Kirchhof, P;
Radaideh, G;
Kim, Y-H;
Lanas, F;
Haas, S;
Amarenco, P;
Turpie, AGG;
Bach, M;
Lambelet, M;
Hess, S;
et al.
Kirchhof, P; Radaideh, G; Kim, Y-H; Lanas, F; Haas, S; Amarenco, P; Turpie, AGG; Bach, M; Lambelet, M; Hess, S; Camm, AJ; Global XANTUS program Investigators
(2018)
Global Prospective Safety Analysis of Rivaroxaban.
J Am Coll Cardiol, 72 (2).
pp. 141-153.
ISSN 1558-3597
https://doi.org/10.1016/j.jacc.2018.04.058
SGUL Authors: Camm, Alan John
Abstract
BACKGROUND: The efficacy of direct oral anticoagulants (DOACs) for stroke prevention in patients with atrial fibrillation (AF) has been established in clinical trials. However, well-conducted, prospective, real-world observational studies of the safety and effectiveness of DOACs are needed. OBJECTIVES: This study sought to assess the real-world safety profile of rivaroxaban through a pooled analysis of patients with AF enrolled in the XANTUS (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation) program worldwide. METHODS: A pre-planned pooled analysis of the XANTUS, XANAP (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia), and XANTUS-EL (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latin America and EMEA Region) registries was performed. Patients with AF newly starting rivaroxaban for stroke prevention were followed for 1 year. Primary outcomes were treatment-emergent major bleeding, adverse events (AEs)/serious AEs, and all-cause death. Secondary outcomes included treatment-emergent thromboembolic events and nonmajor bleeding. Major outcomes were centrally adjudicated. RESULTS: Overall, 11,121 patients were included (mean age 70.5 ± 10.5 years; female 42.9%). Comorbidities included heart failure (21.2%), hypertension (76.2%), and diabetes (22.3%). Event rates were: events/100 patient-years: major bleeding 1.7 (95% confidence interval [CI]: 1.5 to 2.0; lowest: Latin America 0.7; highest: Western Europe, Canada, and Israel 2.3); all-cause death 1.9 (95% CI: 1.6 to 2.2; lowest: Eastern Europe 1.5; highest: Latin America, Middle East, and Africa 2.7); and stroke or systemic embolism 1.0 (95% CI: 0.8 to 1.2; lowest: Latin America 0; highest: East Asia 1.8). One-year treatment persistence was 77.4% (lowest: East Asia 66.4%; highest: Eastern Europe 84.4%). CONCLUSIONS: This large, prospective, real-world analysis in 11,121 patients from 47 countries showed low bleeding and stroke rates in rivaroxaban-treated patients with AF, with low treatment discontinuation in different regions of the world. Results were broadly consistent across regions. (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation [XANTUS]; NCT01606995; Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latin America and EMEA Region [XANTUS-EL]; NCT01800006; and Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia [XANAP]; NCT01750788).
Item Type: |
Article
|
Additional Information: |
© 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
Keywords: |
XANTUS, atrial fibrillation, real-world, rivaroxaban, safety, stroke prevention, atrial fibrillation, real-world, rivaroxaban, safety, stroke prevention, XANTUS, Cardiovascular System & Hematology, 1102 Cardiovascular Medicine And Haematology, 1117 Public Health And Health Services |
SGUL Research Institute / Research Centre: |
Academic Structure > Molecular and Clinical Sciences Research Institute (MCS) |
Journal or Publication Title: |
J Am Coll Cardiol |
ISSN: |
1558-3597 |
Language: |
eng |
Dates: |
Date | Event |
---|
10 July 2018 | Published | 2 July 2018 | Published Online | 12 April 2018 | Accepted |
|
Publisher License: |
Creative Commons: Attribution-Noncommercial-No Derivative Works 4.0 |
Projects: |
|
PubMed ID: |
29976287 |
Web of Science ID: |
WOS:000437218000003 |
![](http://static.pubmed.gov/portal/portal3rc.fcgi/2745237/img/27842) |
Go to PubMed abstract |
URI: |
https://openaccess.sgul.ac.uk/id/eprint/110003 |
Publisher's version: |
https://doi.org/10.1016/j.jacc.2018.04.058 |
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