Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non valvular atrial fibrillation: a randomized controlled trial

Prior treatment

• Use of powerful inhibitors of CYP3A4 and gp-P: o azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, miconazole - systemic route and oral gel) o HIV protease inhibitors.
  • Taking acetylsalicylic acid in doses of 500 mg per dose to 3 g per day
  • Patient with history of TIA or stroke in the 3 months preceding inclusion
  • Patient treated with hemodialysis (hybrid dialysis)
  • Moderate or severe mitral stenosis
  • Conditions other than non-valvular atrial fibrillation requiring anticoagulation, such as mechanical prosthetic valves, anti-phospholipid syndrome
  • Life expectancy less than 3 months
  • Registration on the waiting list for a kidney transplant with a cadaveric donor
  • Pregnant or breastfeeding woman
  • Patient under legal protection (Curatelle-Tutelle – Protection of justice)

Other illness

• Patients not considered candidates for oral anticoagulation (active bleeding, recent gastrointestinal bleeding, severe hepatic impairment)
• History of anaphylactic reaction to apixaban

Other

• Use of millepertuis (potent CYP3A4 inducer).

• Men and women, aged at least 18 years, with end-stage renal disease (ESRD) treated with peritoneal dialysis for ≥ 3 months.
• Patients with a history of non-valvular atrial fibrillation treated with oral anticoagulation or patients starting oral anticoagulation for a diagnosis of non-valvular atrial fibrillation
• CHA2DS2-VASc score ≥ 2.
• For women of childbearing age and sexually active, use of an effective method of contraception
• Signing of informed consent
• Affiliation to a social security scheme