What is the efficacy and safety of rivaroxaban (Xarelto) use in patients with atrial fibrillation (Afib) (AF)?

Updated: Nov 18, 2019
  • Author: Lawrence Rosenthal, MD, PhD, FACC, FHRS; Chief Editor: Jeffrey N Rottman, MD  more...
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Rivaroxaban (Xarelto) was approved by the FDA in November 2011 for nonvalvular AF. [80] It is a highly selective direct factor Xa inhibitor with high oral bioavailability, and with rapid onset of action. Clinical trial data have shown that it allows predictable anticoagulation with no need for dose adjustments and routine coagulation monitoring. [81]

Approval of rivaroxaban was based on the ROCKET-AF multinational, double-blind trial, in which the risk of major bleeding was similar for rivaroxaban and warfarin, but a significantly lower risk of intracranial hemorrhage and fatal bleeding was seen with rivaroxaban when compared with warfarin. [82]  The study included over 14,000 patients who were randomized to either rivaroxaban or warfarin; rivaroxaban 20 mg once daily was used for patients with normal renal function and 15 mg once daily for patients with mild renal failure (creatinine clearance of 30-49 mL/min). In the primary analysis of this study, rivaroxaban was found to be noninferior to warfarin for prevention of stroke or systemic embolism in patients with nonvalvular AF. [82] During the approval process, there was concern expressed over the amount of time the warfarin-treated patients spent at the optimal INR during the study (57.8%), which was lower than in other trials with warfarin (eg, RE-LY trial for Dabigatran). [75] Also, the participants of the ROCKET-AF trial had higher mean CHADS2 scores (3.67) when compared to those of the RE-LY trial (2.1).

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