Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial

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dc.contributor.authorWang, Kaijun
dc.contributor.authorLi, Haiyan
dc.contributor.authorKwong, Winghan J.
dc.contributor.authorAntman, Elliott M.
dc.contributor.authorRuff, Christian T.
dc.contributor.authorGiugliano, Robert P.
dc.contributor.authorCohen, David J.
dc.date.accessioned2024-02-23T14:26:44Z
dc.date.available2024-02-23T14:26:44Z
dc.date.issued2017
dc.departmentNEÜen_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; 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.en_US
dc.description.sponsorshipDaiichi Sankyo, Inc.en_US
dc.description.sponsorshipThe study was funded by a grant from Daiichi Sankyo, Inc.en_US
dc.identifier.doi10.1161/JAHA.117.006703
dc.identifier.issn2047-9980
dc.identifier.issue8en_US
dc.identifier.pmid28862934en_US
dc.identifier.urihttps://doi.org/10.1161/JAHA.117.006703
dc.identifier.urihttps://hdl.handle.net/20.500.12452/14312
dc.identifier.volume6en_US
dc.identifier.wosWOS:000427296800031en_US
dc.identifier.wosqualityQ2en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherWileyen_US
dc.relation.ispartofJournal Of The American Heart Associationen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectAnticoagulationen_US
dc.subjectBleedingen_US
dc.subjectQuality Of Lifeen_US
dc.subjectUtilityen_US
dc.titleImpact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trialen_US
dc.typeArticleen_US

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