Abstract 14365: Rivaroxaban is Associated with a Reduced Risk of Thromboembolic events and Hemorrhagic Stroke in Patient with Heart Failure: Insights from ROCKET AF
Background: In the ROCKET-AF trial, rivaroxaban was non-inferior to warfarin for the prevention of stroke and systemic embolic events and significantly reduced intracranial bleeding in patients with non-valvular atrial fibrillation (AF). The prevalence of both AF and heart failure (HF) are increasing, however, little is known about the efficacy and safety of rivaroxaban in HF patients.
Methods: In the ROCKET-AF trial, we evaluated treatment related differences between patients with and without baseline HF and compared the efficacy and safety of rivaroxaban and warfarin in the 9,019 (63.2%) patients with HF. The primary efficacy outcome was stroke or systemic embolism rate per 100 patient years by intention to treat. The safety outcomes were the rates of major or non-major clinically relevant (MNCR) bleeding and hemorrhagic stroke.
Results: The efficacy outcome in rivaroxaban and warfarin treated patients were similar in patients with HF (1.55 vs. 2.07) and without HF (1.94 vs. 2.28) (p =0.47 for interaction, Figure). In patients with HF, rivaroxaban was independently associated with a lower risk of the primary outcome (adjusted Hazard Ratio [adj HR] 0.74: 95% CI, 0.58 to 0.96; p=0.021). The risk of MNCR bleeding in HF patients was similar (adj HR 1.05, 95% CI 0.96 to 1.16, p=0.62); however, the incidence of hemorrhagic stroke was significantly lower with rivaroxaban (adj HR 0.38, 95% CI, 0.19 to 0.75, p=0.006). The observed efficacy of rivaroxaban was similar in HF patients with an ejection fraction <40 or ≥ 40% (p=0.41 for interaction) and New York Heart Association class I-II vs III-IV (p=0.80 for interaction).
Conclusions: In ROCKET AF, treatment related outcomes were similar in patients with and without HF. Compared to warfarin, point estimates suggested a lower risk of stroke and systemic embolism and hemorrhagic stroke in rivaroxaban treated HF patients. These findings support the use of rivaroxaban as an alternative to warfarin in patients with HF.
- © 2012 by American Heart Association, Inc.