Sociedad Americana de Hirudoterapia

Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score.

Research article published in Journal of the American College of Cardiology (2011)

Última actualización: 18 de junio de 2026Revisado por: ASH Editorial Board
Artículo de investigación — revisión de evidenciaReferencia del artículo
Evidence: Randomized controlled trialEnsayos clínicosLip et al. · Journal of the American College of Cardiology, 2011

Abstract

OBJECTIVES: The purpose of this study was to investigate predictors of bleeding in a cohort of anticoagulated patients and to evaluate the predictive value of several bleeding risk stratification schemas. BACKGROUND: The risk of bleeding during antithrombotic therapy in patients with atrial fibrillation (AF) is not homogeneous, and several clinical risk factors have been incorporated into clinical bleeding risk stratification schemas. Current risk stratification schemas for bleeding during anticoagulation therapy have been based on complex scoring systems that are difficult to apply in clinical practice, and few have been derived and validated in AF cohorts. METHODS: We investigated predictors of bleeding in a cohort of 7,329 patients with AF participating in the SPORTIF (Stroke Prevention Using an ORal Thrombin Inhibitor in Atrial Fibrillation) III and V clinical trials and evaluated the predictive value of several risk stratification schemas by multivariate analysis. Patients were anticoagulated orally with either adjusted-dose warfarin (target international normalized ratio 2 to 3) or fixed-dose ximelagatran 36 mg twice daily. Major bleeding was centrally adjudicated, and concurrent aspirin therapy was allowed in patients with clinical atherosclerosis. RESULTS: By multivariate analyses, significant predictors of bleeding were concurrent aspirin use (hazard ratio [HR]: 2.10; 95% confidence interval [CI]: 1.59 to 2.77; p < 0.001); renal impairment (HR: 1.98; 95% CI: 1.42 to 2.76; p < 0.001); age 75 years or older (HR: 1.63; 95% CI: 1.23 to 2.17; p = 0.0008); diabetes (HR: 1.47; 95% CI: 1.10 to 1.97; p = 0.009), and heart failure or left ventricular dysfunction (HR: 1.32; 95% CI: 1.01 to 1.73; p = 0.041). Of the tested schemas, the new HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score performed best, with a stepwise increase in rates of major bleeding with increasing HAS-BLED score (p(trend) <0.0001). The c statistic for bleeding varied between 0.50 and 0.67 in the overall entire cohort and 0.68 among patients naive to warfarin at baseline (n = 769). CONCLUSIONS: This analysis identifies diabetes and heart failure or left ventricular dysfunction as potential risk factors for bleeding in AF beyond those previously recognized. Of the contemporary bleeding risk stratification schemas, the new HAS-BLED scheme offers useful predictive capacity for bleeding over previously published schemas and may be simpler to apply.

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

Publication typeClinical Trial, Phase IIIComparative StudyJournal ArticleMulticenter StudyRandomized Controlled TrialResearch Support, Non-U.S. Gov't
Indexed MeSH termsAgedAnticoagulantsAtrial FibrillationAzetidinesBenzylaminesBlood CoagulationDouble-Blind MethodFemaleFollow-Up StudiesHemorrhageHumansMale

Resumen

Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score.

Por qué esto importa para la hirudoterapia

Este estudio evaluó diversos esquemas de estratificación del riesgo hemorrágico, en particular validando la puntuación HAS-BLED, en una cohorte de 7.329 pacientes anticoagulados con fibrilación auricular que participaron en los ensayos clínicos SPORTIF III y V. La investigación identificó predictores significativos de hemorragia, como el uso concomitante de aspirina y la insuficiencia renal, para ayudar a los clínicos a equilibrar los riesgos del tratamiento antitrombótico. Dado que el manejo del riesgo hemorrágico es primordial en cualquier terapia anticoagulante, comprender estos predictores clínicos es teóricamente relevante para los efectos sistémicos y locales de la hirudina administrada durante la hirudoterapia. Sin embargo, la limitación del estudio es que se enfoca exclusivamente en anticoagulantes orales farmacéuticos (warfarina y ximelagatrán). Carece de cualquier investigación directa sobre sanguijuelas, el secretoma de la sanguijuela o la aplicación tópica de hirudina.

Citación

Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score.

Lip et al. · Journal of the American College of Cardiology, 2011

Contexto clínico relacionado

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

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