Comparative Effectiveness and Safety of Factor Xa Inhibitors in Atrial Fibrillation: A Systematic Literature Review of Real-World Evidence in Europe
Author(s)
Siqi Yang, MPH1, Binkai Liu, MS2, Lixia Yao, PhD3, Shivani Kapoor, PharmD4, Rosa Wang, MHA4.
1Boston University, Boston, MA, USA, 2Harvard University, Cambridge, MA, USA, 3Polygon Health Analytics LLC, Philadelphia, PA, USA, 4Daiichi Sankyo, Basking Ridge, NJ, USA.
1Boston University, Boston, MA, USA, 2Harvard University, Cambridge, MA, USA, 3Polygon Health Analytics LLC, Philadelphia, PA, USA, 4Daiichi Sankyo, Basking Ridge, NJ, USA.
OBJECTIVES: This study investigates the comparative effectiveness and safety of factor Xa inhibitors prescribed for atrial fibrillation in routine clinical settings across the EU through a systematic literature review of independent research conducted from 2022 to 2024.
METHODS: We conducted a systematic search in MEDLINE, focusing on English-language publications from the specified period. Articles co-authored with pharmaceutical companies were excluded. Two reviewers independently assessed the studies, with a third reviewer resolving conflicts. Effectiveness outcomes included stroke and systemic embolism, while safety outcomes encompassed major bleeding, gastrointestinal bleeding, other bleeding events, and mortality. Evidence synthesis was conducted for different sub-populations extracted from the identified literature.
RESULTS: All factor Xa inhibitors (edoxaban, apixaban, and rivaroxaban) demonstrated robust efficacy and safety profiles. Edoxaban generally showed a similar or lower risk of stroke and systemic embolism compared to Apixaban, while maintaining a comparable bleeding risk among atrial fibrillation patients. Rivaroxaban was associated with a higher risk of bleeding and mortality compared to Apixaban. Analyses across different comorbid subgroups revealed no specific preference for either drug in the geriatric population. For patients with atrial fibrillation and anemia, both edoxaban and apixaban demonstrated a low risk of major bleeding. In individuals with obesity, the effectiveness and safety of factor Xa remained consistent, regardless of body mass index.
CONCLUSIONS: Factor Xa inhibitors are effective for treating atrial fibrillation, offering significant benefits in preventing stroke and systemic embolism. These medications are particularly valuable for patients with comorbidities, including anemia and obesity, as they provide a favorable balance between efficacy and safety. The ability to maintain consistent anticoagulation without the need for frequent monitoring makes factor Xa inhibitors a practical and reliable choice in diverse patient populations. Their effectiveness and safety profile support their use in routine clinical practice, contributing to improved patient outcomes and quality of life.
METHODS: We conducted a systematic search in MEDLINE, focusing on English-language publications from the specified period. Articles co-authored with pharmaceutical companies were excluded. Two reviewers independently assessed the studies, with a third reviewer resolving conflicts. Effectiveness outcomes included stroke and systemic embolism, while safety outcomes encompassed major bleeding, gastrointestinal bleeding, other bleeding events, and mortality. Evidence synthesis was conducted for different sub-populations extracted from the identified literature.
RESULTS: All factor Xa inhibitors (edoxaban, apixaban, and rivaroxaban) demonstrated robust efficacy and safety profiles. Edoxaban generally showed a similar or lower risk of stroke and systemic embolism compared to Apixaban, while maintaining a comparable bleeding risk among atrial fibrillation patients. Rivaroxaban was associated with a higher risk of bleeding and mortality compared to Apixaban. Analyses across different comorbid subgroups revealed no specific preference for either drug in the geriatric population. For patients with atrial fibrillation and anemia, both edoxaban and apixaban demonstrated a low risk of major bleeding. In individuals with obesity, the effectiveness and safety of factor Xa remained consistent, regardless of body mass index.
CONCLUSIONS: Factor Xa inhibitors are effective for treating atrial fibrillation, offering significant benefits in preventing stroke and systemic embolism. These medications are particularly valuable for patients with comorbidities, including anemia and obesity, as they provide a favorable balance between efficacy and safety. The ability to maintain consistent anticoagulation without the need for frequent monitoring makes factor Xa inhibitors a practical and reliable choice in diverse patient populations. Their effectiveness and safety profile support their use in routine clinical practice, contributing to improved patient outcomes and quality of life.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO82
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)