Sociedad Americana de Hirudoterapia

Clinical Outcomes of Anticoagulated Patients With Atrial Fibrillation After Falls or Head Injury: Insights From RE-LY.

Randomized controlled trial published in Stroke (2023)

Última actualización: June 18, 2026Revisado por: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Randomized controlled trialEnsayos clínicosDesarrollo de fármacosCaldeira et al. · Stroke, 2023

Abstract

BACKGROUND: Falls are always a concern regarding the balance of risk/benefit in patients with atrial fibrillation treated with anticoagulants. In this analysis, we aimed to evaluate the outcomes of patients that had a fall/head injury reported in the RE-LY clinical trial (Randomized Evaluation of Long-Term Anticoagulation Therapy) and to explore the safety of dabigatran (a nonvitamin K antagonist oral anticoagulant). METHODS: We performed a post hoc retrospective analysis of intracranial hemorrhage and major bleeding outcomes in the RE-LY trial with 18 113 individuals with atrial fibrillation, according to the status occurrence of falls (or head injury) reported as adverse events. Multivariate Cox regression models were used to provide adjusted hazard ratio (HR) and 95% CI. RESULTS: In the study, 974 falls or head injury events were reported among 716 patients (4%). These patients were older and had more frequently comorbidities such as diabetes, previous stroke, or coronary artery disease. Patients with fall had a higher risk of major bleeding (HR, 2.41 [95% CI, 1.90-3.05]), intracranial hemorrhage (HR, 1.69 [95% CI, 1.35-2.13]), and mortality (HR, 3.91 [95% CI, 2.51-6.10]) compared to those who did not have reported falls or head injury. Among patients who had falls, those allocated to dabigatran showed a lower intracranial hemorrhage risk (HR, 0.42 [95% CI, 0.18-0.98]) compared with warfarin. CONCLUSIONS: In this population, the risk of falls is important and confers a worse prognosis, increasing intracranial hemorrhage, and major bleeding. Patients who fell and were under dabigatran was associated with lower intracranial hemorrhage risk than those anticoagulated with warfarin, but the analysis was merely exploratory.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

Publication typeRandomized Controlled TrialJournal Article
Indexed MeSH termsHumansWarfarinAtrial FibrillationDabigatranAccidental FallsRetrospective StudiesAnticoagulantsStrokeHemorrhageIntracranial HemorrhagesCraniocerebral Trauma

Resumen

Falls are always a concern regarding the balance of risk/benefit in patients with atrial fibrillation treated with anticoagulants. In this analysis, we aimed to evaluate the outcomes of patients that had a fall/head injury reported in the RE-LY clinical trial (Randomized Evaluation of Long-Term...

Por qué esto importa para la hirudoterapia

This post hoc retrospective analysis of the RE-LY trial evaluated outcomes among 716 atrial fibrillation patients who experienced falls or head injury while anticoagulated, finding that falls conferred significantly higher risks of major bleeding (HR 2.41), intracranial hemorrhage (HR 1.69), and mortality (HR 3.91) compared to patients without falls. Among patients who fell, those on dabigatran showed lower intracranial hemorrhage risk than those on warfarin (HR 0.42), though the analysis was described as merely exploratory. The abstract does not mention leeches, hirudotherapy, hirudin, or any leech-derived therapy. Its relevance to ASH is absent, as the study compares two conventional oral anticoagulants without any connection to leech-based interventions or the leech secretome.

Citación

Clinical Outcomes of Anticoagulated Patients With Atrial Fibrillation After Falls or Head Injury: Insights From RE-LY.

Caldeira et al. · Stroke, 2023

Contexto clínico relacionado

Añadido a la biblioteca ASH: May 28, 2026 · Última actualización del sitio: June 18, 2026

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