Early versus Later Anticoagulation for Stroke with Atrial Fibrillation.
Details
Serval ID
serval:BIB_8A4FEEEA34C1
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Early versus Later Anticoagulation for Stroke with Atrial Fibrillation.
Journal
The New England journal of medicine
Working group(s)
ELAN Investigators
Contributor(s)
Abdul-Rahim A., Abousleiman Y., Adamou A., Adeyemi A.K., Albert S.J., Alteheld L., Akiyama H., Altmann M., Tarnutzer A.A., Anjum T., Annamalai A., Anwar I., Arnold M., Barber M., Berberich A., Bersas I.O., Bhatia R., Bianco G., Bolognese M., Bonvin C., Borisova V., Bradley D., Caporale C., Cassidy T., Cereda C.W., Charissé D., Ciobanu C., Clarke B., Clarke S., Collins R., Costa T., De Herdt V., De Marchis G.M., Del Gaudio N., Delvoye F., Devroye A., Dhasan A., Dixon L., Pandian J.D., Dymond H., Eichel R., Sreedharan S.E., Esson D., Falcou A., Fandler-Höfler S., Fisch L., Fischer A., Fujimoto S., Galego S., Garcia-Pons M., Gbadamosh L., Gentile L., Mosconi M.G., Globas C., Gonçalves Martins C., Greisenegger S., Greulich M., Grimshaw B., Gupta V., Guzman-Gutierrez G., Haley M., Harbison J., Healy L., Honig A., Hostens A., Huded V., Humm A.M., Al Hussayni Husseini S., Iguchi Y., Ihle-Hansen H., Inoue M., Iype T., Jankovicova Z., MacLeod M.J., Kägi G., Kallmünzer B., Karagkiozi E., Katan M., Klimcikova K., Kato R., Kellermair L., Kellert L., Khurana D., Koundal H., Krogias C., Kumar V., Kunieda T., Lang M., De Magistris I.L., Leker R.R., Liesz A., Loos C., Macha K., Magriço M., Mahajan N., Mako M., Marcelis E., Marian R., Marnane M., Martinez-Majander N., Marto J.P., Matsubara S., Mbroh J., McAlpine C., McCabe J.J., Medlin F., Melancia D., Menezes B., Michalski D., Rønning O.M., Mulcahy R., Müller M., Müller A., Seljeseth Y.M., Muresan I.P., Nabavi D.G., Nair P., Nakajima M., Nallasivan A., Nambiar V., Niederhauser J., Noone I., Oberndorfer S., Offermann J., Olbert E., Onur O.A., Orion D., Ostanek S., Paliantonis A., Pamidimukkala V., Pap T., Parthasarathy R., Pelz J., Pencz Z., Peeters A., Peters N., Pfeilschifter W., Pichler A., Pinho E Melo T., Pøhner Skahjem M., Polavarapu N., Politz S., Polymeris A., Pope G., Psychogios M., Rani K., Ray S., Renaud S., Richter D., Riebau S., Ringleb P., Rodic B., Royl G., Rutgers M.P., Ryan D., Sargento-Freitas J., Sato T., Saukkonen A.M., Schell M., Schelosky L., Schlemm E., Schrammel D., Scutelnic A., Sibolt G., Silimon N., Sipilä J., Sirimarco G., Sellimi A., Smith K., Smith G.M., Soltesova K., Sousa J.A., Spetalen T., Staykov D., Stetefeld H.R., Stoop W., Storton S., Strambo D., Szabo K., Takayuki F., Tanaka R., Toni D., Vanhoorne A., Vanpanteghem I., Vedamurthy A., Sharma A.V., Von Oertzen T.J., Vosko M., Vynckier J., Wagner J., Whyte C., Wilkinson A., Wilson A., Wright F., Yoshimura S., Yperzeele L., Zini A.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Publication state
Published
Issued date
29/06/2023
Peer-reviewed
Oui
Volume
388
Number
26
Pages
2411-2421
Language
english
Notes
Publication types: Randomized Controlled Trial ; Journal Article
Publication Status: ppublish
Publication Status: ppublish
Abstract
The effect of early as compared with later initiation of direct oral anticoagulants (DOACs) in persons with atrial fibrillation who have had an acute ischemic stroke is unclear.
We performed an investigator-initiated, open-label trial at 103 sites in 15 countries. Participants were randomly assigned in a 1:1 ratio to early anticoagulation (within 48 hours after a minor or moderate stroke or on day 6 or 7 after a major stroke) or later anticoagulation (day 3 or 4 after a minor stroke, day 6 or 7 after a moderate stroke, or day 12, 13, or 14 after a major stroke). Assessors were unaware of the trial-group assignments. The primary outcome was a composite of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, or vascular death within 30 days after randomization. Secondary outcomes included the components of the composite primary outcome at 30 and 90 days.
Of 2013 participants (37% with minor stroke, 40% with moderate stroke, and 23% with major stroke), 1006 were assigned to early anticoagulation and 1007 to later anticoagulation. A primary-outcome event occurred in 29 participants (2.9%) in the early-treatment group and 41 participants (4.1%) in the later-treatment group (risk difference, -1.18 percentage points; 95% confidence interval [CI], -2.84 to 0.47) by 30 days. Recurrent ischemic stroke occurred in 14 participants (1.4%) in the early-treatment group and 25 participants (2.5%) in the later-treatment group (odds ratio, 0.57; 95% CI, 0.29 to 1.07) by 30 days and in 18 participants (1.9%) and 30 participants (3.1%), respectively, by 90 days (odds ratio, 0.60; 95% CI, 0.33 to 1.06). Symptomatic intracranial hemorrhage occurred in 2 participants (0.2%) in both groups by 30 days.
In this trial, the incidence of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, or vascular death at 30 days was estimated to range from 2.8 percentage points lower to 0.5 percentage points higher (based on the 95% confidence interval) with early than with later use of DOACs. (Funded by the Swiss National Science Foundation and others; ELAN ClinicalTrials.gov number, NCT03148457.).
We performed an investigator-initiated, open-label trial at 103 sites in 15 countries. Participants were randomly assigned in a 1:1 ratio to early anticoagulation (within 48 hours after a minor or moderate stroke or on day 6 or 7 after a major stroke) or later anticoagulation (day 3 or 4 after a minor stroke, day 6 or 7 after a moderate stroke, or day 12, 13, or 14 after a major stroke). Assessors were unaware of the trial-group assignments. The primary outcome was a composite of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, or vascular death within 30 days after randomization. Secondary outcomes included the components of the composite primary outcome at 30 and 90 days.
Of 2013 participants (37% with minor stroke, 40% with moderate stroke, and 23% with major stroke), 1006 were assigned to early anticoagulation and 1007 to later anticoagulation. A primary-outcome event occurred in 29 participants (2.9%) in the early-treatment group and 41 participants (4.1%) in the later-treatment group (risk difference, -1.18 percentage points; 95% confidence interval [CI], -2.84 to 0.47) by 30 days. Recurrent ischemic stroke occurred in 14 participants (1.4%) in the early-treatment group and 25 participants (2.5%) in the later-treatment group (odds ratio, 0.57; 95% CI, 0.29 to 1.07) by 30 days and in 18 participants (1.9%) and 30 participants (3.1%), respectively, by 90 days (odds ratio, 0.60; 95% CI, 0.33 to 1.06). Symptomatic intracranial hemorrhage occurred in 2 participants (0.2%) in both groups by 30 days.
In this trial, the incidence of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, or vascular death at 30 days was estimated to range from 2.8 percentage points lower to 0.5 percentage points higher (based on the 95% confidence interval) with early than with later use of DOACs. (Funded by the Swiss National Science Foundation and others; ELAN ClinicalTrials.gov number, NCT03148457.).
Keywords
Humans, Atrial Fibrillation/complications, Atrial Fibrillation/drug therapy, Anticoagulants/adverse effects, Ischemic Stroke/complications, Treatment Outcome, Stroke/prevention & control, Stroke/complications, Hemorrhage/chemically induced, Embolism/etiology, Embolism/prevention & control, Intracranial Hemorrhages/chemically induced
Pubmed
Web of science
Funding(s)
Swiss National Science Foundation
Create date
26/05/2023 16:34
Last modification date
04/07/2023 5:54
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