XANAP: A real‐world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in Asia

• Main Authors: Young‐Hoon Kim, Jaemin Shim, Chia‐Ti Tsai, Chun‐Chieh Wang, Gilbert Vilela, Sombat Muengtaweepongsa, Mohammad Kurniawan, Oteh Maskon, Hsu Li Fern, Thang Huy Nguyen, Thititat Thanachartwet, Kenneth Sim, A. John Camm, the XANAP investigators
• Format: Article
• Language: English
• Published: Wiley 2018-08-01
• Series: Journal of Arrhythmia
• Subjects: Asia‐Pacific; bleeding risk; real world; rivaroxaban; stroke prevention
• Online Access: https://doi.org/10.1002/joa3.12073

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 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. 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.