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.
Egypt Heart J
; 70(4): 307-313, 2018 Dec.
Article
em En
| MEDLINE
| ID: mdl-30591748
ABSTRACT
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 1â¯year, at approximately 3-month intervals, or for ≥30â¯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⯱â¯standard deviation was 67.1⯱â¯11.32â¯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%.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.
AE, adverse event; AF, atrial fibrillation; CI, confidence interval; CNS, central nervous system; CrCl, creatinine clearance; EEMEA; EEMEA, Eastern Europe the Middle East and Africa; ISTH, International Society on Thrombosis and Haemostasis; Latin America; MI, myocardial infarction; NOAC, non-vitamin K antagonist oral anticoagulant; NVAF, non-valvular atrial fibrillation; PE, pulmonary embolism; Real-world; Rivaroxaban; SAE, serious adverse event; SD, standard deviation; SE, systemic embolism; Stroke prevention; TIA, transient ischaemic attack; VKA, vitamin K antagonist; od, once daily
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Observational_studies
Idioma:
En
Revista:
Egypt Heart J
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
México