Abstract 15544: Rivaroxaban Compared with Warfarin in Patients with Atrial Fibrillation and Diabetes: A Subgroup Analysis of the ROCKET AF Trial
Background: In patients with nonvalvular AF enrolled in ROCKET AF, rivaroxaban was noninferior to warfarin for prevention of stroke and systemic embolism and caused less intracranial hemorrhage (ICH) and fatal bleeding events. The prevalence of both AF and diabetes mellitus (DM) are rising, and the 2 commonly occur together, but the efficacy and safety of rivaroxaban in patients with DM and AF have not been described.
Methods: We compared the efficacy and safety of rivaroxaban and warfarin in patients with (n=5635) and without (n=8508) DM enrolled in ROCKET AF. The primary efficacy outcome was the rate of stroke or systemic embolism; principal safety outcomes were the rates of major or non-major clinically relevant (NMCR) bleeding and hemorrhagic stroke.
Results: In patients with DM randomized to rivaroxaban vs warfarin, rates of primary events (1.59 vs 2.15/100 pt-yrs) were similar to those in patients without DM (1.77 vs 2.16/100 pt-yrs; interaction p=0.60; Figure), and the same was true for rates of ischemic stroke and systemic embolism (1.32 vs 1.56/100 pt-yrs in patients with DM, and 1.43 vs 1.66/100 pt-yrs in those without DM; interaction p=0.95). Compared with warfarin, the risk of the primary outcome during treatment with rivaroxaban in patients with DM (HR 0.74; 95% CI 0.54-1.01; p=0.055) was consistent with overall trial results. The rates of major (HR 0.98; 95% CI 0.79-1.21; p=0.84) and major or NMCR bleeding (HR 0.97; 95% CI 0.86-1.08; p=0.57) in patients with DM treated with rivaroxaban were similar to those on warfarin, but there was a trend toward less frequent ICH with rivaroxaban (HR 0.50; 95% CI 0.23-1.06, p=0.070). The interaction of treatment effect with the presence or absence of DM was statistically insignificant (all p>0.16).
Conclusions: Compared with warfarin, the relative efficacy and safety of rivaroxaban were similar in patients with and without DM, supporting its use as an alternative to warfarin for stroke prevention in patients with DM and AF.
- © 2012 by American Heart Association, Inc.