Afficher la notice abrégée

Direct oral anticoagulants versus no anticoagulation for the prevention of stroke in survivors of intracerebral haemorrhage with atrial fibrillation (PRESTIGE-AF): a multicentre, open-label, randomised, phase 3 trial

dc.rights.licenseopenen_US
dc.contributor.authorVELTKAMP, Roland
dc.contributor.authorKOROMPOKI, Eleni
dc.contributor.authorHARVEY, Kirsten H
dc.contributor.authorHARVEY, Emily R
dc.contributor.authorFIESSLER, Cornelia
dc.contributor.authorMALZAHN, Uwe
dc.contributor.authorRUCKER, Viktoria
dc.contributor.authorMONTANER, Joan
dc.contributor.authorCASO, Valeria
dc.contributor.authorSIBON, Igor
dc.contributor.authorRINGLEB, Peter
dc.contributor.authorHALSE, Omid
dc.contributor.authorHUGEN, Klemens
dc.contributor.authorULLMANN, Sabine
dc.contributor.authorSCHUHMANN, Carolin
dc.contributor.authorTODD, Gabriele Putz
dc.contributor.authorHAAS, Kirsten
dc.contributor.authorPALA, Elena
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorDEBETTE, Stephanie
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorLACHAIZE, Morgane
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorD'AOUST, Tim
dc.contributor.authorENZINGER, Christian
dc.contributor.authorROPELE, Stefan
dc.contributor.authorFANDLER-HOFLER, Simon
dc.contributor.authorHAIDEGGER, Melanie
dc.contributor.authorWANG, Yanzhong
dc.contributor.authorWAFA, Hatem A
dc.contributor.authorCANCELLONI, Virginia
dc.contributor.authorMOSCONI, Maria Giulia
dc.contributor.authorLIP, Gregory Y H
dc.contributor.authorLANE, Deirdre A
dc.contributor.authorHAEFELI, Walter E
dc.contributor.authorFOERSTER, Kathrin I
dc.contributor.authorWURMBACH, Viktoria S
dc.contributor.authorNIELSEN, Peter Bronnum
dc.contributor.authorHAJJAR, Karim
dc.contributor.authorMULLER, Patrick
dc.contributor.authorPOLI, Sven
dc.contributor.authorPURRUCKER, Jan
dc.contributor.authorLAIBLE, Mona
dc.contributor.authorD'ANNA, Lucio
dc.contributor.authorSILVA, Yolanda
dc.contributor.authorDE TORRES CHACON, Reyes
dc.contributor.authorMARTINEZ-SANCHEZ, Patricia
dc.contributor.authorBOULANGER, Marion
dc.contributor.authorNORRVING, Bo
dc.contributor.authorPARE, Guillaume
dc.contributor.authorWACHTER, Rolf
dc.contributor.authorNTAIOS, George
dc.contributor.authorWOLFE, Charles D A
dc.contributor.authorHEUSCHMANN, Peter U
dc.date.accessioned2025-04-11T08:51:09Z
dc.date.available2025-04-11T08:51:09Z
dc.date.issued2025-03-15
dc.identifier.issn1474-547Xen_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/206131
dc.description.abstractEnBACKGROUND: Direct oral anticoagulants (DOACs) reduce the rate of thromboembolism in patients with atrial fibrillation but the benefits and risks in survivors of intracerebral haemorrhage are uncertain. We aimed to determine whether DOACs reduce the risk of ischaemic stroke without substantially increasing the risk of recurrent intracerebral haemorrhage. METHODS: PRESTIGE-AF is a multicentre, open-label, randomised, phase 3 trial conducted at 75 hospitals in six European countries. Eligible patients were aged 18 years or older with spontaneous intracerebral haemorrhage, atrial fibrillation, an indication for anticoagulation, and a score of 4 or less on the modified Rankin Scale. Patients were randomly assigned (1:1) to a DOAC or no anticoagulation, stratified by intracerebral haemorrhage location and sex. Only the events adjudication committee was masked to treatment allocation. The coprimary endpoints were first ischaemic stroke and first recurrent intracerebral haemorrhage. Hierarchical testing for superiority and non-inferiority, respectively, was performed in the intention-to-treat population. The margin to establish non-inferiority regarding intracerebral haemorrhage was less than 1·735. The safety analysis was done in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, NCT03996772, and is complete. FINDINGS: Between May 31, 2019, and Nov 30, 2023, 319 participants were enrolled and 158 were randomly assigned to the DOAC group and 161 to the no anticoagulant group. Patients' median age was 79 years (IQR 73-83). 113 (35%) of 319 patients were female and 206 (65%) were male. Median follow-up was 1·4 years (IQR 0·7-2·3). First ischaemic stroke occurred less frequently in the DOAC group than in the no anticoagulant group (hazard ratio [HR] 0·05 [95% CI 0·01-0·36]; log-rank p<0·0001). The rate of all ischaemic stroke events was 0·83 (95% CI 0·14-2·57) per 100 patient-years in the DOAC group versus 8·60 (5·43-12·80) per 100 patient-years in the no anticoagulant group. For first recurrent intracerebral haemorrhage, the DOAC group did not meet the prespecified HR for the non-inferiority margin of less than 1·735 (HR 10·89 [90% CI 1·95-60·72]; p=0·96). The event rate of all intracerebral haemorrhage was 5·00 (95% CI 2·68-8·39) per 100 patient-years in the DOAC group versus 0·82 (0·14-2·53) per 100 patient years in the no anticoagulant group. Serious adverse events occurred in 70 (44%) of 158 patients in the DOAC group and 89 (55%) of 161 patients in the no anticoagulant group. 16 (10%) patients in the DOAC group and 21 (13%) patients in the no anticoagulant group died. No patients died in the placebo group. INTERPRETATION: DOACs effectively prevent ischaemic strokes in survivors of intracerebral haemorrhage with atrial fibrillation but a part of this benefit is offset by a substantially increased risk of recurrent intracerebral haemorrhage. To optimise stroke prevention in these vulnerable patients, further evidence from ongoing trials and a meta-analysis of randomised data is needed, as well as the evaluation of safer medical or mechanical alternatives for selected patients. FUNDING: European Commission.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.title.enDirect oral anticoagulants versus no anticoagulation for the prevention of stroke in survivors of intracerebral haemorrhage with atrial fibrillation (PRESTIGE-AF): a multicentre, open-label, randomised, phase 3 trial
dc.title.alternativeLanceten_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/s0140-6736(25)00333-2en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed40023176en_US
bordeaux.journalThe Lanceten_US
bordeaux.page927-936en_US
bordeaux.volume405en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue10482en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamELEANOR_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDImperial College Londonen_US
bordeaux.identifier.funderIDHorizon 2020en_US
hal.identifierhal-05030487
hal.version1
hal.date.transferred2025-04-11T08:51:16Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&amp;rft_val_fmt=info:ofi/fmt:kev:mtx:journal&amp;rft.jtitle=The%20Lancet&amp;rft.date=2025-03-15&amp;rft.volume=405&amp;rft.issue=10482&amp;rft.spage=927-936&amp;rft.epage=927-936&amp;rft.eissn=1474-547X&amp;rft.issn=1474-547X&amp;rft.au=VELTKAMP,%20Roland&amp;KOROMPOKI,%20Eleni&amp;HARVEY,%20Kirsten%20H&amp;HARVEY,%20Emily%20R&amp;FIESSLER,%20Cornelia&amp;rft.genre=article


Fichier(s) constituant ce document

Thumbnail
Nom:
BPH_Lancet_2025_Veltkamp.pdf
Taille:
828.9Ko
Format:
PDF
Voir/Ouvrir
Thumbnail
Nom:
license_rdf
Taille:
914octets
Format:
application/rdf+xml
Voir/Ouvrir

Ce document figure dans la(les) collection(s) suivante(s)

Afficher la notice abrégée