Abstract 10343: Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Peripheral Artery Disease and Non-valvular Atrial Fibrillation: Insights From the Aristotle Trial
Introduction: Vascular disease has been incorporated in the CHA2DS2-VASc risk tool to predict the risk of stroke/systemic embolism in patients with atrial fibrillation (AF).
Hypothesis: This post hoc analysis of the ARISTOTLE trial aimed to determine the absolute rates of stroke/systemic embolism and bleeding associated with peripheral artery disease (PAD) as well as the efficacy and safety of apixaban vs warfarin in AF patients with and without PAD.
Methods: ARISTOTLE randomized patients with AF and risk of stroke to apixaban and warfarin for the prevention of stroke/systemic embolism.
Results: A total of 884 (4.9%) patients had PAD at baseline as defined by site investigators on the case report form. Patients with versus without PAD had non-significantly higher rates of stroke/systemic embolism [HR 1.32, 95% CI 0.93-1.88, p=0.12] and major or clinically relevant non-major (CRNM) bleeding [HR 1.12, 95% CI 0.90-1.39, p=0.31]. Those with PAD had an increased risk of all-cause death [HR 1.36, 95% CI 1.11-1.67, p=0.003] and CV death [HR 1.44, 95% CI 1.08-1.90, p=0.01] when compared with those without PAD. The effect of apixaban vs warfarin for the prevention of stroke/systemic embolism was similar in patients with PAD [HR 0.66, 95% CI 0.33- 1.31] and without PAD [HR 0.80, 95% CI 0.66-0.96, interaction p=0.61] [Table]. Patients with PAD appeared to have less reduction in major or CRNM bleeding with apixaban compared with warfarin [HR 1.04, 95% CI 0.69-1.57] versus those without PAD [HR 0.66, 95% CI 0.59-0.73, interaction p=0.03].
Conclusions: Patients with PAD in ARISTOTLE had non-significantly higher risk of stroke/systemic embolism when compared with patients without PAD. The benefits of apixaban versus warfarin on stroke and all-cause death are similar in patients with and without PAD. However, the reduction in bleeding with apixaban seemed to be greater in patients without PAD than in patients with PAD (interaction p=0.03).
Author Disclosures: P. Hu: None. R.D. Lopes: Consultant/Advisory Board; Modest; Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Portola. Research Grant; Significant; Bristol-Myers Squibb, GlaxoSmithKline. Consultant/Advisory Board; Significant; Pfizer. S. Stevens: None. L. Wallentin: Honoraria; Modest; Boehringer-Ingelheim, AstraZeneca, Bristol-Myers Squibb/Pfizer, GlaxoSmithKline. Consultant/Advisory Board; Modest; Merck & Co, Boehringer-Ingelheim, AstraZeneca, GlaxoSmithKline, Bristol-Myers Squibb/Pfizer. Research Grant; Significant; AstraZeneca, Merck & Co, Boehringer-Ingelheim, Bristol-Myers Squibb/Pfizer, GlaxoSmithKline. L. Thomas: None. J.H. Alexander: Research Grant; Modest; Bristol-Myers Squibb, Boehringer Ingelheim, CSL Behring, National Institutes of Health, Regado Biosciences, Sanofi, Tenex Therapeutics, Vivus Pharmaceuticals. Consultant/Advisory Board; Modest; Portola Pharmaceuticals, Sohmalution, VA Cooperative Studies Program. Consultant/Advisory Board; Significant; Bristol Myers Squibb, Duke Private Diagnostic Clinic. M. Hanna: Employment; Significant; Bristol Myers Squibb. B.S. Lewis: None. F.W. Verheugt: Research Grant; Modest; Bristol-Myers Squibb, Pfizer. Consultant/Advisory Board; Modest; Bristol-Myers Squibb, Pfizer. C.B. Granger: Research Grant; Significant; Bristol Myers Squibb, GlaxoSmithKline, Medtronic Foundation, Merck & Co, Pfizer, Sanofi-Aventis, Takeda, The Medicines Company, AstraZeneca, Daiichi Sankyo, Janssen Pharmaceuticals, Bayer, Armetheon, Boehringer Ingelheim. Consultant/Advisory Board; Modest; Bristol Myers Squibb, GlaxoSmithKline, Hoffman-La Roche, Eli Lilly, Pfizer, Sanofi-Aventis, Takeda, The Medicines Company, AstraZeneca, Daiichi Sankyo, Ross Medical Corporation, Janssen Pharmaceuticals, Salix Pharmaceuticals, Bayer, Gilead, Medtronic Inc. Consultant/Advisory Board; Significant; Boehringer Ingelheim. W.S. Jones: Research Grant; Modest; American Heart Association, AstraZeneca, Boston Scientific. Honoraria; Modest; American College of Physicians, American Physician Institute. Honoraria; Significant; American College of Radiology.
- © 2015 by American Heart Association, Inc.