Apixaban: Preliminary Phase III data

Preliminary data from the double-blind, international Phase III AVERROES trial in 5,600 patients showed that apixaban was superior to aspirin on the annual rate of the composite primary endpoint of stroke or systemic embolism (1.6% vs. 3.6%, p<0.001). On the primary safety endpoint, there was no significant difference in the annual rate of major hemorrhage between apixaban and aspirin (1.4% vs. 1.2%, p=0.56). Apixaban also was superior to aspirin on the annual rate of the composite secondary endpoint of stroke, systemic embolism, MI or vascular death (4.1% vs. 6.2%, p<0.001), and led to a significantly lower annual rate of cardiovascular hospitalizations vs. aspirin (11.8% vs. 14.9%, p<0.001). Annual rates of hemorrhagic stroke were 0.2% for both treatment groups (p=0.99).

The trial enrolled patients with AF at risk for stroke who were considered intolerant of or unsuitable for therapy with a vitamin K antagonist such as warfarin. Patients received 5 mg twice-daily apixaban or 81-324 mg daily aspirin. Data were presented at the European Society of Cardiology meeting in Stockholm. ...