BACKGROUND: Atrial fibrillation (AF), the most common cardiac arrhythmia, is a 
major risk factor for stroke. Rivaroxaban, an oral factor Xa inhibitor, is 
approved for the prevention of stroke in patients with non-valvular AF. In the 
pivotal phase III trial ROCKET AF, rivaroxaban demonstrated non-inferiority 
compared with warfarin for reducing the risk of stroke or systemic embolism (SE) 
in patients with AF (intention-to-treat analysis), without an increased risk of 
major bleeding. Superior efficacy vs. warfarin was achieved while patients were 
on study medication. Other direct oral factor Xa inhibitors have completed phase 
III clinical trials in this indication. Compared with warfarin, apixaban (in the 
ARISTOTLE trial) and edoxaban (in the ENGAGE-AF trial) were shown to be superior 
or non-inferior, respectively, for reduction in stroke or SE risk in patients 
with AF. Baseline stroke risk, as indicated by CHADS2 scores, was lower in 
patients in the ARISTOTLE and ENGAGE-AF trials than in ROCKET AF.
OBJECTIVES: This review discusses the main findings from ROCKET AF, specifically 
examining recent subgroup analyses investigating rivaroxaban use across various 
patient types at high risk for adverse outcomes, including those with prior 
stroke or transient ischaemic attack, reduced renal function, prior myocardial 
infarction, peripheral artery disease, heart failure or patients aged ≥ 75 years 
and those resident in East Asia.
CONCLUSIONS: These subgroup analyses demonstrate that the treatment effect for 
rivaroxaban vs. warfarin is broadly consistent across a wide range of patient 
groups, with respect to both efficacy and safety.