Application of rivaroxaban in clinical practice: results of a prospective observational study XANTUS in patients with atrial fibrillation

In XANTUS study the safety and efficacy of factor Xa inhibitor rivaroxaban were evaluated in routine clinical practice in patients with non-valvular atrial fibrillation. In consecutive patients who started treatment with rivaroxaban, all adverse events were recorded every 3 months for 1 year. Conclusions of major bleeding, symptomatic thromboembolic complications (stroke, systemic embolism, transient ischemic attack, and myocardial infarction) and death from all causes were centrally adjudicated. In total 6784 patients were treated with rivaroxaban at 311 centers in Europe, Israel, and Canada, on average, 329 days. The mean CHADS(2) and CHA(2)DS(2)-VASc scores were 2.0 and 3.4, respectively. Treatment-emergent major bleeding occurred in 128 patients (2.1 events per 100 patient-years), 118 (1.9 events per 100 patient-years) died, and 43 (0.7 events per 100 patient-years) suffered a stroke. XANTUS is the first international, prospective, observational study to describe the use of rivaroxaban in a broad non-valvular atrial fibrillation patient population. Rates of stroke and major bleeding were low in patients receiving rivaroxaban in routine clinical practice.