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Systematic review of clinical trials on antithrombotic therapy with factor XI inhibitors
A Franco-Moreno1, N Muñoz-Rivas1, J Torres-Macho2
1Servicio de Medicina Interna, Unidad de Tromboembolismo Venoso, Hospital Universitario Infanta Leonor-Virgen de la Torre, Madrid, Spain.
Introduction And Objective:
Data from phase 2 clinical trials suggest that factor XI inhibitors may exhibit a more favorable efficacy/safety profile compared to current antithrombotic therapies. The aim of this systematic review is to analyze the available evidence derived from these studies.
Methods:
A literature search in the PubMed, Cochrane Library, Scopus, EMBASE databases, and clinical trial registration platforms Clinical Trials and Cochrane Central Register of Controlled was conducted. In accordance with the PRISMA statement, results were reported.
Results:
A total of 18 completed or ongoing clinical trials addressing multiple scenarios, including atrial fibrillation, stroke, myocardial infarction, and venous thromboembolism, were identified. Evidence from 8 studies with available results was analyzed. Phase 2 studies with factor XI inhibitors, overall, demonstrated an acceptable efficacy and safety profile. The benefit-risk balance, in terms of reducing venous thromboembolism in patients undergoing total knee arthroplasty, was more favorable. For this scenario, factor XI inhibitors showed a 50% reduction in the overall rate of thrombotic complications and a 60% reduction in the rate of bleeding compared to enoxaparin. Modest results in studies involving patients with atrial fibrillation, stroke, and myocardial infarction were observed.
Conclusions:
Factor XI inhibitors offer new prospects in antithrombotic treatment and prophylaxis. Ongoing phase 3 studies will help define the most suitable drugs and indications.
Insights
Factor XI inhibitors show promise as safer antithrombotic therapies. Phase 2 trials suggest a favorable efficacy and safety profile, particularly for preventing venous thromboembolism after knee arthroplasty.
Area of Science:
- Pharmacology
- Clinical Trials
- Thrombosis Research
Background:
- Current antithrombotic therapies present challenges in balancing efficacy and safety.
- Factor XI inhibitors are emerging as a potential alternative with a theoretically improved profile.
- This systematic review evaluates early clinical data on factor XI inhibitors.
Approach:
- Systematic literature search across major databases (PubMed, Scopus, EMBASE) and trial registries.
- Adherence to PRISMA guidelines for reporting.
- Analysis of evidence from completed and ongoing Phase 2 clinical trials.
Key Points:
- Factor XI inhibitors demonstrated an acceptable efficacy and safety profile in Phase 2 studies.
- A notable benefit-risk balance was observed in preventing venous thromboembolism post-total knee arthroplasty, with significant reductions in thrombotic complications and bleeding.
- Modest efficacy was noted in studies for atrial fibrillation, stroke, and myocardial infarction.
Conclusions:
- Factor XI inhibitors represent a promising new class for antithrombotic treatment and prophylaxis.
- Further Phase 3 studies are crucial to establish optimal drug selection and indications.
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