New clinical trial findings presented at the ESC Congress 2026 reveal that the blood thinner edoxaban did not reduce stroke or systemic embolism in high-risk atrial fibrillation patients with a prior intracranial hemorrhage, while significantly increasing major bleeding risks over an average 28-month follow-up.
ENRICH-AF Trial Results Presented at ESC Congress 2026
For aging populations living with atrial fibrillation, balancing the risk of stroke against the danger of bleeding has long created a complex clinical dilemma. Patients with a prior intracranial hemorrhage—meaning bleeding within or around the brain—have historically been excluded from landmark trials evaluating oral anticoagulants. To address this evidence gap, researchers conducted the large international ENRICH-AF trial across 174 sites in 20 countries, evaluating the efficacy and safety of oral anticoagulants in high-risk patients with atrial fibrillation and prior intracranial hemorrhage.
The study population included 948 participants with a mean age of 77 years, of whom 39 percent were women. Following a review by the Data and Safety Monitoring Board in 2023, investigators stopped enrolling further patients with lobar intraparenchymal hemorrhage or convexity subarachnoid hemorrhage due to safety concerns. Eligible participants were randomized on a one-to-one basis to receive either edoxaban 60 milligrams once daily—with label-directed dose adjustments to 30 milligrams daily—or no anticoagulation therapy, as determined by their clinician.
Over an average follow-up period of 28 months, edoxaban did not significantly reduce the primary endpoint of stroke—encompassing both ischemic and hemorrhagic stroke—or systemic embolism compared to the no-anticoagulation group, occurring in 11.8 percent of edoxaban patients versus 12.8 percent of controls. While ischemic stroke and myocardial infarction showed meaningful reductions with edoxaban, that protection was offset by an almost three-fold excess in hemorrhagic stroke.
Bleeding Risks Outweigh Ischemic Benefits in Selected Populations
The primary safety outcome of major bleeding, defined by the International Society on Thrombosis and Hemostasis, occurred in 11.6 percent of patients taking edoxaban, compared to just 5.2 percent of those receiving no anticoagulation. Professor Shoamanesh noted that ongoing investigations, including the double-blinded, randomized ASPIRE trial comparing apixaban against aspirin, will expand the existing evidence base. Furthermore, a prospective individual participant data meta-analysis encompassing all related trials, known as COCROACH, aims to provide additional insights into tailoring stroke prevention strategies for this vulnerable population.
While the trial results clarify risks for patients recovering from brain bleeds, a separate study from the University of Bath highlights the opposite danger for older adults: the unintended risks introduced when routine blood thinners are stopped.
Deprescribing Blood Thinners in Older Adults Examined in UK Study
Clinicians frequently worry about prescribing blood-thinning medications to older patients due to fears of falls and major bleeding, but research funded by the Dunhill Medical Trust indicates that for patients with atrial fibrillation, the health risks of withholding these drugs are significantly higher than the risk of a life-threatening bleed. Atrial fibrillation carries a fivefold increase in stroke risk, contributing to an estimated 20,000 strokes annually in the UK, alongside heightened risks of heart attacks and death.
Examining data from the UK Clinical Practice Research Datalink between 2013 and 2017, researchers analyzed patients aged 75 and older who were newly prescribed anticoagulants. The study discovered that the risks of stroke and death were three times higher during periods when patients were not receiving anticoagulant therapy, while the risk of heart attacks nearly doubled.
Contrary to widespread clinical belief, stopping anticoagulants in patients aged 75 and older did not alter the incidence of major bleeds.
Shifting Clinical Perspectives from Warfarin to Direct Oral Anticoagulants
Rising diagnoses of atrial fibrillation underscore the urgency of these prescribing choices. Among individuals aged 85 and older, diagnosed cases doubled in men from 11.6 percent in 2000 to 22.1 percent in 2016, and rose in women from 9.6 percent to 16.5 percent over the same timeframe.
Dr. Mitchell suggests that many physician decisions to withhold anticoagulants stem from historical experiences with warfarin, the only available option for treating AF before 2012. Warfarin requires complex dosing regimens, strict dietary limitations, and frequent blood monitoring. Since 2013, however, direct oral anticoagulants have become the first line option for most patients.
Drugs such as apixaban offer an improved safety profile with a lower risk of significant bleeding compared to warfarin, alongside a much simpler daily regimen. Researchers emphasize that thorough discussions regarding both risks and benefits must take place between clinicians and patients before any decision is made to discontinue blood-thinning therapy.
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