Xarelto: Ph IIIb PIONEER AF-PCI data

The open-label, international Phase IIIb PIONEER AF-PCI trial in 2,124 patients with non-valvular AF who received background antiplatelet therapy following PCI with stenting showed that once-daily15 mg oral Xarelto plus single antiplatelet therapy (clopidogrel or another thienopyridine) and twice-daily 2.5 mg Xarelto plus dual antiplatelet therapy (clopidogrel or another thienopyridine plus aspirin) each met the primary endpoint of reducing the rate of clinically significant bleeding at 1 year vs. warfarin plus dual antiplatelet therapy (16.8% and 18%, respectively, vs. 26.7%, p<0.001 for both). The rates of MACE were similar between the once- and twice-daily Xarelto and warfarin arms (6.5% and 5.6%, respectively, vs. 6%). A sub-analysis showed that the once- and twice-daily Xarelto arms both significantly reduced the rate of re-hospitalization vs. the warfarin arm (34.1% and 31.2%, respectively, vs. 41.5%, p=0.005 and p=0.001). Data were published in The New England Journal of Medicine and in Circulation and presented at the American Heart Association meeting in New Orleans...