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

doi:10.1093/eurheartj/eht445

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 journal › Article › Academic › peer-review

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.

Original language	English
Pages (from-to)	224-32
Number of pages	9
Journal	European Heart Journal
Volume	35
Issue number	4
DOIs	https://doi.org/10.1093/eurheartj/eht445
Publication status	Published - Jan 2014
Externally published	Yes

Keywords

Administration, Oral
Aged
Anticoagulants/administration & dosage
Aspirin/administration & dosage
Atrial Fibrillation/drug therapy
Double-Blind Method
Drug Therapy, Combination
Embolism/prevention & control
Female
Fibrinolytic Agents/administration & dosage
Hemorrhage/prevention & control
Humans
Male
Middle Aged
Pyrazoles/administration & dosage
Pyridones/administration & dosage
Stroke/prevention & control
Treatment Outcome
Warfarin/administration & dosage

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10.1093/eurheartj/eht445

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Alexander, J. H., Lopes, R. D., Thomas, L., Alings, M., Atar, D., Aylward, P., Goto, S., Hanna, M., Huber, K., Husted, S., Lewis, B. S., McMurray, J. J. V., Pais, P., Pouleur, H., Steg, P. G., Verheugt, F. W. A., Wojdyla, D. M., Granger, C. B., & Wallentin, L. (2014). Apixaban vs. warfarin with concomitant aspirin in patients with atrial fibrillation: insights from the ARISTOTLE trial. European Heart Journal, 35(4), 224-32. https://doi.org/10.1093/eurheartj/eht445

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

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 = "Administration, Oral, Aged, Anticoagulants/administration & dosage, Aspirin/administration & dosage, Atrial Fibrillation/drug therapy, Double-Blind Method, Drug Therapy, Combination, Embolism/prevention & control, Female, Fibrinolytic Agents/administration & dosage, Hemorrhage/prevention & control, Humans, Male, Middle Aged, Pyrazoles/administration & dosage, Pyridones/administration & dosage, Stroke/prevention & control, Treatment Outcome, Warfarin/administration & dosage",

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

year = "2014",

month = jan,

doi = "10.1093/eurheartj/eht445",

language = "English",

volume = "35",

pages = "224--32",

number = "4",

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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. 224-32. https://doi.org/10.1093/eurheartj/eht445

TY - JOUR

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

T2 - insights from the ARISTOTLE trial

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

PY - 2014/1

Y1 - 2014/1

N2 - 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.

AB - 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.

KW - Administration, Oral

KW - Aged

KW - Anticoagulants/administration & dosage

KW - Aspirin/administration & dosage

KW - Atrial Fibrillation/drug therapy

KW - Double-Blind Method

KW - Drug Therapy, Combination

KW - Embolism/prevention & control

KW - Female

KW - Fibrinolytic Agents/administration & dosage

KW - Hemorrhage/prevention & control

KW - Humans

KW - Male

KW - Middle Aged

KW - Pyrazoles/administration & dosage

KW - Pyridones/administration & dosage

KW - Stroke/prevention & control

KW - Treatment Outcome

KW - Warfarin/administration & dosage

U2 - 10.1093/eurheartj/eht445

DO - 10.1093/eurheartj/eht445

M3 - Article

C2 - 24144788

SN - 0195-668X

VL - 35

SP - 224

EP - 232

JO - European Heart Journal

JF - European Heart Journal

IS - 4

ER -

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

Abstract

Keywords

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