Edoxaban did not reduce stroke or systemic embolism but increased major bleeding in high-risk patients with atrial fibrillation who had had an intracranial hemorrhage,\u00a0according to results\u00a0presented in a Hot Line session today at ESC Congress 2026.<\/p>\n
Atrial fibrillation (AF) is the most\u00a0common form\u00a0of irregular heart rhythm\u00a0and a leading cause of ischemic stroke, where a blood clot cuts off the blood supply to part of the brain. Oral anticoagulants\u00a0such as\u00a0edoxaban\u00a0are\u00a0highly effective at preventing ischemic stroke in patients with AF, but\u00a0they\u00a0come with concerns over bleeding risk. These concerns are amplified in patients with AF who have had a prior\u00a0intracranial hemorrhage, which includes bleeding within or around the brain.\u00a0<\/p>\n
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The ideal strategy to prevent\u00a0ischemic stroke is uncertain\u00a0in\u00a0patients with AF and a prior\u00a0intracranial hemorrhage,\u00a0as these patients\u00a0have been excluded from\u00a0the large landmark\u00a0trials assessing\u00a0oral anticoagulants.”<\/p>\n
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Professor Ashkan Shoamanesh\u00a0from McMaster University, Hamilton, Canada, Principal Investigator of the ENRICH-AF trial<\/p>\n
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“This leaves us with a\u00a0challenging clinical\u00a0dilemma that is becoming more frequent with our aging population.\u00a0Data from small studies indicate that oral anticoagulation may result in net overall benefit among survivors of\u00a0intracranial hemorrhage with AF.\u00a0We conducted the\u00a0large\u00a0ENRICH-AF trial to\u00a0evaluate the efficacy<\/a> and safety of\u00a0oral anticoagulants\u00a0further\u00a0in these patients,”\u00a0he explained.\u00a0<\/p>\n This\u00a0was an investigator-initiated, open-label, blinded endpoint, event-driven trial\u00a0conducted across 174 sites in 20 countries.\u00a0Patients with high-risk AF and prior intracranial hemorrhage\u00a0were enrolled.\u00a0Following Data and Safety Monitoring Board review in 2023, no further patients with lobar intraparenchymal hemorrhage or convexity subarachnoid hemorrhage were included because of safety concerns.\u202f<\/p>\n Eligible participants\u00a0were\u00a0randomized (1:1) to\u00a0edoxaban\u00a060\u00a0mg\u00a0once daily (with dose adjustments to 30 mg daily according to the label) or\u00a0no\u00a0anticoagulation (no antithrombotic therapy or single\u00a0antiplatelet therapy,\u00a0as\u00a0determined\u00a0by the\u00a0clinician).\u00a0The study population included\u00a0948\u00a0patients who\u00a0had a mean age of 77 years and 39% were women.\u00a0<\/p>\n Over\u00a0an average of 28 months of follow-up,\u00a0edoxaban\u00a0did not significantly reduce the primary endpoint of stroke\u00a0(including ischemic and hemorrhagic stroke)\u00a0or systemic embolism compared with no anticoagulation\u00a0(11.8% vs. 12.8%; hazard ratio\u00a0[HR]\u00a00.88; 95% confidence interval\u00a0[CI]\u00a00.61 to 1.26; p=0.48). Ischaemic stroke and myocardial infarction were significantly reduced with\u00a0edoxaban\u00a0vs. no anticoagulation; however, this benefit was offset by an almost three-fold excess in haemorrhagic stroke.\u00a0<\/p>\n The primary safety outcome of\u00a0International Society on Thrombosis and Hemostasis\u00a0major bleeding occurred in 11.6% of patients with\u00a0edoxaban\u00a0and 5.2% with no anticoagulation\u00a0(HR 2.23; 95% CI\u00a01.39\u00a0to\u00a03.59; p<0.001).\u00a0<\/p>\n “Our\u00a0findings\u00a0do not support the use of\u00a0edoxaban\u00a0in unselected patients\u00a0with\u00a0AF\u00a0after intracranial hemorrhage,\u00a0but highlight the need for an individualized decision-making approach,”\u00a0commented\u00a0Professor\u00a0Shoamanesh.\u00a0“Ongoing\u00a0trials, including the\u00a0double-blinded, randomized\u00a0ASPIRE trial\u00a0comparing\u00a0apixaban vs. aspirin, will add to the evidence base. Additionally,\u00a0a\u00a0prospective,\u00a0individual participant data\u00a0meta-analysis of all\u00a0trials\u00a0(COCROACH) will\u00a0ultimately\u00a0provide\u00a0useful\u00a0additional\u00a0insights\u00a0on how best to individualize\u00a0optimal\u00a0stroke prevention in this\u00a0very\u00a0vulnerable patient population,” he concluded.\u00a0<\/p>\n Source:<\/p>\n