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dc.contributor.authorWang, K
dc.contributor.authorLi, H
dc.contributor.authorKwong, WJ
dc.contributor.authorAntman, EM
dc.contributor.authorRuff, CT
dc.contributor.authorGiugliano, RP
dc.contributor.authorCohen, DJ
dc.contributor.authorMagnuson, EA
dc.contributor.authorENGAGE AF‐TIMI 48 Trial Investigators
dc.date.accessioned2021-06-11T11:37:37Z
dc.date.available2021-06-11T11:37:37Z
dc.date.issued2017-08-11
dc.identifier.citationJournal of the American Heart Association, 2017, 6 (8)
dc.identifier.issn2047-9980
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4615
dc.identifier.eissn2047-9980
dc.identifier.eissn2047-9980en_US
dc.identifier.doi10.1161/jaha.117.006703
dc.identifier.doi10.1161/jaha.117.006703en_US
dc.description.abstractBackground The impact of different types of extracranial bleeding events on health-related quality of life and health-state utility among patients with atrial fibrillation is not well understood.Methods and results The ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) Trial compared edoxaban with warfarin with respect to the prevention of stroke or systemic embolism in atrial fibrillation. Data from the EuroQol-5D (EQ-5D-3L) questionnaire, prospectively collected at 3-month intervals for up to 48 months, were used to estimate the impact of different categories of bleeding events on health-state utility over 12 months following the event. Longitudinal mixed-effect models revealed that major gastrointestinal bleeds and major nongastrointestinal bleeds were associated with significant immediate decreases in utility scores (-0.029 [-0.044 to -0.014; <i>P</i><0.001] and -0.029 [-0.046 to -0.012; <i>P</i>=0.001], respectively). These effects decreased in magnitude over time, and were no longer significant for major nongastrointestinal bleeds at 9 months, but remained borderline significant for major gastrointestinal bleeds at 12 months. Clinically relevant nonmajor and minor bleeds were associated with smaller but measurable immediate impacts on utility (-0.010 [-0.016 to -0.005] and -0.016 [-0.024 to -0.008]; <i>P</i><0.001 for both), which remained relatively constant and statistically significant over the 12 months following the bleeding event.Conclusions All categories of bleeding events were associated with negative impacts on health-state utility in patients with atrial fibrillation. Major bleeds were associated with relatively large immediate decreases in utility scores that gradually diminished over 12 months; clinically relevant nonmajor and minor bleeds were associated with smaller immediate decreases in utility that persisted over 12 months.Clinical trial registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00781391.
dc.formatElectronic
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0
dc.subjectENGAGE AF‐TIMI 48 Trial Investigators
dc.subjectHumans
dc.subjectAtrial Fibrillation
dc.subjectEmbolism
dc.subjectHemorrhage
dc.subjectGastrointestinal Hemorrhage
dc.subjectPyridines
dc.subjectThiazoles
dc.subjectWarfarin
dc.subjectAnticoagulants
dc.subjectTreatment Outcome
dc.subjectRisk Factors
dc.subjectProspective Studies
dc.subjectHealth Status
dc.subjectBlood Coagulation
dc.subjectTime Factors
dc.subjectQuality of Life
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectStroke
dc.subjectFactor Xa Inhibitors
dc.subjectSurveys and Questionnaires
dc.titleImpact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial.
dc.typeJournal Article
dcterms.dateAccepted2017-08-11
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1161/jaha.117.006703
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by-nc/4.0
rioxxterms.licenseref.startdate2017-08-11
rioxxterms.licenseref.startdate2017-08-11en_US
dc.relation.isPartOfJournal of the American Heart Association
pubs.issue8
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research/Molecular Oncology
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research/Molecular Oncology
pubs.publication-statusPublished
pubs.volume6en_US
pubs.embargo.termsNot known
icr.researchteamMolecular Oncology
icr.researchteamMolecular Oncologyen_US
dc.contributor.icrauthorTurner, Nicholasen


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