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      Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR CT: outcome and resource impacts study

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      European Heart Journal
      Oxford University Press
      Angina, Coronary computed tomographic angiography, Fractional flow reserve, Non-invasive testing

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          In symptomatic patients with suspected coronary artery disease (CAD), computed tomographic angiography (CTA) improves patient selection for invasive coronary angiography (ICA) compared with functional testing. The impact of measuring fractional flow reserve by CTA (FFR CT) is unknown.

          Methods and results

          At 11 sites, 584 patients with new onset chest pain were prospectively assigned to receive either usual testing ( n = 287) or CTA/FFR CT ( n = 297). Test interpretation and care decisions were made by the clinical care team. The primary endpoint was the percentage of those with planned ICA in whom no significant obstructive CAD (no stenosis ≥50% by core laboratory quantitative analysis or invasive FFR < 0.80) was found at ICA within 90 days. Secondary endpoints including death, myocardial infarction, and unplanned revascularization were independently and blindly adjudicated. Subjects averaged 61 ± 11 years of age, 40% were female, and the mean pre-test probability of obstructive CAD was 49 ± 17%. Among those with intended ICA (FFR CT-guided = 193; usual care = 187), no obstructive CAD was found at ICA in 24 (12%) in the CTA/FFR CT arm and 137 (73%) in the usual care arm (risk difference 61%, 95% confidence interval 53–69, P< 0.0001), with similar mean cumulative radiation exposure (9.9 vs. 9.4 mSv, P = 0.20). Invasive coronary angiography was cancelled in 61% after receiving CTA/FFR CT results. Among those with intended non-invasive testing, the rates of finding no obstructive CAD at ICA were 13% (CTA/FFR CT) and 6% (usual care; P = 0.95). Clinical event rates within 90 days were low in usual care and CTA/FFR CT arms.


          Computed tomographic angiography/fractional flow reserve by CTA was a feasible and safe alternative to ICA and was associated with a significantly lower rate of invasive angiography showing no obstructive CAD.

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          Most cited references8

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          A clinical prediction rule for the diagnosis of coronary artery disease: validation, updating, and extension.

          The aim was to validate, update, and extend the Diamond-Forrester model for estimating the probability of obstructive coronary artery disease (CAD) in a contemporary cohort. Prospectively collected data from 14 hospitals on patients with chest pain without a history of CAD and referred for conventional coronary angiography (CCA) were used. Primary outcome was obstructive CAD, defined as ≥ 50% stenosis in one or more vessels on CCA. The validity of the Diamond-Forrester model was assessed using calibration plots, calibration-in-the-large, and recalibration in logistic regression. The model was subsequently updated and extended by revising the predictive value of age, sex, and type of chest pain. Diagnostic performance was assessed by calculating the area under the receiver operating characteristic curve (c-statistic) and reclassification was determined. We included 2260 patients, of whom 1319 had obstructive CAD on CCA. Validation demonstrated an overestimation of the CAD probability, especially in women. The updated and extended models demonstrated a c-statistic of 0.79 (95% CI 0.77-0.81) and 0.82 (95% CI 0.80-0.84), respectively. Sixteen per cent of men and 64% of women were correctly reclassified. The predicted probability of obstructive CAD ranged from 10% for 50-year-old females with non-specific chest pain to 91% for 80-year-old males with typical chest pain. Predictions varied across hospitals due to differences in disease prevalence. Our results suggest that the Diamond-Forrester model overestimates the probability of CAD especially in women. We updated the predictive effects of age, sex, type of chest pain, and hospital setting which improved model performance and we extended it to include patients of 70 years and older.
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            2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards).

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                Author and article information

                Eur Heart J
                Eur. Heart J
                European Heart Journal
                Oxford University Press
                14 December 2015
                01 September 2015
                01 September 2015
                : 36
                : 47
                : 3359-3367
                [1 ]Duke Clinical Research Institute, Duke University School of Medicine , 7022 North Pavilion DUMC, PO Box 17969, Durham, NC 27715, USA
                [2 ]Centro Cardiologico Monzino, IRCCS, University of Milan , Milan, Italy
                [3 ]Department of Health Research and Policy, Stanford University School of Medicine , Stanford, CA, USA
                [4 ]Department of Cardiology, Aarhus University Hospital , Aarhus Skejby, Denmark
                [5 ]Deutsches Herzzentrum München, Technische Universität München , Munich, Germany
                [6 ]University Hospital Southampton NHS Trust , Southampton, UK
                [7 ]Freeman Hospital , Newcastle upon Tyne, UK
                [8 ]University of Leipzig Heart Centre , Leipzig, Germany
                [9 ]Hospices Civils de Lyon and CARMEN INSERM 1060 , Lyon, France
                [10 ]Department of Cardiology, Johannes Gutenberg University Hospital , Mainz, Germany
                [11 ]LKH Graz West , Graz, Austria
                [12 ]Department of Radiology, Innsbruck Medical University , Innsbruck, Austria
                [13 ]Department of Cardiology, Cavale Blanche Hospital , Brest, France
                [14 ]HeartFlow , Redwood City, CA, USA
                [15 ]Cardiovascular Centre Aalst , Aalst, Belgium
                Author notes
                [* ]Corresponding author. Tel: +1 919 681 2690, Fax: +1 919 668 7059, Email: pamela.douglas@ 123456duke.edu

                Members are listed in Appendix.

                © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

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                angina,coronary computed tomographic angiography,fractional flow reserve,non-invasive testing


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