burden and reclassification of management plans, but nearly identical clinical integration. Actual care corresponded equally well to post-FFR recommendations at both sites.
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http://dx.doi.org/10.1253/circrep.CR-20-0038DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7932815PMC
June 2020

Rationale and design of the precise percutaneous coronary intervention plan (P3) study: Prospective evaluation of a virtual computed tomography-based percutaneous intervention planner.

Clin Cardiol 2021 Apr 3;44(4):446-454. Epub 2021 Mar 3.

Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium.

Introduction: Fractional flow reserve (FFR) measured after percutaneous coronary intervention (PCI) has been identified as a surrogate marker for vessel related adverse events. FFR can be derived from standard coronary computed tomography angiography (CTA). Moreover, the FFR derived from coronary CTA (FFR ) Planner is a tool that simulates PCI providing modeled FFR values after stenosis opening.

Aim: To validate the accuracy of the FFR Planner in predicting FFR after PCI with invasive FFR as a reference standard.

Methods: Prospective, international and multicenter study of patients with chronic coronary syndromes undergoing PCI. Patients will undergo coronary CTA with FFR prior to PCI. Combined morphological and functional evaluations with motorized FFR hyperemic pullbacks, and optical coherence tomography (OCT) will be performed before and after PCI. The FFR Planner will be applied by an independent core laboratory blinded to invasive data, replicating the invasive procedure. The primary objective is to assess the agreement between the predicted FFR post-PCI derived from the Planner and invasive FFR. A total of 127 patients will be included in the study.

Results: Patient enrollment started in February 2019. Until December 2020, 100 patients have been included. Mean age was 64.1 ± 9.03, 76% were males and 24% diabetics. The target vessels for PCI were LAD 83%, LCX 6%, and RCA 11%. The final results are expected in 2021.

Conclusion: This study will determine the accuracy and precision of the FFR Planner to predict post-PCI FFR in patients with chronic coronary syndromes undergoing percutaneous revascularization.
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http://dx.doi.org/10.1002/clc.23551DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8027584PMC
April 2021

Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFR in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study.

BMJ Open 2020 12 10;10(12):e038152. Epub 2020 Dec 10.

National University of Ireland Galway, Galway, Ireland

Introduction: The previously published SYNTAX III REVOLUTION trial demonstrated that clinical decision-making between coronary artery bypass graft (CABG) and percutaneous coronary intervention based on coronary CT angiography (CCTA) had a very high agreement with the treatment decision derived from invasive coronary angiography (ICA). The study objective of the FASTTRACK CABG is to assess the feasibility of CCTA and fractional flow reserve derived from CTA (FFR) to replace ICA as a surgical guidance method for planning and execution of CABG in patients with three-vessel disease with or without left main disease.

Methods And Analysis: The FASTTRACK CABG is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept and first-in-man study with feasibility and safety analysis. Surgical revascularisation strategy and treatment planning will be solely based on CCTA and FFR without knowledge of the anatomy defined by ICA. Clinical follow-up visit including CCTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularisation with respect to the surgical planning based on non-invasive imaging (CCTA) with functional assessment (FFR) and compared with ICA. Primary feasibility endpoint is CABG planning and execution solely based on CCTA and FFR in 114 patients. Primary safety endpoint based on 30 day CCTA is graft assessment and topographical adequacy of the revascularisation procedure. Automatic non-invasive assessment of functional coronary anatomy complexity is also evaluated with FFR for functional Synergy Between percutaneous coronary intervention With Taxus and Cardiac Surgery Score assessment on CCTA. CCTA with FFR might provide better anatomical and functional analysis of the coronary circulation leading to appropriate anatomical and functional revascularisation, and thereby contributing to a better outcome.

Ethics And Dissemination: Each patient has to provide written informed consent as approved by the ethical committee of the respective clinical site. Results will be submitted for publication in peer-reviewed journals and will be disseminated at scientific conferences.

Trial Registration Number: NCT04142021.
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http://dx.doi.org/10.1136/bmjopen-2020-038152DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7733219PMC
December 2020

The clinical utility of FFR stratified by age.

J Cardiovasc Comput Tomogr 2021 Mar-Apr;15(2):121-128. Epub 2020 Sep 23.

Department of Radiology, Providence Health Care, St. Paul's Hospital, University of British Columbia, Vancouver, Canada. Electronic address:

Background: CT coronary angiography (CTA) with Fractional Flow Reserve as determined by CT (FFR) is a safe alternative to invasive coronary angiography. A negative FFR has been shown to have low cardiac event rates compared to those with a positive FFR. However, the clinical utility of FFR according to age is not known.

Methods: Patients' in the ADVANCE (Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care) registry, were stratified into those ≥65 or <65 years of age. The impact of FFR on clinical decision-making, as assessed by patient age, was determined by evaluating patient management using CTA results alone, followed by site investigators submitting a report on the treatment plan based upon the newly provided FFR data. Outcomes at 1-year post CTA were assessed, including major adverse cardiovascular events (myocardial infarction, all-cause mortality or unplanned hospitalization for ACS leading to revascularisation) and total revascularisation. Positive FFR was deemed to be ​≤ ​0.8.

Results: FFR was calculated in 1849 (40.6%) subjects aged <65 and 2704 (59.4%) ​≥ ​65 years of age. Subjects ≥65 years were more likely to have anatomic obstructive disease on CTA (≥50% stenosis), compared to those aged <65 (69.7% and 73.2% respectively, p ​= ​0.008). There was a similar graded increase in recommended and actual revascularisation with either CABG or PCI, with declining FFR strata for subjects above and below the age of 65. MACE and revascularisation rates were not significantly different for those ​≥ ​or <65, regardless of FFR positivity or stenosis severity <50% or ≥50%. With a negative FFR result, and anatomical stenosis ≥50%, those ​≥ ​and <65 years of age, had similar rates of MACE (0.2% for both, p ​= ​0.1) and revascularisation (8.7% and 10.4% respectively p ​= ​0.4). Logistic regression analysis, with age as a continuous variable, and adjustment for Diamond Forrester Risk, baseline FFR and treatment (CABG, PCI, medical therapy), indicated a statistically significant, but small increase in the odds of a MACE event with increasing age (OR 1.04, 95% CI 1.006-1.08, p ​= ​0.02). Amongst patients with a FFR > 0.80, there was no effect of age on the odds of revascularisation.

Conclusion: The findings of this study point to a low risk of MACE events or need for revascularisation in those aged ​≥ ​or <65 with a FFR>0.80, despite the higher incidence of anatomic obstructive CAD in those ≥65 years. The findings show the clinical usefulness and outcomes of FFR are largely constant regardless of age.
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http://dx.doi.org/10.1016/j.jcct.2020.08.006DOI Listing
July 2021

Coronary Computed Tomography Angiography From Clinical Uses to Emerging Technologies: JACC State-of-the-Art Review.

J Am Coll Cardiol 2020 09;76(10):1226-1243

National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. Electronic address:

Evaluation of coronary artery disease (CAD) using coronary computed tomography angiography (CCTA) has seen a paradigm shift in the last decade. Evidence increasingly supports the clinical utility of CCTA across various stages of CAD, from the detection of early subclinical disease to the assessment of acute chest pain. Additionally, CCTA can be used to noninvasively quantify plaque burden and identify high-risk plaque, aiding in diagnosis, prognosis, and treatment. This is especially important in the evaluation of CAD in immune-driven conditions with increased cardiovascular disease prevalence. Emerging applications of CCTA based on hemodynamic indices and plaque characterization may provide personalized risk assessment, affect disease detection, and further guide therapy. This review provides an update on the evidence, clinical applications, and emerging technologies surrounding CCTA as highlighted at the 2019 National Heart, Lung and Blood Institute CCTA Summit.
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http://dx.doi.org/10.1016/j.jacc.2020.06.076DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7480405PMC
September 2020

Sex Differences in Coronary Computed Tomography Angiography-Derived Fractional Flow Reserve: Lessons From ADVANCE.

JACC Cardiovasc Imaging 2020 12 26;13(12):2576-2587. Epub 2020 Aug 26.

Department of Radiology, University of British Columbia, Vancouver, British Columbia, Canada.

Objectives: This study is to determine the management and clinical outcomes of patients investigated with coronary computed tomography angiography (CCTA)-derived fractional flow reserve (FFR) according to sex.

Background: Women are underdiagnosed with conventional ischemia testing, have lower rates of obstructive coronary artery disease (CAD) at invasive coronary angiography (ICA), yet higher mortality compared to men. Whether FFR improves sex-based patient management decisions compared to CCTA alone is unknown.

Methods: Subjects with symptoms and CAD on CCTA were enrolled (2015 to 2017). Demographics, symptom status, CCTA anatomy, coronary volume to myocardial mass ratio (V/M), lowest FFR values, and management plans were captured. Endpoints included reclassification rate between CCTA and FFR management plans, incidence of ICA demonstrating obstructive CAD (≥50% stenosis) and revascularization rates.

Results: A total of 4,737 patients (n = 1,603 females, 33.8%) underwent CCTA and FFR. Women were older (age 68 ± 10 years vs. 65 ± 10 years; p < 0.0001) with more atypical symptoms (41.5% vs. 33.9%; p < 0.0001). Women had less obstructive CAD (65.4% vs. 74.7%; p < 0.0001) at CCTA, higher FFR (0.76 ± 0.10 vs. 0.73 ± 0.10; p < 0.0001), and lower likelihood of positive FFR ≤ 0.80 for the same degree stenosis (p < 0.0001). A positive FFR ≤0.80 resulted in equal referral to ICA (n = 510 [54.5%] vs. n = 1,249 [56.5%]; p = 0.31), but more nonobstructive CAD (n = 208 [32.1%] vs. n = 354 [24.5%]; p = 0.0003) and less revascularization (n = 294 [31.4%] vs. n = 800 [36.2%]; p < 0.0001) in women, unless the FFR was ≤0.75 where revascularization rates were similar (n = 253 [41.9%] vs. n = 715 [46.4%]; p = 0.06). Women have a higher V/M ratio (26.17 ± 7.58 mm/g vs. 24.76 ± 7.22 mm/g; p < 0.0001) that is associated with higher FFR independent of degree stenosis (p < 0.001). Predictors of revascularization included stenosis severity, FFR symptoms, and V/M ratio (p < 0.001) but not female sex (p = 0.284).

Conclusions: FFR differs between the sexes, as women have a higher FFR for the same degree of stenosis. In FFR-positive CAD, women have less obstructive CAD at ICA and less revascularization, which is associated with higher V/M ratio. The findings suggest that CAD and FFR variations by sex need specific interpretation as these differences may affect therapeutic decision making and clinical outcomes. (Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care [ADVANCE]; NCT02499679).
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http://dx.doi.org/10.1016/j.jcmg.2020.07.008DOI Listing
December 2020

Coronary Computed Tomography Angiography Demonstrates a High Burden of Coronary Artery Disease Despite Low-Risk Nuclear Studies in Pre-Liver Transplant Evaluation.

Liver Transpl 2020 11;26(11):1398-1408

Cardiovascular Division, Departments of Medicine, University of Virginia Health System, Charlottesville, VA.

We investigated the presence and severity of coronary artery disease (CAD) in orthotopic liver transplantation (OLT) candidates using coronary artery calcium score (CACS) and coronary computed tomography angiography (CCTA) as compared with the prevalence of normal and abnormal single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI). A total of 140 prospective OLT candidates without known CAD underwent coronary artery calcium (CAC) scans with (n = 77) or without CCTA and coronary computed tomography angiography-derived fractional flow reserve (FFR ; n = 57) using a dual-source computed tomography (CT) and were followed for 2.6 ± 1.4 years. Coronary plaque was quantified using the segment-involvement score (SIS) and segment stenosis score (SSS). The mean age was 59 ± 6 years, and 65.0% of patients were male. Mean Agatston CACS was 367 ± 653, and 15.0% of patients had CACSs of 0; 83.6% received a SPECT MPI, of which 95.7% were interpreted as normal/probably normal. By CCTA, 9.1% had obstructive CAD (≥70% stenosis), 67.5% had nonobstructive CAD, and 23.4% had no CAD. Nonobstructive CAD was diffuse with mean SIS 3.0 ± 2.9 and SSS 4.5 ± 5.4. Only 14 patients had high risk-findings (severe 3v CAD, n = 4, CACS >1000 n = 10) that prompted X-ray angiography in 3 patients who had undergone CCTA, resulting in revascularization of a high-risk obstruction in 1 patient who had a normal SPECT study. Patients with end-stage liver disease have a high prevalence of nonobstructive CAD by CCTA, which is undiagnosed by SPECT MPI, potentially underestimating cardiovascular risk. Deferring X-ray angiography unless high-risk CCTA findings are present is a potential strategy for avoiding unnecessary X-ray angiography.
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http://dx.doi.org/10.1002/lt.25869DOI Listing
November 2020

Temporal changes in FFR-Guided Management of Coronary Artery Disease - Lessons from the ADVANCE Registry.

J Cardiovasc Comput Tomogr 2021 Jan-Feb;15(1):48-55. Epub 2020 May 1.

Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands; Department of Radiology and Nuclear Medicine, Erasmus Medical Center, Rotterdam, the Netherlands; Department of Cardiovascular Medicine, Stanford University, Stanford, CA, USA; Department of Radiology, Stanford University, Stanford, CA, USA. Electronic address:

Background: The ADVANCE registry is a large prospective study of outcomes and resource utilization in patients undergoing coronary computed tomography angiography (CCTA) and CT-based fractional flow reserve (FFR). As experience with new technologies and practices develops over time, we investigated temporal changes in the use of FFR within the ADVANCE registry.

Methods: 5083 patients with coronary artery disease (CAD) on CCTA were prospectively enrolled in the ADVANCE registry and were divided into 3 equally sized cohorts based on the temporal order of enrollment per site. Demographics, CCTA and FFR findings, and clinical outcomes through 1-year follow-up, were recorded and compared between tertiles.

Results: The number of patients with a ≥70% stenosis on CCTA was similar over time (33.6%, 30.9%, and 33.8% for cohort 1-3). The rate of positive FFR ≤0.80 was higher for cohorts 2 (67.3%) and 3 (74.6%) than for cohort 1 (57.1%, p < 0.001). Invasive FFR rates decreased from 25.8% to 22.4% between cohort 1 and 3 (p = 0.023). Moreover, patients with a FFR ≤0.80 were less frequently referred for invasive coronary angiography (ICA) (from 62.9% to 52.9%, p < 0.001), and underwent fewer revascularizations between cohort 1 and 3 (from 41.9% to 32.0%, p < 0.001). The prevalence of major events was low (1.2%) and similar between cohorts.

Conclusions: Growing experience with FFR improved the likelihood of identifying hemodynamically significant CAD and safely reduced the need for ICA and revascularization in patients with anatomically significant disease even in the instance of an abnormal FFR
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http://dx.doi.org/10.1016/j.jcct.2020.04.011DOI Listing
April 2021

Fractional Flow Reserve Derived from Coronary Computed Tomography Angiography Safely Defers Invasive Coronary Angiography in Patients with Stable Coronary Artery Disease.

J Clin Med 2020 Feb 24;9(2). Epub 2020 Feb 24.

Division of Cardiology, Loyola University Medical Center, Maywood, IL 60153, USA.

Objectives: In the United States, the real-world feasibility and outcome of using fractional flow reserve from coronary computed tomography angiography (FFR) is unknown. We sought to determine whether a strategy that combined coronary computed tomography angiography (CTA) and FFR could safely reduce the need for invasive coronary angiography (ICA), as compared to coronary CTA alone.

Methods: The study included 387 consecutive patients with suspected CAD referred for coronary CTA with selective FFR and 44 control patients who underwent CTA alone. Lesions with 30-90% diameter stenoses were considered of indeterminate hemodynamic significance and underwent FFR. Nadir FFR ≤ 0.80 was positive. The rate of patients having ICA, revascularization and major adverse cardiac events were recorded.

Results: Using coronary CTA and selective FFR, 121 patients (32%) had at least one vessel with ≥50% diameter stenosis; 67/121 (55%) patients had at least one vessel with FFR ≤ 0.80; 55/121 (45%) underwent ICA; and 34 were revascularized. The proportion of ICA patients undergoing revascularization was 62% (34 of 55). The number of patients with vessels with 30-50% diameter of stenosis was 90 (23%); 28/90 (31%) patients had at least one vessel with FFR ≤ 0.80; 8/90 (9%) underwent ICA; and five were revascularized. In our institutional practice, compared to coronary CTA alone, coronary CTA with selective FFR reduced the rates of ICA (45% vs. 80%) for those with obstructive CAD. Using coronary CTA with selective FFR, no major adverse cardiac events occurred over a mean follow-up of 440 days.

Conclusion: FFR safely deferred ICA in patients with CAD of indeterminate hemodynamic significance. A high proportion of those who underwent ICA were revascularized.
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http://dx.doi.org/10.3390/jcm9020604DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7074264PMC
February 2020

Determinants of Rejection Rate for Coronary CT Angiography Fractional Flow Reserve Analysis.

Radiology 2019 09 23;292(3):597-605. Epub 2019 Jul 23.

From the Department of Cardiovascular Imaging, Centro Cardiologico Monzino, IRCCS, Via C. Parea 4, 20138 Milan, Italy (G.P., A.B., A.D.T., L.F., M.G., G.M., D.A.); Department of Radiology, School of Clinical Medicine, University of Cambridge, Cambridge, England (J.R.W.); Institute of Cardiovascular Disease, Department of Emergency and Organ Transplantation, University Hospital Policlinico of Bari, Bari, Italy (A.I.G.); Duke University School of Medicine, Durham, NC (M.P., L.H.K.); Department of Cardiology, Stanford University School of Medicine, Stanford, Calif (K.N.); Wakayama Medical University, Wakayama, Japan (T.A.); HeartFlow, Redwood City, Calif (C.R.); Department of Cardiology, Aarhus University Hospital, Aarhus Skejby, Denmark (B.L.N.); Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands (J.B.); William Beaumont Hospital, Royal Oak, Mich (G.L.R., K.C.); Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, Calif (D.B.); Liverpool Heart and Chest Hospital, Liverpool, England (T.F.); and Department of Radiology, University of British Columbia, Vancouver, Canada (J.L.).

Background Coronary artery fractional flow reserve (FFR) derived from CT angiography (FFT) enables functional assessment of coronary stenosis. Prior clinical trials showed 13%-33% of coronary CT angiography studies had insufficient quality for quantitative analysis with FFR Purpose To determine the rejection rate of FFR analysis and to determine factors associated with technically unsuccessful calculation of FFR Materials and Methods Prospectively acquired coronary CT angiography scans submitted as part of the Assessing Diagnostic Value of Noninvasive FFR in Coronary Care (ADVANCE) registry (: NCT02499679) and coronary CT angiography series submitted for clinical analysis were included. The primary outcome was the FFR rejection rate (defined as an inability to perform quantitative analysis with FFR). Factors that were associated with FFR rejection rate were assessed with multiple linear regression. Results In the ADVANCE registry, FFR rejection rate due to inadequate image quality was 2.9% (80 of 2778 patients; 95% confidence interval [CI]: 2.1%, 3.2%). In the 10 621 consecutive patients who underwent clinical analysis, the FFR rejection rate was 8.4% ( = 892; 95% CI: 6.2%, 7.2%; < .001 vs the ADVANCE cohort). The main reason for the inability to perform FFR analysis was the presence of motion artifacts (63 of 80 [78%] and 729 of 892 [64%] in the ADVANCE and clinical cohorts, respectively). At multivariable analysis, section thickness in the ADVANCE (odds ratio [OR], 1.04; 95% CI: 1.001, 1.09; = .045) and clinical (OR, 1.03; 95% CI: 1.02, 1.04; < .001) cohorts and heart rate in the ADVANCE (OR, 1.05; 95% CI: 1.02, 1.08; < .001) and clinical (OR, 1.06; 95% CI: 1.05, 1.07; < .001) cohorts were independent predictors of rejection. Conclusion The rates for technically unsuccessful CT-derived fractional flow reserve in the ADVANCE registry and in a large clinical cohort were 2.9% and 8.4%, respectively. Thinner CT section thickness and lower patient heart rate may increase rates of completion of CT fractional flow reserve analysis. Published under a CC BY 4.0 license. See also the editorial by Sakuma in this issue.
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http://dx.doi.org/10.1148/radiol.2019182673DOI Listing
September 2019

1-Year Impact on Medical Practice and Clinical Outcomes of FFR: The ADVANCE Registry.

JACC Cardiovasc Imaging 2020 01 17;13(1 Pt 1):97-105. Epub 2019 Mar 17.

Department of Radiology, Providence Health Care, St. Paul's Hospital, University of British Columbia, Vancouver, Canada.

Objectives: The 1-year data from the international ADVANCE (Assessing Diagnostic Value of Non-invasive FFR in Coronary Care) Registry of patients undergoing coronary computed tomography angiography (CTA) was used to evaluate the relationship of fractional flow reserve derived from coronary CTA (FFR) with downstream care and clinical outcomes.

Background: Guidelines for management of chest pain using noninvasive imaging pathways are based on short- to intermediate-term outcomes.

Methods: Patients (N = 5,083) evaluated for clinically suspected coronary artery disease and in whom atherosclerosis was identified by coronary CTA were prospectively enrolled at 38 international sites from July 15, 2015, to October 20, 2017. Demographics, symptom status, coronary CTA and FFR findings and resultant site-based treatment plans, and clinical outcomes through 1 year were recorded and adjudicated by a blinded core laboratory. Major adverse cardiac events (MACE), death, myocardial infarction (MI), and acute coronary syndrome leading to urgent revascularization were captured.

Results: At 1 year, 449 patients did not have follow-up data. Revascularization occurred in 1,208 (38.40%) patients with an FFR ≤0.80 and in 89 (5.60%) with an FFR >0.80 (relative risk [RR]: 6.87; 95% confidence interval [CI]: 5.59 to 8.45; p < 0.001). MACE occurred in 55 patients, 43 events occurred in patients with an FFR ≤0.80 and 12 occurred in those with an FFR >0.80 (RR: 1.81; 95% CI: 0.96 to 3.43; p = 0.06). Time to first event (all-cause death or MI) occurred in 38 (1.20%) patients with an FFR ≤0.80 compared with 10 (0.60%) patients with an FFR >0.80 (RR: 1.92; 95% CI: 0.96 to 3.85; p = 0.06). Time to first event (cardiovascular death or MI) occurred cardiovascular death or MI occurred more in patients with an FFR ≤0.80 compared with patients with an FFR >0.80 (25 [0.80%] vs. 3 [0.20%]; RR: 4.22; 95% CI: 1.28 to 13.95; p = 0.01).

Conclusions: The 1-year outcomes from the ADVANCE FFR Registry show low rates of events in all patients, with less revascularization and a trend toward lower MACE and significantly lower cardiovascular death or MI in patients with a negative FFR compared with patients with abnormal FFR values. (Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Wave [ADVANCE]; NCT02499679).
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http://dx.doi.org/10.1016/j.jcmg.2019.03.003DOI Listing
January 2020

Clinical Impact of Coronary Computed Tomography Angiography-Derived Fractional Flow Reserve on Japanese Population in the ADVANCE Registry.

Circ J 2019 05 18;83(6):1293-1301. Epub 2019 Apr 18.

Wakayama Medical University.

Background: Coronary computed tomography angiography (cCTA)-derived fractional flow reserve (FFR) is a promising diagnostic method for the evaluation of coronary artery disease (CAD). However, clinical data regarding FFRin Japan are scarce, so we assessed the clinical impact of using FFRin a Japanese population.Methods and Results:The ADVANCE registry is an international prospective FFRregistry of patients suspected of CAD. Of 5,083 patients, 1,829 subjects enrolled from Japan were analyzed. Demographics, symptoms, cCTA, FFR, treatment strategy, and 90-day major cardiovascular events (MACE) were assessed. Reclassification of treatment strategy between cCTA alone and cCTA+FFRoccurred in 55.8% of site investigations and in 56.9% in the core laboratory analysis. Patients with positive FFR (FFR≤0.80) were less likely to have non-obstructive disease on invasive coronary angiography than patients with negative FFR (FFR>0.80) (20.5% vs. 46.1%, P=0.0001). After FFR, 67.0% of patients with positive results underwent revascularization, whereas 96.1% of patients with negative FFRwere medically treated. MACE occurred in 5 patients with positive FFR, but none occurred in patients with negative FFRwithin 90 days.

Conclusions: In this Japanese population, FFRmodified the treatment strategy in more than half of the patients. FFRshowed potential for stratifying patients suspected of CAD properly into invasive or non-invasive management pathways.
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http://dx.doi.org/10.1253/circj.CJ-18-1269DOI Listing
May 2019

Predicting the Physiological Effect of Revascularization in Serially Diseased Coronary Arteries.

Circ Cardiovasc Interv 2019 02;12(2):e007577

NIHR Biomedical Research Centre and British Heart Foundation Centre of Excellence, School of Cardiovascular Medicine and Sciences, King's College London (B.N.M., H.E., R.R., D.P.).

Background: Fractional flow reserve (FFR) is commonly used to assess the functional significance of coronary artery disease but is theoretically limited in evaluating individual stenoses in serially diseased vessels. We sought to characterize the accuracy of assessing individual stenoses in serial disease using invasive FFR pullback and the noninvasive equivalent, fractional flow reserve by computed tomography (FFR). We subsequently describe and test the accuracy of a novel noninvasive FFR-derived percutaneous coronary intervention (PCI) planning tool (FFR) in predicting the true significance of individual stenoses.

Methods And Results: Patients with angiographic serial coronary artery disease scheduled for PCI were enrolled and underwent prospective coronary CT angiography with conventional FFR-derived post hoc for each vessel and stenosis (FFR). Before PCI, the invasive hyperemic pressure-wire pullback was performed to derive the apparent FFR contribution of each stenosis (FFR). The true FFR attributable to individual lesions (FFR) was then measured following PCI of one of the lesions. The predictive accuracy of FFR, FFR, and the novel technique (FFR) was then assessed against FFR. From the 24 patients undergoing the protocol, 19 vessels had post hoc FFR and FFR calculation. When assessing the distal effect of all lesions, FFR correlated moderately well with invasive FFR ( R=0.71; P<0.001). For lesion-specific assessment, there was significant underestimation of FFR using FFR (mean discrepancy, 0.06±0.05; P<0.001, representing a 42% error) and conventional trans-lesional FFR (0.05±0.06; P<0.001, 37% error). Using FFR, stenosis underestimation was significantly reduced to a 7% error (0.01±0.05; P<0.001).

Conclusions: FFR pullback and conventional FFR significantly underestimate true stenosis contribution in serial coronary artery disease. A novel noninvasive FFR-based PCI planner tool more accurately predicts the true FFR contribution of each stenosis in serial coronary artery disease.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.118.007577DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6794156PMC
February 2019

Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE Registry.

Eur Heart J 2018 11;39(41):3701-3711

Duke University School of Medicine, 2301 Erwin Road, Durham, NC, USA.

Aims: Non-invasive assessment of stable chest pain patients is a critical determinant of resource utilization and clinical outcomes. Increasingly coronary computed tomography angiography (CCTA) with selective CCTA-derived fractional flow reserve (FFRCT) is being used. The ADVANCE Registry, is a large prospective examination of using a CCTA and FFRCT diagnostic pathway in real-world settings, with the aim of determining the impact of this pathway on decision-making, downstream invasive coronary angiography (ICA), revascularization, and major adverse cardiovascular events (MACE).

Methods And Results: A total of 5083 patients with symptoms concerning for coronary artery disease (CAD) and atherosclerosis on CCTA were enrolled at 38 international sites from 15 July 2015 to 20 October 2017. Demographics, symptom status, CCTA and FFRCT findings, treatment plans, and 90 days outcomes were recorded. The primary endpoint of reclassification between core lab CCTA alone and CCTA plus FFRCT-based management plans occurred in 66.9% [confidence interval (CI): 64.8-67.6] of patients. Non-obstructive coronary disease was significantly lower in ICA patients with FFRCT ≤0.80 (14.4%) compared to patients with FFRCT >0.80 (43.8%, odds ratio 0.19, CI: 0.15-0.25, P < 0.001). In total, 72.3% of subjects undergoing ICA with FFRCT ≤0.80 were revascularized. No death/myocardial infarction (MI) occurred within 90 days in patients with FFRCT >0.80 (n = 1529), whereas 19 (0.6%) MACE [hazard ratio (HR) 19.75, CI: 1.19-326, P = 0.0008] and 14 (0.3%) death/MI (HR 14.68, CI 0.88-246, P = 0.039) occurred in subjects with an FFRCT ≤0.80.

Conclusions: In a large international multicentre population, FFRCT modified treatment recommendation in two-thirds of subjects as compared to CCTA alone, was associated with less negative ICA, predicted revascularization, and identified subjects at low risk of adverse events through 90 days.
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http://dx.doi.org/10.1093/eurheartj/ehy530DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6215963PMC
November 2018

Incidence and predictors of lesion-specific ischemia by FFR: Learnings from the international ADVANCE registry.

J Cardiovasc Comput Tomogr 2018 Mar - Apr;12(2):95-100. Epub 2018 Feb 2.

Wakayama Medical University, Wakayama, Japan.

Background: To date, the clinical utility of coronary computed tomography angiography (CTA)-derived fractional flow reserve (FFRCT) has been limited to trials and single center experiences. We herein report the incidence of abnormal FFRCT (≤0.80) and the relationship of lesion-specific ischemia to subject demographics, symptoms, and degree of stenosis in the multicenter, prospective ADVANCE registry.

Methods: One thousand patients with suspected angina having documented coronary artery disease on coronary CTA and clinically referred for FFR were prospectively enrolled in the registry. Patient demographics, symptom status, coronary CTA and FFR findings were recorded. Univariate and multivariate analyses were performed to investigate the predictors related to abnormal FFR.

Results: FFR data were analyzed in 952 patients (95.2%). Overall, 51.1% patients had a positive FFR value (≤0.80). Patients with ≥3 risk factors had a significantly higher rate of abnormal FFR than those with <3 risk factors (60.2% vs. 43.9%, p = 0.0001). On multivariate analysis, baseline diabetes (odds ratio [OR] 1.52, 95% confidence interval [CI] 1.04-2.21, p = 0.030) and hypertension (OR 1.56, 95%CI 1.14-2.14, p = 0.005) were both predictive of abnormal FFR. In addition, >70% stenosis was significantly associated with low FFR (OR 31.16, 95%CI 12.25-79.22, p < 0.0001) vs. <30% stenosis. Notably, stenosis 30-49% vs. <30% had an increased likelihood of ischemia (OR 3.74, 95%CI 1.52-9.17, p < 0.0001).

Conclusions: In this real-world registry, CT angiographic stenosis severity in addition to baseline cardiovascular risk factors conferred an increased likelihood of an abnormal FFR. Importantly, however, mild CT angiographic stenoses were noted to have an increased hazard for ischemia and the converse holding true for more severe stenoses as well.
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http://dx.doi.org/10.1016/j.jcct.2018.01.008DOI Listing
August 2018

The diagnostic performance of SPECT-MPI to predict functional significant coronary artery disease by fractional flow reserve derived from CCTA (FFR): sub-analysis from ACCURACY and VCT001 studies.

Int J Cardiovasc Imaging 2017 Dec 11;33(12):2067-2072. Epub 2017 Jul 11.

Los Angeles BioMedical Research Institute at Harbor UCLA Medical Center, Torrance, CA, USA.

Although single photon emission computed tomography-myocardial perfusion image (SPECT-MPI) and fractional flow reserve (FFR) derived from coronary computed tomographic angiography (CCTA) (FFR) have permitted functional assessment of coronary artery disease (CAD), the concordance between these modalities has not been well described. The aim of this study is to compare SPECT-MPI and anatomical stenosis by CCTA and invasive coronary angiography to FFR for assessing functional significance of CAD. We identified 62 patients with suspected CAD who underwent ≥64 slice coronary CTA and SPECT-MPI within 3 months. FFR was analyzed from CCTA data using the computational fluid dynamic techniques. The association between SPECT-MPI ischemia and FFR (≤0.80) was evaluated. Out of 62 patients, 186 vessels were evaluated. On a per-vessel analysis, accuracy, sensitivity and specificity of SPECT-MPI to predict FFR ≤ 0.80 was 74.2, 45.0 and 77.7%, respectively. The area under the curve (AUC) by receiver-operating characteristic curve analysis for SPECT-MPI demonstrated a modest performance for predicting FFR ≤ 0.80 (AUC 0.56). Among patients with suspected CAD who were assessed by non-invasive functional modalities, SPECT-MPI showed modest concordance with FFR.
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http://dx.doi.org/10.1007/s10554-017-1207-yDOI Listing
December 2017

An FFR diagnostic strategy versus usual care in patients with suspected coronary artery disease planned for invasive coronary angiography at German sites: one-year results of a subgroup analysis of the PLATFORM (Prospective Longitudinal Trial of FFR: Outcome and Resource Impacts) study.

Open Heart 2017;4(1):e000526. Epub 2017 Mar 22.

Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.

Aim: Diagnostic evaluation practices for suspected coronary artery disease (CAD) may vary between countries. Our objective was to compare a CT-derived fractional flow reserve (FFR) diagnostic strategy with usual care in patients with planned invasive coronary angiography (ICA) enrolled in the PLATFORM (Prospective Longitudinal Trial of FFR: Outcome and Resource Impacts) study at German sites.

Methods: Patients were divided into two consecutive observational cohorts, receiving either usual care or CT angiography (CTA)/FFR. The primary endpoint was the percentage of patients planned for ICA, with no obstructive CAD on ICA within 90 days. Secondary endpoints included death, myocardial infarction, unstable angina, hospitalisation leading to unplanned revascularisation, cumulative radiation exposure, estimated medical costs and quality of life (QOL) at 1 year.

Results: 116 patients were included. The primary endpoint occurred in 4 of the 52 patients (7.7%) in the CTA/FFR group and in 55 of the 64 patients (85.9%) in the usual care group (risk difference 78.2%, 95% CI 67.1% to 89.4%, p<0.001). ICA was cancelled in 40 of the 52 patients (77%) who underwent CTA/FFR. Clinical event rates were low overall. The mean radiation exposure was lower in the FFR versus the usual care group (7.28 vs 9.80 mSv, p<0.001). Mean estimated medical costs were €4217 (CTA/FFR) versus €6894 (usual care), p<0.001. Improvement in QOL (EQ-5D score) was greater in the FFR (+0.09 units) versus the usual care cohort (+0.03 units), p=0.04.

Conclusions: In patients with suspected CAD planned for ICA at German sites, initial CTA/FFR compared with usual care was associated with a markedly reduced rate of ICA showing no obstructive CAD, lower cumulative radiation exposure and estimated costs and greater improvement in QOL.
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http://dx.doi.org/10.1136/openhrt-2016-000526DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5471869PMC
March 2017

Change in angiogram-derived management strategy of patients with chest pain when some FFR data are available: How consistent is the effect?

Cardiovasc Revasc Med 2017 Jul - Aug;18(5):320-327. Epub 2017 Feb 27.

Faculty of Medicine, University of Southampton, UK; University Hospital Southampton NHS Foundation Trust, UK. Electronic address:

Background: The assessment of patients presenting with angina using invasive angiography alone is imperfect. By contrast, fractional flow reserve (FFR) allows for assessment of lesion-specific ischemia, which is predictive of clinical outcome. A series of studies has demonstrated that the availability of FFR data at the time of diagnostic angiography leads to significant differences in the management of those patients.

Hypothesis: The objective of this paper is to assess the consistency in the difference in management resulting from an FFR-directed versus and angiogram-directed strategy in appropriate observational and randomized trials.

Methods: A methodical search was made using MEDLINE, Current Contents Connect, Google Scholar, EMBASE, Cochrane library, PubMed, Science Direct, and Web of Science.

Results: Eight studies were identified using the eligibility criteria. A total of 2468 patients were recommended to have optimal medical therapy (OMT) alone after initial angiographic assessment but, after FFR results were available, a total of 716 (29.0%) were referred for revascularization (PCI 626 patients [25.36%]; CABG 90 patients [3.64%]). Similarly, 3766 patients were originally committed to PCI after initial angiography: of these 1454 patients (38.61%) were reconsidered to be suitable for OMT alone and 71 individuals (1.8%) were deemed suitable for CABG after FFR data were available. Further, of 366 patients referred for CABG based on angiographic data, the availability of FFR data changed the final decision to OMT alone in 65 patients (17.76%) and PCI in 51 patients (13.9%). Overall, the angiogram-derived management was changed in 22%-48% of these study populations when FFR data were available.

Conclusions: Some use of FFR during coronary angiography alters the angiogram-directed management in a remarkably consistent manner. These data suggest that routine use of FFR at the diagnostic angiogram would improve patient care.
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http://dx.doi.org/10.1016/j.carrev.2017.01.014DOI Listing
May 2018

Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFR in Coronary Care (ADVANCE) registry.

J Cardiovasc Comput Tomogr 2017 Jan - Feb;11(1):62-67. Epub 2016 Dec 14.

William Beaumont Hospital, Royal Oaks, MI, USA.

Background: Coronary CT angiography (CTA) is a reliable tool for the detection of coronary artery disease (CAD) that conveys significant prognostic information. It does not provide data on the hemodynamic significance of a given lesion, particularly in intermediate-grade stenosis. Fractional flow reserve by CT (FFR) can accurately predict the hemodynamic significance of coronary lesions. The primary objective of this registry is to determine whether the integration of FFR as an adjunct to coronary CTA will lead to a significant change in the management of CAD in patients with stable angina.

Methods: The ADVANCE Registry is a multi-center, prospective registry designed to evaluate utility, clinical outcomes and resource utilization following FFR-guided treatment in clinically stable, symptomatic patients diagnosed with CAD by coronary CTA. Approximately 5000 patients will be enrolled from up to 50 sites in Europe, USA, Canada and Asia. Requirement for enrollment is the presence of atherosclerosis on coronary CTA. For each enrolled patient, a clinical management review committee will use data from coronary CTA and FFR to determine the management plan using the following criteria: (a) optimal medical therapy, (b) percutaneous coronary intervention, (c) coronary artery bypass graft surgery, or (d) more information required. The primary endpoint of the registry is the reclassification rate between the management plan based on coronary CTA alone versus CTA plus FFR. The secondary endpoints of the registry include the evaluation of the rate of invasive coronary angiography (ICA), revascularization, major adverse coronary events, resource utilization, cumulative radiation dose exposure and the rate of ICA without obstructive CAD at 3-year follow-up.

Conclusions: The ADVANCE registry is designed to assess the real-world impact of FFR on the clinical management of stable CAD when used along with coronary CTA.
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http://dx.doi.org/10.1016/j.jcct.2016.12.002DOI Listing
June 2017

Non-invasive Heart Team assessment of multivessel coronary disease with coronary computed tomography angiography based on SYNTAX score II treatment recommendations: design and rationale of the randomised SYNTAX III Revolution trial.

EuroIntervention 2017 Mar;12(16):2001-2008

Erasmus University Medical Center, Rotterdam, The Netherlands.

Aims: The aim of this study was to investigate whether a Heart Team decision-making process regarding the choice of revascularisation strategy based on non-invasive coronary multislice computed tomography angiography (MSCT) assessment of coronary artery disease (CAD) is equivalent to the standard-of-care invasive angiography-based assessment in patients with multivessel CAD.

Methods And Results: The SYNTAX III Revolution trial is a prospective, multicentre, all-comers randomised trial that will randomise two Heart Teams to select between surgical and percutaneous treatment according to either an invasive conventional angiography or a non-invasive MSCT angiography assessment in patients with multivessel CAD. The treatment selection by each Heart Team will be guided by the SYNTAX score II calculation. The primary endpoint is the level of agreement according to kappa of the initial decision by the Heart Teams on the modality of the revascularisation based on MSCT and angiography assessments. Secondary endpoints include agreement on the number of vessels requiring treatment and the coronary segments in need of revascularisation.

Conclusions: The SYNTAX III Revolution trial will provide valuable information regarding the ability of a purely non-invasive coronary anatomy assessment to select accurately the most appropriate revascularisation strategy for patients with multivessel CAD.
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http://dx.doi.org/10.4244/EIJ-D-16-00612DOI Listing
March 2017

Severe in-stent restenosis missed by coronary CT angiography and accurately detected with FFR.

Int J Cardiovasc Imaging 2017 Jan 31;33(1):119-120. Epub 2016 Aug 31.

Centro Cardiologico Monzino, Via C. Parea 4, 20138, Milan, Italy.

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http://dx.doi.org/10.1007/s10554-016-0971-4DOI Listing
January 2017

1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study.

J Am Coll Cardiol 2016 08;68(5):435-445

Department of Health Research and Policy and Department of Medicine, Stanford University School of Medicine, Stanford, California.

Background: Coronary computed tomographic angiography (CTA) plus estimation of fractional flow reserve using CTA (FFRCT) safely and effectively guides initial care over 90 days in patients with stable chest pain. Longer-term outcomes are unknown.

Objectives: The study sought to determine the 1-year clinical, economic, and quality-of-life (QOL) outcomes of using FFRCT instead of usual care.

Methods: Consecutive patients with stable, new onset chest pain were managed by either usual testing (n = 287) or CTA (n = 297) with selective FFRCT (submitted in 201, analyzed in 177); 581 of 584 (99.5%) completed 1-year follow-up. Endpoints were adjudicated major adverse cardiac events (MACE) (death, myocardial infarction, unplanned revascularization), total medical costs, and QOL.

Results: Patients averaged 61 years of age with a mean 49% pre-test probability of coronary artery disease. At 1 year, MACE events were infrequent, with 2 in each arm of the planned invasive group and 1 in the planned noninvasive cohort (usual care strategy). In the planned invasive stratum, mean costs were 33% lower with CTA and selective FFRCT ($8,127 vs. $12,145 usual care; p < 0.0001); in the planned noninvasive stratum, mean costs did not differ when using an FFRCT cost weight of zero ($3,049 FFRCT vs. $2,579; p = 0.82), but were higher when using an FFRCT cost weight equal to CTA. QOL scores improved overall at 1 year (p < 0.001), with similar improvements in both groups, apart from the 5-item EuroQOL scale scores in the noninvasive stratum (mean change of 0.12 for FFRCT vs. 0.07 for usual care; p = 0.02).

Conclusions: In patients with stable chest pain and planned invasive coronary angiography, care guided by CTA and selective FFRCT was associated with equivalent clinical outcomes and QOL, and lower costs, compared with usual care over 1-year follow-up. (The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts [PLATFORM]; NCT01943903).
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http://dx.doi.org/10.1016/j.jacc.2016.05.057DOI Listing
August 2016

Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM.

J Am Coll Cardiol 2015 Dec 14;66(21):2315-2323. Epub 2015 Oct 14.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.

Background: Fractional flow reserve estimated using computed tomography (FFRCT) might improve evaluation of patients with chest pain.

Objectives: The authors sought to determine the effect on cost and quality of life (QOL) of using FFRCT instead of usual care to evaluate stable patients with symptoms suspicious for coronary disease.

Methods: Symptomatic patients without known coronary disease were enrolled into 2 strata based on whether invasive or noninvasive diagnostic testing was planned. In each stratum, consecutive observational cohorts were evaluated with either usual care or FFRCT. The number of diagnostic tests, invasive procedures, hospitalizations, and medications during 90-day follow-up were multiplied by U.S. cost weights and summed to derive total medical costs. Changes in QOL from baseline to 90 days were assessed using the Seattle Angina Questionnaire, the EuroQOL, and a visual analog scale.

Results: In the 584 patients, 74% had atypical angina, and the pre-test probability of coronary disease was 49%. In the planned invasive stratum, mean costs were 32% lower among the FFRCT patients than among the usual care patients ($7,343 vs. $10,734 p < 0.0001). In the noninvasive stratum, mean costs were not significantly different between the FFRCT patients and the usual care patients ($2,679 vs. $2,137; p = 0.26). In a sensitivity analysis, when the cost weight of FFRCT was set to 7 times that of computed tomography angiography, the FFRCT group still had lower costs than the usual care group in the invasive testing stratum ($8,619 vs. $ 10,734; p < 0.0001), whereas in the noninvasive testing stratum, when the cost weight of FFRCT was set to one-half that of computed tomography angiography, the FFRCT group had higher costs than the usual care group ($2,766 vs. $2,137; p = 0.02). Each QOL score improved in the overall study population (p < 0.0001). In the noninvasive stratum, QOL scores improved more in FFRCT patients than in usual care patients: Seattle Angina Questionnaire 19.5 versus 11.4, p = 0.003; EuroQOL 0.08 versus 0.03, p = 0.002; and visual analog scale 4.1 versus 2.3, p = 0.82. In the invasive cohort, the improvements in QOL were similar in the FFRCT and usual care patients.

Conclusions: An evaluation strategy based on FFRCT was associated with less resource use and lower costs within 90 days than evaluation with invasive coronary angiography. Evaluation with FFRCT was associated with greater improvement in quality of life than evaluation with usual noninvasive testing. (Prospective Longitudinal Trial of FFRCT: Outcomes and Resource Impacts [PLATFORM]; NCT01943903).
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http://dx.doi.org/10.1016/j.jacc.2015.09.051DOI Listing
December 2015

Rationale and design of the Prospective LongitudinAl Trial of FFRCT: Outcome and Resource IMpacts study.

Am Heart J 2015 Sep 10;170(3):438-46.e44. Epub 2015 Jun 10.

Duke Clinical Research Institute, Durham, NC.

Background: Fractional flow reserve (FFR) measured by coronary computed tomography angiography (FFRCT) has been validated against invasive FFR. However, there are no data on how the use of FFRCT affects patient care and outcomes. The aim of this study is to compare standard practice guided by usual care testing to FFRCT-guided management in symptomatic subjects with suspected coronary artery disease (CAD).

Methods: In this prospective nonrandomized trial, symptomatic patients with suspected CAD will be enrolled in 2 consecutive cohorts: a usual care-guided pathway (cohort 1) and an FFRCT-guided pathway (cohort 2). Each cohort is divided into 2 groups according to whether noninvasive or invasive diagnostic testing was planned before enrollment. In all subjects, the patient's clinical team will review all diagnostic test results and determine a treatment strategy. A total sample size of 580 subjects will be enrolled and followed up for 12 months.

Results: The primary end point is the comparison of the percentage of patients with planned invasive testing who have a catheterization (invasive coronary angiography) within 90 days from initial assessment, which does not show a significant stenosis (defined as coronary artery stenosis >50% or invasive FFR ≤0.80). Secondary end points include the rate of invasive coronary angiography without obstructive CAD in those with planned noninvasive testing and, in all groups, noninferiority of resource use, quality of life, medical radiation exposure, and major adverse cardiac events up to 365 days of follow-up.

Conclusions: The study compares clinical and economic outcomes based on diagnostic evaluation using FFRCT with that based on standard diagnostic strategies.
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http://dx.doi.org/10.1016/j.ahj.2015.06.002DOI Listing
September 2015
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