A Pooled Analysis of the Global XANTUS Programme

Safety Analysis of Xarelto®: a Pooled Analysis of the Global XANTUS Programme (Real World, Prospective, Observational Studies for Stroke Prevention in Patients with Atrial Fibrillation)

Objective1

  • To assess the global safety profile of Xarelto in routine practice through a pooled analysis of studies in the XANTUS programme, collecting information on AF AF
    Atrial fibrillation (= AF). A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
    patients in 47 countries

Study Design1

  • A pre-planned pooled analysis of the prospective, observational XANTUS, XANAP and XANTUS-EL studies of unselected patients with AF newly starting rivaroxaban for stroke prevention was performed
  • Patients were followed for 1 year, at ∼3-month intervals, or for ≥30 days after permanent discontinuation

Study End Points1

  • Primary outcomes were major bleeding, adverse events (AEs) or serious AEs (SAEs) and all-cause mortality
  • Secondary outcomes included symptomatic thromboembolic events and non-major bleeding
  • Treatment emergent major outcomes were adjudicated by a central committee

Key Findings1

  • This large analysis in >11,000 patients shows low bleeding and stroke rates in AF patients treated with Xarelto for 1 year
  • Treatment discontinuation in ∼23% of patients illustrates the need to develop care models that ensure consistent delivery of evidence-based therapy

AF AF
Atrial fibrillation (= AF). A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
, atrial fibrillation; AE, adverse event; SAE, serious adverse event.