Fischer, U. et al. (2023) Early versus later anticoagulation for stroke with atrial fibrillation. New England Journal of Medicine, 388(26), pp. 2411-2421. (doi: 10.1056/NEJMoa2303048) (PMID:37222476)
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Abstract
Background: 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. Methods: 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. Results: 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. Conclusions: 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.
| Item Type: | Articles |
|---|---|
| Additional Information: | Supported by grants from the Swiss National Science Foundation (32003B_197009; 32003B_169975), the Swiss Heart Foundation, the Stroke Association in the United Kingdom (2017/02), and the Intramural Research Fund (20-4-5) for Cardiovascular Diseases of the National Cerebral and Cardiovascular Center, Japan. |
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Dawson, Professor Jesse |
| Authors: | Fischer, U., Koga, M., Strbian, D., Branca, M., Abend, S., Trelle, S., Paciaroni, M., Thomalla, G., Michel, P., Nedeltchev, K., Bonati, L. H., Ntaios, G., Gattringer, T., Sandset, E.-C., Kelly, P., Lemmens, R., Sylaja, P.N., Aguiar de Sousa, D., Bornstein, N. M., Gdovinova, Z., Yoshimoto, T., Tiainen, M., Thomas, H., Krishnan, M., Shim, G. C., Gumbinger, C., Vehoff, J., Zhang, L., Matsuzono, K., Kristoffersen, E., Desfontaines, P., Vanacker, P., Alonso, A., Yakushiji, Y., Kulyk, C., Hemelsoet, D., Poli, S., Paiva Nunes, A., Caracciolo, N., Slade, P., Demeestere, J., Salerno, A., Kneihsl, M., Kahles, T., Giudici, D., Tanaka, K., Räty, S., Hidalgo, R., Werring, D. J., Göldlin, M., Arnold, M., Ferrari, C., Beyeler, S., Fung, C., Weder, B. J., Tatlisumak, T., Fenzl, S., Rezny-Kasprzak, B., Hakim, A., Salanti, G., Bassetti, C., Gralla, J., Seiffge, D. J., Horvath, T., and Dawson, J. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health |
| Journal Name: | New England Journal of Medicine |
| Publisher: | Massachusetts Medical Society |
| ISSN: | 0028-4793 |
| ISSN (Online): | 1533-4406 |
| Published Online: | 24 May 2023 |
| Copyright Holders: | Copyright © 2023 Massachusetts Medical Society |
| First Published: | First published in New England Journal of Medicine 388(26):2411-2421 |
| Publisher Policy: | Reproduced in accordance with the publisher copyright policy |
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