Monitoring of anti-Xa activity and factors related to bleeding events: A study in Japanese patients with nonvalvular atrial fibrillation receiving rivaroxaban

J Cardiol. 2017 Sep;70(3):244-249. doi: 10.1016/j.jjcc.2016.11.013. Epub 2016 Dec 22.

Abstract

Background: Anti-Xa activity (AXA) in patients with nonvalvular atrial fibrillation (NVAF) and relationship to bleeding events remains unclear.

Methods: We evaluated AXA in 94 patients at both trough and peak rivaroxaban concentrations. Rivaroxaban dosage was determined according to creatinine clearance (CrCl): 10 and 15mg once daily for patients with CrCl 15-49 and CrCl ≥50mL/min, respectively. AXA value distribution and its association with bleeding events were examined in enrolled subjects.

Results: The mean peak AXA level was significantly higher than the mean trough level (1.98±0.81 vs. 0.16±0.15IU/mL; p<0.001). The peak AXA level significantly differed among patients with CrCl 15-29, 30-49, 50-79, and ≥80mL/min (2.51±0.83, 1.72±0.76, 2.05±0.82, and 1.66±0.51IU/mL, respectively; p=0.004). Major and non-major clinically relevant bleeding events occurred in 22 patients (23.4% and 14.6% per year, respectively). The mean peak AXA level was significantly higher in patients who experienced bleeding events than in those who did not (2.40±0.70 vs. 1.84±0.80IU/mL; p=0.001). A Cox multivariate analysis showed that the peak AXA level was independently related to the incidence of major and non-major clinically relevant bleeding events (p=0.012). Cumulative bleeding rates were significantly higher in patients with high peak AXA levels (p<0.001).

Conclusion: Peak AXA level was an independent predictor for bleeding events in Japanese NVAF patients receiving rivaroxaban.

Keywords: Bleeding complication; Coagulation test; Factor Xa inhibitor; Nonvalvular atrial fibrillation.

Publication types

  • Clinical Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Asian People
  • Atrial Fibrillation / drug therapy*
  • Atrial Fibrillation / metabolism
  • Factor Xa Inhibitors / adverse effects*
  • Factor Xa Inhibitors / blood
  • Factor Xa Inhibitors / pharmacokinetics
  • Female
  • Hemorrhage / chemically induced*
  • Hemorrhage / metabolism
  • Humans
  • Male
  • Middle Aged
  • Rivaroxaban / adverse effects*
  • Rivaroxaban / blood
  • Rivaroxaban / pharmacokinetics

Substances

  • Factor Xa Inhibitors
  • Rivaroxaban