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In Brief | Neurology & Neurosurgery, Cardiovascular Disease
 
OPTIMAS Trial reviews timing for starting anticoagulation after acute ischaemic stroke in atrial fibrillation


Time to read: 03:07
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Published on MedED:  11 November 2024
Originally Published: 2 November 2024
Sourced: The Lancet
Type of article: In Brief
MedED Catalogue Reference: MNIB005
Category: Neurology & Neurosurgery
Cross Reference: Cardiovascular Disease
Keywords: ISS, ischemic stroke, atrial fibrillation, DOACs

 

Key Takeaway
The OPTIMAS trial demonstrated that starting DOACs within 4 days after an acute ischaemic stroke in patients with atrial fibrillation is as effective as delaying initiation to 7–14 days in preventing recurrent strokes, with no increased risk of intracranial haemorrhage
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Originally published in The Lancet,2 November 2024. This summary does not represent the original research, nor is it intended to replace the original research. Access the full Disclaimer Information
 
 

Atrial fibrillation (AF) is present in approximately 20% of ischaemic stroke cases and is likely to be the key risk factor in these events.

While long-term direct oral anticoagulants (DOACs) reduce the risk of stroke in AF patients, the optimal timing for starting anticoagulation post-acute stroke remains unclear. Some guidelines recommend anticoagulation based on the 1-3-6-12-day rule according to stroke severity, while others advise a 2-week delay for severe cases to minimise bleeding risk.
 
The OPTIMAS trial aimed to establish the optimal timing for initiating direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) after an acute ischaemic stroke in a broad population.
 
This phase 4, multicentre, open-label, randomised controlled trial involved 3,621 patients across 100 hospitals in the UK. 
 
The study compared early (≤4 days) versus delayed (7–14 days) initiation of DOACs in patients with acute ischaemic stroke associated with AF. 
 
Participants were randomly assigned (1:1) to either an early initiation protocol (1814 patients) or a delayed initiation treatment protocol (1,814 patients). 
 
Baseline characteristics such as demographics and clinical features were comparable between the two groups.
 
The following findings were recorded:
 
On admission, 24.6% of the cohort had moderate-to-severe strokes, and 14.6% had moderate-to-severe strokes at randomisation, reflecting a broad range of stroke severities
 
 
The average time to DOAC initiation from stroke onset was 3.1 days (SD 1.8) in the early group and 8.3 days (SD 3.1) in the delayed group. The mean time from randomisation to DOAC administration was 1 day for early initiation and 6.2 days for delayed initiation
 
 
The primary composite outcome was a measure of recurrent ischaemic stroke, symptomatic intracranial haemorrhage, unclassifiable stroke, or systemic embolism within 90 days
 
 
At the 90-day follow-up, the primary outcome was observed in 3.3% of both groups ( adjusted RD 0·000, 95% CI –0·011 to 0·012), confirming non-inferiority of early initiation compared to delayed initiation. Specifically, the 95% CI upper limit for the risk difference was below the pre-specified non-inferiority margin of 2%, demonstrating that early initiation did not increase the risk of adverse outcomes (p_non-inferiority = 0.0003)
 
 
Adherence rates were high, with 95.6% of the early initiation group and 94.5% of the delayed group remaining on anticoagulation at the end of the study period
 
 
Symptomatic intracranial haemorrhage occurred in 0.6% of participants in the early group and 0.7% in the delayed group ( adjusted RD 0.001, 95% CI: –0.004 to 0.006; p=0.78), indicating no significant increase in bleeding risk with earlier anticoagulation


The researchers concluded that initiating DOACs within 4 days of an ischaemic stroke in patients with AF is as safe and effective as delaying initiation to 7–14 days. There was no significant difference in recurrent stroke prevention, intracranial haemorrhage, or systemic embolism between the two strategies.

These findings challenge the current practice guidelines, which often recommend a delayed approach. Further analysis of cognitive, functional, and quality-of-life outcomes is ongoing, which may provide additional insights into the benefits and risks of early anticoagulation initiation.
 
 
OPTIMAS is registered with ISRCTN (ISRCTN17896007) and ClinicalTrials.gov (NCT03759938), and the trial is ongoing. 

 
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This article is reproduced under the terms of CC-BY-Licence. It is in no way presented as an original work.  Every effort has been made to attribute quotes and content correctly. Where possible, all information has been independently verified. The Medical Education Network bears no responsibility for any inaccuracies which may occur from the use of third-party sources. If you have any queries regarding this article contact us 

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The Medical Education Network makes every effort to review and fact-check the articles used as source material in our summaries and original material. We have strict guidelines in relation to the publications we use as our source data, favouring peer-reviewed research wherever possible. Every effort is made to ensure that the information contained here is an accurate reflection of the original material. Should you find inaccuracies, out of date content or have any additional issues with our articles, please  contact us 

 
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