Phase IIIb trial of Xarelto (rivaroxaban) shows reduced risk of bleeding in non-valvular atrial fibrillation- Janssen

New Phase IIIb results from the PIONEER AF-PCI study met its primary endpoint and showed that both groups on Xarelto (rivaroxaban), from Janssen, had significantly reduced risk of bleeding compared to the warfarin arm in people with non-valvular atrial fibrillation (NVAF) receiving antiplatelet therapy following angioplasty with stenting. At one year, Both Xarelto groups had significantly lower rates of bleeding compared to the group taking warfarin. Specifically, the Xarelto 15 mg group reduced clinically significant bleeding by 41 percent , and the Xarelto 2.5 mg group by 37 percent compared to the warfarin group. This reduction in bleeding for the two Xarelto groups was consistent across multiple subgroups; fatal bleeds were rare and numerically fewer in patients taking Xarelto compared to those taking warfarin.

A separate sub-analysis of PIONEER AF-PCI showed a reduction in the risk of re-hospitalization or all-cause mortality (due to an adverse event, including bleeding, a cardiovascular cause or other cause) in both Xarelto groups compared to the warfarin group. Specifically, all-cause mortality or re-hospitalization was observed in 34.9 percent of the Xarelto 15 mg group and 31.9 percent of the Xarelto 2.5 mg group compared to 41.9 percent of the warfarin group.

The findings of this exploratory, open-label, randomized study were announced during a Late-Breaking Clinical Trial session at the American Heart Association (AHA) Scientific Sessions 2016 and simultaneously published in The New England Journal of Medicine. A sub-analysis, also published in Circulation, showed people in both Xarelto groups had a significantly reduced risk of being re-hospitalized compared to those in the warfarin arm.

See: "Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI" C. Michael Gibson et al. New England Journal of Medicine November 14, 2016 DOI: 10.1056/NEJMoa1611594