Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial
机构:[1]Saint Luke’s Mid America Heart Institute, Kansas City, MO[2]University of Missouri—Kansas City School of Medicine, Kansas City, MO[3]Daiichi Sankyo, Inc, Parsippany, NJ[4]TIMI Study Group, Brigham and Women’s Hospital, Boston, MA
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.
基金:
The study was funded by a grant from Daiichi Sankyo, Inc.
第一作者机构:[1]Saint Luke’s Mid America Heart Institute, Kansas City, MO
通讯作者:
通讯机构:[1]Saint Luke’s Mid America Heart Institute, Kansas City, MO[2]University of Missouri—Kansas City School of Medicine, Kansas City, MO[*1]Saint Luke’s Mid America Heart Institute, University of Missouri—Kansas City School of Medicine, 4401 Wornall Rd, Kansas City, MO.
推荐引用方式(GB/T 7714):
Kaijun Wang,Haiyan Li,Winghan J. Kwong,et al.Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial[J].JOURNAL OF THE AMERICAN HEART ASSOCIATION.2017,6(8):doi:10.1161/JAHA.117.006703.
APA:
Kaijun Wang,Haiyan Li,Winghan J. Kwong,Elliott M. Antman,Christian T. Ruff...&the ENGAGE AF-TIMI 48 Trial Investigators.(2017).Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial.JOURNAL OF THE AMERICAN HEART ASSOCIATION,6,(8)
MLA:
Kaijun Wang,et al."Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial".JOURNAL OF THE AMERICAN HEART ASSOCIATION 6..8(2017)