Safety and effectiveness of rivaroxaban and apixaban in patients with venous thromboembolism: a nationwide study
Open accessAbstract
Aims: To investigate the risk of all-cause mortality, recurrent venous thromboembolism (VTE), and hospitalized bleeding in patients with VTE treated with either rivaroxaban or apixaban. Methods and results: Using Danish nationwide registries, patients with VTE treated with rivaroxaban or apixaban in the period from 1 January 2015 to 30 June 2017 were identified. Standardized absolute risks were estimated based on outcome-specific Cox regression models, adjusted for potential confounders. A total of 8187 patients were included in the study, of which 1504 (18%) were treated with apixaban [50% males, median age 70 years; interquartile range (IQR) 56-80] and 6683 (82%) were treated with rivaroxaban (55% males, median age 67 years; IQR 53-76). The 180 days risk of all-cause mortality was 5.08% [95% confidence interval (95% CI) 4.08% to 6.08%)] in the apixaban group and 4.60% (95% CI 4.13% to 5.18%) in the rivaroxaban group [absolute risk difference: -0.48% (95% CI -1.49% to 0.72%)]. The 180 days risk of recurrent VTE was 2.16% (95% CI 1.49% to 2.88%) in the apixaban group and 2.22% (95% CI 1.89% to 2.52%) in the rivaroxaban group [absolute risk difference of 0.06% (95% CI -0.72% to 0.79%)]. The 180 days risk of hospitalized bleeding was 1.73% (95% CI 1.22% to 2.35%) for patients in the apixaban group and 1.89% (95% CI 1.56% to 2.20%) in the rivaroxaban group [absolute risk difference: 0.16% (95% CI -0.59% to 0.81%)]. Conclusion: In a nationwide cohort of 8187 patients with VTE treated with rivaroxaban or apixaban, there were no significant differences in the risks of all-cause mortality, recurrent VTE, or hospitalized bleeding.
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The 5 selected studies assessed similar efficacy end points and outcomes but were slightly different in overall design and outcome definitions.
“Although the 5 selected studies 8-11,14 assessed similar efficacy end points and outcomes, they were slightly different in terms of overall design and outcome definitions (Table 1).”
From Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world (2019) · cites this paper as [8]
The Outcome measures section (page not provided) shows that this study assessed recurrent VTE and other outcomes and defined recurrent VTE using inpatient admissions. The Discussion (page not provided) says the EINSTEIN and AMPLIFY trials differed in study design, but it does not establish that all five selected studies had similar efficacy endpoints or differing outcome definitions. (LLM, conf=0.82)
Experimental — accuracy not yet measuredA total of 5 studies were included for analysis: 1 thrombophilia clinic registry review, 1 retrospective review of veterans, and 3 database studies from the United States and Denmark.
“A total of 5 studies were included for analysis: 1 study included a review of data from a thrombophilia clinic registry, 1 study included a review of retrospective data of veterans, and 3 were database studies from the United States and Denmark.”
From Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world (2019) · cites this paper as [8]
Various retrospective studies have been carried out looking at head-to-head comparisons between apixaban and rivaroxaban on VTE recurrence risk and bleeding risk.
“Various retrospective studies (database, registries) have been carried out looking at head-to-head comparisons between apixaban and rivaroxaban on VTE recurrence risk and bleeding risk. 8-11”
From Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world (2019) · cites this paper as [8]
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- Authors
- Sindet-Pedersen, C., Staerk, L., Pallisgaard, J. L., Gerds, T. A., Berger, J. S., Torp-Pedersen, C., Gislason, G. H., & Olesen, J. B.
- Affiliations
- Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Kildegaardsvej 28, Hellerup, Denmark
- Copenhagen University Hospital (DK)
- University of Copenhagen (DK)
- New York University (US)
- Aalborg University Hospital (DK)
- ORCID
- Venue
- European Heart Journal - Cardiovascular Pharmacotherapy
- Publisher
- Oxford University Press (OUP)
- Published
- 2018-06-26
- Volume
- 4
- Issue
- 4
- Pages
- 220-227
- ISSN
- 2055-6837 (ISSN-L)
- 2055-6845
- OpenAlex
- W2810639661
- Cited by
- 30
- References
- 25
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 1 · 2023: 4 · 2022: 8 · 2021: 4 · 2020: 2 · 2019: 4 · 2018: 2
- FWCI
- 2.84
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- European Heart Journal - Cardiovascular Pharmacotherapy (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- VBN Forskningsportal (Aalborg Universitet) (submittedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
- Funders
- The Danish Counsel of Independent Research (4183-00008)
- Topics
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Keywords
- rivaroxaban, apixaban, venous thromboembolism, direct oral anticoagulants, all-cause mortality, recurrent venous thromboembolism, bleeding risk, thromboprophylaxis, anticoagulation duration, treatment discontinuation
- MeSH terms
- Rivaroxaban, Aged, Aged, 80 and over, Denmark, Female, Fibrinolytic Agents, Hemorrhage, Hospitalization, Humans, Male, Middle Aged, Pyrazoles, Pyridones, Recurrence, Registries, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, Venous Thromboembolism, Factor Xa Inhibitors
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