Xarelto^® is a novel, oral convenient approach to the prevention of stroke and systemic embolism in adult patients with non-valvular AF

The ROCKET AF study evaluated once-daily Xarelto in comparison with dose-adjusted warfarin for the prevention of stroke and systemic embolism in more than 14,000 patients with non­valvular AF at moderate-to-high risk of stroke.^{74, 75} Risk factors included prior stroke or transient ischaemic attack, congestive heart failure, hypertension, age ≥75 years or diabetes mellitus. Current treatment guidelines recommend oral anticoagulation for this patient group.^{70, 76}
Xarelto was given as a fixed, once-daily dose of either 20 mg for most patients or 15 mg for patients with moderate renal impairment (creatinine clearance, 30–49 ml/min).^{74, 75} Warfarin was dose adjusted to achieve a target international normalized ratio of 2.5 (range 2.0–3.0). The median duration of treatment was 590 days; the median follow-up period was 707 days.

Data from ROCKET AF support Xarelto as a novel approach to preventing stroke in patients with non-valvular AF.⁷⁵

Xarelto demonstrated, in comparison with warfarin:⁷⁵

• Equivalent efficacy for the prevention of stroke or systemic embolism In the per-protocol on-treatment population, the primary efficacy endpoint, the composite incidence of stroke and systemic embolism, occurred in 1.7%/year of patients receiving Xarelto (188/6958) and 2.2%/year of patients receiving warfarin (241/7004; p < 0.001 for non-inferiority). This was achieved with a median TTR of 55% in the warfarin arm.
  
  Source: Patel MR et al. (2011).⁷⁵
• A reassuring safety profile
  • The incidence of the composite of major and non-major clinically relevant bleeding was similar for both treatments: 14.9%/year for Xarelto and 14.5%/year for warfarin (p=0.44)
  • A decrease in haemoglobin level of 2 g/dl or more was significantly more common among patients treated with Xarelto (2.8%/per year versus 2.3%/year; p=0.02), as was a requirement for blood transfusion (1.6%/year versus 1.3%/year; p=0.04)
    • Incidence of major bleeding from a gastrointestinal site (upper, lower or rectal) was higher in the rivaroxaban group than in the warfarin group.
  • In contrast, fatal bleeding occurred significantly less frequently with Xarelto (0.2%/year) than with warfarin (0.5%/year; p=0.003), as did intracranial haemorrhage (Xarelto, 0.5% per year; warfarin, 0.7% per year; p=0.02)