ORIGINAL RESEARCH
Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial Kaijun Wang, PhD; Haiyan Li, MS; Winghan J. Kwong, PharmD, PhD; Elliott M. Antman, MD; Christian T. Ruff, MD, MPH; Robert P. Giugliano, MD, MS; David J. Cohen, MD, MSc; Elizabeth A. Magnuson, ScD; on behalf of the ENGAGE AF-TIMI 48 Trial Investigators*
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
Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial Kaijun Wang, PhD; Haiyan Li, MS; Winghan J. Kwong, PharmD, PhD; Elliott M. Antman, MD; Christian T. Ruff, MD, MPH; Robert P. Giugliano, MD, MS; David J. Cohen, MD, MSc; Elizabeth A. Magnuson, ScD; on behalf of the ENGAGE AF-TIMI 48 Trial Investigators*
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
