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

• Published in: The Egyptian heart journal 2018-12, Vol.70 (4), p.307-313
• Main Authors: Martínez, Carlos Arturo Areán, Lanas, Fernando, Radaideh, Ghazi, Kharabsheh, Suleiman M., Lambelet, Marc, Viaud, Marco Antonio Lavagnino, Ziadeh, Naser Samih, Turpie, Alexander G.G.
• Format: Article
• Language: English
• Subjects: Arrhythmia; EEMEA; Latin America; Real-world; Rivaroxaban; Stroke prevention
• ISSN: 1110-2608; 2090-911X
• DOI: 10.1016/j.ehj.2018.09.002

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. 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. 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 CHADS2, CHA2DS2-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%. 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.