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Apixaban vs. warfarin with concomitant aspirin in patients with atrial fibrillation: Insights from the ARISTOTLE trial
Alexander, John H. Lopes, Renato D. Thomas, Laine Alings, Marco Atar, Dan Aylward, Philip Goto, Shinya Hanna, Michael Huber, Kurt Husted, Steen
Alexander, John H.
Lopes, Renato D.
Thomas, Laine
Alings, Marco
Atar, Dan
Aylward, Philip
Goto, Shinya
Hanna, Michael
Huber, Kurt
Husted, Steen
Author
Alexander, John H.
Lopes, Renato D.
Thomas, Laine
Alings, Marco
Atar, Dan
Aylward, Philip
Goto, Shinya
Hanna, Michael
Huber, Kurt
Husted, Steen
Lewis, Basil S.
McMurray, John J. V.
Pais, Prem
Pouleur, Hubert
Steg, Philippe Gabriel
Verheugt, Freek W. A.
Wojdyla, Daniel M.
Granger, Christopher B.
Wallentin, Lars
Lopes, Renato D.
Thomas, Laine
Alings, Marco
Atar, Dan
Aylward, Philip
Goto, Shinya
Hanna, Michael
Huber, Kurt
Husted, Steen
Lewis, Basil S.
McMurray, John J. V.
Pais, Prem
Pouleur, Hubert
Steg, Philippe Gabriel
Verheugt, Freek W. A.
Wojdyla, Daniel M.
Granger, Christopher B.
Wallentin, Lars
Abstract
Aims: We assessed the effect of concomitant aspirin use on the efficacy and safety of apixaban compared with warfarin in patients with atrial fibrillation (AF). Methods and results: In ARISTOTLE, 18 201 patients were randomized to apixaban 5 mg twice daily or warfarin. Concomitant aspirin use was left to the discretion of the treating physician. In this predefined analysis, simple and marginal structured models were used to adjust for baseline and time-dependent confounders associated with aspirin use. Outcome measures included stroke or systemic embolism, ischaemic stroke, myocardial infarction, mortality, major bleeding, haemorrhagic stroke, major or clinically relevant non-major bleeding, and any bleeding. On Day 1, 4434 (24%) patients were taking aspirin. Irrespective of concomitant aspirin use, apixaban reduced stroke or systemic embolism [with aspirin: apixaban 1.12% vs. warfarin 1.91%, hazard ratio (HR) 0.58, 95% confidence interval (CI) 0.39–0.85 vs. without aspirin: apixaban 1.11% vs. warfarin 1.32%, HR 0.84, 95% CI 0.66–1.07; P interaction = 0.10] and caused less major bleeding than warfarin (with aspirin: apixaban 3.10% vs. warfarin 3.92%, HR 0.77, 95% CI 0.60–0.99 vs. without aspirin: apixaban 1.82% vs. warfarin 2.78%, HR without aspirin 0.65, 95% CI 0.55–0.78; P interaction = 0.29). Similar results were seen in the subgroups of patients with and without arterial vascular disease. Conclusion: Apixaban had similar beneficial effects on stroke or systemic embolism and major bleeding compared with warfarin, irrespective of concomitant aspirin use.
Keywords
concomitant medications, aspirin, atrial fibrillation, stroke, systemic embolism, major bleeding
Date
2014
Type
Journal article
Journal
European Heart Journal
Book
Volume
35
Issue
4
Page Range
224-232
Article Number
ACU Department
Collections
Relation URI
Source URL
Event URL
Open Access Status
License
File Access
Controlled