PMID- 30591748 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220330 IS - 2090-911X (Electronic) IS - 1110-2608 (Print) IS - 1110-2608 (Linking) VI - 70 IP - 4 DP - 2018 Dec TI - XANTUS-EL: A real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in Eastern Europe, Middle East, Africa and Latin America. PG - 307-313 LID - 10.1016/j.ehj.2018.09.002 [doi] AB - BACKGROUND: The prospective, observational XANTUS study demonstrated low rates of stroke and major bleeding in real-world rivaroxaban-treated patients with non-valvular atrial fibrillation (NVAF) from Western Europe, Canada and Israel. XANTUS-EL is a component of the overall XANTUS programme and enrolled patients with NVAF treated with rivaroxaban from Eastern Europe, the Middle East and Africa (EEMEA) and Latin America. METHODS: Patients with NVAF starting rivaroxaban for stroke prevention were consecutively recruited and followed for 1 year, at approximately 3-month intervals, or for >/=30 days after permanent rivaroxaban discontinuation. Primary outcomes were major bleeding, adverse events (AEs), serious AEs and all-cause mortality. Secondary outcomes included stroke, non-central nervous system systemic embolism (non-CNS SE), transient ischaemic attack (TIA), myocardial infarction (MI) and non-major bleeding. All major outcomes were centrally adjudicated. RESULTS: Overall, 2064 patients were enrolled; mean age +/- standard deviation was 67.1 +/- 11.32 years; 49.3% were male. Co-morbidities included heart failure (30.9%), hypertension (84.2%), diabetes mellitus (26.5%), prior stroke/non-CNS SE/TIA (16.2%) and prior MI (10.7%). Mean CHADS(2), CHA(2)DS(2)-VASc and HAS-BLED scores were 2.0, 3.6 and 1.6, respectively. Treatment-emergent event rates were (events/100 patient-years, [95% confidence interval]): major bleeding 0.9 (0.5-1.4); all-cause mortality 1.7 (1.2-2.4); stroke/non-CNS SE 0.7 (0.4-1.2); any AE 18.1 (16.2-20.1) and any serious AE 8.3 (7.0-9.7). One-year treatment persistence was 81.9%. CONCLUSIONS: XANTUS-EL confirmed low stroke and major bleeding rates in patients with NVAF from EEMEA and Latin America. The population was younger but with more heart failure and hypertension than XANTUS; stroke/SE rate was similar but major bleeding lower. FAU - Martinez, Carlos Arturo Arean AU - Martinez CAA AD - Department of Interventional Cardiology, General Hospital "Dr Miguel Silva", Morelia, Michoacan, Mexico. FAU - Lanas, Fernando AU - Lanas F AD - Departamento de Medicina Interna, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile. FAU - Radaideh, Ghazi AU - Radaideh G AD - Department of Cardiology, Rashid Hospital, Dubai Health Authority, Dubai, United Arab Emirates. FAU - Kharabsheh, Suleiman M AU - Kharabsheh SM AD - Department of Cardiovascular Diseases, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia. FAU - Lambelet, Marc AU - Lambelet M AD - Chrestos Concept GmbH & Co KG, Essen, Germany. FAU - Viaud, Marco Antonio Lavagnino AU - Viaud MAL AD - Medical Affairs, Bayer AG, NJ, USA. FAU - Ziadeh, Naser Samih AU - Ziadeh NS AD - Medical Affairs, Bayer AG, Amman, Jordan. FAU - Turpie, Alexander G G AU - Turpie AGG AD - Department of Medicine, McMaster University, Hamilton, ON, Canada. CN - XANTUS Investigators LA - eng PT - Journal Article DEP - 20180924 PL - Germany TA - Egypt Heart J JT - The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology JID - 9106952 PMC - PMC6303362 OTO - NOTNLM OT - AE, adverse event OT - AF, atrial fibrillation OT - CI, confidence interval OT - CNS, central nervous system OT - CrCl, creatinine clearance OT - EEMEA OT - EEMEA, Eastern Europe the Middle East and Africa OT - ISTH, International Society on Thrombosis and Haemostasis OT - Latin America OT - MI, myocardial infarction OT - NOAC, non-vitamin K antagonist oral anticoagulant OT - NVAF, non-valvular atrial fibrillation OT - PE, pulmonary embolism OT - Real-world OT - Rivaroxaban OT - SAE, serious adverse event OT - SD, standard deviation OT - SE, systemic embolism OT - Stroke prevention OT - TIA, transient ischaemic attack OT - VKA, vitamin K antagonist OT - od, once daily EDAT- 2018/12/29 06:00 MHDA- 2018/12/29 06:01 PMCR- 2018/09/24 CRDT- 2018/12/29 06:00 PHST- 2018/03/19 00:00 [received] PHST- 2018/09/02 00:00 [accepted] PHST- 2018/12/29 06:00 [entrez] PHST- 2018/12/29 06:00 [pubmed] PHST- 2018/12/29 06:01 [medline] PHST- 2018/09/24 00:00 [pmc-release] AID - S1110-2608(18)30018-8 [pii] AID - 10.1016/j.ehj.2018.09.002 [doi] PST - ppublish SO - Egypt Heart J. 2018 Dec;70(4):307-313. doi: 10.1016/j.ehj.2018.09.002. Epub 2018 Sep 24.