Cargando…
Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study
INTRODUCTION: Although the direct oral anticoagulant rivaroxaban is recommended for stroke prevention in patients with non-valvular atrial fibrillation based on Phase III clinical trials, there is still a need for additional safety data from everyday clinical practice. The ROSE study was initiated t...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546486/ https://www.ncbi.nlm.nih.gov/pubmed/33035259 http://dx.doi.org/10.1371/journal.pone.0240489 |
_version_ | 1783592238684569600 |
---|---|
author | Evans, Alison Davies, Miranda Osborne, Vicki Roy, Debabrata Shakir, Saad |
author_facet | Evans, Alison Davies, Miranda Osborne, Vicki Roy, Debabrata Shakir, Saad |
author_sort | Evans, Alison |
collection | PubMed |
description | INTRODUCTION: Although the direct oral anticoagulant rivaroxaban is recommended for stroke prevention in patients with non-valvular atrial fibrillation based on Phase III clinical trials, there is still a need for additional safety data from everyday clinical practice. The ROSE study was initiated to collect further information on the safety and utilisation of rivaroxaban in a broader range of patient groups in routine clinical practice. METHODS AND RESULTS: The ROSE study was conducted in hospitals in England and Wales. Consenting adults with non-valvular atrial fibrillation newly started on rivaroxaban were eligible and followed up for 12 weeks. Data was derived through secondary use of medical records. The primary outcome was major bleeding within gastrointestinal, urogenital and intracranial sites. A total of 4846 patients were enrolled in the study September 2013 to January 2016, 965 of which were treated with rivaroxaban for non-valvular atrial fibrillation. The median age in the rivaroxaban non-valvular atrial fibrillation cohort was 76 years, 53.6% were male. The median HAS-BLED score was 2 and the median CHA(2)DS(2)-VASc score was 4. The risk of major bleeding within each of the primary sites of gastrointestinal, urogenital and intracranial during the 12 week observation period was low (0.2%; n = 2). The risk of major bleeding in all sites was 1.0% (n = 10) at a rate of 5.5 events per 100 patient years. CONCLUSION: In terms of the primary outcome risk of major bleeding within gastrointestinal, urogenital and intracranial sites during the 12 week observation period, the risk estimates in the non-valvular atrial fibrillation rivaroxaban user population were low (<1%), and consistent with risk estimated from clinical trial data and in routine clinical practice. |
format | Online Article Text |
id | pubmed-7546486 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-75464862020-10-19 Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study Evans, Alison Davies, Miranda Osborne, Vicki Roy, Debabrata Shakir, Saad PLoS One Research Article INTRODUCTION: Although the direct oral anticoagulant rivaroxaban is recommended for stroke prevention in patients with non-valvular atrial fibrillation based on Phase III clinical trials, there is still a need for additional safety data from everyday clinical practice. The ROSE study was initiated to collect further information on the safety and utilisation of rivaroxaban in a broader range of patient groups in routine clinical practice. METHODS AND RESULTS: The ROSE study was conducted in hospitals in England and Wales. Consenting adults with non-valvular atrial fibrillation newly started on rivaroxaban were eligible and followed up for 12 weeks. Data was derived through secondary use of medical records. The primary outcome was major bleeding within gastrointestinal, urogenital and intracranial sites. A total of 4846 patients were enrolled in the study September 2013 to January 2016, 965 of which were treated with rivaroxaban for non-valvular atrial fibrillation. The median age in the rivaroxaban non-valvular atrial fibrillation cohort was 76 years, 53.6% were male. The median HAS-BLED score was 2 and the median CHA(2)DS(2)-VASc score was 4. The risk of major bleeding within each of the primary sites of gastrointestinal, urogenital and intracranial during the 12 week observation period was low (0.2%; n = 2). The risk of major bleeding in all sites was 1.0% (n = 10) at a rate of 5.5 events per 100 patient years. CONCLUSION: In terms of the primary outcome risk of major bleeding within gastrointestinal, urogenital and intracranial sites during the 12 week observation period, the risk estimates in the non-valvular atrial fibrillation rivaroxaban user population were low (<1%), and consistent with risk estimated from clinical trial data and in routine clinical practice. Public Library of Science 2020-10-09 /pmc/articles/PMC7546486/ /pubmed/33035259 http://dx.doi.org/10.1371/journal.pone.0240489 Text en © 2020 Evans et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Evans, Alison Davies, Miranda Osborne, Vicki Roy, Debabrata Shakir, Saad Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study |
title | Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study |
title_full | Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study |
title_fullStr | Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study |
title_full_unstemmed | Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study |
title_short | Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study |
title_sort | incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: results from the rivaroxaban observational safety evaluation (rose) study |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546486/ https://www.ncbi.nlm.nih.gov/pubmed/33035259 http://dx.doi.org/10.1371/journal.pone.0240489 |
work_keys_str_mv | AT evansalison incidenceofmajorandclinicallyrelevantnonmajorbleedinginpatientsprescribedrivaroxabanforstrokepreventioninnonvalvularatrialfibrillationinsecondarycareresultsfromtherivaroxabanobservationalsafetyevaluationrosestudy AT daviesmiranda incidenceofmajorandclinicallyrelevantnonmajorbleedinginpatientsprescribedrivaroxabanforstrokepreventioninnonvalvularatrialfibrillationinsecondarycareresultsfromtherivaroxabanobservationalsafetyevaluationrosestudy AT osbornevicki incidenceofmajorandclinicallyrelevantnonmajorbleedinginpatientsprescribedrivaroxabanforstrokepreventioninnonvalvularatrialfibrillationinsecondarycareresultsfromtherivaroxabanobservationalsafetyevaluationrosestudy AT roydebabrata incidenceofmajorandclinicallyrelevantnonmajorbleedinginpatientsprescribedrivaroxabanforstrokepreventioninnonvalvularatrialfibrillationinsecondarycareresultsfromtherivaroxabanobservationalsafetyevaluationrosestudy AT shakirsaad incidenceofmajorandclinicallyrelevantnonmajorbleedinginpatientsprescribedrivaroxabanforstrokepreventioninnonvalvularatrialfibrillationinsecondarycareresultsfromtherivaroxabanobservationalsafetyevaluationrosestudy |