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

Abstract

BackgroundThe 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.MethodsPatients 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.ResultsOverall, 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%.ConclusionsXANTUS-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.

Characteristics of patients with atrial fibrillation prescribed edoxaban in Belgium and the Netherlands: insights from the ETNA-AF-Europe study

“…Several large real-world evidence studies have been performed to study the safety of the non-vitamin K antagonist oral anticoagulants (NOACs) for stroke prevention in unselected patients with atrial fibrillation (AF). These studies confirm that use of NOACs in routine clinical practice is safe and efficacious, but also show that their reduced doses are far more often prescribed than in the randomised controlled trials (RCTs) [1][2][3][4][5][6][7][8][9][10][11][12][13][14]. These and other phase IV studies on the use of NOACs in patients with AF show important differences among geographical regions regarding patient characteristics and prescription patterns [1,[5][6][7][8][9][10][12][13][14].…”

Meta-analysis of the efficacy and safety of non-vitamin K antagonist oral anticoagulants with warfarin in Latin American patients with atrial fibrillation

“…The model estimations using epidemiological data in Argentina also suggested that apixaban relative to warfarin in AF patients could reduce the disease burden and costs, and improve patients’ survival and quality of life. [ 30 ] In Eastern Europe, the Middle East, Africa and Latin America, XANTUS-EL study confirmed low stroke and bleeding risks in AF patients treated with rivaroxaban [ 31 ] ;however, warfarin was not the reference in this study. To date, there are still no observational studies directly focusing on the effect of NOACs versus warfarin in LatAm patients with AF.…”

Prevalencia y perfil clínico-terapéutico de la fibrilación auricular en consultorios de cardiología privados del noreste de México

“…Regarding the prescriptions of antiarrhythmic drugs in our patients, it is relevant that these were directed more towards control of heart rate than to control of heart rhythm, with use of type III antiarrhythmics being observed in 38.57%, propafenone in 4.45%, BB in 50.44% and digoxin in 26.70%. The REMEFA study (The Mexican Registry of Atrial Fibrillation) 13 compared the rate-control strategy vs the rhythm control strategy in 1,201 patients, reporting better control of arrhythmia and lower incidence of cerebrovascular disease in the rhythm control group. If we analyze the rate-control group of that study, we can observe higher prescriptions than in our study of digoxin (69%), type III antiarrhythmics (59.0%) and BB (56.0%).…”