☆ 4.4 Review

Factor XI/XIa inhibitors for the prevention and treatment of venous and arterial thromboembolism: A narrative review

VASCULAR MEDICINE (2023)

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Article Cardiac & Cardiovascular Systems

Pharmacology and Clinical Development of Factor XI Inhibitors

Antonio Greco et al.

Summary: Therapeutic anticoagulation is used to prevent or treat blood clots, but it can increase the risk of bleeding. Inhibitors of Factor XI (FXI) show promise in reducing the adverse events of anticoagulation. Large-scale phase 3 clinical trials are needed to confirm the role of FXI inhibitors and determine their clinical indications.

CIRCULATION (2023)

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Review Cardiac & Cardiovascular Systems

Reversal agents for current and forthcoming direct oral anticoagulants

Nick van Es et al.

Summary: In the past 20 years, there has been a transition from vitamin K antagonists to direct oral anticoagulants (DOACs). DOACs include dabigatran, apixaban, edoxaban, and rivaroxaban. Although DOACs are associated with less serious bleeding, reversal agents may be needed in cases of serious bleeding or urgent surgery/intervention. This paper provides insight into reversing the effects of DOACs, discusses new reversal agents, and outlines a strategic framework for reversing factor XI inhibitors in clinical trials.

EUROPEAN HEART JOURNAL (2023)

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Article Cardiac & Cardiovascular Systems

Direct Oral Anticoagulants vs Vitamin K Antagonists in Patients With Antiphospholipid Syndromes Meta-Analysis of Randomized Trials

Candrika D. Khairani et al.

Summary: A systematic review and meta-analysis of randomized controlled trials comparing direct oral anticoagulants (DOACs) with vitamin K antagonists (VKAs) for thrombotic antiphospholipid syndrome patients found that DOACs were associated with an increased risk of subsequent arterial thrombotic events compared to VKAs. However, there were no significant differences in the risk of subsequent venous thromboembolic events or major bleeding between the two groups.

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY (2023)

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Article Medicine, Research & Experimental

First-in-human study of milvexian, an oral, direct, small molecule factor XIa inhibitor

Vidya Perera et al.

Summary: The study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of Milvexian in healthy adults, showing that the drug's properties are suitable for further clinical development.

CTS-CLINICAL AND TRANSLATIONAL SCIENCE (2022)

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Article Hematology

Pharmacokinetics and pharmacodynamics of Abelacimab (MAA868), a novel dual inhibitor of Factor XI and Factor XIa

Byungdoo A. Yi et al.

Summary: Abelacimab, a novel fully human monoclonal antibody targeting Factor XI, demonstrates dual activity against the inactive and activated FXI. Studies show that abelacimab effectively reduces free FXI levels after intravenous and subcutaneous administration, with a favorable safety profile, supporting its clinical development.

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2022)

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Article Hematology

Milvexian, an orally bioavailable, small-molecule, reversible, direct inhibitor of factor XIa: In vitro studies and in vivo evaluation in experimental thrombosis in rabbits

Pancras C. Wong et al.

Summary: Milvexian is an effective antithrombotic agent with limited impact on hemostasis, even when combined with aspirin. The study results suggest that Milvexian has a wide therapeutic window for antithrombotic therapy.

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2022)

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Article Urology & Nephrology

Phase 2 Study of the Factor XI Antisense Inhibitor IONIS-FXIRx in Patients With ESRD

Michael Walsh et al.

Summary: This study demonstrates that IONIS-FXIRx can effectively reduce FXI activity in patients with ESRD receiving HD, with few treatment-related serious adverse events. Further research is needed to determine the benefits and risks of targeting FXI as a therapeutic target for patients receiving HD.

KIDNEY INTERNATIONAL REPORTS (2022)

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Article Hematology

Pharmacological profile of asundexian, a novel, orally bioavailable inhibitor of factor XIa

Stefan Heitmeier et al.

Summary: Asundexian is an oral inhibitor targeting FXIa, which has antithrombotic effects on arterial and venous thrombosis without increasing the risk of bleeding.

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2022)

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Article Medicine, General & Internal

Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study

Jonathan P. Piccini et al.

Summary: This study compared the incidence of bleeding in patients with atrial fibrillation between Asundexian and apixaban, showing that Asundexian resulted in lower rates of bleeding compared with standard dosing of apixaban.

LANCET (2022)

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Article Cardiac & Cardiovascular Systems

A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction

Sunil Rao et al.

Summary: This study investigated the pharmacodynamics, safety, and efficacy of the oral FXIa inhibitor asundexian for secondary prevention after acute myocardial infarction (MI). The results showed that asundexian effectively inhibited coagulation activity without increasing the risk of bleeding or ischemic events.

CIRCULATION (2022)

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Article Neurosciences

Rationale and design of the AXIOMATIC-SSP phase II trial: Antithrombotic treatment with factor XIa inhibition to Optimize Management of Acute Thromboembolic events for Secondary Stroke Prevention

Mukul Sharma et al.

Summary: The study aims to evaluate the dose-response relationship of the oral medication Milvexian in patients with ischemic stroke or TIA to reduce the risk of stroke.

JOURNAL OF STROKE & CEREBROVASCULAR DISEASES (2022)

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Review Hematology

Achieving higher efficacy without compromising safety with factor XI inhibitors versus low molecular weight heparin for the prevention of venous thromboembolism in major orthopedic surgery-Systematic review and meta-analysis

Joao Presume et al.

Summary: This study systematically evaluated the use of FXI inhibitors in major orthopedic surgery and found that FXI inhibitors significantly reduced the incidence of venous thromboembolism and bleeding events among patients.

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2022)

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Article Medicine, General & Internal

Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo- controlled, phase 2b trial

Ashkan Shoamanesh et al.

Summary: In this phase 2b trial, FXIa inhibition with asundexian did not reduce the occurrence of covert brain infarction or ischemic stroke and did not increase the risk of major or clinically relevant non-major bleeding compared to placebo in patients with acute, non-cardioembolic ischemic stroke.

LANCET (2022)

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Review Medicine, General & Internal

Anticoagulation Strategies during Extracorporeal Membrane Oxygenation: A Narrative Review

Sasa Rajsic et al.

Summary: The development of ECMO technology has provided a new treatment option for critically ill patients. However, the use of ECMO carries the risk of complications such as thrombosis and bleeding. Therefore, careful selection and monitoring of anticoagulants is crucial.

JOURNAL OF CLINICAL MEDICINE (2022)

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Review Hematology

DOACs in Mechanical and Bioprosthetic Heart Valves: A Narrative Review of Emerging Data and Future Directions

Rachel Ryu et al.

Summary: In recent years, there have been significant changes in the management of valvular heart disease (VHD) due to the development of new minimally invasive technologies such as transcatheter aortic valve implantation (TAVI). There is notable heterogeneity in the antithrombotic regimen for patients with VHD, and further research is needed on the use of direct-acting oral anticoagulants (DOACs) in different situations.

CLINICAL AND APPLIED THROMBOSIS-HEMOSTASIS (2022)

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Review Cardiac & Cardiovascular Systems

Factor XI/XIa Inhibition: The Arsenal in Development for a New Therapeutic Target in Cardio- and Cerebrovascular Disease

Juan J. Badimon et al.

Summary: Despite advancements in anticoagulant therapy, bleeding complications remain a concern. Drugs targeting factor XI are being developed and have the potential to revolutionize anticoagulation therapy.

JOURNAL OF CARDIOVASCULAR DEVELOPMENT AND DISEASE (2022)

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Review Hematology

The Pathophysiology of The Antiphospholipid Syndrome: A Perspective From The Blood Coagulation System

R. Arreola-Diaz et al.

Summary: Antiphospholipid syndrome is a systemic autoimmune disease characterized by hypercoagulability and obstetric complications. Antiphospholipid antibodies induce various physiological responses, leading to thrombosis and obstetric morbidity.

CLINICAL AND APPLIED THROMBOSIS-HEMOSTASIS (2022)

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Article Pharmacology & Pharmacy

PK/PD modeling of FXI antisense oligonucleotides to bridge the dose-FXI activity relation from healthy volunteers to end-stage renal disease patients

Stefan Willmann et al.

Summary: A model-informed bridging approach was used to extrapolate dose-exposure-FXI relationship from IONIS-FXIRX to FXI-LICA in patients with ESRD, supporting the selection of doses being investigated. This approach helped predict dose-dependent steady-state FXI activity following repeat once-monthly doses of FXI-LICA in ESRD patients, with doses of 40 mg, 80 mg, and 120 mg covering the target range of clinical interest.

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY (2021)

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Article Pharmacology & Pharmacy

ONO-7684 a novel oral FXIa inhibitor: Safety, tolerability, pharmacokinetics and pharmacodynamics in a first-in-human study

Dominic Beale et al.

Summary: The study demonstrated that ONO-7684 was well-tolerated in healthy subjects at both single and multiple doses, with low incidence of adverse events. Pharmacokinetic data showed dose proportionality for ONO-7684. Pharmacodynamic results revealed a strong inhibition of FXI coagulation activity and an increase in aPTT at 250 mg ONO-7684 daily. These findings support the potential of ONO-7684 as an oral FXIa inhibitor for anticoagulation indications.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2021)

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Article Cardiac & Cardiovascular Systems

Bleeding Risk of Direct Oral Anticoagulants in Patients With Heart Failure And Atrial Fibrillation

Cynthia A. Jackevicius et al.

Summary: The study found that for patients with heart failure and atrial fibrillation, DOACs had lower risks of total bleeding, major bleeding, and death compared to warfarin, regardless of renal function levels. However, around 53% of DOAC-treated patients experienced a transient/persistent decline in renal function during follow-up, leading to increased bleeding risk.

CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES (2021)

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Article Medicine, General & Internal

Milvexian for the Prevention of Venous Thromboembolism

Jeffrey Weitz et al.

Summary: The study results showed that in knee arthroplasty patients receiving different doses of milvexian treatment, the incidence of venous thromboembolism with twice-daily dosing was significantly lower than the prespecified benchmark of 30%, with a lower risk of bleeding compared to enoxaparin.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Review Hematology

Factor XI as a Target for New Anticoagulants

James C. Fredenburgh et al.

Summary: The article discusses the rationale for developing factor XI inhibitors, identifies the most advanced stage agents, describes the results of completed clinical trials and ongoing trials, highlighting opportunities and challenges for this new generation of anticoagulants.

HAMOSTASEOLOGIE (2021)

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Article Hematology

Contact Activation Inhibitor, AB023, in Heparin-Free Hemodialysis: Results of a Randomized Phase 2 Clinical Trial

Christina U. Lorentz et al.

BLOOD (2021)

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Article Oncology

Factor XI Deficiency

Magdalena Dorota Lewandowska et al.

HEMATOLOGY-ONCOLOGY CLINICS OF NORTH AMERICA (2021)

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Article Medicine, General & Internal

Abelacimab for Prevention of Venous Thromboembolism

Peter Verhamme et al.

Summary: Factor XI plays a significant role in the development of postoperative venous thromboembolism. Inhibition of Factor XI with a single intravenous dose of abelacimab after total knee arthroplasty was effective in preventing venous thromboembolism and had a low risk of bleeding.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Article Medicine, General & Internal

Effect of Osocimab in Preventing Venous Thromboembolism Among Patients Undergoing Knee Arthroplasty The FOXTROT Randomized Clinical Trial

Jeffrey I. Weitz et al.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2020)

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Central venous catheter-related thrombosis in children and adults

Divyaswathi Citla Sridhar et al.

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Use of direct oral anticoagulants in patients with thrombotic antiphospholipid syndrome: Guidance from the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis

Stephane Zuily et al.

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2020)

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American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism

Thomas L. Ortel et al.

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Anticoagulant treatment and bleeding complications in patients with left ventricular assist devices

Paul L. den Exter et al.

EXPERT REVIEW OF CARDIOVASCULAR THERAPY (2020)

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Intrinsic Pathway of Coagulation and Thrombosis: Insights From Animal Models

Steven P. Grover et al.

ARTERIOSCLEROSIS THROMBOSIS AND VASCULAR BIOLOGY (2019)

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Article Hematology

MAA868, a novel FXI antibody with a unique binding mode, shows durable effects on markers of anticoagulation in humans

Alexander W. Koch et al.

BLOOD (2019)

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Editorial Material Hematology

AB023, A Novel Antibody That Binds Factor XI and Blocks Its Activation by Factor XIIa

Noel C. Chan et al.

ARTERIOSCLEROSIS THROMBOSIS AND VASCULAR BIOLOGY (2019)

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Article Biochemistry & Molecular Biology

Allosteric Inhibition as a New Mode of Action for BAY 1213790, a Neutralizing Antibody Targeting the Activated Form of Coagulation Factor XI

Martina Schaefer et al.

JOURNAL OF MOLECULAR BIOLOGY (2019)

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Article Hematology

Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome

Vittorio Pengo et al.

BLOOD (2018)

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Review Hematology

Plasma contact factors as therapeutic targets

Benjamin F. Tillman et al.

BLOOD REVIEWS (2018)

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Article Pharmacology & Pharmacy

First-in-human study to assess the safety, pharmacokinetics and pharmacodynamics of BMS-962212, a direct, reversible, small molecule factor XIa inhibitor in non-Japanese and Japanese healthy subjects

Vidya Perera et al.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2018)

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Article Hematology

Factor XI deficiency is associated with lower risk for cardiovascular and venous thromboembolism events

Meir Preis et al.

BLOOD (2017)

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Article Hematology

Polyphosphate, platelets, and coagulation

R. J. Travers et al.

INTERNATIONAL JOURNAL OF LABORATORY HEMATOLOGY (2015)

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Article Medicine, General & Internal

Factor XI Antisense Oligonucleotide for Prevention of Venous Thrombosis

Harry R. Bueller et al.

NEW ENGLAND JOURNAL OF MEDICINE (2015)

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Article Medicine, General & Internal

Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials

Christian T. Ruff et al.

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Review Anesthesiology

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Sanjeev Palta et al.

INDIAN JOURNAL OF ANAESTHESIA (2014)

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SEMINARS IN THROMBOSIS AND HEMOSTASIS (2009)

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