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)

Objective

• 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 patients in 47 countries
   

Study Design

• 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 Points

• 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 independent committee
   

Key Findings

• 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, atrial fibrillation; AE, adverse event; SAE, serious adverse event.

PP-XAR-ALL-1815-1