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Outpatient Management in Patients with Venous Thromboembolism with Edoxaban: A Post Hoc Analysis of the Hokusai-VTE Study
Direct oral anticoagulants (DOACs) facilitate the outpatient treatment of venous thromboembolism (VTE). However, the pivotal trials of DOACs have not reported outcomes separately for patients managed either as outpatients or in the hospital. We performed a subgroup analysis of the Hokusai-VTE study...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Schattauer GmbH
2017
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6260115/ https://www.ncbi.nlm.nih.gov/pubmed/29212128 http://dx.doi.org/10.1160/TH17-05-0523 |
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author | Medina, Andria Raskob, Gary Ageno, Walter Cohen, Alexander T. Brekelmans, Marjolein P.A. Chen, Cathy Z. Grosso, Michael A. Mercuri, Michele F. Segers, Annelise Verhamme, Peter Vanassche, Thomas Wells, Philip S. Lin, Min Winters, Shannon M. Weitz, Jeffrey I. Büller, Harry R. |
author_facet | Medina, Andria Raskob, Gary Ageno, Walter Cohen, Alexander T. Brekelmans, Marjolein P.A. Chen, Cathy Z. Grosso, Michael A. Mercuri, Michele F. Segers, Annelise Verhamme, Peter Vanassche, Thomas Wells, Philip S. Lin, Min Winters, Shannon M. Weitz, Jeffrey I. Büller, Harry R. |
author_sort | Medina, Andria |
collection | PubMed |
description | Direct oral anticoagulants (DOACs) facilitate the outpatient treatment of venous thromboembolism (VTE). However, the pivotal trials of DOACs have not reported outcomes separately for patients managed either as outpatients or in the hospital. We performed a subgroup analysis of the Hokusai-VTE study comparing efficacy and safety of edoxaban with warfarin in 8,292 patients with acute VTE. Patients received initial therapy with open-label enoxaparin or unfractionated heparin for ≥5 days in the hospital or as an outpatient at the discretion of the treating physician. Edoxaban or warfarin was then given for 3 to 12 months. The primary efficacy outcome was the cumulative incidence of symptomatic recurrent VTE at 12 months. The principal safety outcome was the incidence of clinically relevant bleeding (composite of major or clinically relevant non-major bleeding). Of the 5,223 consecutively enrolled patients with recorded hospital status and length of stay, 1,414 patients (27.1%) were managed as outpatients and 3,809 were managed in hospital. Among the outpatients, initial presentation was symptomatic deep-vein thrombosis (DVT) in 1,183 patients (83.7%) and pulmonary embolism (PE) in 231 patients (16.3%). Among the outpatients with DVT, recurrent VTE occurred in 18 (3.0%) given edoxaban and in 21 (3.6%) given warfarin (risk difference: −0.61, 95% confidence interval [CI]: −2.6 to 1.4). The principal safety outcome in outpatients occurred in 46 edoxaban patients (7.7%) and in 48 warfarin patients (8.3%; risk difference: −0.59, 95% CI: −3.7 to 2.5). Most outpatients had symptomatic DVT at presentation. In these patients, initial heparin followed by edoxaban had similar efficacy and safety to standard therapy with heparin and warfarin. |
format | Online Article Text |
id | pubmed-6260115 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Schattauer GmbH |
record_format | MEDLINE/PubMed |
spelling | pubmed-62601152018-11-29 Outpatient Management in Patients with Venous Thromboembolism with Edoxaban: A Post Hoc Analysis of the Hokusai-VTE Study Medina, Andria Raskob, Gary Ageno, Walter Cohen, Alexander T. Brekelmans, Marjolein P.A. Chen, Cathy Z. Grosso, Michael A. Mercuri, Michele F. Segers, Annelise Verhamme, Peter Vanassche, Thomas Wells, Philip S. Lin, Min Winters, Shannon M. Weitz, Jeffrey I. Büller, Harry R. Thromb Haemost Direct oral anticoagulants (DOACs) facilitate the outpatient treatment of venous thromboembolism (VTE). However, the pivotal trials of DOACs have not reported outcomes separately for patients managed either as outpatients or in the hospital. We performed a subgroup analysis of the Hokusai-VTE study comparing efficacy and safety of edoxaban with warfarin in 8,292 patients with acute VTE. Patients received initial therapy with open-label enoxaparin or unfractionated heparin for ≥5 days in the hospital or as an outpatient at the discretion of the treating physician. Edoxaban or warfarin was then given for 3 to 12 months. The primary efficacy outcome was the cumulative incidence of symptomatic recurrent VTE at 12 months. The principal safety outcome was the incidence of clinically relevant bleeding (composite of major or clinically relevant non-major bleeding). Of the 5,223 consecutively enrolled patients with recorded hospital status and length of stay, 1,414 patients (27.1%) were managed as outpatients and 3,809 were managed in hospital. Among the outpatients, initial presentation was symptomatic deep-vein thrombosis (DVT) in 1,183 patients (83.7%) and pulmonary embolism (PE) in 231 patients (16.3%). Among the outpatients with DVT, recurrent VTE occurred in 18 (3.0%) given edoxaban and in 21 (3.6%) given warfarin (risk difference: −0.61, 95% confidence interval [CI]: −2.6 to 1.4). The principal safety outcome in outpatients occurred in 46 edoxaban patients (7.7%) and in 48 warfarin patients (8.3%; risk difference: −0.59, 95% CI: −3.7 to 2.5). Most outpatients had symptomatic DVT at presentation. In these patients, initial heparin followed by edoxaban had similar efficacy and safety to standard therapy with heparin and warfarin. Schattauer GmbH 2017-12 2017-12-06 /pmc/articles/PMC6260115/ /pubmed/29212128 http://dx.doi.org/10.1160/TH17-05-0523 Text en https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited. |
spellingShingle | Medina, Andria Raskob, Gary Ageno, Walter Cohen, Alexander T. Brekelmans, Marjolein P.A. Chen, Cathy Z. Grosso, Michael A. Mercuri, Michele F. Segers, Annelise Verhamme, Peter Vanassche, Thomas Wells, Philip S. Lin, Min Winters, Shannon M. Weitz, Jeffrey I. Büller, Harry R. Outpatient Management in Patients with Venous Thromboembolism with Edoxaban: A Post Hoc Analysis of the Hokusai-VTE Study |
title | Outpatient Management in Patients with Venous Thromboembolism with Edoxaban: A Post Hoc Analysis of the Hokusai-VTE Study |
title_full | Outpatient Management in Patients with Venous Thromboembolism with Edoxaban: A Post Hoc Analysis of the Hokusai-VTE Study |
title_fullStr | Outpatient Management in Patients with Venous Thromboembolism with Edoxaban: A Post Hoc Analysis of the Hokusai-VTE Study |
title_full_unstemmed | Outpatient Management in Patients with Venous Thromboembolism with Edoxaban: A Post Hoc Analysis of the Hokusai-VTE Study |
title_short | Outpatient Management in Patients with Venous Thromboembolism with Edoxaban: A Post Hoc Analysis of the Hokusai-VTE Study |
title_sort | outpatient management in patients with venous thromboembolism with edoxaban: a post hoc analysis of the hokusai-vte study |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6260115/ https://www.ncbi.nlm.nih.gov/pubmed/29212128 http://dx.doi.org/10.1160/TH17-05-0523 |
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