Clinical and health care resource use burden of hospitalizations for oral factor Xa inhibitor‐associated major bleeding: A real‐world analysis of Medicare beneficiaries

Abstract Objective To characterize the burden of illness associated with oral factor Xa (FXa) inhibitor‐related bleeding in the US Medicare population. Methods This retrospective cohort study used the full 20% Medicare random sample claims database to identify patients who experienced their first ho...

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Main Authors: James M. Williams, Belinda Lovelace, Mary J. Christoph, Suying Li, Haifeng Guo, Madison Hoover, Craig I. Coleman
Format: Article
Language:English
Published: Elsevier 2023-06-01
Series:Journal of the American College of Emergency Physicians Open
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Online Access:https://doi.org/10.1002/emp2.12956
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author James M. Williams
Belinda Lovelace
Mary J. Christoph
Suying Li
Haifeng Guo
Madison Hoover
Craig I. Coleman
author_facet James M. Williams
Belinda Lovelace
Mary J. Christoph
Suying Li
Haifeng Guo
Madison Hoover
Craig I. Coleman
author_sort James M. Williams
collection DOAJ
description Abstract Objective To characterize the burden of illness associated with oral factor Xa (FXa) inhibitor‐related bleeding in the US Medicare population. Methods This retrospective cohort study used the full 20% Medicare random sample claims database to identify patients who experienced their first hospitalization for an FXa inhibitor‐related major bleed between October 2013 and September 2017. Bleeding types were classified as intracranial hemorrhage (ICH), gastrointestinal (GI), and other. Associations between risk factors and outcomes (in‐hospital and 30‐day mortality, 30‐day readmission, and discharge to a location other than home) adjusted for patient demographic characteristics, baseline clinical conditions, index event characteristics, treatment with hemostatic/factor replacement agents or transfusion (ie, usual care prereversal agent availability), multicompartment ICH and neurosurgical procedures (ICH cohort), and endoscopy (GI cohort) were assessed using multivariable regression and reported as crude incidences and adjusted odds ratios (ORs) stratified by bleed type. Results Of the 11,593 patients identified, 2737 (23.6%) had ICH, 8169 (70.5%) had GI bleeds, and 687 (5.9%) had other bleeds. The incidences of in‐hospital mortality, 30‐day mortality, need for postdischarge out‐of‐home care, and 30‐day readmission were 15.7%, 29.1%, 78.3%, and 20.3% in the single‐compartment ICH cohort, respectively; and 1.7%, 6.8%, 41.3%, and 18.8% in the GI bleeds cohort, respectively. Increased odds of both in‐hospital mortality and 30‐day mortality were significantly associated with: multicompartment ICH (reference, single compartment ICH; OR = 3.35 [95% confidence interval (CI): 2.41–4.66]; 2.18 [95% CI: 1.63–2.91]), loss of consciousness during index hospitalization (yes vs no; OR = 2.03 [95% CI: 1.38–2.97]; 1.49 [95% CI: 1.11–2.02]), receiving usual care (yes vs no; OR = 1.55 [95% CI: 1.22–1.98]; 1.33 [95% CI: 1.09–1.63]) during index hospitalization, and increasing number of Elixhauser comorbidities at baseline (OR = 1.07 [95% CI: 1.03–1.10]; 1.09 [95% CI: 1.06–1.12]) in the ICH cohort; intensive care unit admission (yes vs no; OR = 1.88 [95% CI: 1.32–2.67]; 1.51 [95% CI: 1.26–1.81]), increasing number of Elixhauser comorbidities at baseline (OR = 1.12 [95% CI: 1.07–1.18]; 1.15 [1.12–1.18]), and increasing age on index date (OR = 1.04 [95% CI: 1.02–1.07]; 1.05 [95% CI: 1.04–1.07]) in the GI bleeds cohort. Conclusions In this large sample of Medicare patients, FXa inhibitor‐related major bleeding was associated with substantial burden in terms of adverse clinical outcomes and health care resource use. Incidence of ICH was lower than GI bleeds; however, burden of illness was notably higher with ICH.
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spelling doaj-art-b234e6f95f164e549d0ec7424fb3e0ab2025-08-20T01:51:10ZengElsevierJournal of the American College of Emergency Physicians Open2688-11522023-06-0143n/an/a10.1002/emp2.12956Clinical and health care resource use burden of hospitalizations for oral factor Xa inhibitor‐associated major bleeding: A real‐world analysis of Medicare beneficiariesJames M. Williams0Belinda Lovelace1Mary J. Christoph2Suying Li3Haifeng Guo4Madison Hoover5Craig I. Coleman6Medical Center Emergency Department Meritus Health Hagerstown Maryland USAAlexion AstraZeneca Rare Disease Boston Massachusetts USAAlexion AstraZeneca Rare Disease Boston Massachusetts USAChronic Disease Research Group Hennepin Healthcare Research Institute Minneapolis Minnesota USAChronic Disease Research Group Hennepin Healthcare Research Institute Minneapolis Minnesota USAChronic Disease Research Group Hennepin Healthcare Research Institute Minneapolis Minnesota USADepartment of Pharmacy Practice University of Connecticut School of Pharmacy Storrs Connecticut USAAbstract Objective To characterize the burden of illness associated with oral factor Xa (FXa) inhibitor‐related bleeding in the US Medicare population. Methods This retrospective cohort study used the full 20% Medicare random sample claims database to identify patients who experienced their first hospitalization for an FXa inhibitor‐related major bleed between October 2013 and September 2017. Bleeding types were classified as intracranial hemorrhage (ICH), gastrointestinal (GI), and other. Associations between risk factors and outcomes (in‐hospital and 30‐day mortality, 30‐day readmission, and discharge to a location other than home) adjusted for patient demographic characteristics, baseline clinical conditions, index event characteristics, treatment with hemostatic/factor replacement agents or transfusion (ie, usual care prereversal agent availability), multicompartment ICH and neurosurgical procedures (ICH cohort), and endoscopy (GI cohort) were assessed using multivariable regression and reported as crude incidences and adjusted odds ratios (ORs) stratified by bleed type. Results Of the 11,593 patients identified, 2737 (23.6%) had ICH, 8169 (70.5%) had GI bleeds, and 687 (5.9%) had other bleeds. The incidences of in‐hospital mortality, 30‐day mortality, need for postdischarge out‐of‐home care, and 30‐day readmission were 15.7%, 29.1%, 78.3%, and 20.3% in the single‐compartment ICH cohort, respectively; and 1.7%, 6.8%, 41.3%, and 18.8% in the GI bleeds cohort, respectively. Increased odds of both in‐hospital mortality and 30‐day mortality were significantly associated with: multicompartment ICH (reference, single compartment ICH; OR = 3.35 [95% confidence interval (CI): 2.41–4.66]; 2.18 [95% CI: 1.63–2.91]), loss of consciousness during index hospitalization (yes vs no; OR = 2.03 [95% CI: 1.38–2.97]; 1.49 [95% CI: 1.11–2.02]), receiving usual care (yes vs no; OR = 1.55 [95% CI: 1.22–1.98]; 1.33 [95% CI: 1.09–1.63]) during index hospitalization, and increasing number of Elixhauser comorbidities at baseline (OR = 1.07 [95% CI: 1.03–1.10]; 1.09 [95% CI: 1.06–1.12]) in the ICH cohort; intensive care unit admission (yes vs no; OR = 1.88 [95% CI: 1.32–2.67]; 1.51 [95% CI: 1.26–1.81]), increasing number of Elixhauser comorbidities at baseline (OR = 1.12 [95% CI: 1.07–1.18]; 1.15 [1.12–1.18]), and increasing age on index date (OR = 1.04 [95% CI: 1.02–1.07]; 1.05 [95% CI: 1.04–1.07]) in the GI bleeds cohort. Conclusions In this large sample of Medicare patients, FXa inhibitor‐related major bleeding was associated with substantial burden in terms of adverse clinical outcomes and health care resource use. Incidence of ICH was lower than GI bleeds; however, burden of illness was notably higher with ICH.https://doi.org/10.1002/emp2.12956cost of illnessfactor Xa inhibitorsgastrointestinal hemorrhagesintracranial hemorrhages
spellingShingle James M. Williams
Belinda Lovelace
Mary J. Christoph
Suying Li
Haifeng Guo
Madison Hoover
Craig I. Coleman
Clinical and health care resource use burden of hospitalizations for oral factor Xa inhibitor‐associated major bleeding: A real‐world analysis of Medicare beneficiaries
Journal of the American College of Emergency Physicians Open
cost of illness
factor Xa inhibitors
gastrointestinal hemorrhages
intracranial hemorrhages
title Clinical and health care resource use burden of hospitalizations for oral factor Xa inhibitor‐associated major bleeding: A real‐world analysis of Medicare beneficiaries
title_full Clinical and health care resource use burden of hospitalizations for oral factor Xa inhibitor‐associated major bleeding: A real‐world analysis of Medicare beneficiaries
title_fullStr Clinical and health care resource use burden of hospitalizations for oral factor Xa inhibitor‐associated major bleeding: A real‐world analysis of Medicare beneficiaries
title_full_unstemmed Clinical and health care resource use burden of hospitalizations for oral factor Xa inhibitor‐associated major bleeding: A real‐world analysis of Medicare beneficiaries
title_short Clinical and health care resource use burden of hospitalizations for oral factor Xa inhibitor‐associated major bleeding: A real‐world analysis of Medicare beneficiaries
title_sort clinical and health care resource use burden of hospitalizations for oral factor xa inhibitor associated major bleeding a real world analysis of medicare beneficiaries
topic cost of illness
factor Xa inhibitors
gastrointestinal hemorrhages
intracranial hemorrhages
url https://doi.org/10.1002/emp2.12956
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