Format

Send to

Choose Destination
Eur Heart J. 2016 Apr 7;37(14):1145-53. doi: 10.1093/eurheartj/ehv466. Epub 2015 Sep 1.

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

Collaborators (310)

Al-Zoebi A, Schön N, Scheuermann O, Schröder T, Weyers G, Salefsky M, Appel KF, Jocham K, Rieker W, Schnabel A, Bosch R, Dahm J, Brachmann J, Schwencke C, Ragab S, Jung W, Stenzel G, Antz M, Grebe M, Diedrichs H, Mügge A, Gabelmann M, Hoffmann U, Krummenerl A, Leicht M, Merke J, Proskynitopoulos N, Richard F, Schulze U, Taggeselle J, Conze M, Frees U, Leschke M, Heuer H, Piper C, Sarnighausen HE, Krämer A, Hübner G, Krings P, Stellbrink C, Bauknecht C, Nickenig G, Hügl B, Steinhard R, Hambrecht R, Kroll M, Gulba D, Stöhring R, Drude L, Stadelmann A, Schwimmbeck P, Axthelm C, Pröpper F, Harinath C, Kausik C, Finlayson J, Dixit A, Osman F, Davey P, Mangion D, Nair P, Kadr H, Sharma P, Arya R, Kirchhof P, Amarenco P, Pillot M, Ansaldi S, Bellefleur JP, Bouchlaghem K, Chemin P, Chevalier P, Chisseray Pramotton C, Chokron R, Ciausu A, Coisne D, Combes S, Cottin Y, Crespy R, Dabboura A, Dematteo P, Elbaz M, Farges JL, Faucheux JM, Fauchier L, Foltzer E, Fournier P-, Gauthier J, Grivet B, Guillon B, Khalvadjian R, Koujan B, Labeque JN, Labbe JP, Long JL, Loubet M, Samama P, Martelet M, Mielot S, Neau JP, Probst V, Rifai A, Samson Y, Ky B, Viader F, Corbin A, Dafaye P, Lang P, Dompnier A, Hagege A, Lellouche N, Destrac S, Nighoghossian N, Guerard S, Davy J, Aupetit J, Durand Dubief A, Gacem A, Zylberberg M, Fournier E, Kownator S, Amara W, Elkaim J, Ferrari E, Napporn G, Winum P, Aliot E, Sarov-Riviére M, Kornacewicz-Jach Z, Zinka E, Nartowicz-Słoniewska M, Mocarska-Górna B, Latocha-Korecka G, Stasiewski A, Tyszkiewicz J, Lepich T, Kluba R, Piotrowski W, Mikłaszewicz B, Pawłowska M, Mazur S, Houde G, Grondin F, Craig B, Lai C, Lam S, Kucktaruk A, Sabe-Affaki G, Miller M, Hill L, Kelly A, Fikry S, St-Maurice F, Filteau P, Fréchette A, Csanadi M, Mason M, Chouinard G, Gendreau R, Melon P, De Wolf L, Heidbüchel H, Janssens L, Scavée C, Hoffer E, Leroy J, Boussy T, Elvan A, Hermans W, Suryapranata H, van Eck M, Van Haelst P, Meeder J, Hoogslag P, Kragten H, Tukkie R, Hemels M, Van Wijk L, Nierop P, Ten Holt W, Zwart P, Bakx A, Kuijper A, de Nooijer R, Van der Heijden R, ten Berg J, Beyerbacht H, Brouwer J, Van den Berg B, Den Hartog F, Blomström Lundqvist C, Laska AC, Rorsman C, Moor E, Lindholm CJ, Lind S, Teichert J, Grähs T, Falk L, Bandh S, Nielsen H, Riahi S, Pehrson S, Zeuten E, Jensen G, Gislason G, Ibsen H, Hildebrandt P, Øie E, Kurz M, Rønnevik P, Škoda O, Málek F, Souček M, Spinar J, Marek D, Mikulik R, Jansky P, Bar M, Barsovsky M, Krajcova L, Homza M, Shohat Zabarski R, Nseir W, Vered Z, Rosenschein U, Martinez J, Canhão P, Gregorio T, Fontes Carvalho R, Nesser H, Hoppe U, Pieske B, Weber J, Brenneis C, Winkler A, Huber K, Gatterer A, Podczeck-Schweighofer A, Gwechenberger M, Weidinger F, Csanadi Z, Jarai Z, Vertes A, Zamolyi K, Tarasov A, Baychorov I, Kubova M, Ryabinina M, Matskeplishvilli S, Sulimov V, Kozhevnikova S, Adonina E, Lartseva V, Shimkevich A, Rychkov A, Khorkova N, Kolycheva O, Zenin S, Kononenko O, Vlasyants E, Dereva M, Vedeneva E, Minasova E, Popov S, Usenkov S, Kisteneva I, Batalov R, Spacenkov G, Kuznetsov S, Tsybulskaya T, Vitsenya M, Vyborov O, Shlyk I, Voznyuk I, Muhamedrahimova A, Obrezan A, Tvrdikova M, Filipova S, Roskova E, Strbova J, Farsky S, Pella D, Nedělová I, Fazekas F, Pacherová J, Lašanová Z, Hlivák P, Spurný P, Pokorna V, Mora M, Stefanik M, Karlinska O, Sychov O, Grygorieva T, Gukov O, Romanenko O, Petrovskyy T, Gorbach M, Reshotko D, Maxym G, Kanic V, Marija M, Mirjam G, Šubic T, Mahon N, Grosu A, Grivenco A, Grajdieru R, Diaconu N.

Author information

1
Cardiovascular and Cell Sciences Research Institute, St George's, University of London, Cranmer Terrace, SW170RE London, UK jcamm@sgul.ac.uk.
2
Department of Neurology and Stroke Center, Paris-Diderot-Sorbonne University, Paris, France.
3
Vascular Center, Munich, Germany.
4
Global Medical Affairs, Bayer HealthCare Pharmaceuticals, Berlin, Germany.
5
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.
6
Global Integrated Analysis, Bayer HealthCare Pharmaceuticals, Wuppertal, Germany.
7
Department of Medicine, McMaster University, Hamilton, ON, Canada.

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

PMID:
26330425
PMCID:
PMC4823634
DOI:
10.1093/eurheartj/ehv466
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Silverchair Information Systems Icon for PubMed Central
Loading ...
Support Center