TY - JOUR
T1 - XANAP
T2 - A real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in asia
AU - XANAP investigators
AU - Kim, Young Hoon
AU - Shim, Jaemin
AU - Tsai, Chia Ti
AU - Wang, Chun Chieh
AU - Vilela, Gilbert
AU - Muengtaweepongsa, Sombat
AU - Kurniawan, Mohammad
AU - Maskon, Oteh
AU - Hsu, Li Fern
AU - Nguyen, Thang Huy
AU - Thanachartwet, Thititat
AU - Sim, Kenneth
AU - Camm, A. John
N1 - Funding Information:
Janssen Pharmaceuticals; Bayer The XANAP steering committee thanks all patients, caregivers and families who participated in the study as well as the XANAP Investigators and their associated teams. The authors thank Carole Mon-gin-Bulewski for editorial assistance in the preparation of the manuscript, with funding from Bayer AG and Janssen Scientific Affairs, LLC.
PY - 2018/8
Y1 - 2018/8
N2 - 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.
AB - 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.
KW - Asia-pacific
KW - Bleeding risk
KW - Real world
KW - Rivaroxaban
KW - Stroke prevention
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U2 - 10.1002/joa3.12073
DO - 10.1002/joa3.12073
M3 - Article
AN - SCOPUS:85054738871
VL - 34
SP - 418
EP - 427
JO - Journal of Arrhythmia
JF - Journal of Arrhythmia
SN - 1880-4276
IS - 4
ER -