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Cited by 94Atrial Fibrillation Management and OutcomesAcute Ischemic Stroke ManagementVenous Thromboembolism Diagnosis and Management

Bleeding During Treatment With Aspirin Versus Apixaban in Patients With Atrial Fibrillation Unsuitable for Warfarin: The Apixaban Versus Acetylsalicylic Acid to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin k Antagonist Treatment (AVERROES) Trial

Flaker, Greg C., Eikelboom, John W., Shestakovska, Olga, Connolly, Stuart J., Kaatz, Scott, Budaj, Andrzej, Husted, Steen, Yusuf, Salim +2 more·2012·Stroke
DOI 10.1161/strokeaha.112.664144
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Abstract

BACKGROUND AND PURPOSE: Apixaban reduces stroke with comparable bleeding risks when compared with aspirin in patients with atrial fibrillation who are unsuitable for vitamin k antagonist therapy. This analysis explores patterns of bleeding and defines bleeding risks based on stroke risk with apixaban and aspirin. METHODS: The Apixaban versus Acetylsalicylic Acid to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin k Antagonist Treatment (AVERROES) trial randomized 5599 patients with atrial fibrillation and risk factors to receive either apixaban or aspirin. Bleeding events were defined as the first occurrence of either major bleeding or clinically relevant nonmajor bleeding. RESULTS: The rate of a bleeding event was 3.8%/year with aspirin and 4.5%/year with apixaban (hazard ratio with apixaban, 1.18; 95% CI, 0.92-1.51; P=0.19). The anatomic site of bleeding did not differ between therapies. Risk factors for bleeding common to apixaban and aspirin were use of nonstudy aspirin>50% of the time and a history of daily/occasional nosebleeds. The rates of both stroke and bleeding increased with higher CHADS2 scores but apixaban compared with aspirin was associated with a similar relative risk of bleeding (P interaction 0.21) and a reduced relative risk of stroke (P interaction 0.37) irrespective of CHADS2 category. CONCLUSIONS: Anatomic sites and predictors of bleeding are similar for apixaban and aspirin in these patients. Higher CHADS2 scores are associated with increasing rates of bleeding and stroke, but the balance between risks and benefits of apixaban compared with aspirin is favorable irrespective of baseline stroke risk. Clinical Trial Registration Information- www.clinicaltrials.gov. Unique identifier: NCT 00496769.

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Crossref · 10.1161/strokeaha.112.664144

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  • Apixaban significantly reduced stroke or systemic embolism by 55% compared with aspirin, with no significant difference in rates of major bleeding or intracranial haemorrhage.

    “apixaban significantly reduced stroke or systemic embolism by 55% compared with aspirin, with no significant difference in rates of major bleeding or intracranial haemorrhage.354,403”

    From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [403]

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Authors
Flaker, G. C., Eikelboom, J. W., Shestakovska, O., Connolly, S. J., Kaatz, S., Budaj, A., Husted, S., Yusuf, S., Lip, G. Y. H., & Hart, R. G.
Affiliations
Birmingham City Hospital (GB)
ORCID
Venue
Stroke
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2012-12
Volume
43
Issue
12
Pages
3291-3297
ISSN
  • 0039-2499 (ISSN-L)
  • 1524-4628
DOI
10.1161/strokeaha.112.664144
OpenAlex
W2154189451
Cited by
94
References
26
Citations by year
2026: 1 · 2025: 7 · 2024: 4 · 2023: 4 · 2022: 2 · 2021: 4 · 2020: 4 · 2019: 7 · 2018: 7 · 2017: 2 · 2016: 10 · 2015: 9 · 2014: 16 · 2013: 14 · 2012: 1
FWCI
8.23
Type
journal article
Language
en
Open access
closed
Locations
  • Stroke (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
  • Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
  • Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
Keywords
apixaban, aspirin, atrial fibrillation, bleeding risk, stroke prevention, CHADS2 score, major bleeding, AVERROES trial, bleeding risk factors
MeSH terms
Contraindications, Aged, Anticoagulants, Aspirin, Atrial Fibrillation, Cerebral Hemorrhage, Brain Ischemia, Female, Fibrinolytic Agents, Follow-Up Studies, Humans, Male, Platelet Aggregation Inhibitors, Pyrazoles, Pyridones, Risk Factors, Vitamin K, Warfarin, Stroke

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