Net Benefit of Early Anticoagulation for Stroke With Atrial Fibrillation: Post Hoc Analysis of the ELAN Randomized Clinical Trial.
Details
Serval ID
serval:BIB_B9755FFBBBD8
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Net Benefit of Early Anticoagulation for Stroke With Atrial Fibrillation: Post Hoc Analysis of the ELAN Randomized Clinical Trial.
Journal
JAMA network open
Working group(s)
ELAN Investigators
Contributor(s)
Adeyemi A.K., Vedamurthy A., Scutelnic A., Hisanao A., Wilson A., Pichler A., Salerno A., Vanhoorne A., Wilkinson A., Paiva Nunes A., Adamou A., Peeters A., Humm A.M., Zini A., Dhasan A., Alonso A., Fischer A., Saukkonen A.M., Müller A., Berberich A., Falcou A., Devroye A., Hostens A., Hakim A., Liesz A., Annamalai A., Sharma A.V., Paliantonis A., Nallasivan A., Abdul-Rahim A., Rezny-Kasprzak B., Grimshaw B., Kallmünzer B., Rodic B., Clarke B., Menezes B., Weder B.J., Ciobanu C., Cereda C.W., Loos C., Kulyk C., Gonçalves Martins C., Ferrari C., Fung C., Caporale C., McAlpine C., Globas C., Gumbinger C., Bonvin C., Krogias C., Whyte C., Bassetti C., Ryan D., Charissé D., Richter D., Schrammel D., Giudici D., Nabavi D.G., Bradley D., Orion D., Seiffge D.J., Werring D., Strambo D., Esson D., Khurana D., Melancia D., Staykov D., Hemelsoet D., Michalski D., Schlemm E., Karagkiozi E., Olbert E., Saxhaug Kristoffersen E., Marcelis E., Wright F., Delvoye F., Medlin F., Takayuki F., Sirimarco G., Shim G., Smith G.M., Royl G., Pope G., Salanti G., Sibolt G., Guzman-Gutierrez G., De Marchis G.M., Bianco G., Dymond H., Ihle-Hansen H., Thomas H., Stetefeld H.R., Koundal H., Asaf H., Anwar I., De Magistris I.L., Noone I., Olave Bersas I., Muresan I.P., Vanpanteghem I., Gralla J., Vynckier J., Demeestere J., Offermann J., Pandian J.D., Sousa J.A., Marto J.P., Sargento-Freitas J., Vehoff J., Pelz J., McCabe J.J., Harbison J., Mbroh J., Wagner J., Niederhauser J., Sipilä J., Tanaka K., Rani K., Klimcikova K., Smith K., Soltesova K., Macha K., Matzusono K., Szabo K., Yperzeele L., Alteheld L., Kellert L., Healy L., Zhang L., Fisch L., Gentile L., Schelosky L., Kellermair L., Gbadamosh L., Dixon L., Nakajima M., Inoue M., Krishnan M., Bolognese M., Arnold M., Mosconi M.G., Altmann M., Lang M., Psychogios M., Tiainen M., Barber M., Arnold M., Kneihsl M., Magriço M., Müller M., Joan MacLeod M., Greulich M., Rutgers M.P., Schell M., Garcia-Pons M., Pøhner Skahjem M., Haley M., Marnane M., Vosko M., Mako M., Polavarapu N., Martinez-Majander N., Del Gaudio N., Caracciolo N.G., Peters N., Mahajan N., Silimon N., Onur O.A., Morten Rønning O., Ringleb P., Slade P., Vanacker P., Desfontaines P., Nair P., Marian R., Parthasarathy R., Hidalgo R., Mulcahy R., Kato R., Bhatia R., Collins R., Leker R.R., Eichel R., Fenzl S., Tanaka R., Hussayni Husseini S.A., Clarke S., Sreedharan S.E., Ostanek S., Amina S., Beyeler S., Storton S., Fujimoto S., Räty S., Fandler-Höfler S., Galego S., Yoshimura S., Matsubara S., Greisenegger S., Oberndorfer S., Ray S., Renaud S., Riebau S., Poli S., Politz S., Albert S.J., Kunieda T., Sato T., Yoshimoto T., Anjum T., Pap T., Costa T., Pinho E Melo T., Iype T., Cassidy T., Von Oertzen T.J., Kahles T., Danilo T., Spetalen T., Tatlisumak T., De Herdt V., Borisova V., Pamidimukkala V., Huded V., Gupta V., Kumar V., Nambiar V., Pfeilschifter W., Stoop W., Iguchi Y., Müller Seljeseth Y., Abousleiman Y., Yakushiji Y., Pencz Z.
ISSN
2574-3805 (Electronic)
ISSN-L
2574-3805
Publication state
Published
Issued date
02/01/2025
Peer-reviewed
Oui
Volume
8
Number
1
Pages
e2456307
Language
english
Notes
Publication types: Journal Article ; Randomized Controlled Trial ; Multicenter Study
Publication Status: epublish
Publication Status: epublish
Abstract
The net clinical effect of early vs later direct oral anticoagulant (DOAC) initiation after atrial fibrillation-associated ischemic stroke is unclear.
To investigate whether early DOAC treatment is associated with a net clinical benefit (NCB).
This was a post hoc analysis of the Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients With Atrial Fibrillation (ELAN) open-label randomized clinical trial conducted across 103 sites in 15 countries in Europe, the Middle East, and Asia between November 6, 2017, and September 12, 2022, with a 90-day follow-up. Participants included patients with atrial fibrillation-associated acute ischemic stroke, excluding those with therapeutic anticoagulation at stroke onset or with severe hemorrhagic transformation of the ischemic infarct.
Early DOAC initiation (<48 hours after minor and moderate stroke, 6-7 days after major stroke) vs later initiation (3-4 days after minor stroke, 6-7 days after moderate stroke, and 12-14 days after major stroke).
The main measure was the NCB of early treatment over later treatment, calculated by subtracting the weighted rate of excess bleeding events (major extracranial or intracranial hemorrhage) attributable to early treatment from the rate of excess ischemic events (recurrent stroke or systemic embolism) possibly prevented by early treatment within 30 days (main analysis) or 90 days (ancillary analysis). An established weighting scheme was used to account for the different clinical impact of bleeding relative to ischemic outcomes. Event rates were derived from adjusted logistic models. The analysis included all evaluable randomized ELAN participants.
Of the original 2013 ELAN participants, 1966 were eligible for analysis (977 [49.7%] assigned to early DOAC initiation, 989 [50.3%] assigned to later DOAC initiation; median [IQR] age 77 [70-84] years; 1075 [54.7%] male). The 30-day NCB of early treatment over later treatment ranged from 1.73 (95% CI, 0.06-3.40) to 1.72 (95% CI, -0.63 to 3.98) weighted events possibly prevented per 100 participants for intracranial hemorrhage weights 1.5 to 3.3. The 90-day NCB ranged from 2.16 (95% CI, 0.30-3.87) to 2.14 (95% CI, -0.26 to 4.41) weighted events per 100 participants.
This post hoc analysis of a randomized clinical trial estimated a sizeable NCB of early anticoagulation for patients after atrial fibrillation-associated ischemic stroke. Although estimates cannot exclude the possibility of no benefit or small net harm, the findings suggest that early treatment may be more favorable.
ClinicalTrials.gov Identifier: NCT03148457.
To investigate whether early DOAC treatment is associated with a net clinical benefit (NCB).
This was a post hoc analysis of the Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients With Atrial Fibrillation (ELAN) open-label randomized clinical trial conducted across 103 sites in 15 countries in Europe, the Middle East, and Asia between November 6, 2017, and September 12, 2022, with a 90-day follow-up. Participants included patients with atrial fibrillation-associated acute ischemic stroke, excluding those with therapeutic anticoagulation at stroke onset or with severe hemorrhagic transformation of the ischemic infarct.
Early DOAC initiation (<48 hours after minor and moderate stroke, 6-7 days after major stroke) vs later initiation (3-4 days after minor stroke, 6-7 days after moderate stroke, and 12-14 days after major stroke).
The main measure was the NCB of early treatment over later treatment, calculated by subtracting the weighted rate of excess bleeding events (major extracranial or intracranial hemorrhage) attributable to early treatment from the rate of excess ischemic events (recurrent stroke or systemic embolism) possibly prevented by early treatment within 30 days (main analysis) or 90 days (ancillary analysis). An established weighting scheme was used to account for the different clinical impact of bleeding relative to ischemic outcomes. Event rates were derived from adjusted logistic models. The analysis included all evaluable randomized ELAN participants.
Of the original 2013 ELAN participants, 1966 were eligible for analysis (977 [49.7%] assigned to early DOAC initiation, 989 [50.3%] assigned to later DOAC initiation; median [IQR] age 77 [70-84] years; 1075 [54.7%] male). The 30-day NCB of early treatment over later treatment ranged from 1.73 (95% CI, 0.06-3.40) to 1.72 (95% CI, -0.63 to 3.98) weighted events possibly prevented per 100 participants for intracranial hemorrhage weights 1.5 to 3.3. The 90-day NCB ranged from 2.16 (95% CI, 0.30-3.87) to 2.14 (95% CI, -0.26 to 4.41) weighted events per 100 participants.
This post hoc analysis of a randomized clinical trial estimated a sizeable NCB of early anticoagulation for patients after atrial fibrillation-associated ischemic stroke. Although estimates cannot exclude the possibility of no benefit or small net harm, the findings suggest that early treatment may be more favorable.
ClinicalTrials.gov Identifier: NCT03148457.
Keywords
Humans, Atrial Fibrillation/drug therapy, Atrial Fibrillation/complications, Male, Female, Aged, Anticoagulants/therapeutic use, Stroke/etiology, Stroke/prevention & control, Middle Aged, Aged, 80 and over, Administration, Oral, Ischemic Stroke/drug therapy, Ischemic Stroke/prevention & control, Ischemic Stroke/etiology, Time-to-Treatment/statistics & numerical data, Treatment Outcome, Hemorrhage/chemically induced
Pubmed
Web of science
Open Access
Yes
Create date
31/01/2025 17:43
Last modification date
21/02/2025 8:29
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