Affiliations 

  • 1 Korea University Medical Centre Seoul South Korea
  • 2 National Taiwan University Hospital Taipei Taiwan
  • 3 Chang Gung Memorial Hospital Chang Gung University Taoyuan Taiwan
  • 4 Philippine Heart Center Quezon City Philippines
  • 5 Faculty of Medicine Stroke Excellence Center Thammasat University Pathum Thani Thailand
  • 6 Department of Neurology Faculty of Medicine Cipto Mangunkusumo National Hospital Universitas Indonesia Jakarta Indonesia
  • 7 Department of Medicine National University of Malaysia Medical Centre (UKMMC) Kuala Lumpur Malaysia
  • 8 Novena Heart Centre Mount Elizabeth Novena Specialist Centre Singapore City Singapore
  • 9 Neurology Department Pham Ngoc Thach Medical University Ho Chi Minh City Vietnam
  • 10 Bayer (South East Asia) Pte Ltd Singapore City Singapore
  • 11 Cardiology Clinical Academic Group St. George's University of London and Imperial College London UK
J Arrhythm, 2018 Aug;34(4):418-427.
PMID: 30167013 DOI: 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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.