Savaysa (edoxaban) / Daiichi Sankyo - LARVOL DELTA

Is there a role for anticoagulation with dabigatran in S. aureus bacteremia? Protocol for the adjunctive treatment domain of the Staphylococcus aureus Network Adaptive Platform (SNAP) randomised controlled trial. (PubMed, BMJ Open) - P4 | "Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication. The trial is registered at clinicaltrials.gov with the identifier NCT06650501. NCT0665050."

Clinical protocol • Journal • Atrial Fibrillation • Cardiovascular • Infectious Disease • Venous Thromboembolism

Real-world comparative bleeding outcomes of direct oral anticoagulants versus warfarin in adults: Insights from observational evidence (ASH 2025) - "Background: Direct oral anticoagulants (DOACs) – apixaban, rivaroxaban, dabigatran, and edoxaban– are increasingly preferred over warfarin for stroke prevention in atrial fibrillation and treatment of venous thromboembolism. This review provides robust real-world evidence that DOACs offer a superior safety and effectiveness profile compared to warfarin in adult patients requiring anticoagulation. DOACs significantly reduce the incidence of ICH and stroke– two of the most clinically devasting complications– while maintaining comparable or lower rates of major and GI bleeding. These findings validate guideline recommendations and strongly support the preferential use of DOACs as the standard of care for anticoagulation in everyday clinical practice."

Clinical • Real-world • Real-world evidence • Atrial Fibrillation • Cerebral Hemorrhage • CNS Disorders • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Venous Thromboembolism

Risk of bleeding in chronic lymphocytic leukemia patients in remission treated with covalent Bruton tyrosine kinase inhibitors and contemporary anticoagulant or antiplatelet drugs: Real-world data analysis (ASH 2025) - "The study population was divided into two main cohorts: 1) Cohort 1: CLLpatients in remission treated with covalent BTKi (ibrutinib/acalabrutinib/zanubrutinib) concurrentlytreated with AC (rivaroxaban/apixaban/edoxaban/dabigatran) or AP agents (acetylsalicylicacid/clopidogrel/prasugrel/ticagrelor/ticlopidin), and 2) Cohort 2: CLL patients in remission treated withcovalent BTKi (ibrutinib/acalabrutinib/zanubrutinib) not concurrently treated with AC or AP agents.Cohort 1 was further subdivided into two groups: those treated only with AC and those treated only withAP. CLL patients in remission treated with covalent BTKis experience a significant risk ofbleeding events. This risk is substantially elevated when covalent BTKis therapy is combined with eitheranticoagulant or antiplatelet agents. Notably, our findings indicate no discernible difference in bleedingrisk between AC or AP agents when used concurrently with covalent BTKis."

Clinical • Real-world • Real-world evidence • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia

Outcomes and resource utilization during and after oral anticoagulant-related bleeding in chronic kidney disease (ORACLE-CKD): A population-based cohort study (ASH 2025) - "We accrued patients ≥66 years who were hospitalized for bleedingand had an OAC (apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin) dispensed precedingadmission (April 2012 to March 2022). Patients hospitalized with OAC-related bleeding are at high risk of death during andimmediately following hospitalization. Mortality risk was greater among patients with CKD. Within 1 yearof hospital discharge, three-quarters of patients with moderate or severe CKD visited the ED, and overhalf were readmitted to hospital."

Clinical • HEOR • Alzheimer's Disease • Atrial Fibrillation • Chronic Kidney Disease • CNS Disorders • Congestive Heart Failure • Dementia • Gastroenterology • Heart Failure • Ischemic stroke • Myocardial Infarction • Nephrology • Renal Disease • Respiratory Diseases • Venous Thromboembolism

Safety of prothrombin complex concentrate for emergency surgery according to the oral factor xa inhibitor level (ASH 2025) - "The PCC used was almost exclusively Octaplex (Octapharma)...The study was approved by Hamilton IntegratedResearch Ethics Board. PCC at a median dose of 2000 units (interquartile range, 2000-2000) was administered to 224patients on apixaban (142; 63%), rivaroxaban (71; 32%) or edoxaban (11; 5%) for emergency surgery orinvasive procedures... The risk of thromboembolic events after 4F-PCC for management of hemostasis in patientson XaI and emergency surgery/invasive procedures appears to be similar among patients withpreoperative drug levels that are high, low or not measured. These findings support the safe use of PCCin settings where rapid anti‑Xa testing is unavailable."

Clinical • Surgery • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Myocardial Infarction • Respiratory Diseases • Venous Thromboembolism

Real-world incidence of bleeding events in patients with chronic lymphocytic leukemia treated with acalabrutinib +/- obinutuzumab and requiring direct oral anticoagulation (ASH 2025) - "Most pts received either Apixaban® (39.5%), Edoxaban® (30.2%) or Rivaroxaban® (27.9%). In a cohort of elderly and comorbid CLL pts, the CICERO study demonstrated the feasibility ofacala +/- obi in pts receiving DOAC in real-world. The rate of major bleeding events according to Ghia etal. did not dramatically increase compared to the pivotal studies (7.0% vs 4.5% in Byrd et al."

Clinical • Real-world • Real-world evidence • Atrial Fibrillation • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Thrombosis

Thrombophilia testing and thrombotic risk evaluation in beta-thalassemia: A cohort analysis from a hub regional center (ASH 2025) - "Patients with FAreceived direct oral anticoagulants (DOACs, Edoxaban, N=3; Rivaroxaban, N=1 and Apixaban ,N=1) whilepatients with VTE were mainly managed with long term vitamn K antagonists (N=7) or Low MolecularWeight Heparin (N=5) for a mean of 4 months after a deep vein thrombosis (DVT) with completerecanalization. Thrombophilia screening is not routinely performed in βT patients but it is primarilyrequested for those with a history of VTE or before splenectomy. Patients with βT may be safely a treatedwith long-term direct oral anticoagulants or vitamin k antagonists.The low prevalence of common geneticmutations and antiphospholipid antibodies suggests that other factors may contribute more significantlyto thrombotic risk in βT patients. Further research is needed to explore alternative genetic and acquiredthrombophilic conditions in this population."

Atrial Fibrillation • Beta-Thalassemia • Cardiovascular • Genetic Disorders • Hematological Disorders • Hepatology • Immunology • Inflammatory Arthritis • Osteoporosis • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Rheumatology • Venous Thromboembolism

Comparative safety and effectiveness of direct oral anticoagulants and low-molecular weight heparin in patients with venous thromboembolism and cancer in europe (ASH 2025) - "ResultsBefore IPTW, we identified 34,687 LMWH users, 3,045 apixaban users, 4,537 rivaroxaban users, 145dabigatran users, and 580 edoxaban users across the five countries. Comparative assessment of rVTE was notpossible due to low event numbers. These findings contribute to the limited body of real-world evidencesupporting the use of DOACs over LMWH for treating patients with VTE and cancer."

Clinical • Cerebral Hemorrhage • CNS Disorders • Oncology • Venous Thromboembolism

Baseline Clinical Characteristics of Patients from the Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in Türkiye (ETAF-TR) Study. (PubMed, Turk Kardiyol Dern Ars) - P=N/A | "Edoxaban has been used wide spectrum of patients with AF in daily routine practice with a good overall adherence to the SmPC. As the biggest national pharmacovigilance study to date, the ETAF-TR Study will provide detailed insight into the safety of edoxaban treatment. *ETAF-TR Investigators Eyüp Avcı, Çağatay Önal, Ferit Böyük, Salih Kılıç, Serhat Çalışkan, Özkan Vural, Nurullah Çetin, Eren Ozan Bakır, Turgay Işık, Özcan Başaran, Oğuzhan Çelik, Nijad Bakhshaliyev, Ufuk Eryılmaz, Mustafa Çalışkan, Ömer Faruk Baycan, Adem Atıcı, Aysu Oktay, Sinan İnci, Mehmet Erdoğan, Ender Özgün Çakmak, Özge Turgay Yıldırım, Mehmet Ballı, Fazilet Ertürk Sağ, Nihat Söylemez, Fatma Köksal, Mahmut Yılmaz, Veysel Özgür Barış, Şahin Dost, Serhat Sığırcı, Şahin Topuz, Ataç Çelik, Erkan Borazan, Ömer Taşbulak, Gökhan Demirci, Mustafa Ali Yavaş, Demet Menekşe..."

Journal • Atrial Fibrillation • Cardiovascular

A UK-wide analysis of 2265 patients receiving a reversal agent for direct oral anticoagulant-associated bleeding. (PubMed, J Thromb Haemost) - "Reversal agents were generally used in patients with clinical evidence of major bleeding but were administered long after the last anticoagulant dose. In gastrointestinal bleeding, andexanet alfa was associated with a higher thrombotic risk than PCC."

Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Gastroenterology • Hematological Disorders • Thrombosis

Postoperative D-dimer as a signal of venous thromboembolism in patients receiving Edoxaban after hip or knee arthroplasty. (PubMed, J Pharm Health Care Sci) - "This retrospective exploratory study demonstrated that D-dimer values in patients receiving edoxaban after LE-OS may serve as a signal for VTE occurrence."

Journal • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

Edoxaban for stroke prevention in patients with atrial fibrillation: Of randomized and real-world evidence. (PubMed, Indian Pacing Electrophysiol J) - "The ENGAGE-AF TIMI 48 study demonstrated that edoxaban 60/30 mg was non-inferior to warfarin for stroke or systemic embolism (SEE) prevention, while superior with regard to major bleeding. In conclusion, edoxaban is an effective and safe direct anticoagulant for stroke prevention in AF. The large evidence base in Asian patients, in patients with cardiovascular and non-cardiovascular comorbidities and with different dosing regimens provide clinicians with a valuable option for stroke prevention in their patients with AF."

HEOR • Journal • Real-world evidence • Review • Atrial Fibrillation • Cardiovascular • Ischemic stroke

Posterior alien hand syndrome in a patient with parieto-occipital infarction: a presentation mimicking anterior variant features-a case report. (PubMed, J Med Case Rep) - "This case underscores the varied manifestations of alien hand syndrome variations, indicating a complicated interaction among anatomical regions. A multidisciplinary approach is crucial for the management of alien hand syndrome, especially in instances with overlapping features."

Journal • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • Pulmonary Embolism • Respiratory Diseases

Anticoagulation in Frail Older Adults with Non-Valvular Atrial Fibrillation: Clinical Challenges and Personalized Approach. (PubMed, J Clin Med) - "Among DOACs, apixaban seems to be the safest. Also, edoxaban at a very low dosage (15 mg/day) could be an effective therapy in patients for whom the standard anticoagulation is contraindicated. Moreover, switching from VKAs to DOACs in frail older adults is a complex decision and should be personalized according to the stability of the ongoing anticoagulant therapy, the bleeding risk profile, and the severity of frailty. Finally, although further studies are required to confirm their effectiveness, factor XIa inhibitors are emerging as new promising alternative therapies because they have been associated with a lower bleeding risk compared with DOACs."

Journal • Review • Atrial Fibrillation • Cardiovascular • Geriatric Disorders

Characteristics of Intracranial Hemorrhage in Patients on Factor-Xa Inhibitors: Japan Stroke Data Bank. (PubMed, Intern Med) - "Results A total of 859 patients (rivaroxaban, n=227; apixaban, n=355; edoxaban, n=277) with ICH (ICH: n=822, age 79±9 years, 38.6% female; SAH: n=37, age 79±10, 75.7% female) were investigated. Conclusion This study presents the clinical outcomes prior to the approval of andexanet alfa. Further studies are needed to evaluate post-approval outcome changes."

Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Subarachnoid Hemorrhage

Serial Embolic Events From Left Atrial Appendage Thrombus Detected After Mechanical Thrombectomy: A Case Report and Management Considerations. (PubMed, Cureus) - "We report the case of an 82-year-old woman with AF on edoxaban who presented with acute right internal carotid artery (ICA) occlusion...Two days after onset, contrast-enhanced chest CT unexpectedly demonstrated an LAA thrombus, prompting initiation of intravenous heparin...Anticoagulation could not be promptly resumed due to hemorrhagic transformation, and the patient subsequently experienced recurrent embolic events. These findings underscore the need for thorough evaluation of potential embolic sources after thrombectomy, thoughtful consideration of when and how to restart anticoagulation, and the possible role of LAA occlusion as a secondary prevention strategy."

Journal • Atrial Fibrillation • Cardiovascular • CNS Disorders • Hematological Disorders • Ischemic stroke • Thrombosis

Effect of enzalutamide on anticoagulant therapy with edoxaban in patients with prostate cancer. (PubMed, Br J Clin Pharmacol) - "The average exposure of edoxaban was not affected by enzalutamide. However, bioequivalence could not be established due to the broader than anticipated CI. Despite this, the larger variability in edoxaban exposure is not expected to be clinically relevant, supporting the safe co-administration of both drugs."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Evaluating the impact of a structured medication optimisation review on prescribing patterns and bleeding risk among patients prescribed direct oral anticoagulants (DOACs): a difference-in-differences study. (PubMed, BMJ Open Qual) - "SMORs can be delivered at scale and used to switch medications for a large proportion of people. There was no evidence of an increased risk of admissions for bleeding complications in AF patients following a large-scale switch from apixaban to edoxaban supported by SMORs. Such reviews could improve prescribing quality and patient safety by ensuring patients are on the most appropriate dose and choice of DOAC and lead to cost savings to health services (by facilitating a switch to a better value product) while not increasing risks for patients."

Journal • Atrial Fibrillation • Cardiovascular

Edoxaban Dose Adjustment and Age-Associated Outcomes in Patients With Atrial Fibrillation Post-Transcatheter Aortic Valve Replacement. (PubMed, JACC Adv) - P3 | "Patients aged ≥80 years without eDAC were at a higher risk of major bleeding and MGIB events with edoxaban 60 mg vs VKA. An optimized edoxaban dose for octogenarians with AF post-TAVR, regardless of eDAC, may help improve outcomes. (Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation [ENVISAGE-TAVI AF]; NCT02943785)."

Journal • Atrial Fibrillation • Cardiovascular • Gastroenterology

Perioperative Opioid Prescriptions in Patients on Oral Anticoagulants Undergoing Elective Soft Tissue Hand Surgery. (PubMed, J Hand Surg Am) - "Preoperative oral anticoagulant use was associated with an increased incidence of perioperative opioid prescriptions in patients undergoing elective soft tissue hand surgery."

Journal • Pain

Clinical laboratory testing of blood from patients presenting to the emergency department with acute bleeding due to factor Xa inhibitors: An unmet medical need. (PubMed, Clin Chim Acta) - "For patients on warfarin, stat testing of blood for the prothrombin time and calculation of the International Ratio (PT-INR) are used to determine if acute bleeding is caused by excess anticoagulation. Direct acting oral anticoagulants (DOACs) include those that inhibit Factor Xa (apixaban, rivaroxaban, edoxaban, and betrixaban) or Factor IIa (dabagatran)...However, current laboratory assays for anti-Factor Xa are calibrated for the specific DOAC used and results are not typically available in emergency departments. Therefore, there is a need to produce a rapid bedside blood test that can detect bleeding to any DOAC drug that was prescribed."

Journal • Cardiovascular • Ischemic stroke

Predictors of hematoma expansion in intracerebral hemorrhage associated with factor Xa inhibitors. (PubMed, Front Neurol) - "Andexanet alfa, a specific reversal agent for factor Xa inhibitors, has the potential to mitigate hematoma expansion (HE)...In univariate analysis, significant predictors of HE were an irregular margin and/or heterogeneity of the hematoma on computed tomography (CT) (p = 0.009), an initial CT performed within 4 h after drug intake (p = 0.034), and edoxaban use (p = 0.041)...The predictors of HE were an irregular margin or heterogeneous hematoma, and an initial CT performed within 4 h after drug intake. Reversal decisions based on hematoma volume, or interval from onset to initial CT may be inappropriate."

Journal • Cerebral Hemorrhage • Hematological Disorders

Month-Long Unclotted Hemoperitoneum on Edoxaban Confirmed by Laparoscopy: A Case Report. (PubMed, Cureus) - "The findings suggest that factor Xa inhibition, by suppressing thrombin generation and fibrin polymerization, may impede secondary coagulation of blood already leaked into the peritoneal space, allowing intraperitoneal blood to persist in a liquid state for weeks even after hemostasis and temporary drug withdrawal. This case provides laparoscopic evidence that edoxaban-associated hemoperitoneum can remain unclotted for about one month, and it highlights the need for surgeons planning interval procedures in anticoagulated patients to anticipate liquid collections, prepare for early/repeated suction-irrigation, and operate with the expectation that identification of dissection planes and transection lines may be difficult."

Journal • Atrial Fibrillation • Cardiovascular • Gastroenterology • Hepatology

Real-World Edoxaban Concentrations in Older Patients Receiving Reduced-Dose Regimens. (PubMed, Clin Pharmacol Ther) - "In conclusion, low edoxaban concentrations have been associated with thromboembolic events. Among ELDERCARE-AF-eligible patients, the 15-mg regimen results in underexposure to edoxaban, particularly when the CrCL exceeded 50 mL/min."

Journal • Real-world evidence • Atrial Fibrillation • Cardiovascular • Ischemic stroke

Transitioning of Patients from Direct-Acting Oral Anticoagulant to Heparin: Impact on Laboratory Testing. (PubMed, Semin Thromb Hemost) - "Direct oral anticoagulants (DOACs), including direct thrombin inhibitors (dabigatran) and direct factor Xa inhibitors (apixaban, rivaroxaban, edoxaban), have transformed anticoagulant management in recent years due to their predictable pharmacodynamics, rapid onset of action, and fixed dosing without the need for routine laboratory monitoring. Here, we examine the laboratory implications of transitioning from DOAC therapy to UFH, with a focus on the performance and interpretation of APTT and anti-Xa assays in the presence of residual DOAC levels and how to overcome the interference of DOAC in UFH monitoring. We suggest an algorithm to follow during this transition."

Journal • Cardiovascular • Critical care