XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation

Abstract

Aims: Although non-vitamin K antagonist oral anticoagulants are recommended for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) based on clinical trial results, there is a need for safety and efficacy data from unselected patients in everyday clinical practice. XANTUS investigated the safety and efficacy of the Factor Xa inhibitor rivaroxaban in routine clinical use in the NVAF setting.

Methods and results: Consecutive consenting patients with NVAF newly started on rivaroxaban were eligible and were followed up at ∼3-month intervals for 1 year, or for at least 30 days after permanent discontinuation. All adverse events (AEs) were recorded as AEs or serious AEs; major outcomes (including major bleeding, symptomatic thromboembolic events [stroke, systemic embolism, transient ischaemic attack, and myocardial infarction], and all-cause death) were centrally adjudicated. There were 6784 patients treated with rivaroxaban at 311 centres in Europe, Israel, and Canada. Mean patient age was 71.5 years (range 19-99), 41% were female, and 9.4% had documented severe or moderate renal impairment (creatinine clearance <50 mL/min). The mean CHADS2 and CHA2DS2-VASc scores were 2.0 and 3.4, respectively; 859 (12.7%) patients had a CHA2DS2-VASc score of 0 or 1. The mean treatment duration was 329 days. 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.

Conclusion: XANTUS is the first international, prospective, observational study to describe the use of rivaroxaban in a broad NVAF patient population. Rates of stroke and major bleeding were low in patients receiving rivaroxaban in routine clinical practice.

Trial registration number: Clinicaltrials.gov: NCT01606995.

Keywords: Anticoagulants; Atrial fibrillation; Real world; Rivaroxaban; Stroke; Thromboembolism.

© The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Figure 1

Patient disposition during the study. *Reasons for not continuing in the study included, but were not limited to, patient decision and administrative and medical reasons. Some patients could have more than one reason for exclusion. †Other dose includes any initial rivaroxaban dose besides 15/20 mg once daily (excluding missing information, n = 3).

Figure 2

(A) Cumulative rates (Kaplan–Meier) for treatment-emergent all-cause death, major bleeding events, and stroke/systemic embolism. (B) Event-free rate (Kaplan–Meier) for treatment-emergent all-cause death, major bleeding events, and stroke/systemic embolism. In total, 6522 (96.1%) patients did not experience any of the outcomes of treatment-emergent all-cause death, major bleeding, or stroke/systemic embolism. Safety analysis set.

Figure 3

Outcomes as a function of (A) CHADS2 and (B) CHA2DS2-VASc scores.