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Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study

Objective To determine the safety of direct oral anticoagulant (DOAC) use compared with warfarin use for the treatment of venous thromboembolism. Design Retrospective matched cohort study conducted between 1 January 2009 and 31 March 2016. Setting Community based, using healthcare data from six juri...

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Autores principales: Jun, Min, Lix, Lisa M, Durand, Madeleine, Dahl, Matt, Paterson, J Michael, Dormuth, Colin R, Ernst, Pierre, Yao, Shenzhen, Renoux, Christel, Tamim, Hala, Wu, Cynthia, Mahmud, Salaheddin M, Hemmelgarn, Brenda R
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5641962/
https://www.ncbi.nlm.nih.gov/pubmed/29042362
http://dx.doi.org/10.1136/bmj.j4323
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author Jun, Min
Lix, Lisa M
Durand, Madeleine
Dahl, Matt
Paterson, J Michael
Dormuth, Colin R
Ernst, Pierre
Yao, Shenzhen
Renoux, Christel
Tamim, Hala
Wu, Cynthia
Mahmud, Salaheddin M
Hemmelgarn, Brenda R
author_facet Jun, Min
Lix, Lisa M
Durand, Madeleine
Dahl, Matt
Paterson, J Michael
Dormuth, Colin R
Ernst, Pierre
Yao, Shenzhen
Renoux, Christel
Tamim, Hala
Wu, Cynthia
Mahmud, Salaheddin M
Hemmelgarn, Brenda R
author_sort Jun, Min
collection PubMed
description Objective To determine the safety of direct oral anticoagulant (DOAC) use compared with warfarin use for the treatment of venous thromboembolism. Design Retrospective matched cohort study conducted between 1 January 2009 and 31 March 2016. Setting Community based, using healthcare data from six jurisdictions in Canada and the United States. Participants 59 525 adults (12 489 DOAC users; 47 036 warfarin users) with a new diagnosis of venous thromboembolism and a prescription for a DOAC or warfarin within 30 days of diagnosis. Main outcome measures Outcomes included hospital admission or emergency department visit for major bleeding and all cause mortality within 90 days after starting treatment. Propensity score matching and shared frailty models were used to estimate adjusted hazard ratios of the outcomes comparing DOACs with warfarin. Analyses were conducted independently at each site, with meta-analytical methods used to estimate pooled hazard ratios across sites. Results Of the 59 525 participants, 1967 (3.3%) had a major bleed and 1029 (1.7%) died over a mean follow-up of 85.2 days. The risk of major bleeding was similar for DOAC compared with warfarin use (pooled hazard ratio 0.92, 95% confidence interval 0.82 to 1.03), with the overall direction of the association favouring DOAC use. No difference was found in the risk of death (pooled hazard ratio 0.99, 0.84 to 1.16) for DOACs compared with warfarin use. There was no evidence of heterogeneity across centres, between patients with and without chronic kidney disease, across age groups, or between male and female patients. Conclusions In this analysis of adults with incident venous thromboembolism, treatment with DOACs, compared with warfarin, was not associated with an increased risk of major bleeding or all cause mortality in the first 90 days of treatment. Trial registration Clinical trials NCT02833987.
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spelling pubmed-56419622017-10-24 Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study Jun, Min Lix, Lisa M Durand, Madeleine Dahl, Matt Paterson, J Michael Dormuth, Colin R Ernst, Pierre Yao, Shenzhen Renoux, Christel Tamim, Hala Wu, Cynthia Mahmud, Salaheddin M Hemmelgarn, Brenda R BMJ Research Objective To determine the safety of direct oral anticoagulant (DOAC) use compared with warfarin use for the treatment of venous thromboembolism. Design Retrospective matched cohort study conducted between 1 January 2009 and 31 March 2016. Setting Community based, using healthcare data from six jurisdictions in Canada and the United States. Participants 59 525 adults (12 489 DOAC users; 47 036 warfarin users) with a new diagnosis of venous thromboembolism and a prescription for a DOAC or warfarin within 30 days of diagnosis. Main outcome measures Outcomes included hospital admission or emergency department visit for major bleeding and all cause mortality within 90 days after starting treatment. Propensity score matching and shared frailty models were used to estimate adjusted hazard ratios of the outcomes comparing DOACs with warfarin. Analyses were conducted independently at each site, with meta-analytical methods used to estimate pooled hazard ratios across sites. Results Of the 59 525 participants, 1967 (3.3%) had a major bleed and 1029 (1.7%) died over a mean follow-up of 85.2 days. The risk of major bleeding was similar for DOAC compared with warfarin use (pooled hazard ratio 0.92, 95% confidence interval 0.82 to 1.03), with the overall direction of the association favouring DOAC use. No difference was found in the risk of death (pooled hazard ratio 0.99, 0.84 to 1.16) for DOACs compared with warfarin use. There was no evidence of heterogeneity across centres, between patients with and without chronic kidney disease, across age groups, or between male and female patients. Conclusions In this analysis of adults with incident venous thromboembolism, treatment with DOACs, compared with warfarin, was not associated with an increased risk of major bleeding or all cause mortality in the first 90 days of treatment. Trial registration Clinical trials NCT02833987. BMJ Publishing Group Ltd. 2017-10-17 /pmc/articles/PMC5641962/ /pubmed/29042362 http://dx.doi.org/10.1136/bmj.j4323 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Research
Jun, Min
Lix, Lisa M
Durand, Madeleine
Dahl, Matt
Paterson, J Michael
Dormuth, Colin R
Ernst, Pierre
Yao, Shenzhen
Renoux, Christel
Tamim, Hala
Wu, Cynthia
Mahmud, Salaheddin M
Hemmelgarn, Brenda R
Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study
title Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study
title_full Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study
title_fullStr Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study
title_full_unstemmed Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study
title_short Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study
title_sort comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5641962/
https://www.ncbi.nlm.nih.gov/pubmed/29042362
http://dx.doi.org/10.1136/bmj.j4323
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