Apixaban vs. warfarin with concomitant aspirin in patients with atrial fibrillation: insights from the ARISTOTLE trial

John Alexander, Renato Lopes, Laine Thomas, Marco Alings, Dan Atar, Philip Aylward, Shinya Goto, Michael Hanna, Kurt Huber, Steen Husted, Basil Lewis, John McMurray, Prem Pais, Hubert Pouleur, Philippe Steg, F Verheugt, Daniel Wojdyla, Christopher Granger, Lars Wallentin

    Research output: Contribution to journalArticlepeer-review

    123 Citations (Scopus)

    Abstract

    AimsWe 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 resultsIn 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.ConclusionApixaban had similar beneficial effects on stroke or systemic embolism and major bleeding compared with warfarin, irrespective of concomitant aspirin use. Published on behalf of the European Society of Cardiology. All rights reserved.

    Original languageEnglish
    Pages (from-to)224-232
    Number of pages9
    JournalEuropean Heart Journal
    Volume35
    Issue number4
    DOIs
    Publication statusPublished - Jan 2014

    Keywords

    • Aspirin
    • Atrial fibrillation
    • Concomitant medications
    • Major bleeding
    • Stroke
    • Systemic embolism

    Fingerprint

    Dive into the research topics of 'Apixaban vs. warfarin with concomitant aspirin in patients with atrial fibrillation: insights from the ARISTOTLE trial'. Together they form a unique fingerprint.

    Cite this