Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment

  • K.A.A. F
  • J.P. P
  • D. W
 et al. 
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Abstract

Aim s Patients with non-valvular atrial fibrillation (AF) and renal insufficiency are at increased risk for ischaemic stroke and bleeding during anticoagulation. Rivaroxaban, an oral, direct factor Xa inhibitor metabolized predominantly by the liver, preserves the benefit of warfarin for stroke prevention while causing fewer intracranial and fatal haemorrhages. Methods and resultsWe randomized 14 264 patients with AF in a double-blind trial to rivaroxaban 20 mg/day [15 mg/day if creatinine clearance (CrCl) 3049 mL/min] or dose-adjusted warfarin (target international normalized ratio 2.03.0). Compared with patients with CrCl >50 mL/min (mean age 73 years), the 2950 (20.7) patients with CrCl 3049 mL/min were older (79 years) and had higher event rates irrespective of study treatment. Among those with CrCl 3049 mL/min, the primary endpoint of stroke or systemic embolism occurred in 2.32 per 100 patient-years with rivaroxaban 15 mg/day vs. 2.77 per 100 patient-years with warfarin [hazard ratio (HR) 0.84; 95 confidence interval (CI) 0.571.23] in the per-protocol population. Intention-to-treat analysis yielded similar results (HR 0.86; 95 CI 0.631.17) to the per-protocol results. Rates of the principal safety endpoint (major and clinically relevant non-major bleeding: 17.82 vs. 18.28 per 100 patient-years; P 0.76) and intracranial bleeding (0.71 vs. 0.88 per 100 patient-years; P 0.54) were similar with rivaroxaban or warfarin. Fatal bleeding (0.28 vs. 0.74 per 100 patient-years; P 0.047) occurred less often with rivaroxaban.ConclusionPatients with AF and moderate renal insufficiency have higher rates of stroke and bleeding than those with normal renal function. There was no evidence of heterogeneity in treatment effect across dosing groups. Dose adjustment in ROCKET-AF yielded results consistent with the overall trial in comparison with dose-adjusted warfarin. © 2011 The Author.

Author-supplied keywords

  • aged
  • arthralgia
  • article
  • atrial fibrillation
  • backache
  • bleeding
  • brain hemorrhage
  • brain ischemia
  • bronchitis
  • controlled study
  • coughing
  • creatinine clearance
  • diarrhea
  • dizziness
  • double blind procedure
  • drug induced headache
  • dyspnea
  • embolism
  • epistaxis
  • female
  • heart failure
  • hematuria
  • human
  • kidney failure
  • major clinical study
  • male
  • multicenter study
  • peripheral edema
  • priority journal
  • randomized controlled trial
  • rhinopharyngitis
  • rivaroxaban
  • treatment outcome
  • upper respiratory tract infection
  • urinary tract infection
  • warfarin

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Authors

  • Fox K.A.A.

  • Piccini J.P.

  • Wojdyla D.

  • Becker R.C.

  • Halperin J.L.

  • Nessel C.C.

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