Apaxiban is an Option in Severe Renal Dysfunction
The anticoagulation options for patients with concomitant renal impairment are limited and until recently, warfarin was the only recommended option due to insufficient data supporting alternative drugs in such patients. A new study published in Blood Advances suggests that apixaban is a viable option in patients with severe renal dysfunction.
Apixaban in patients with impaired renal function is supported by limited data. Landmark clinical trials evaluating apixaban in patients with atrial fibrillation and/or acute venous thromboembolism excluded patients with creatinine clearance (CrCl) <25 mL/min.
A multicentre, retrospective chart review was conducted to evaluate the safety and effectiveness of apixaban compared with warfarin in patients with CrCl <25 mL/min. Included patients were newly initiated on apixaban or warfarin for at least 45 days with a CrCl <25 mL/min.
Patients were evaluated for thrombosis and bleeding outcomes six months following initiation of anticoagulation. The primary outcome was the time to first bleeding or thrombosis event. A total of 128 patients met inclusion criteria in the apixaban group and 733 patients in the warfarin group.
Time to first bleeding or thrombosis event was significantly different between the apixaban and warfarin groups. After controlling for atrial fibrillation and coronary artery bypass grafting, risk of thrombotic and bleeding events was lower in the apixaban group (hazard ratio 0.47). There was no statistical difference between time to thrombosis (83 days vs 54 days, P = .648), rate of thrombosis (5.5% vs 10.3%, P = .08), time to bleeding (46 days vs 54 days, P = .886), or rate of bleeding (5.5% vs 10.9%, P = .06). The severity of bleeding and thrombotic events was not different between groups.
The results suggest apixaban may be a reasonable option for patients with severe renal dysfunction despite the known increase in apixaban exposure, the researchers concluded. They add that, “These results add to the growing body of evidence of real-world data that apixaban is a reasonable option for patients with severe renal dysfunction.”
The researchers recommend investigating the use of apixaban in patients with a severe renal dysfunction, especially those on haemodialysis, in order to definitively determine the role of apixaban in this patient population.
Source: Blood Advances
