Kliniske studier vedrørende akut og kronisk tromboembolisk sygdom
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)(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 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 independent 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, atrial fibrillation; AE, adverse event; SAE, serious adverse event.
PP-XAR-ALL-1815-1
Referencer
- Kirchhof P, et al. J Am Coll Cardiol. 2018;72:141–153. Kirchhof P, et al. J Am Coll Cardiol. 2018;72:141–153. Return to content
