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      Health-Related Quality of Life and Angina in Fractional Flow Reserve- Versus Angiography-Guided Coronary Artery Bypass Grafting: FARGO Trial (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization)

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          Abstract

          Background:

          In coronary artery bypass grafting (CABG), the use of fractional flow reserve (FFR) is insufficiently investigated. Stenosis assessment usually relies on visual estimates of lesion severity. This study evaluated health-related quality of life (HRQoL) and angina after FFR- versus angiography-guided CABG.

          Methods:

          One hundred patients referred for CABG were randomized to FFR- or angiography-guided CABG. In the FFR group, lesions with FFR>0.80 were deferred, while the surgeon was blinded to the FFR values in the angiography group. Before and 6 months after CABG, HRQoL was assessed by the health state classifier EQ-5D of the EuroQoL 5-level instrument and angina status based on the Canadian Cardiovascular Society classification system were registered.

          Results:

          Six-month angiography included FFR evaluations of deferred lesions. In total, completed EQ-5D of the EuroQoL 5-level instrument questionnaires were available in 86 patients (43 in the FFR versus 43 in the angiography-guided group). HRQoL was significantly improved and angina significantly decreased from baseline to 6 months after CABG with no difference between the randomization groups. Graft failure rates and clinical outcomes were similar in both groups. Patients with graft failure or FFR<0.80 of the previous deferred lesions had significantly lower visual analogue scale scores (78.7±14.2 versus 86.8±14.7, P =0.004) and more angina compared with patients without graft failure or FFR≥0.80 at 6-month follow-up.

          Conclusions:

          FFR- versus angiography-guided CABG demonstrated similar improvements in HRQoL and angina 6 months after CABG. Graft failure or low FFR in deferred lesions were associated with low HRQoL and angina.

          Registration:

          URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02477371

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          Most cited references33

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          Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

          Purpose This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. Methods EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument’s sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. Results Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording ‘slight-moderate-severe’ problems, with anchors of ‘no problems’ and ‘unable to do’ in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. Conclusions A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.
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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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              EQ-SD: a measure of health status from the EuroQol Group

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                Author and article information

                Contributors
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                Journal
                Circulation: Cardiovascular Quality and Outcomes
                Circ: Cardiovascular Quality and Outcomes
                Ovid Technologies (Wolters Kluwer Health)
                1941-7713
                1941-7705
                June 2021
                June 2021
                : 14
                : 6
                Affiliations
                [1 ]Department of Cardiology (A.L.T., K.T.V., B.B., A.J., L.O.J.), Odense University Hospital, Denmark.
                [2 ]Department of Cardiothoracic Surgery (A.L.T., L.P.R., P.E.M.), Odense University Hospital, Denmark.
                [3 ]Department of Cardiology (E.H.C.), Aarhus University Hospital, Skejby, Denmark.
                [4 ]Department of Cardiology, Aalborg University Hospital, Denmark (S.E.J.).
                [5 ]Department of Cardiothoracic Surgery (I.M.), Aarhus University Hospital, Skejby, Denmark.
                [6 ]Department of Cardiothoracic Surgery, Aalborg University Hospital, Denmark (J.J.A.).
                [7 ]Department of Clinical Research, Aalborg University, Denmark (J.J.A.).
                [8 ]Department of Clinical Research, University of Southern Denmark, Odense, Denmark (B.B., L.O.J.).
                Article
                10.1161/CIRCOUTCOMES.120.007302
                34078097
                682661c0-f6aa-444a-a751-b7f801d85fb5
                © 2021
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