The efficacy of rivaroxaban in patients with atrial fibrillation.

Atrial fibrillation (AF), the most common form of cardiac arrhythmia, is a major risk factor for cardioembolic stroke. Dose-adjusted warfarin has been the gold standard for stroke prophylaxis in moderate- to high-risk patients with AF. However, the use of warfarin therapy is greatly limited by its narrow therapeutic window, numerous dietary restrictions, and drug-drug interactions, and an increased risk of hemorrhage. As a result, great emphasis has been placed on developing a new anticoagulant agent with fewer risks and limitations. Current data suggest that the oral direct factor Xa inhibitor rivaroxaban is a safe and effective alternative to warfarin. Furthermore, rivaroxaban does not require routine coagulation monitoring, which may improve patient compliance to anticoagulant therapy. The ROCKET AF trial demonstrated that 20-mg oral rivaroxaban taken once daily was noninferior to dose-adjusted warfarin in the prevention of stroke and non-central nervous system systemic embolism and had a comparable risk of bleeding. Based primarily on the ROCKET AF trial results, the US Food and Drug Administration recently approved the use of rivaroxaban for stroke prophylaxis in patients with nonvalvular AF. However, additional postmarketing studies on its safety and cost effectiveness are needed before it can be widely accepted as a sound alternative to warfarin.