dc.contributor.author | Wang, K | |
dc.contributor.author | Li, H | |
dc.contributor.author | Kwong, WJ | |
dc.contributor.author | Antman, EM | |
dc.contributor.author | Ruff, CT | |
dc.contributor.author | Giugliano, RP | |
dc.contributor.author | Cohen, DJ | |
dc.contributor.author | Magnuson, EA | |
dc.contributor.author | ENGAGE AF‐TIMI 48 Trial Investigators, | |
dc.date.accessioned | 2021-06-11T11:37:37Z | |
dc.date.available | 2021-06-11T11:37:37Z | |
dc.date.issued | 2017-08-11 | |
dc.identifier.citation | Journal of the American Heart Association, 2017, 6 (8) | |
dc.identifier.issn | 2047-9980 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4615 | |
dc.identifier.eissn | 2047-9980 | |
dc.identifier.doi | 10.1161/jaha.117.006703 | |
dc.description.abstract | BACKGROUND: 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; P<0.001] and -0.029 [-0.046 to -0.012; P=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]; P<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.format | Electronic | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | WILEY | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc/4.0 | |
dc.subject | ENGAGE AF‐TIMI 48 Trial Investigators | |
dc.subject | Humans | |
dc.subject | Atrial Fibrillation | |
dc.subject | Embolism | |
dc.subject | Hemorrhage | |
dc.subject | Gastrointestinal Hemorrhage | |
dc.subject | Pyridines | |
dc.subject | Thiazoles | |
dc.subject | Warfarin | |
dc.subject | Anticoagulants | |
dc.subject | Treatment Outcome | |
dc.subject | Risk Factors | |
dc.subject | Prospective Studies | |
dc.subject | Health Status | |
dc.subject | Blood Coagulation | |
dc.subject | Time Factors | |
dc.subject | Quality of Life | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Male | |
dc.subject | Stroke | |
dc.subject | Factor Xa Inhibitors | |
dc.subject | Surveys and Questionnaires | |
dc.title | Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2017-08-11 | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1161/jaha.117.006703 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by-nc/4.0 | |
rioxxterms.licenseref.startdate | 2017-08-11 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Journal of the American Heart Association | |
pubs.issue | 8 | |
pubs.notes | Not 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-status | Published | |
pubs.volume | 6 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Molecular Oncology | |
icr.researchteam | Molecular Oncology | |
dc.contributor.icrauthor | Turner, Nicholas | |