SynthesisEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2013
Major bleeding in patients with atrial fibrillation receiving vitamin K antagonists: a systematic review of randomized and observational studies.
Synthesis in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06168838 (Anticoagulant-associated Intracranial Hemorrhage), which is not on this map. Cited by 35 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Anticoagulant-associated Intracranial Hemorrhage: Patient Characteristics and Outcomes From National Institute of Neurology and Neurosurgery Manuel Velasco: Single-Center Observational Study
Who cites it
35 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Pooled it
- Development of a clinical prediction model for an international normalised ratio ≥ 4·5 in hospitalised patients using vitamin K antagonists.British journal of haematology · 2018Trial
- Number needed to treat for net clinical benefit of oral anticoagulants in Asian patients with atrial fibrillation.Journal of arrhythmia · 2025Article
- Effectiveness and safety in non-valvular atrial fibrillation patients switching from warfarin to direct oral anticoagulants in US healthcare claims.Journal of thrombosis and thrombolysis · 2024Article
- Performance of risk scores in predicting major bleeding in left ventricular assist device recipients: a comparative external validation.Research and practice in thrombosis and haemostasis · 2024Article
- Bleeding events in thrombotic antiphospholipid syndrome: prevalence, severity, and associated damage accrual.Research and practice in thrombosis and haemostasis · 2024Article
- Influence of thrombocytopenia on bleeding and vascular events in atrial fibrillation.Blood advances · 2023Article
- Less major bleeding and higher hemoglobin after left atrial appendage closure in high-risk patients: Data from a long-term, longitudinal, two-center observational study.Clinical cardiology · 2023Observational
- Stroke-Specific Predictors of Major Bleeding in Anticoagulated Patients With Stroke and Atrial Fibrillation: A Nationwide Multicenter Registry-Based Study.Journal of clinical neurology (Seoul, Korea) · 2023Article
- Healthcare resources and costs associated with nonvalvular atrial fibrillation in Spain: apixaban versus acenocoumarol.Journal of comparative effectiveness research · 2023Observational
- Time Trends in Patient Characteristics, Anticoagulation Treatment, and Prognosis of Incident Nonvalvular Atrial Fibrillation in the Netherlands.JAMA network open · 2023Article
- Testing P2Y12 platelet inhibitors generics beyond bioequivalence: a parallel single-blinded randomized trial.Thrombosis journal · 2022Article
- Risk of Recurrent Bleeding Events in Nonvalvular Atrial Fibrillation Treated with Vitamin K Antagonists: A Clinical Practice Research Datalink Study.TH open : companion journal to thrombosis and haemostasis · 2019Article
- Animal models of arrhythmia: classic electrophysiology to genetically modified large animals.Nature reviews. Cardiology · 2019Review
- Cost-Effectiveness Analysis of Direct-Acting Oral Anticoagulants for Stroke Prevention in Thai Patients with Non-Valvular Atrial Fibrillation and a High Risk of Bleeding.PharmacoEconomics · 2019Article
- Acute Lower Gastrointestinal Bleeding in Patients Treated With Non-Vitamin K Antagonist Oral Anticoagulants Compared With Warfarin in Clinical Practice: Characteristics and Clinical Outcome.Gastroenterology research · 2019Article
- The CHA₂DS₂-VASc Score Predicts Major Bleeding in Non-Valvular Atrial Fibrillation Patients Who Take Oral Anticoagulants.Journal of clinical medicine · 2018Article
- Development of Quality Indicators to Assess Oral Anticoagulant Management in Community Pharmacies for Patients with Atrial Fibrillation.Journal of managed care & specialty pharmacy · 2018Article
- Atrial Fibrillation for the Neurologist: Preventing both Ischemic and Hemorrhagic Strokes.Current neurology and neuroscience reports · 2018Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsClinical trials have shown that anticoagulation with vitamin K antagonists (VKAs), e.g. warfarin, decreases the risk of stroke in patients with atrial fibrillation (AF); however, increased bleeding risk is one of the safety concerns. The primary objective was to conduct a systematic review of the published literature, assessing the risk of major bleeding and mortality in patients with AF treated with VKAs. METHODS AND
resultsOnline searches of MEDLINE, EMBASE, BIOSIS, and the Cochrane Library were performed to a pre-specified protocol from 1960 to March 2012 for randomized controlled trials (RCTs) and from January 1990 to March 2012 for observational studies. A total of 47 studies (16 RCTs and 31 observational studies) were included. Cumulative follow-up was 61,563 patient-years for RCTs and 484 241 patient-years for observational studies. The overall median incidence of major bleeding was 2.1 per 100 patient-years (range, 0.9-3.4 per 100 patient-years) for RCTs and 2.0 per 100 patient-years (range, 0.2-7.6 per 100 patient-years) for observational studies. With study year as a proxy for changing management patterns, some evidence of bleeding rates and/or their reporting increasing over time was noted. Mortality rates from observational studies were inadequately reported to allow comparison with those from RCT data.
conclusionThe median rate of major bleeding in observational studies and RCTs is similar. The larger heterogeneity in bleeding rates observed in a real-life setting could reflect a high variability in standard of care of patients on VKAs and/or methodological differences between observational studies and/or variability in data sources.
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Registered trials
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.