Major bleeding in patients with atrial fibrillation receiving vitamin K antagonists: a systematic review of randomized and observational studies
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AIMS: Clinical 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 RESULTS: Online 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. CONCLUSION: The 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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In a meta-analysis of 47 studies, the overall incidence of major bleeding with VKAs was 2.1 (range 0.9-3.4) per 100 patient-years in controlled trials and 2.0 (range 0.2-7.6) per 100 patient-years for observational data sets.
“In a meta-analysis of 47 studies, the overall incidence of major bleeding with VKAs was 2.1 (range 0.9-3.4) per 100 patient-years in controlled trials and 2.0 (range 0.2-7.6)per 100 patient-years for observational data sets.488”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [488]
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- Authors
- Roskell, N. S., Samuel, M., Noack, H., & Monz, B. U.
- Affiliations
- RTI Health Solutions (US)
- Boehringer Ingelheim (Germany) (DE)
- Corresponding author
- Roskell, Neil S.
- Venue
- EP Europace
- Publisher
- Oxford University Press (OUP)
- Published
- 2013-06
- Volume
- 15
- Issue
- 6
- Pages
- 787-797
- ISSN
- 1099-5129 (ISSN-L)
- 1532-2092
- PMC
- PMC3663334
- OpenAlex
- W1976575956
- Cited by
- 91
- References
- 65
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 6 · 2023: 5 · 2022: 8 · 2021: 3 · 2020: 3 · 2019: 8 · 2018: 11 · 2017: 12 · 2016: 11 · 2015: 9 · 2014: 6 · 2013: 4
- FWCI
- 1.70
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- EP Europace (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
- Keywords
- atrial fibrillation, vitamin K antagonists, warfarin, major bleeding, bleeding risk, mortality, anticoagulant safety, stroke prevention, observational studies, randomized controlled trials
- MeSH terms
- Anticoagulants, Atrial Fibrillation, Hemorrhage, Humans, Thromboembolism, Vitamin K, Comorbidity, Incidence, Survival Analysis, Randomized Controlled Trials as Topic, Risk Assessment, Evidence-Based Medicine, Observational Studies as Topic
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