Revisión sistemática de los ensayos clínicos sobre terapia antitrombótica con inhibidores del factor XI

Abstract

Background and objective

Data from phase 2 clinical trials suggest that factor XI inhibitors may exhibit a more favourable efficacy/safety profile than current antithrombotic therapies. This systematic review aims 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. The results were reported in accordance with the PRISMA statement.

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. Overall, phase 2 studies with factor XI inhibitors 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 favourable. For this scenario, factor XI inhibitors showed a 50% reduction in the overall rate of thrombotic complications and a 60% reduction in 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 prevention. Ongoing phase 3 studies will help define the most suitable drugs and indications.