Xarelto® is a novel, oral convenient approach to the prevention of stroke and systemic embolism in adult patients with non-valvular AF
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.
- Xarelto demonstrated equivalent efficacy and safety compared with warfarin
- Xarelto demonstrated a similar rate of major bleeding compared with warfarin but a significant reduction in the incidence of fatal bleeding and intracranial haemorrhage
- Xarelto offers a simple, once-daily oral treatment solution without the need for dose adjustment or routine coagulation monitoring
Key findings from ROCKET AF
- 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)
- 74 - The Executive Steering Committee on behalf of the ROCKET AF Study Investigators. Rivaroxaban – once daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: Rationale and Design of the ROCKET AF study. Am Heart J 2010;159:340–347.
- 75 - Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883–891.
- 70 - Camm AJ, Kirchhof P, Lip GY et al. Guidelines for the management of atrial fibrillation: The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J 2010;31:2369–2429.
- 76 - Singer DE, Albers GW, Dalen JE et al. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians evidence-based clinical practice guidelines (8th Edition). Chest 2008;133:546S–592S.
- International Normalized Ratio
- A system for assessing the clotting tendency of blood in patients receiving anticoagulant therapy. For patients with atrial fibrillation, the recommended target INR range is between 2 and 3. If the INR is higher than 3, patients are at risk of serious bleeding. If the INR is less than 2, patients are at risk of a blood clotting event.
- Atrial fibrillation
- A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
- The ability of a drug to produce the desired effect.