XANAP: A real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in asia
Journal
Journal of Arrhythmia
Journal Volume
34
Journal Issue
4
Pages
418-427
Date Issued
2018
Author(s)
Kim Y.-H.
Shim J.
Wang C.-C.
Vilela G.
Muengtaweepongsa S.
Kurniawan M.
Maskon O.
Hsu L.F.
Nguyen T.H.
Thanachartwet T.
Sim K.
Camm A.J.
XANAP investigators
Abstract
Background: ROCKET AF and its East Asian subanalysis demonstrated that rivaroxaban was non-inferior to warfarin for stroke/systemic embolism (SE) prevention in patients with non-valvular atrial fibrillation (NVAF), with a favorable benefit–risk profile. XANAP investigated the safety and effectiveness of rivaroxaban in routine care in Asia-Pacific. Methods: XANAP was a prospective, real-world, observational study in patients with NVAF newly starting rivaroxaban. Patients were followed at ~3-month intervals for 1 year, or for ?30 days after permanent discontinuation. Primary outcomes were major bleeding events, adverse events (AEs), serious AEs and all-cause mortality; secondary outcomes included stroke/SE. Major outcomes were adjudicated centrally. Results: XANAP enrolled 2273 patients from 10 countries: mean age was 70.5 years and 58.1% were male. 49.8% of patients received rivaroxaban 20 mg once daily (od), 43.8% 15 mg od and 5.9% 10 mg od. Mean treatment duration was 296 days, and 72.8% of patients had received prior anticoagulation therapy. Co-morbidities included heart failure (20.1%), hypertension (73.6%), diabetes mellitus (26.6%), prior stroke/non-central nervous system SE/transient ischemic attack (32.8%) and myocardial infarction (3.8%). Mean CHADS2, CHA2DS2-VASc and HASBLED scores were 2.3, 3.7 and 2.1, respectively. The rates (events/100 patient-years [95% confidence interval]) of treatment-emergent major bleeding, stroke and all-cause mortality were 1.5 (1.0-2.1), 1.7 (1.2-2.5) and 2.0 (1.4-2.7), respectively. Persistence was 66.2% at the study end. Conclusions: The real-world XANAP study demonstrated low rates of stroke and bleeding in rivaroxaban-treated patients with NVAF from Asia-Pacific. The results were consistent with the real-world XANTUS study and ROCKET AF. ? 2018 The Authors.
Subjects
Asia-pacific; Bleeding risk; Real world; Rivaroxaban; Stroke prevention
SDGs
Other Subjects
rivaroxaban; aged; all cause mortality; anticoagulant therapy; Article; Asia; atrial fibrillation; cardiovascular disease assessment; cerebrovascular accident; CHA2DS2-VASc score; CHADS2 score; cohort analysis; comorbidity; diabetes mellitus; drug efficacy; drug safety; female; follow up; HAS-BLED score; heart failure; heart infarction; human; hypertension; major clinical study; male; observational study; open study; outcome assessment; prospective study; transient ischemic attack; treatment duration
Publisher
Wiley-Blackwell
Type
journal article