PMID- 26330425 OWN - NLM STAT- MEDLINE DCOM- 20170117 LR - 20240417 IS - 1522-9645 (Electronic) IS - 0195-668X (Print) IS - 0195-668X (Linking) VI - 37 IP - 14 DP - 2016 Apr 7 TI - XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. PG - 1145-53 LID - 10.1093/eurheartj/ehv466 [doi] AB - 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 approximately 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. CI - (c) The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology. FAU - Camm, A John AU - Camm AJ AD - Cardiovascular and Cell Sciences Research Institute, St George's, University of London, Cranmer Terrace, SW170RE London, UK jcamm@sgul.ac.uk. FAU - Amarenco, Pierre AU - Amarenco P AD - Department of Neurology and Stroke Center, Paris-Diderot-Sorbonne University, Paris, France. FAU - Haas, Sylvia AU - Haas S AD - Vascular Center, Munich, Germany. FAU - Hess, Susanne AU - Hess S AD - Global Medical Affairs, Bayer HealthCare Pharmaceuticals, Berlin, Germany. FAU - Kirchhof, Paulus AU - Kirchhof P AD - Centre for Cardiovascular Sciences, University of Birmingham and Sandwell & West Birmingham Hospitals NHS Trust, Birmingham, UK Department of Cardiovascular Medicine, University of Munster, Munster, Germany. FAU - Kuhls, Silvia AU - Kuhls S AD - Global Integrated Analysis, Bayer HealthCare Pharmaceuticals, Wuppertal, Germany. FAU - van Eickels, Martin AU - van Eickels M AD - Global Medical Affairs, Bayer HealthCare Pharmaceuticals, Berlin, Germany. FAU - Turpie, Alexander G G AU - Turpie AG AD - Department of Medicine, McMaster University, Hamilton, ON, Canada. CN - XANTUS Investigators LA - eng SI - ClinicalTrials.gov/NCT01606995 PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20150901 PL - England TA - Eur Heart J JT - European heart journal JID - 8006263 RN - 0 (Anticoagulants) RN - 0 (Factor Xa Inhibitors) RN - 9NDF7JZ4M3 (Rivaroxaban) SB - IM CIN - Eur Heart J. 2016 Apr 7;37(14):1154-7. PMID: 26516173 EIN - Eur Heart J. 2024 Apr 17;:. PMID: 38630622 MH - Adult MH - Aged MH - Anticoagulants/*therapeutic use MH - Atrial Fibrillation/*complications MH - Factor Xa Inhibitors/*therapeutic use MH - Female MH - Humans MH - Male MH - Middle Aged MH - Prospective Studies MH - Rivaroxaban/*therapeutic use MH - Stroke/*prevention & control MH - Young Adult PMC - PMC4823634 OTO - NOTNLM OT - Anticoagulants OT - Atrial fibrillation OT - Real world OT - Rivaroxaban OT - Stroke OT - Thromboembolism FIR - Al-Zoebi, A IR - Al-Zoebi A FIR - Schon, N IR - Schon N FIR - Scheuermann, O IR - Scheuermann O FIR - Schroder, T IR - Schroder T FIR - Weyers, G IR - Weyers G FIR - Salefsky, M IR - Salefsky M FIR - Appel, K-F IR - Appel KF FIR - Jocham, K IR - Jocham K FIR - Rieker, W IR - Rieker W FIR - Schnabel, A IR - Schnabel A FIR - Bosch, R IR - Bosch R FIR - Dahm, J IR - Dahm J FIR - Brachmann, J IR - Brachmann J FIR - Schwencke, C IR - Schwencke C FIR - Ragab, S IR - Ragab S FIR - Jung, W IR - Jung W FIR - Stenzel, G IR - Stenzel G FIR - Antz, M IR - Antz M FIR - Grebe, M IR - Grebe M FIR - Diedrichs, H IR - Diedrichs H FIR - Mugge, A IR - Mugge A FIR - Gabelmann, M IR - Gabelmann M FIR - Hoffmann, U IR - Hoffmann U FIR - Krummenerl, A IR - Krummenerl A FIR - Leicht, M IR - Leicht M FIR - Merke, J IR - Merke J FIR - Proskynitopoulos, N IR - Proskynitopoulos N FIR - Richard, F IR - Richard F FIR - Schulze, U IR - Schulze U FIR - Taggeselle, J IR - Taggeselle J FIR - Conze, M IR - Conze M FIR - Frees, U IR - Frees U FIR - Leschke, M IR - Leschke M FIR - Heuer, H IR - Heuer H FIR - Piper, C IR - Piper C FIR - Sarnighausen, H-E IR - Sarnighausen HE FIR - Kramer, A IR - Kramer A FIR - Hubner, G IR - Hubner G FIR - Krings, P IR - Krings P FIR - Stellbrink, C IR - Stellbrink C FIR - Bauknecht, C IR - Bauknecht C FIR - Nickenig, G IR - Nickenig G FIR - Hugl, B IR - Hugl B FIR - Steinhard, R IR - Steinhard R FIR - Hambrecht, R IR - Hambrecht R FIR - Kroll, M IR - Kroll M FIR - Gulba, D IR - Gulba D FIR - Stohring, R IR - Stohring R FIR - Drude, L IR - Drude L FIR - Stadelmann, A IR - Stadelmann A FIR - Schwimmbeck, P IR - Schwimmbeck P FIR - Axthelm, C IR - Axthelm C FIR - Propper, F IR - Propper F FIR - Harinath, C IR - Harinath C FIR - Kausik, C IR - Kausik C FIR - Finlayson, J IR - Finlayson J FIR - Dixit, A IR - Dixit A FIR - Osman, F IR - Osman F FIR - Davey, P IR - Davey P FIR - Mangion, D IR - Mangion D FIR - Nair, P IR - Nair P FIR - Kadr, H IR - Kadr H FIR - Sharma, P IR - Sharma P FIR - Arya, R IR - Arya R FIR - Kirchhof, P IR - Kirchhof P FIR - Amarenco, P IR - Amarenco P FIR - Pillot, M IR - Pillot M FIR - Ansaldi, S IR - Ansaldi S FIR - Bellefleur, J-P IR - Bellefleur JP FIR - Bouchlaghem, K IR - Bouchlaghem K FIR - Chemin, P IR - Chemin P FIR - Chevalier, P IR - Chevalier P FIR - Chisseray Pramotton, C IR - Chisseray Pramotton C FIR - Chokron, R IR - Chokron R FIR - Ciausu, A IR - Ciausu A FIR - Coisne, D IR - Coisne D FIR - Combes, S IR - Combes S FIR - Cottin, Y IR - Cottin Y FIR - Crespy, R IR - Crespy R FIR - Dabboura, A IR - Dabboura A FIR - Dematteo, P IR - Dematteo P FIR - Elbaz, M IR - Elbaz M FIR - Farges, J-L IR - Farges JL FIR - Faucheux, J-M IR - Faucheux JM FIR - Fauchier, L IR - Fauchier L FIR - Foltzer, E IR - Foltzer E FIR - Fournier, P -Y IR - Fournier P- FIR - Gauthier, J IR - Gauthier J FIR - Grivet, B IR - Grivet B FIR - Guillon, B IR - Guillon B FIR - Khalvadjian, R IR - Khalvadjian R FIR - Koujan, B IR - Koujan B FIR - Labeque, J-N IR - Labeque JN FIR - Labbe, J-P IR - Labbe JP FIR - Long, J-L IR - Long JL FIR - Loubet, M IR - Loubet M FIR - Samama, P IR - Samama P FIR - Martelet, M IR - Martelet M FIR - Mielot, S IR - Mielot S FIR - Neau, J-P IR - Neau JP FIR - Probst, V IR - Probst V FIR - Rifai, A IR - Rifai A FIR - Samson, Y IR - Samson Y FIR - Ky, B Truong Minh IR - Ky B FIR - Viader, F IR - Viader F FIR - Corbin, A IR - Corbin A FIR - Dafaye, P IR - Dafaye P FIR - Lang, P IR - Lang P FIR - Dompnier, A IR - Dompnier A FIR - Hagege, A IR - Hagege A FIR - Lellouche, N IR - Lellouche N FIR - Destrac, S IR - Destrac S FIR - Nighoghossian, N IR - Nighoghossian N FIR - Guerard, S IR - Guerard S FIR - Davy, J M IR - Davy J FIR - Aupetit, J F IR - Aupetit J FIR - Durand Dubief, A IR - Durand Dubief A FIR - Gacem, A IR - Gacem A FIR - Zylberberg, M IR - Zylberberg M FIR - Fournier, E IR - Fournier E FIR - Kownator, S IR - Kownator S FIR - Amara, W IR - Amara W FIR - Elkaim, J P IR - Elkaim J FIR - Ferrari, E IR - Ferrari E FIR - Napporn, G IR - Napporn G FIR - Winum, P F IR - Winum P FIR - Aliot, E IR - Aliot E FIR - Sarov-Riviere, M IR - Sarov-Riviere M FIR - Kornacewicz-Jach, Z IR - Kornacewicz-Jach Z FIR - Zinka, E IR - Zinka E FIR - Nartowicz-Sloniewska, M IR - Nartowicz-Sloniewska M FIR - Mocarska-Gorna, B IR - Mocarska-Gorna B FIR - Latocha-Korecka, G IR - Latocha-Korecka G FIR - Stasiewski, A IR - Stasiewski A FIR - Tyszkiewicz, J IR - Tyszkiewicz J FIR - Lepich, T IR - Lepich T FIR - Kluba, R IR - Kluba R FIR - Piotrowski, W IR - Piotrowski W FIR - Miklaszewicz, B IR - Miklaszewicz B FIR - Pawlowska, M IR - Pawlowska M FIR - Mazur, S IR - Mazur S FIR - Houde, G IR - Houde G FIR - Grondin, F IR - Grondin F FIR - Craig, B IR - Craig B FIR - Lai, C IR - Lai C FIR - Lam, S IR - Lam S FIR - Kucktaruk, A IR - Kucktaruk A FIR - Sabe-Affaki, G IR - Sabe-Affaki G FIR - Miller, M IR - Miller M FIR - Hill, L IR - Hill L FIR - Kelly, A IR - Kelly A FIR - Fikry, S IR - Fikry S FIR - St-Maurice, F IR - St-Maurice F FIR - Filteau, P IR - Filteau P FIR - Frechette, A IR - Frechette A FIR - Csanadi, M IR - Csanadi M FIR - Mason, M IR - Mason M FIR - Chouinard, G IR - Chouinard G FIR - Gendreau, R IR - Gendreau R FIR - Melon, P IR - Melon P FIR - De Wolf, L IR - De Wolf L FIR - Heidbuchel, H IR - Heidbuchel H FIR - Janssens, L IR - Janssens L FIR - Scavee, C IR - Scavee C FIR - Hoffer, E IR - Hoffer E FIR - Leroy, J IR - Leroy J FIR - Boussy, T IR - Boussy T FIR - Elvan, A IR - Elvan A FIR - Hermans, W IR - Hermans W FIR - Suryapranata, H IR - Suryapranata H FIR - van Eck, M IR - van Eck M FIR - Van Haelst, P IR - Van Haelst P FIR - Meeder, J IR - Meeder J FIR - Hoogslag, P IR - Hoogslag P FIR - Kragten, H IR - Kragten H FIR - Tukkie, R IR - Tukkie R FIR - Hemels, M IR - Hemels M FIR - Van Wijk, L IR - Van Wijk L FIR - Nierop, P IR - Nierop P FIR - Ten Holt, W IR - Ten Holt W FIR - Zwart, P IR - Zwart P FIR - Bakx, A IR - Bakx A FIR - Kuijper, A IR - Kuijper A FIR - de Nooijer, R IR - de Nooijer R FIR - Van der Heijden, R IR - Van der Heijden R FIR - ten Berg, J IR - ten Berg J FIR - Beyerbacht, H IR - Beyerbacht H FIR - Brouwer, J L IR - Brouwer J FIR - Van den Berg, B IR - Van den Berg B FIR - Den Hartog, F IR - Den Hartog F FIR - Blomstrom Lundqvist, C IR - Blomstrom Lundqvist C FIR - Laska, A-C IR - Laska AC FIR - Rorsman, C IR - Rorsman C FIR - Moor, E IR - Moor E FIR - Lindholm, C-J IR - Lindholm CJ FIR - Lind, S IR - Lind S FIR - Teichert, J IR - Teichert J FIR - Grahs, T IR - Grahs T FIR - Falk, L IR - Falk L FIR - Bandh, S IR - Bandh S FIR - Nielsen, H IR - Nielsen H FIR - Riahi, S IR - Riahi S FIR - Pehrson, S IR - Pehrson S FIR - Zeuten, E IR - Zeuten E FIR - Jensen, G IR - Jensen G FIR - Gislason, G IR - Gislason G FIR - Ibsen, H IR - Ibsen H FIR - Hildebrandt, P IR - Hildebrandt P FIR - Oie, E IR - Oie E FIR - Kurz, M IR - Kurz M FIR - Ronnevik, P K IR - Ronnevik P FIR - Skoda, O IR - Skoda O FIR - Malek, F IR - Malek F FIR - Soucek, M IR - Soucek M FIR - Spinar, J IR - Spinar J FIR - Marek, D IR - Marek D FIR - Mikulik, R IR - Mikulik R FIR - Jansky, P IR - Jansky P FIR - Bar, M IR - Bar M FIR - Barsovsky, M IR - Barsovsky M FIR - Krajcova, L IR - Krajcova L FIR - Homza, M IR - Homza M FIR - Shohat Zabarski, R IR - Shohat Zabarski R FIR - Nseir, W IR - Nseir W FIR - Vered, Z IR - Vered Z FIR - Rosenschein, U IR - Rosenschein U FIR - Martinez, J IR - Martinez J FIR - Canhao, P IR - Canhao P FIR - Gregorio, T IR - Gregorio T FIR - Fontes Carvalho, R IR - Fontes Carvalho R FIR - Nesser, H J IR - Nesser H FIR - Hoppe, U IR - Hoppe U FIR - Pieske, B M IR - Pieske B FIR - Weber, J R IR - Weber J FIR - Brenneis, C IR - Brenneis C FIR - Winkler, A IR - Winkler A FIR - Huber, K IR - Huber K FIR - Gatterer, A IR - Gatterer A FIR - Podczeck-Schweighofer, A IR - Podczeck-Schweighofer A FIR - Gwechenberger, M IR - Gwechenberger M FIR - Weidinger, F IR - Weidinger F FIR - Csanadi, Z IR - Csanadi Z FIR - Jarai, Z IR - Jarai Z FIR - Vertes, A IR - Vertes A FIR - Zamolyi, K IR - Zamolyi K FIR - Tarasov, A IR - Tarasov A FIR - Baychorov, I IR - Baychorov I FIR - Kubova, M IR - Kubova M FIR - Ryabinina, M IR - Ryabinina M FIR - Matskeplishvilli, S IR - Matskeplishvilli S FIR - Sulimov, V IR - Sulimov V FIR - Kozhevnikova, S IR - Kozhevnikova S FIR - Adonina, E IR - Adonina E FIR - Lartseva, V IR - Lartseva V FIR - Shimkevich, A IR - Shimkevich A FIR - Rychkov, A IR - Rychkov A FIR - Khorkova, N IR - Khorkova N FIR - Kolycheva, O IR - Kolycheva O FIR - Zenin, S IR - Zenin S FIR - Kononenko, O IR - Kononenko O FIR - Vlasyants, E IR - Vlasyants E FIR - Dereva, M IR - Dereva M FIR - Vedeneva, E IR - Vedeneva E FIR - Minasova, E IR - Minasova E FIR - Popov, S IR - Popov S FIR - Usenkov, S IR - Usenkov S FIR - Kisteneva, I IR - Kisteneva I FIR - Batalov, R IR - Batalov R FIR - Spacenkov, G IR - Spacenkov G FIR - Kuznetsov, S IR - Kuznetsov S FIR - Tsybulskaya, T IR - Tsybulskaya T FIR - Vitsenya, M IR - Vitsenya M FIR - Vyborov, O IR - Vyborov O FIR - Shlyk, I IR - Shlyk I FIR - Voznyuk, I IR - Voznyuk I FIR - Muhamedrahimova, A IR - Muhamedrahimova A FIR - Obrezan, A IR - Obrezan A FIR - Tvrdikova, M IR - Tvrdikova M FIR - Filipova, S IR - Filipova S FIR - Roskova, E IR - Roskova E FIR - Strbova, J IR - Strbova J FIR - Farsky, S IR - Farsky S FIR - Pella, D IR - Pella D FIR - Nedelova, I IR - Nedelova I FIR - Fazekas, F IR - Fazekas F FIR - Pacherova, J IR - Pacherova J FIR - Lasanova, Z IR - Lasanova Z FIR - Hlivak, P IR - Hlivak P FIR - Spurny, P IR - Spurny P FIR - Pokorna, V IR - Pokorna V FIR - Mora, M IR - Mora M FIR - Stefanik, M IR - Stefanik M FIR - Karlinska, O IR - Karlinska O FIR - Sychov, O IR - Sychov O FIR - Grygorieva, T IR - Grygorieva T FIR - Gukov, O IR - Gukov O FIR - Romanenko, O IR - Romanenko O FIR - Petrovskyy, T IR - Petrovskyy T FIR - Gorbach, M IR - Gorbach M FIR - Reshotko, D IR - Reshotko D FIR - Maxym, G IR - Maxym G FIR - Kanic, V IR - Kanic V FIR - Marija, M IR - Marija M FIR - Mirjam, G IR - Mirjam G FIR - Subic, T IR - Subic T FIR - Mahon, N IR - Mahon N FIR - Grosu, A IR - Grosu A FIR - Grivenco, A IR - Grivenco A FIR - Grajdieru, R IR - Grajdieru R FIR - Diaconu, N IR - Diaconu N EDAT- 2015/09/04 06:00 MHDA- 2017/01/18 06:00 PMCR- 2015/09/01 CRDT- 2015/09/03 06:00 PHST- 2015/07/27 00:00 [received] PHST- 2015/08/20 00:00 [accepted] PHST- 2015/09/03 06:00 [entrez] PHST- 2015/09/04 06:00 [pubmed] PHST- 2017/01/18 06:00 [medline] PHST- 2015/09/01 00:00 [pmc-release] AID - ehv466 [pii] AID - 10.1093/eurheartj/ehv466 [doi] PST - ppublish SO - Eur Heart J. 2016 Apr 7;37(14):1145-53. doi: 10.1093/eurheartj/ehv466. Epub 2015 Sep 1.