Rivaroxaban safely treats NVAF in those with worsening renal function
Rivaroxaban is mostly safe for the treatment of nonvalvular atrial fibrillation (NVAF) in patients with worsening renal function (WRF), a recent study has found.
This sub-analysis of the Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) included 7,509 patients who completed the 1-year follow-up and for whom change in creatinine clearance could be measured. WRF was defined as a decrease in clearance rate of at least 20 percent from enrolment to any time point.
Of the participants, 1,229 met the criteria for WRF (mean age, 75.0±9.6 years; 43.6 percent female), while the remaining 6,280 had stable renal function (SRF; mean age, 72.9±9.5 years; 36.9 percent female). Majority (55 percent) of those with WRF received 15-mg once-daily (od) doses of rivaroxaban, while the others were underdosed, at 10 mg od.
Over a mean treatment duration of 316±102 days, 85 bleeding events were reported in the WRF group. This corresponded to an incidence rate of 8.1 per 100 patient-years, which was not significantly different than that in their SRF counterparts (hazard ratio [HR], 1.12, 95 percent CI, 0.88–1.41; p=0.350). At the 1-year follow-up, 66.9 percent of the WRF group were still on rivaroxaban treatment, 13.0 percent discontinued, and 20.1 percent were lost to follow-up.
Of all types of bleeding events, only the need for transfusion of ≥2 units of packed red blood cells or whole blood was significantly greater in the WRF group (HR, 3.19, 1.04–9.74; p=0.032). Mortality risk was also significantly elevated as compared to SRF patients (HR, 2.29, 1.62–3.24; p<0.001).