Apixaban vs. warfarin with concomitant aspirin in patients with atrial fibrillation: Insights from the ARISTOTLE trial
Journal article
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. and Wallentin, Lars. (2014). Apixaban vs. warfarin with concomitant aspirin in patients with atrial fibrillation: Insights from the ARISTOTLE trial. European Heart Journal. 35(4), pp. 224 - 232. https://doi.org/10.1093/eurheartj/eht445
Authors | 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. and Wallentin, Lars |
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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 |
Year | 2014 |
Journal | European Heart Journal |
Journal citation | 35 (4), pp. 224 - 232 |
Publisher | Oxford University Press |
ISSN | 0195-668X |
Digital Object Identifier (DOI) | https://doi.org/10.1093/eurheartj/eht445 |
Scopus EID | 2-s2.0-84890427300 |
Page range | 224 - 232 |
Research Group | Mary MacKillop Institute for Health Research |
Publisher's version | File Access Level Controlled |
Place of publication | United Kingdom |
https://acuresearchbank.acu.edu.au/item/8qx59/apixaban-vs-warfarin-with-concomitant-aspirin-in-patients-with-atrial-fibrillation-insights-from-the-aristotle-trial
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