Early anticoagulation unlikely to cause harm after stroke with atrial fibrillation
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Key takeaways:
- Data show early anticoagulation after acute stroke in people with atrial fibrillation is safe when indicated.
- Risk for recurrent ischemic stroke at 30 days was lower in the early vs. late treatment group.
In patients with acute stroke and atrial fibrillation, oral anticoagulation therapy may be administered within 48 hours after stroke when appropriate or indicated, researchers reported.
Direct oral anticoagulants (DOACs) reduce risk for ischemic stroke and systemic embolism among people with AF; however, whether the timing of DOAC initiation influences the risks for stroke recurrence and bleeding after an acute ischemic stroke is unclear, Urs Fischer, MD, MSc, chairman of the department of neurology at the University Hospital in Basel, Switzerland, and former secretary general of the European Stroke Association, and colleagues wrote in The New England Journal of Medicine in a publication simultaneous with a presentation at the European Stroke Organization Conference. The researchers wrote that early initiation may increase the risk for intracranial hemorrhage, whereas later initiation may increase the risk for early stroke recurrence.
“Rates of symptomatic intracranial hemorrhage are low with early anticoagulation if imaging-based classification for stroke is used,” Fischer told Healio. “Early treatment initiation is reasonable if indicated or if desired for logistic or other reasons. Early treatment initiation is probably better and is unlikely to cause harm.”
Outcomes after early vs. late treatment
In an open-label trial, Fischer and colleagues analyzed data from 2,013 adults from 103 sites in 15 countries. Researchers randomly assigned participants 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).
“Our participants underwent randomization within 48 hours after a minor or moderate stroke, we used an imaging-based approach, and we compared early initiation with the 1-3-6-12-day rule, which is widely used,” the researchers wrote.
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.
Within the cohort, 37% had a minor stroke; 40% had moderate stroke and 23% had major stroke. There were 1,006 participants in the early anticoagulation group and 1,007 participants in the later anticoagulation group.
A primary outcome event occurred in 2.9% of the early treatment group and 4.1% in the later-treatment group, for a risk difference of –1.18 percentage points (95% CI, –2.84 to 0.47) by 30 days.
Recurrent ischemic stroke occurred in 1.4% of participants in the early treatment group and 2.5% in the later treatment group, for an OR of 0.57 (95% CI, 0.29-1.07) by 30 days and in 1.9% of participants in the early treatment group and 3.1% in the later treatment group by 90 days, for an OR of 0.6 (95% CI, 0.33-1.06).
Incidence of symptomatic intracranial hemorrhage was low, occurring in 0.2% of participants in both groups by 30 days.
‘No reason to delay’ DOAC use after stroke
The researchers noted that the trial was designed to estimate the treatment effects of early initiation and later initiation of DOACs and the degree of precision of this estimate. No statistical hypothesis was tested for superiority or noninferiority, and the results are intended to provide qualitative data that may be of use to clinicians.
“There is no reason to delay anticoagulation with DOACs in patients with acute ischemic stroke and AF,” Fischer told Healio. “This can change clinical practice and will reassure physicians to start early with anticoagulation after a stroke.”
Fischer said there is still uncertainty with respect to how patients with an acute ischemic stroke under full anticoagulation should be treated, and when to start anticoagulation with an intracranial hemorrhage.
Reference:
For more information:
Urs Fischer, MD, MSc, can be reached at urs.fischer@usb.ch; Twitter: @fishingneurons.