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Rivaroxaban Treatment for Patients With Unprovoked or Provoked Venous Thromboembolism ― Subanalysis of the J’xactly Study ―
Background: The efficacy and safety of direct oral anticoagulants (DOACs) in patients with unprovoked venous thromboembolism (VTE) remain unclear. Methods and Results: In this subanalysis of the J’xactly study, a multicenter prospective observational study, we evaluated the safety and effectiveness...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Japanese Circulation Society
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9535131/ https://www.ncbi.nlm.nih.gov/pubmed/36304427 http://dx.doi.org/10.1253/circrep.CR-22-0082 |
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author | Hisatake, Shinji Ikeda, Takanori Fukuda, Ikuo Nakamura, Mashio Yamada, Norikazu Takayama, Morimasa Maeda, Hideaki Yamashita, Takeshi Mo, Makoto Yamazaki, Tsutomu Okumura, Yasuo Hirayama, Atsushi |
author_facet | Hisatake, Shinji Ikeda, Takanori Fukuda, Ikuo Nakamura, Mashio Yamada, Norikazu Takayama, Morimasa Maeda, Hideaki Yamashita, Takeshi Mo, Makoto Yamazaki, Tsutomu Okumura, Yasuo Hirayama, Atsushi |
author_sort | Hisatake, Shinji |
collection | PubMed |
description | Background: The efficacy and safety of direct oral anticoagulants (DOACs) in patients with unprovoked venous thromboembolism (VTE) remain unclear. Methods and Results: In this subanalysis of the J’xactly study, a multicenter prospective observational study, we evaluated the safety and effectiveness of rivaroxaban in patients with acute VTE according to unprovoked (n=388) or provoked (n=557) VTE status. Median follow-up was 21.2 months. Compared with patients in the provoked group, patients in the unprovoked group were younger, less likely to be female, and had higher body weight. The incidence of symptomatic VTE recurrence was significantly higher in the unprovoked than provoked VTE group (3.54% vs. 1.77% per patient-year; P=0.032). There was no significant difference in the incidence of major bleeding events between rivaroxaban-treated patients with unprovoked and provoked VTE (2.31% vs. 3.75% per patient-year; P=0.289). Although the proportion of patients with a body mass index (BMI) ≥25 kg/m(2) who were non-users of antiplatelet agents was higher in the unprovoked VTE group, there was no interaction effect (BMI: 4.58% vs. 1.55% per patient-year [P=0.040; P for interaction=0.361]; concomitant antiplatelet agent non-users: 3.65% vs. 1.72% per patient-year [P=0.028; P for interaction=0.627]). Conclusions: This subanalysis suggests the safety and effectiveness of rivaroxaban in patients with unprovoked VTE. In such patients, DOAC discontinuation should be considered carefully, particularly in those not using antiplatelet agents and those with a high BMI. |
format | Online Article Text |
id | pubmed-9535131 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | The Japanese Circulation Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-95351312022-10-26 Rivaroxaban Treatment for Patients With Unprovoked or Provoked Venous Thromboembolism ― Subanalysis of the J’xactly Study ― Hisatake, Shinji Ikeda, Takanori Fukuda, Ikuo Nakamura, Mashio Yamada, Norikazu Takayama, Morimasa Maeda, Hideaki Yamashita, Takeshi Mo, Makoto Yamazaki, Tsutomu Okumura, Yasuo Hirayama, Atsushi Circ Rep Original article Background: The efficacy and safety of direct oral anticoagulants (DOACs) in patients with unprovoked venous thromboembolism (VTE) remain unclear. Methods and Results: In this subanalysis of the J’xactly study, a multicenter prospective observational study, we evaluated the safety and effectiveness of rivaroxaban in patients with acute VTE according to unprovoked (n=388) or provoked (n=557) VTE status. Median follow-up was 21.2 months. Compared with patients in the provoked group, patients in the unprovoked group were younger, less likely to be female, and had higher body weight. The incidence of symptomatic VTE recurrence was significantly higher in the unprovoked than provoked VTE group (3.54% vs. 1.77% per patient-year; P=0.032). There was no significant difference in the incidence of major bleeding events between rivaroxaban-treated patients with unprovoked and provoked VTE (2.31% vs. 3.75% per patient-year; P=0.289). Although the proportion of patients with a body mass index (BMI) ≥25 kg/m(2) who were non-users of antiplatelet agents was higher in the unprovoked VTE group, there was no interaction effect (BMI: 4.58% vs. 1.55% per patient-year [P=0.040; P for interaction=0.361]; concomitant antiplatelet agent non-users: 3.65% vs. 1.72% per patient-year [P=0.028; P for interaction=0.627]). Conclusions: This subanalysis suggests the safety and effectiveness of rivaroxaban in patients with unprovoked VTE. In such patients, DOAC discontinuation should be considered carefully, particularly in those not using antiplatelet agents and those with a high BMI. The Japanese Circulation Society 2022-09-13 /pmc/articles/PMC9535131/ /pubmed/36304427 http://dx.doi.org/10.1253/circrep.CR-22-0082 Text en Copyright © 2022, THE JAPANESE CIRCULATION SOCIETY https://creativecommons.org/licenses/by-nc-nd/4.0/This article is licensed under a Creative Commons [Attribution-NonCommercial-NoDerivatives 4.0 International] license. |
spellingShingle | Original article Hisatake, Shinji Ikeda, Takanori Fukuda, Ikuo Nakamura, Mashio Yamada, Norikazu Takayama, Morimasa Maeda, Hideaki Yamashita, Takeshi Mo, Makoto Yamazaki, Tsutomu Okumura, Yasuo Hirayama, Atsushi Rivaroxaban Treatment for Patients With Unprovoked or Provoked Venous Thromboembolism ― Subanalysis of the J’xactly Study ― |
title | Rivaroxaban Treatment for Patients With Unprovoked or Provoked Venous Thromboembolism ― Subanalysis of the J’xactly Study ― |
title_full | Rivaroxaban Treatment for Patients With Unprovoked or Provoked Venous Thromboembolism ― Subanalysis of the J’xactly Study ― |
title_fullStr | Rivaroxaban Treatment for Patients With Unprovoked or Provoked Venous Thromboembolism ― Subanalysis of the J’xactly Study ― |
title_full_unstemmed | Rivaroxaban Treatment for Patients With Unprovoked or Provoked Venous Thromboembolism ― Subanalysis of the J’xactly Study ― |
title_short | Rivaroxaban Treatment for Patients With Unprovoked or Provoked Venous Thromboembolism ― Subanalysis of the J’xactly Study ― |
title_sort | rivaroxaban treatment for patients with unprovoked or provoked venous thromboembolism ― subanalysis of the j’xactly study ― |
topic | Original article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9535131/ https://www.ncbi.nlm.nih.gov/pubmed/36304427 http://dx.doi.org/10.1253/circrep.CR-22-0082 |
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