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 language | English |
|---|---|
| Pages (from-to) | 224-232 |
| Number of pages | 9 |
| Journal | European heart journal |
| Volume | 35 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published or Issued - Jan 2014 |
Keywords
- Aspirin
- Atrial fibrillation
- Concomitant medications
- Major bleeding
- Stroke
- Systemic embolism
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
- APA
- Author
- BIBTEX
- Harvard
- Standard
- RIS
- Vancouver
}
In: European heart journal, Vol. 35, No. 4, 01.2014, p. 224-232.
Research output: Contribution to journal › Article › peer-review
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
N1 - Funding Information: The ARISTOTLE trial was funded by Bristol-Myers Squibb (Princeton, NJ, USA) and Pfizer, Inc. (New York, NY, USA) and they participated in the trial design and data collection. The analyses presented here were designed by the authors, performed at the Duke Clinical Research Institute, and interpreted by the authors. All authors, including two (M.H., H.P.) employed by the sponsors, commented on the manuscript. The decision to publish the final manuscript was made by the first author (J.H.A.). Funding Information: Duke University from Bristol-Myers Squibb and Pfizer; serves or has served as a consultant to Bristol-Myers Squibb and Pfizer. R.D.L.: grants from Bristol-Myers Squibb, AstraZeneca, Boehringer Ingelheim, and Daiichi Sankyo; consulting fees from Bristol-Myers Squibb. L.T.: none. M.A.: consulting fees from Bayer AG, Boehringer-Ingelheim, MSD, and Sanofi-Aventis; travel support from Boston Scientific, Bristol-Myers Squibb, and St Jude Medical. D.A.: consulting fees or honoraria from Bristol-Myers Squibb. P.A.: research grants, honoraria, and advisory boards for Bristol-Myers Squibb, Pfizer, Bayer, Johnson & Johnson, Boehringer Ingelheim, Daiichi Sankyo, AstraZeneca, Sanofi-Aventis, Merck, Eli Lilly, and The Medicines Company. S.G.: board member of Bristol-Myers Squibb and Sanofi-Aventis; grants from Boehringer Ingelheim, Otsuka, Eisai, Sanofi-Aventis, and Daiichi Sankyo; consulting fees from Eisai; lecture fees from Eisai, Otsuka, Daiichi Sankyo, Sanofi-Aventis, Bayer, Novartis, AstraZeneca, Asteras, Pfizer, Medtronics-Japan, Tanabe-Mitsubishi, Takeda, Mochida, and MSD; payments from Bayer and Sanofi-Aventis for developing educational presentations. M.H.: full-time employee of Bristol-Myers Squibb and receives stock as part of his compensation. K.H.: lecture fees from AstraZeneca, Bristol-Myers Squibb/Pfizer, Boehringer Ingelheim, Bayer, Daiichi Sankyo, and Sanofi-Aventis. S.H.: advisory board membership for AstraZeneca, Bristol-Myers Squibb, Pfizer, and Bayer; research support from GlaxoSmithKline, Pfizer, and Sanofi-Aventis. Funding Information: B.S.L.: advisory board member for Bayer HealthCare. J.J.V.M.: none. P.P.: none. H.P.: full-time Pfizer employee and owns stock in this company. P.G.S.: travel support from Bristol-Myers Squibb; board membership for Bayer, Bristol-Myers Squibb/Pfizer, AstraZeneca, and Boehringer Ingelheim; consulting fees from Bristol-Myers Squibb, Eisai, Ablynx, Amarin, Astellas, Eil Lilly, Medtronic, Novartis, Roche, Servier, The Medicines Company, Sanofi, and AstraZeneca; grants from Servier, Sanofi, and New York University School of Medicine; and lecture fees from Pfizer, Amgen, Otsuka, and Aterovax. F.W.A.V.: lecture fees from Bayer and AstraZeneca; consulting fees from Bayer and Daiichi Sankyo. D.M.W.: none. C.B.G.: grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, the Medtronic Foundation, Merck, Sanofi-Aventis, Astellas, and The Medicines Company; consulting fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Hoffmann-La Roche, Novartis, Otsuka Pharmaceutical, Sanofi-Aventis, and The Medicines Company; support from the Medtronic Foundation and Merck for travel, accommodations, or meeting expenses. L.W.: grants from Bristol-Myers Squibb, Pfizer, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Schering-Plough, and Merck; consulting fees from Regado Biosciences, Portola, CSL Behring, Athera Biotechnologies, Boehringer Ingelheim, AstraZeneca, and GlaxoSmithKline; lecture fees from Bristol-Myers Squibb, Pfizer, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Schering-Plough, and Merck. Funding Information: Conflict of interest: The ARISTOTLE trial was funded by Bristol-Myers Squibb and Pfizer. J.H.A.: receives sponsored research support through
PY - 2014/1
Y1 - 2014/1
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
UR - http://www.scopus.com/inward/record.url?scp=84890427300&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/eht445
DO - 10.1093/eurheartj/eht445
M3 - Article
C2 - 24144788
AN - SCOPUS:84890427300
SN - 0195-668X
VL - 35
SP - 224
EP - 232
JO - European heart journal
JF - European heart journal
IS - 4
ER -