ROCKET AF: rivaroxaban demonstrates efficacy and safety for stroke prevention in atrial fibrillation
- Median age: 73 years75
- Mean CHADS2 score: 3.575
- 55% had experienced a previous stroke or transient ischaemic attack75
- Median creatinine clearance: 67 ml/min75
- 21% had creatinine clearance of 30–49 ml/min104
- Mean time in therapeutic range (INR 2.0–3.0) among patients in the warfarin group: 55%75
Patients were treated for a median of 590 days; median follow-up was 707 days, which included ~117 off-treatment days in patients who discontinued study medication prematurely.
Primary efficacy endpoint: rivaroxaban demonstrated similar efficacy to warfarin75
- The primary efficacy analysis (in the per-protocol on-treatment population) showed that the primary endpoint occurred in 1.71%/year in the rivaroxaban arm compared with 2.16%/year with warfarin (hazard ratio=0.79; 95% confidence interval [CI] 0.66–0.96; p<0.001 for noninferiority). This was achieved with a median TTR of 55% in the warfarin arm.
Safety: similar overall bleeding with fewer ICH and fatal bleeds75
- Incidence of major bleeding from a gastrointestinal site (upper, lower or rectal) was higher in the rivaroxaban group than in the warfarin group (3.2% vs 2.2% respectively; p<0.001). This accounted for most of the increase in transfusions and haemoglobin concentration falls seen with rivaroxaban
Other safety outcomes75
- 75 - Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883–891.
- 104 - Fox KAA, Piccini JP, Wojdyla D et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J 2011;32:2387–2394.
- 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.