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

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

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)418-427
Number of pages10
JournalJournal of Arrhythmia
Volume34
Issue number4
DOIs
Publication statusPublished - 2018 Jan 1

Fingerprint

Atrial Fibrillation
Observational Studies
Stroke
Prospective Studies
Embolism
Hemorrhage
Mortality
Rivaroxaban
Transient Ischemic Attack
Warfarin
Nervous System
Diabetes Mellitus
Therapeutics
Heart Failure
Myocardial Infarction
Confidence Intervals
Hypertension
Morbidity
Safety

Keywords

  • Asia-pacific
  • Bleeding risk
  • Real world
  • Rivaroxaban
  • Stroke prevention

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

XANAP : A real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in asia. / Kim, Young Hoon; Shim, Jaemin; Tsai, Chia Ti; Wang, Chun Chieh; Vilela, Gilbert; Muengtaweepongsa, Sombat; Kurniawan, Mohammad; Maskon, Oteh; Li Fern, Hsu; Nguyen, Thang Huy; Thanachartwet, Thititat; Sim, Kenneth; Camm, A. John.

In: Journal of Arrhythmia, Vol. 34, No. 4, 01.01.2018, p. 418-427.

Research output: Contribution to journalArticle

Kim, YH, Shim, J, Tsai, CT, Wang, CC, Vilela, G, Muengtaweepongsa, S, Kurniawan, M, Maskon, O, Li Fern, H, Nguyen, TH, Thanachartwet, T, Sim, K & Camm, AJ 2018, 'XANAP: A real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in asia', Journal of Arrhythmia, vol. 34, no. 4, pp. 418-427. https://doi.org/10.1002/joa3.12073
Kim, Young Hoon ; Shim, Jaemin ; Tsai, Chia Ti ; Wang, Chun Chieh ; Vilela, Gilbert ; Muengtaweepongsa, Sombat ; Kurniawan, Mohammad ; Maskon, Oteh ; Li Fern, Hsu ; Nguyen, Thang Huy ; Thanachartwet, Thititat ; Sim, Kenneth ; Camm, A. John. / XANAP : A real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in asia. In: Journal of Arrhythmia. 2018 ; Vol. 34, No. 4. pp. 418-427.
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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.",
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T2 - A real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in asia

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 - Li Fern, Hsu

AU - Nguyen, Thang Huy

AU - Thanachartwet, Thititat

AU - Sim, Kenneth

AU - Camm, A. John

PY - 2018/1/1

Y1 - 2018/1/1

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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