XANAP: A real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in Asia
- Authors
- Kim, Young-Hoon; Shim, Jaemin; Tsai, Chia-Ti; Wang, Chun-Chieh; Vilela, Gilbert; Muengtaweepongsa, Sombat; Kurniawan, Mohammad; Maskon, Oteh; Hsu, Li Fern; Thang Huy Nguyen; Thanachartwet, Thititat; Sim, Kenneth; Camm, A. John
- Issue Date
- 8월-2018
- Publisher
- WILEY
- Keywords
- Asia-Pacific; bleeding risk; real world; rivaroxaban; stroke prevention
- Citation
- JOURNAL OF ARRHYTHMIA, v.34, no.4, pp.418 - 427
- Indexed
- SCOPUS
- Journal Title
- JOURNAL OF ARRHYTHMIA
- Volume
- 34
- Number
- 4
- Start Page
- 418
- End Page
- 427
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/73858
- DOI
- 10.1002/joa3.12073
- ISSN
- 1880-4276
- Abstract
- BackgroundROCKET 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. MethodsXANAP 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. ResultsXANAP 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 CHADS(2), CHA(2)DS(2)-VASc and HAS-BLED 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. ConclusionsThe 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.
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