ArticlePharmacoepidemiology and drug safety2021
Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies.
Article in Pharmacoepidemiology and drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
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Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Left Atrial Appendage Closure Compared With Oral Anticoagulants for Patients With Atrial Fibrillation: A Systematic Review and Network Meta-Analysis.Journal of the American Heart Association · 2024Pooled it
- Changes in the use of vitamin K antagonists and direct oral anticoagulants and impact on the incidence of oral anticoagulation-related intracerebral hemorrhage: population-wide prescription patterns in two 5-year cohorts.Annals of medicine · 2026Observational
- Implementation of OMOP and ConcePTION Common Data Models in CPRD GOLD: Risk of Bleeding and Cardiovascular Outcomes From Anticoagulant Use.Clinical pharmacology and therapeutics · 2026Article
- Core Concepts in Pharmacoepidemiology: Multi-Database Distributed Data Networks.Pharmacoepidemiology and drug safety · 2025Review
- [Construction of the Chinese-Western Synergistic System for the Prevention and Treatment of Diabetic Lower Extremity Arterial Disease].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2025Article
- Comparative clinical outcomes of acenocoumarol versus direct oral anticoagulants (DOACs) and warfarin in patients with atrial fibrillation: real-world-evidence (SIESTA-A study).Frontiers in pharmacology · 2025Article
- Novel horizons in anticoagulation: the emerging role of factor XI inhibitors across different settings.Haematologica · 2024Review
- State-of-the-Art of Transcatheter Left Atrial Appendage Occlusion.Journal of clinical medicine · 2024Review
- Spontaneous rectal sheath bleed while on DOAC anticoagulation.BMJ case reports · 2023Article
- Blood Coagulation and Beyond: Position Paper from the Fourth Maastricht Consensus Conference on Thrombosis.Thrombosis and haemostasis · 2023Article
- Antithrombotic Treatment in Patients With Hemophilia: an EHA-ISTH-EAHAD-ESO Clinical Practice Guidance.HemaSphere · 2023Article
- Long-term comparative effectiveness and safety of dabigatran, rivaroxaban, apixaban and edoxaban in patients with atrial fibrillation: A nationwide cohort study.Frontiers in pharmacology · 2023Article
- Clinical Characteristics, Patterns of Use, and incidence of Adverse Events in Patients With Nonvalvular Atrial Fibrillation Treated With Oral Anticoagulants in Colombia.Vascular health and risk management · 2023Article
- Article
- Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies.Pharmacoepidemiology and drug safety · 2021Article
- Anticoagulant Therapy Is Associated With Decreased Long-Term Mortality in Splenic Infarction Patients: A Multicenter Study.Frontiers in medicine · 2021Article
Corrections and comments
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Authors and funding
17 authors at 8 institutions in 7 countries.
Funding
Abstract
objectiveTo establish the risk of major bleeding in direct oral anticoagulant (DOAC) users (overall and by class) versus vitamin K antagonist (VKA) users, using health care databases from four European countries and six provinces in Canada.
methodsA retrospective cohort study was performed according to a similar protocol. First-users of VKAs or DOACs with a diagnosis of non-valvular atrial fibrillation (NVAF) were included. The main outcome of interest was major bleeding and secondary outcomes included gastrointestinal (GI) bleeding and intracranial haemorrhage (ICH). Incidence rates of events per 1000 person years were calculated. Hazard ratios (HRs) and 95% confidence intervals (95% CI) were estimated using a Cox proportional hazard regression model. Exposure and confounders were measured and analysed in a time-dependant way. Risk estimates were pooled using a random effect model.
results421 523 patients were included. The risk of major bleeding for the group of DOACs compared to VKAs showed a pooled HR of 0.94 (95% CI: 0.87-1.02). Rivaroxaban showed a modestly increased risk (HR 1.11, 95% CI: 1.06-1.16). Apixaban and dabigatran showed a decreased risk of respectively HR 0.76 (95% CI: 0.69-0.84) and HR 0.85 (95% CI: 0.75-0.96).
conclusionsThis study confirms that the risk of major bleeding of DOACs compared to VKAs is not increased when combining all DOACs. However, we observed a modest higher risk of major bleeding for rivaroxaban, whereas for apixaban and dabigatran lower risks of major bleeding were observed compared to VKAs.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.