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Efficacy and safety of rivaroxaban compared with warfarin in patients with carotid artery disease and nonvalvular atrial fibrillation: Insights from the ROCKET AF trial.

Efficacy and safety of rivaroxaban compared with warfarin in patients with carotid artery disease and nonvalvular atrial fibrillation: Insights from the ROCKET AF trial.
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Kochar A, Hellkamp AS, Lokhnygina Y, Jones WS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Singer DE, Piccini JP, Patel MR,


Kochar A, Hellkamp AS, Lokhnygina Y, Jones WS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Singer DE, Piccini JP, Patel MR, (click to view)

Kochar A, Hellkamp AS, Lokhnygina Y, Jones WS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Singer DE, Piccini JP, Patel MR,

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Clinical cardiology 2018 02 01() doi 10.1002/clc.22846
Abstract
BACKGROUND
Atrial fibrillation (AF) increases risk of stroke 5-fold. Carotid artery disease (CD) also augments the risk of stroke, yet there are limited data about the interplay of these 2 diseases and clinical outcomes in patients with comorbid AF and CD.

HYPOTHESIS
Among patients with both AF and CD, use of rivaroxaban when compared with warfarin is associated with a lower risk of stroke.

METHODS
This post hoc analysis from ROCKET AF aimed to determine absolute rates of stroke/systemic embolism (SE) and bleeding, and the efficacy and safety of rivaroxaban compared with warfarin in patients with AF and CD (defined as history of carotid occlusive disease or carotid revascularization [endarterectomy and/or stenting]).

RESULTS
A total of 593 (4.2%) patients had CD at enrollment. Patients with and without CD had similar rates of stroke or SE (adjusted hazard ratio [HR]: 0.99, 95% confidence interval [CI]: 0.66-1.48, P = 0.96), and there was no difference in major or nonmajor clinically relevant bleeding (adjusted HR: 1.04, 95% CI: 0.88-1.24, P = 0.62). The efficacy of rivaroxaban compared with warfarin for the prevention of stroke/SE was not statistically significant in patients with vs those without CD (interaction P = 0.25). The safety of rivaroxaban vs warfarin for major or nonmajor clinically relevant bleeding was similar in patients with and without CD (interaction P = 0.64).

CONCLUSIONS
Patients with CD in ROCKET AF had similar risk of stroke/SE compared with patients without CD. Additionally, there was no interaction between CD and the treatment effect of rivaroxaban or warfarin for stroke prevention or safety endpoints.

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