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

John H. Alexander, Renato D. Lopes, Laine Thomas, Marco Alings, Dan Atar, Philip Aylward, Shinya Goto, Michael Hanna, Kurt Huber, Steen Husted, Basil S. Lewis, John J V McMurray, Prem Pais, Hubert Pouleur, Philippe Gabriel Steg, Freek W A Verheugt, Daniel M. Wojdyla, Christopher B. Granger, Lars Wallentin

Research output: Contribution to journalArticle

106 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.

LanguageEnglish
Pages224-232
Number of pages9
JournalEuropean Heart Journal
Volume35
Issue number4
DOIs
Publication statusPublished - 1 Jan 2014

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Alexander, J. H., Lopes, R. D., Thomas, L., Alings, M., Atar, D., Aylward, P., ... Wallentin, L. (2014). Apixaban vs. warfarin with concomitant aspirin in patients with atrial fibrillation: Insights from the ARISTOTLE trial. European Heart Journal, 35(4), 224-232. https://doi.org/10.1093/eurheartj/eht445
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. / Apixaban vs. warfarin with concomitant aspirin in patients with atrial fibrillation : Insights from the ARISTOTLE trial. In: European Heart Journal. 2014 ; Vol. 35, No. 4. pp. 224-232.
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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.",
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Alexander, JH, Lopes, RD, Thomas, L, Alings, M, Atar, D, Aylward, P, Goto, S, Hanna, M, Huber, K, Husted, S, Lewis, BS, McMurray, JJV, Pais, P, Pouleur, H, Steg, PG, Verheugt, FWA, Wojdyla, DM, Granger, CB & Wallentin, L 2014, 'Apixaban vs. warfarin with concomitant aspirin in patients with atrial fibrillation: Insights from the ARISTOTLE trial', European Heart Journal, vol. 35, no. 4, pp. 224-232. https://doi.org/10.1093/eurheartj/eht445

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; 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.

In: European Heart Journal, Vol. 35, No. 4, 01.01.2014, p. 224-232.

Research output: Contribution to journalArticle

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T1 - Apixaban vs. warfarin with concomitant aspirin in patients with atrial fibrillation

T2 - European heart journal

AU - Alexander, John H.

AU - Lopes, Renato D.

AU - Thomas, Laine

AU - Alings, Marco

AU - Atar, Dan

AU - Aylward, Philip

AU - Goto, Shinya

AU - Hanna, Michael

AU - Huber, Kurt

AU - Husted, Steen

AU - Lewis, Basil S.

AU - McMurray, John J V

AU - Pais, Prem

AU - Pouleur, Hubert

AU - Steg, Philippe Gabriel

AU - Verheugt, Freek W A

AU - Wojdyla, Daniel M.

AU - Granger, Christopher B.

AU - Wallentin, Lars

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N2 - 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.

AB - 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.

KW - Aspirin

KW - Atrial fibrillation

KW - Concomitant medications

KW - Major bleeding

KW - Stroke

KW - Systemic embolism

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