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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Date
2017-08-11ICR Author
Author
Wang, K
Li, H
Kwong, WJ
Antman, EM
Ruff, CT
Giugliano, RP
Cohen, DJ
Magnuson, EA
ENGAGE AF‐TIMI 48 Trial Investigators,
Type
Journal Article
Metadata
Show full item recordAbstract
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.
Collections
Subject
ENGAGE AF‐TIMI 48 Trial Investigators
Humans
Atrial Fibrillation
Embolism
Hemorrhage
Gastrointestinal Hemorrhage
Pyridines
Thiazoles
Warfarin
Anticoagulants
Treatment Outcome
Risk Factors
Prospective Studies
Health Status
Blood Coagulation
Time Factors
Quality of Life
Aged
Aged, 80 and over
Middle Aged
Female
Male
Stroke
Factor Xa Inhibitors
Surveys and Questionnaires
Research team
Molecular Oncology
Molecular Oncology
Language
eng
Date accepted
2017-08-11
License start date
2017-08-11
Citation
Journal of the American Heart Association, 2017, 6 (8)
Publisher
WILEY