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


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.


CONCLUSIONS
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.


BACKGROUND
Clinicaltrials.gov: NCT01606995.
Cardiovascular and Cell Sciences Research Institute, St George's, University of London, Cranmer Terrace, SW170RE London, UK jcamm@sgul.ac.uk.
A John
AJ
Camm
Department of Neurology and Stroke Center, Paris-Diderot-Sorbonne University, Paris, France.
Pierre
P
Amarenco
Vascular Center, Munich, Germany.
Sylvia
S
Haas
Global Medical Affairs, Bayer HealthCare Pharmaceuticals, Berlin, Germany.
Susanne
S
Hess
Centre for Cardiovascular Sciences, University of Birmingham and Sandwell & West Birmingham Hospitals NHS Trust, Birmingham, UK Department of Cardiovascular Medicine, University of Münster, Münster, Germany.
Paulus
P
Kirchhof
Global Integrated Analysis, Bayer HealthCare Pharmaceuticals, Wuppertal, Germany.
Silvia
S
Kuhls
Global Medical Affairs, Bayer HealthCare Pharmaceuticals, Berlin, Germany.
Martin
M
van Eickels
Department of Medicine, McMaster University, Hamilton, ON, Canada.
Alexander G G
AG
Turpie
D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications*; D065427:Factor Xa Inhibitors / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069552:Rivaroxaban / Q000627:therapeutic use*; D020521:Stroke / Q000517:prevention & control*; D055815:Young Adult
D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban
Anticoagulants; Atrial fibrillation; Real world; Rivaroxaban; Stroke; Thromboembolism