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      Fractional flow reserve derived from computed tomography coronary angiography in the assessment and management of stable chest pain: the FORECAST randomized trial

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          Abstract

          Aims 

          Fractional flow reserve (FFR CT) using computed tomography coronary angiography (CTCA) determines both the presence of coronary artery disease and vessel-specific ischaemia. We tested whether an evaluation strategy based on FFR CT would improve economic and clinical outcomes compared with standard care.

          Methods and results 

          Overall, 1400 patients with stable chest pain in 11 centres were randomized to initial testing with CTCA with selective FFR CT (experimental group) or standard clinical care pathways (standard group). The primary endpoint was total cardiac costs at 9 months. Secondary endpoints were angina status, quality of life, major adverse cardiac and cerebrovascular events, and use of invasive coronary angiography. Randomized groups were similar at baseline. Most patients had an initial CTCA: 439 (63%) in the standard group vs. 674 (96%) in the experimental group, 254 of whom (38%) underwent FFR CT. Mean total cardiac costs were higher by £114 (+8%) in the experimental group, with a 95% confidence interval from −£112 (−8%) to +£337 (+23%), though the difference was not significant ( P = 0.10). Major adverse cardiac and cerebrovascular events did not differ significantly (10.2% in the experimental group vs. 10.6% in the standard group) and angina and quality of life improved to a similar degree over follow-up in both randomized groups. Invasive angiography was reduced significantly in the experimental group (19% vs. 25%, P = 0.01).

          Conclusion 

          A strategy of CTCA with selective FFR CT in patients with stable angina did not differ significantly from standard clinical care pathways in cost or clinical outcomes, but did reduce the use of invasive coronary angiography.

          Graphical Abstract

          Summarising trial design and main results.

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          Most cited references30

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          EuroQol - a new facility for the measurement of health-related quality of life

          (1990)
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            EuroQol--a new facility for the measurement of health-related quality of life.

            (1990)
            In the course of developing a standardised, non-disease-specific instrument for describing and valuing health states (based on the items in Table 1), the EuroQol Group (whose members are listed in the Appendix) conducted postal surveys in England, The Netherlands and Sweden which indicate a striking similarity in the relative valuations attached to 14 different health states. The data were collected using a visual analogue scale similar to a thermometer. The EuroQol instrument is intended to complement other quality-of-life measures and to facilitate the collection of a common data set for reference purposes. Others interested in participating in the extension of this work are invited to contact the EuroQol Group.
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              Fractional flow reserve versus angiography for guiding percutaneous coronary intervention.

              In patients with multivessel coronary artery disease who are undergoing percutaneous coronary intervention (PCI), coronary angiography is the standard method for guiding the placement of the stent. It is unclear whether routine measurement of fractional flow reserve (FFR; the ratio of maximal blood flow in a stenotic artery to normal maximal flow), in addition to angiography, improves outcomes. In 20 medical centers in the United States and Europe, we randomly assigned 1005 patients with multivessel coronary artery disease to undergo PCI with implantation of drug-eluting stents guided by angiography alone or guided by FFR measurements in addition to angiography. Before randomization, lesions requiring PCI were identified on the basis of their angiographic appearance. Patients assigned to angiography-guided PCI underwent stenting of all indicated lesions, whereas those assigned to FFR-guided PCI underwent stenting of indicated lesions only if the FFR was 0.80 or less. The primary end point was the rate of death, nonfatal myocardial infarction, and repeat revascularization at 1 year. The mean (+/-SD) number of indicated lesions per patient was 2.7+/-0.9 in the angiography group and 2.8+/-1.0 in the FFR group (P=0.34). The number of stents used per patient was 2.7+/-1.2 and 1.9+/-1.3, respectively (P<0.001). The 1-year event rate was 18.3% (91 patients) in the angiography group and 13.2% (67 patients) in the FFR group (P=0.02). Seventy-eight percent of the patients in the angiography group were free from angina at 1 year, as compared with 81% of patients in the FFR group (P=0.20). Routine measurement of FFR in patients with multivessel coronary artery disease who are undergoing PCI with drug-eluting stents significantly reduces the rate of the composite end point of death, nonfatal myocardial infarction, and repeat revascularization at 1 year. (ClinicalTrials.gov number, NCT00267774.) 2009 Massachusetts Medical Society
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                Author and article information

                Journal
                Eur Heart J
                Eur Heart J
                eurheartj
                European Heart Journal
                Oxford University Press
                0195-668X
                1522-9645
                01 October 2021
                16 July 2021
                16 July 2021
                : 42
                : 37 , Focus Issue on Ischaemic Heart Disease
                : 3844-3852
                Affiliations
                [1 ] Faculty of Medicine, University of Southampton
                [2 ] Coronary Research Group, University Hospital Southampton
                [3 ] Clinical Trials Unit, University of Southampton
                [4 ] Cardiothoracic Radiology, University Hospital Southampton
                [5 ] Imperial College , London, UK
                [6 ] Sandwell Hospital , Birmingham, UK
                [7 ] Dorset Heart Centre, University Hospitals Dorset , Bournemouth
                [8 ] Queen Alexandra Hospital , Portsmouth
                [9 ] Royal Victoria Hospital , Blackpool
                [10 ] Royal Infirmary , Edinburgh
                [11 ] Department of Cardiovascular Sciences, University of Leicester & NIHR Biomedical Research Centre, Glenfield Hospital , Leicester, UK
                [12 ] British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow
                [13 ] University Hospital of North Tees , Stockton on Tees
                [14 ] Derriford Hospital , Plymouth
                [15 ] Royal Stoke University Hospital , Stoke-on-Trent
                [16 ] Guy’s & St Thomas’ Hospital , London
                [17 ] Robertson Centre for Biostatistics, University of Glasgow , Glasgow
                [18 ] Duke University , Durham, NC, USA
                [19 ] Stanford University , Stanford, CA, USA
                Author notes
                Corresponding author. Tel: 44 2381205523, Email: nick.curzen@ 123456uhs.nhs.uk
                Author information
                https://orcid.org/0000-0001-9651-7829
                https://orcid.org/0000-0001-5432-7437
                https://orcid.org/0000-0003-4184-2821
                https://orcid.org/0000-0001-5289-4454
                https://orcid.org/0000-0002-3084-5106
                https://orcid.org/0000-0003-1234-5455
                https://orcid.org/0000-0002-1981-1976
                https://orcid.org/0000-0002-5826-2594
                https://orcid.org/0000-0002-6349-6635
                https://orcid.org/0000-0002-8549-4673
                https://orcid.org/0000-0002-8211-3484
                https://orcid.org/0000-0002-4547-8636
                https://orcid.org/0000-0001-5066-7645
                https://orcid.org/0000-0001-9241-8890
                https://orcid.org/0000-0001-5927-1823
                https://orcid.org/0000-0001-9876-4049
                https://orcid.org/0000-0003-4686-9441
                Article
                ehab444
                10.1093/eurheartj/ehab444
                8648068
                34269376
                1934716e-9d2f-405e-804f-e5142deee4cb
                © The Author(s) 2021. 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 License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 17 February 2021
                : 10 May 2021
                : 25 June 2021
                : 17 June 2021
                Page count
                Pages: 11
                Funding
                Funded by: Research & Development Department of University Hospital Southampton NHS Foundation Trust;
                Funded by: NIHR Research Professorship;
                Award ID: 2017-08-ST2-007
                Funded by: IHR Leicester Biomedical Research Centre;
                Funded by: NIHR Leicester Clinical Research Facility;
                Categories
                Clinical Research
                Ischaemic Heart Disease
                AcademicSubjects/MED00200

                Cardiovascular Medicine
                computed tomography coronary angiography,cost analysis,fractional flow reserve (ffrct),myocardial,randomized controlled trial,stable angina,quality of life

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