Highlights
- •Guidelines do not recommend aspirin for stroke prevention in atrial fibrillation
- •However, many patients are still treated with aspirin due to presumed safety profile
- •We found no difference in safety between direct oral anticoagulants and aspirin
- •The level of evidence of the related recommendations should be upgraded
Abstract
Background
A considerable proportion of patients with atrial fibrillation (AF) are still treated
with aspirin despite current guidelines due to presumed favorable safety.
Aim
We performed a systematic review and meta-analysis of bleeding outcomes in randomized
controlled trials (RCTs) comparing direct oral anticoagulants (DOACs) at doses approved
for AF vs. aspirin.
Methods
We searched PubMed and Scopus for phase-III RCTs of DOACs at AF-approved doses vs.
aspirin. Outcomes assessed were major-, intracranial-, gastrointestinal-, clinically-relevant-non-major-
and fatal bleeding. We performed two subgroup analyses: one per patient population
i.e. those at high risk of arterial or venous thromboembolism, and one per DOAC. We
also performed a meta-regression to assess the association with patient age.
Results
In 4 eligible trials (20,440 patients) comparing DOACs vs. aspirin, the ORs were:
1.52 (95%CI: 0.91–2.53) for major bleeding in patients at high risk of arterial thromboembolism
and 1.55 (95%CI:0.99-2.45, relative-risk-increase:55%, absolute-risk-increase:0.6%,
number-needed-to-harm:170) in the overall analysis; 1.39 (95%CI:0.62–3.14) for intracranial
bleeding in patients at high risk of arterial thromboembolism which was similar for
the overall analysis; 1.27 (95%CI: 0.84–1.92) for gastrointestinal bleeding in patients
at high risk of arterial thromboembolism and 1.26 (95%CI:0.86-1.85) in the overall
analysis. Patient age was not a predictor of the magnitude of ORs for all bleeding
outcomes.
Conclusion
The present meta-analysis does not support the use of aspirin over DOACs in AF. Accordingly,
the level of evidence of the related recommendations should be upgraded, which in
turn may reduce further the proportion of AF patients treated with antiplatelets.
Keywords
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Article info
Publication history
Published online: May 11, 2020
Accepted:
May 1,
2020
Received in revised form:
April 28,
2020
Received:
December 30,
2019
Identification
Copyright
© 2020 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
