Savaysa (edoxaban) / Daiichi Sankyo - LARVOL DELTA

Concurrent Aspirin Use in Anticoagulated Patients and Risk of Gastrointestinal Bleeding: A Propensity-Score-Matched Cohort Analysis (ACG 2026) - "Cohort 1 comprised adults on chronic anticoagulation (apixaban, rivaroxaban, dabigatran, edoxaban, or warfarin) with concurrent aspirin use; Cohort 2 comprised anticoagulated adults without aspirin. Post-PSM cohorts were well-balanced (all SMDs < 0.003). Aspirin use was associated with significantly higher rates of upper GI bleed (1.51% vs. 1.26%; HR 1.34, 95% CI 1.20â1.48; p< 0.001), unspecified GI hemorrhage (1.39% vs."

Clinical • Cardiovascular • Chronic Kidney Disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Renal Disease • Thrombocytopenia

Impact of Non-Vitamin K Antagonist Oral Anticoagulants on Cardiovascular Outcomes in Diabetes Patients with Atrial Fibrillation: A Single-Center Experience. (PubMed, Acta Cardiol Sin) - "This retrospective cohort study included patients with DM and AF treated with NOACs (apixaban, dabigatran, edoxaban, or rivaroxaban) between December 2012 and June 2022 at a tertiary hospital in Taiwan. In this single-center study, the risk of major bleeding was similar across the four NOACs. In addition, dabigatran was associated with lower risks of MACEs and all-cause mortality compared with apixaban."

Journal • Atrial Fibrillation • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Diabetes • Gastroenterology • Hematological Disorders • Ischemic stroke • Metabolic Disorders • Myocardial Infarction

Longitudinal Plasma Lipidomic Changes in Chinese Patients with Nonvalvular Atrial Fibrillation During 12 Weeks of Edoxaban Treatment. (PubMed, Metabolites) - "The 12 shared features provide focused candidates for targeted validation. Controlled studies are needed to determine whether these changes are specific to edoxaban and to establish their biological and clinical relevance."

Clinical • Journal • Atrial Fibrillation • Cardiovascular • Metabolic Disorders

Adherence to Direct Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation: A Single-Center Retrospective Study. (PubMed, J Cardiovasc Pharmacol Ther) - "Adherence levels for dabigatran, rivaroxaban, apixaban, and edoxaban were compared at 3, 6, 9, and 12 months. The NVBP policy improves adherence short-term, but long-term effects are limited. Targeted interventions are necessary for high-risk populations."

Clinical • Journal • Retrospective data • Atrial Fibrillation • Cardiovascular • Diabetes • Metabolic Disorders

Prophylactic vs Therapeutic Anticoagulation in Hospitalized Patients With COVID-19: A Randomized Clinical Trial. (PubMed, JAMA Netw Open) - P3 | "In patients hospitalized with COVID-19, in-hospital therapeutic anticoagulation with LMWH followed by edoxaban to day 42 did not statistically significantly reduce death and/or thromboembolic events compared with prophylactic anticoagulation followed by placebo. ClinicalTrials.gov Identifier: NCT04542408."

Clinical • Journal • Cardiovascular • Critical care • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Venous Thromboembolism

Real-World Assessment of Direct Oral Factor Xa Inhibitors: Dosing Appropriateness, Drug Exposure, and Inter-Platform Comparability of Chromogenic Anti-Xa Assays. (PubMed, Diagnostics (Basel)) - " This single-center retrospective study included 392 plasma samples from 292 patients with atrial fibrillation treated with apixaban (n = 207), edoxaban (n = 147), or rivaroxaban (n = 38). Chromogenic anti-factor Xa assays showed strong inter-platform agreement, particularly with LRT reagents, supporting their analytical reliability for laboratory assessment of DOAC exposure. Because exact dosing times were unavailable, these concentrations should be interpreted as heterogeneous spot samples rather than standardized pharmacokinetic reference intervals; these findings may nonetheless support individualized interpretation of outpatient spot sample DOAC concentrations in selected clinical settings."

Journal • Real-world evidence • Atrial Fibrillation • Cardiovascular

Kidney injury associated with direct oral anticoagulants: a comparative study of direct thrombin inhibitors and factor Xa inhibitors based on literature and database analysis. (PubMed, Ren Fail) - "We conducted a comprehensive analysis of kidney injury cases from the FDA Adverse Event Reporting System (FAERS, 2008-2024) and systematically reviewed published case reports, comparing DTIs (dabigatran) with FXaIs (rivaroxaban, apixaban, edoxaban). This study demonstrates distinct kidney injury risks among DOAC classes and individual agents, with DTIs and edoxaban showing particularly strong signals. These findings emphasize the need for individualized DOAC selection and enhanced renal monitoring in clinical practice."

Clinical • Journal • Nephrology • Renal Disease

Plasma-Derived Factor VIIa/Factor X Improves Thrombin Generation Potential in a Plasma Model of Haemophilia A Supplemented With Direct Oral Anticoagulants. (PubMed, Haemophilia) - "Pd-FVIIa/FX improved coagulation potential in the in vitro model plasma of PwHA-inh spiked with DOACs, irrespective of concomitant emicizumab. The clinical efficacy and safety of pd-FVIIa/FX require further evaluation."

Journal • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases • Thrombosis

VMX-C001-03: Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: VarmX B.V. | Active, not recruiting ➔ Completed

Trial completion • Hematological Disorders

Use of direct oral anticoagulants (DOACs) in oncology: A phase IV study on impact of edoxaban treatment in Italian patients with cancer with venous thromboembolism during antineoplastic therapy (EDOI trial, GOIRC 05-2018). (ASCO 2023) - P4 | "The results of the study clearly show that the edoxaban treatment is well tolerated and has no relevant impact on the delivery of cancer treatments. Results in terms of quality of life and patients’ satisfaction with anticoagulant treatment are reassuring. Clinical trial information: EUDRACT 2018-003833-14."

Clinical • P4 data • Anemia • Cardiovascular • Hematological Disorders • Hepatology • Immunology • Oncology • Venous Thromboembolism

Integrating pharmacovigilance and machine learning: bleeding signal detection and risk prediction for oral anticoagulants in cancer patients. (PubMed, Res Pract Thromb Haemost) - "Compared with apixaban, the other 4 OACs (warfarin, edoxaban, rivaroxaban, and dabigatran) showed increased risks of bleeding, especially in the gastrointestinal system. Male sex, cardiovascular diseases, cerebral infarction, renal insufficiency, gastrointestinal cancer, and an elevated international normalized ratio may be potential risk factors for bleeding events. The prediction model for OACs-related bleeding developed in this study demonstrated acceptable performance in internal validation."

Adverse events • Journal • Retrospective data • Cardiovascular • CNS Disorders • Gastrointestinal Cancer • Hematological Disorders • Nephrology • Oncology • Renal Disease • Solid Tumor • Thrombosis

Cerebrovascular Safety Profile of Edoxaban versus Rivaroxaban: A Global Pharmacovigilance Analysis with Implications for Asian Populations (AHA 2026) - "Abstract is embargoed at this time."

Adverse events • Clinical • Cardiovascular

Edoxaban Antithrombotic Therapy in Diabetic Patients with Atrial Fibrillation and Stable Coronary Artery Disease: The EPIC-CAD Trial. (PubMed, Europace) - "The risk of primary outcome was similar between diabetic and non-diabetic patients with AF and CAD. Irrespective of diabetes status, edoxaban monotherapy led to a lower risk of a primary outcome at 12 months than dual antithrombotic therapy."

Journal • Atrial Fibrillation • Cardiovascular • Coronary Artery Disease • Diabetes • Metabolic Disorders • Myocardial Infarction

EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF) (clinicaltrials.gov) - P4 | N=948 | Completed | Sponsor: Population Health Research Institute | Active, not recruiting ➔ Completed

Trial completion • Atrial Fibrillation • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders

ENRICH-AF: Edoxaban in intracranial hemorrhage survivors with atrial fibrillation (ESC 2026) - No abstract available

Atrial Fibrillation • Cardiovascular

Timing of anticoagulation therapy resumption among non-valvular atrial fibrillation (NVAF) patients with prior intracranial haemorrhage (ESC 2026) - "Timing of OAC resumption varied across different OAC agents (mean time from index to resumption in months: apixaban 13.4±11 months, dabigatran 10.5±6 months, edoxaban 19.3±13 months rivaroxaban 10.3±9 months, and warfarin 7.5±2 months, p=NS). Our real-world data revealed among patients with prior ICH, delayed resumption of OAC in patients with CHA2DS2VA >=4 may result in increased risk of ischemic stroke. Resumption of OAC <=7 months may be associated with more recurrent ICH and composite cerebrovascular events."

Clinical • Atrial Fibrillation • Cardiovascular • Ischemic stroke

Comparison of CHA2DS2-VASc, CHA2DS2-VASc-60 and CHA2DS2-VA score for stroke risk stratification in patients with atrial fibrillation: insights from the ETNA-AF-China study (ESC 2026) - "In Chinese patients with AF receiving edoxaban treatment, CHA2DS2‑VASc‑60 demonstrated slightly better discrimination for ischemic stroke than CHA2DS2‑VASc, with clearer separation at higher-risk tiers; however, effect sizes were modest and some estimates were imprecise, warranting validation in larger datasets or adjusted models."

Clinical • Atrial Fibrillation • Cardiovascular • Coronary Artery Disease • Heart Failure • Ischemic stroke

Concomitant antiplatelet therapy in anticoagulated TAVI patients with atrial fibrillation: impact of sex on bleeding and ischaemic events in ENVISAGE-TAVI AF (ESC 2026) - "It remains unknown whether the risk-benefit profile of concomitant APT differs by sex in this patient population.Purpose: To determine if the risk-benefit profile of oral anticoagulation with concomitant APT differs by sex in patients with AF undergoing TAVI. This post hoc analysis used the ENVISAGE-TAVI AF safety analysis set (N = 1377), in which patients received edoxaban or vitamin K antagonist therapy after successful TAVI... Among anticoagulated TAVI patients with AF, concomitant APT was associated with a higher risk of NACE. Bleeding risk, particularly major GI bleeding, was higher in females compared with males. APT should be avoided in the absence of a strong indication in anticoagulated patients with AF after TAVI; sex-specific bleeding vulnerability may warrant greater caution."

Clinical • Atrial Fibrillation • Cardiovascular • Dyslipidemia • Ischemic stroke • Myocardial Infarction • Peripheral Arterial Disease

Intraoperative antithrombotic drug removal during urgent CABG: early German experience with a novel hemoadsorption device (ESC 2026) - " Mean age was 66.6±10.1 years, 81.1% were male, and 75.5% were also on aspirin (n=233: 143 ticagrelor, 19 clopidogrel, 12 prasugrel, 22 apixaban, 10 rivaroxaban, 6 edoxaban, 3 dabigatran and 18 on multiple drugs). The results of this German experience from the STAR registry suggest that intraoperative antithrombotic drug removal is a simple and safe procedure that can potentially reduce the high risk of bleeding in patients on antithrombotic drugs requiring urgent CABG."

Cardiovascular

Predictors of major bleeding events among Chinese patients receiving edoxaban for atrial fibrillation at 2-year follow-up (ESC 2026) - "Chinese patients with major bleeding (annualized rate, 1.259%/year) during 2-year follow-up were older, had poorer renal function, higher HAS‑BLED score, and a higher burden of comorbidities. Impaired renal function, previous antiplatelet use, frailty, and history of all strokes were significantly associated with an increased risk of major bleeding and all bleeding events."

Clinical • Atrial Fibrillation • Cardiovascular • Coronary Artery Disease • Heart Failure • Hypertension

Clinical outcomes by prior OAC use and switching to edoxaban in atrial fibrillation: 2-year follow-up data from the ETNA-AF China study (ESC 2026) - "Prior OAC use (OAC-experienced vs naïve) did not significantly impact the clinical outcomes of Chinese patients with AF treated with edoxaban. Patients switching from other DOAC to edoxaban had a lower risk of CRNM bleeding and a trend toward fewer stroke and ischaemic stroke events with comparable composite net clinical outcomes regarding stroke, bleeding events and death than those switching from VKAs."

Clinical • Clinical data • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Ischemic stroke

Clinical characteristics and outcomes of super-low-dose edoxaban 15 mg compared with reduced dose 30 mg for high-bleeding-risk patients with venous thromboembolism: from the COMMAND VTE Registry-2 (ESC 2026) - "In this real-world registry, high-bleeding risk patients with VTE receiving edoxaban of 15 mg/day were markedly older compared with those of 30 mg/day and did not show an apparent signal of increased risk of recurrent VTE, suggesting a potential therapeutic option of anticoagulation therapy for patients with VTE at high bleeding risk."

Clinical • Atrial Fibrillation • Cardiovascular • Venous Thromboembolism

Head-to-head comparison of CHADS₂, CHA₂DS₂-VASc, CHA₂DS₂-VA, HAS-BLED, and HELT-E₂S₂ scores in edoxaban treated atrial fibrillation patients: a 2-year analysis from the ETNA-AF Global program (ESC 2026) - "HELT-E2S2 and CHA2DS2-VA scores provided the best predictive performance for all‑cause mortality, any stroke/SEE, and major bleeding. These data provide real-world evidence that help contextualize the application of risk stratification tools in diverse clinical settings."

Clinical • Head-to-Head • Atrial Fibrillation • Cardiovascular

Prognostic associations of major bleeding in anticoagulated patients with atrial fibrillation after TAVI: a post hoc analysis of the ENVISAGE-TAVI AF trial (ESC 2026) - P3 | "The prognostic implications of bleeding occurrence and anatomical location in this high-risk population remain insufficiently characterised.Purpose: To investigate clinical outcomes after MB in anticoagulated patients with AF after TAVI. ENVISAGE-TAVI AF (NCT02943785) was a randomised trial comparing edoxaban with vitamin K antagonist therapy in patients with AF following successful TAVI... In anticoagulated patients with AF after TAVI, MB was associated with a worse prognosis. GI bleeding identified patients at high risk for recurrence, while ICH conferred the greatest early mortality risk."

Clinical • Retrospective data • Atrial Fibrillation • Cardiovascular • Dyslipidemia • Ischemic stroke • Thrombosis

On-label versus off-label direct oral anticoagulant dosing patterns and associated outcomes in atrial fibrillation: a real-world cohort analysis (ESC 2026) - "Associations between dosing group and clinical outcomes were evaluated using Cox models before and after PSOW. A total of 306,846 patients met the study criteria (171,218 [55.8%] apixaban, 68,620 [22.4%] rivaroxaban, 6,349 [2.0%] dabigatran, and 60,659 [19.8%] edoxaban). In this real-world analysis, on-label DOAC dosing was associated with more favorable clinical outcomes than off-label dosing, highlighting the importance of proper dose selection."

Clinical • Real-world • Real-world evidence • Atrial Fibrillation • Cardiovascular • Ischemic stroke • Venous Thromboembolism