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Non-vitamin K antagonist oral anticoagulants and major bleeding-related fatality in patients with atrial fibrillation and venous thromboembolism : a systematic review and meta-analysis

2015-08Journal article Restricted access
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dc.contributor.authorCaldeira, Daniel
dc.contributor.authorRodrigues, Filipe Brogueira
dc.contributor.authorBarra, Márcio
dc.contributor.authorSantos, Ana Teresa
dc.contributor.authorAbreu, Daisy
dc.contributor.authorGonçalves, Nilza
dc.contributor.authorPinto, Fausto J.
dc.contributor.authorFerreira, Joaquim J
dc.contributor.authorCosta, João
dc.date.accessioned2018-07-18T14:28:04Z
dc.date.available2018-07-18T14:28:04Z
dc.date.issued2015-08
dc.descriptionCopyright © 2015, BMJ Publishing Group Ltd and the British Cardiovascular Society.pt_PT
dc.description.abstractObjective: Non-vitamin K antagonist oral anticoagulants (NOACs) are efficacious and safe antithrombotic drugs but the non-availability of an antidote for potential fatal haemorrhagic events is clinically perceived as a strong limitation. We aimed at evaluating the risk of haemorrhage-related fatalities associated with NOACs in patients requiring long-term anticoagulation. Methods: MEDLINE, Cochrane Library and Web of Science databases were searched in November 2014 for atrial fibrillation (AF) or venous thromboembolism (VTE) phase III randomised controlled trials (RCT) comparing NOACs with vitamin K antagonists (VKAs) or low molecular weight heparin (LMWH) followed by VKAs. Pooled OR and 95% CIs were estimated through metaanalysis. Heterogeneity was assessed with the I2 test. Results: Eleven studies were included: 5 on AF and 6 on VTE. A total of 100 324 patients were evaluated in 4 rivaroxaban, 3 dabigatran, 2 apixaban and 2 edoxaban studies. NOAC-treated patients had a 47% odds reduction compared with VKA (OR 0.53; 95% CI 0.42 to 0.68; I2 =0%; 3 events avoided per 1000 patients) and 64% odds reduction compared with LMWH–VKA (OR 0.36; 95% CI 0.15 to 0.84; I2 =0%; 1 event avoided per 1000 patients) regarding fatal bleeding risk. Case fatality due to major bleeding was lower in NOAC-treated patients both in AF (OR 0.68; 95% CI 0.48 to 0.96; I 2 =37%; 1 death avoided per 39 major bleedings) and VTE (OR 0.54; 95% CI 0.22 to 1.32; I2 =0%) patients. AF survivors of major bleeding events treated with NOACs had lower mortality compared with patients treated with VKAs (OR 0.57; 95% CI 0.45 to 0.73; I2 =0%; 78 events avoided per 1000 survivors to major bleeding). Conclusions: These data suggest that NOACs decrease the risk of fatality cases related to major bleeding events, particularly in AF patients. These results support the safety profile of NOACs even without having a widely available drug-specific antidote.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationHeart 2015;101:1204–1211pt_PT
dc.identifier.doi10.1136/heartjnl-2015-307489pt_PT
dc.identifier.issn1355-6037
dc.identifier.urihttp://hdl.handle.net/10451/34239
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherBMJ Publishing Grouppt_PT
dc.relation.publisherversionhttps://heart.bmj.com/pt_PT
dc.titleNon-vitamin K antagonist oral anticoagulants and major bleeding-related fatality in patients with atrial fibrillation and venous thromboembolism : a systematic review and meta-analysispt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage1211pt_PT
oaire.citation.issue15pt_PT
oaire.citation.startPage1204pt_PT
oaire.citation.titleHeartpt_PT
oaire.citation.volume101pt_PT
person.familyNameCaldeira
person.familyNameRodrigues
person.familyNameabreu
person.familyNameCabral Gonçalves
person.familyNamePinto
person.familyNameFerreira
person.familyNameCosta
person.givenNameDaniel
person.givenNameFilipe Brogueira
person.givenNamedaisy
person.givenNameNilza Karina
person.givenNameFausto J.
person.givenNameJoaquim J
person.givenNameJoão
person.identifier1308889
person.identifier1624753
person.identifier480560
person.identifier.ciencia-idAA19-EC35-8D01
person.identifier.ciencia-id381A-CA67-2A1C
person.identifier.ciencia-idC311-AEDD-6DBB
person.identifier.ciencia-id7D15-5CD6-6159
person.identifier.orcid0000-0002-2520-5673
person.identifier.orcid0000-0002-5567-7938
person.identifier.orcid0000-0002-7979-6456
person.identifier.orcid0000-0001-8187-9501
person.identifier.orcid0000-0002-8034-4529
person.identifier.orcid0000-0003-3950-5113
person.identifier.orcid0000-0002-5831-4921
person.identifier.ridR-2679-2017
person.identifier.ridG-9363-2015
person.identifier.scopus-author-id36623384200
person.identifier.scopus-author-id57191254295
person.identifier.scopus-author-id7102740158
person.identifier.scopus-author-id7403252466
person.identifier.scopus-author-id55499748300
rcaap.rightsrestrictedAccesspt_PT
rcaap.typearticlept_PT
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