Thromboprophylaxis with apixaban in patients undergoing major orthopedic surgery : meta-analysis and trial-sequential analysis

Detalhes bibliográficos
Autor(a) principal: Caldeira, Daniel
Data de Publicação: 2017
Outros Autores: Rodrigues, Filipe Brogueira, Pinto, Fausto J., Ferreira, Joaquim J, Costa, João
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10451/32298
Resumo: © The Author(s) 2017
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spelling Thromboprophylaxis with apixaban in patients undergoing major orthopedic surgery : meta-analysis and trial-sequential analysisVenous thromboembolismNon–vitamin K oral anticoagulantsApixabanHeparinLow-molecular-weightSystematic review© The Author(s) 2017Background: Venous thromboembolism (VTE) is a potentially fatal complication of orthopedic surgery, and until recently, few antithrombotic compounds were available for postoperative thromboprophylaxis. The introduction of the non–vitamin K antagonists oral anticoagulants (NOAC), including apixaban, has extended the therapeutic armamentarium in this field. Therefore, estimation of NOAC net clinical benefit in comparison with the established treatment is needed to inform clinical decision making. Objectives: Systematic review to assess the efficacy and safety of apixaban 2.5 mg twice a day versus low-molecular-weight heparins (LMWH) for thromboprophylaxis in patients undergoing knee or hip replacement. Data sources: MEDLINE, Embase, and CENTRAL were searched from inception to September 2016, other systematic reviews, reference lists, and experts were consulted. Study eligibility criteria, participants, and intervention: All major orthopedic surgery randomized controlled trials comparing apixaban 2.5 mg twice daily with LMWH, reporting thrombotic and bleeding events. Data extraction: Two independent reviewers, using a predetermined form. Study appraisal and synthesis methods: The Cochrane tool to assess risk bias was used by two independent authors. RevMan software was used to estimate pooled risk ratio (RR) and 95% confidence intervals (95% CI) using random-effects meta-analysis. Trial sequential analysis (TSA) was performed in statistical significant results to evaluate whether cumulative sample size was powered for the obtained effect. Overall confidence in cumulative evidence was assessed using the Grading of recommendations Assessment, Development, and Evaluation (GRADE) Working Group methodology. Results: Four studies comparing apixaban 2.5 mg twice daily with LMWH were included, with a total of 11.828 patients (55% undergoing knee and 45% hip replacement). The overall risk of bias across studies was low. In comparison with LMWH (all regimens), apixaban showed a significantly lower risk of VTE events and overall mortality combined (RR: 0.63, 95% CI: 0.42-0.95, I2 = 84%, n = 8346), but not of major VTE events (RR: 0.62, 95% CI: 0.32-1.19, I2 = 63%, n = 9493), or of symptomatic VTE events and VTE-related mortality combined (RR: 1.14, 95% CI: 0.68-1.90, I2 = 0%, n = 11 879). Trial sequential analysis showed that the risk reduction obtained for VTE and mortality was based on underpowered cumulative sample size and effect dimension. Subgroup analysis according to LMWH regimens showed that apixaban reduced the risk of VTE events and overall mortality, and major VTE events, when compared with LMWH once daily, without differences between apixaban and LMWH twice daily. Conclusions: There is low to moderate evidence that in patients undergoing knee or hip replacement, apixaban seems equally effective and safe to LMWH twice a day. When compared with LMWH once a day, apixaban seems a superior thromboprophylaxis option. However, the results are underpowered which precludes definite answers regarding the true net clinical benefit of apixaban versus LMWH in this clinical context.SAGE PublicationsRepositório da Universidade de LisboaCaldeira, DanielRodrigues, Filipe BrogueiraPinto, Fausto J.Ferreira, Joaquim JCosta, João2018-03-12T15:11:58Z20172017-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/32298engClinical Medicine Insights: Blood Disorders Volume 10: 1–81179-545X10.1177/1179545X17704660info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-11-08T16:26:27Zoai:repositorio.ul.pt:10451/32298Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:47:37.107188Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Thromboprophylaxis with apixaban in patients undergoing major orthopedic surgery : meta-analysis and trial-sequential analysis
title Thromboprophylaxis with apixaban in patients undergoing major orthopedic surgery : meta-analysis and trial-sequential analysis
spellingShingle Thromboprophylaxis with apixaban in patients undergoing major orthopedic surgery : meta-analysis and trial-sequential analysis
Caldeira, Daniel
Venous thromboembolism
Non–vitamin K oral anticoagulants
Apixaban
Heparin
Low-molecular-weight
Systematic review
title_short Thromboprophylaxis with apixaban in patients undergoing major orthopedic surgery : meta-analysis and trial-sequential analysis
title_full Thromboprophylaxis with apixaban in patients undergoing major orthopedic surgery : meta-analysis and trial-sequential analysis
title_fullStr Thromboprophylaxis with apixaban in patients undergoing major orthopedic surgery : meta-analysis and trial-sequential analysis
title_full_unstemmed Thromboprophylaxis with apixaban in patients undergoing major orthopedic surgery : meta-analysis and trial-sequential analysis
title_sort Thromboprophylaxis with apixaban in patients undergoing major orthopedic surgery : meta-analysis and trial-sequential analysis
author Caldeira, Daniel
author_facet Caldeira, Daniel
Rodrigues, Filipe Brogueira
Pinto, Fausto J.
Ferreira, Joaquim J
Costa, João
author_role author
author2 Rodrigues, Filipe Brogueira
Pinto, Fausto J.
Ferreira, Joaquim J
Costa, João
author2_role author
author
author
author
dc.contributor.none.fl_str_mv Repositório da Universidade de Lisboa
dc.contributor.author.fl_str_mv Caldeira, Daniel
Rodrigues, Filipe Brogueira
Pinto, Fausto J.
Ferreira, Joaquim J
Costa, João
dc.subject.por.fl_str_mv Venous thromboembolism
Non–vitamin K oral anticoagulants
Apixaban
Heparin
Low-molecular-weight
Systematic review
topic Venous thromboembolism
Non–vitamin K oral anticoagulants
Apixaban
Heparin
Low-molecular-weight
Systematic review
description © The Author(s) 2017
publishDate 2017
dc.date.none.fl_str_mv 2017
2017-01-01T00:00:00Z
2018-03-12T15:11:58Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10451/32298
url http://hdl.handle.net/10451/32298
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Clinical Medicine Insights: Blood Disorders Volume 10: 1–8
1179-545X
10.1177/1179545X17704660
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv SAGE Publications
publisher.none.fl_str_mv SAGE Publications
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
repository.mail.fl_str_mv
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