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)
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.
Summary
In 7,329 anticoagulated atrial fibrillation patients from the SPORTIF III and V trials, aspirin use, renal impairment, age 75 or older, diabetes, and heart failure or left ventricular dysfunction predicted major bleeding, and the HAS-BLED score performed best among tested schemas.
Why This Matters for Hirudotherapy
This study evaluated various bleeding risk stratification schemas, notably validating the HAS-BLED score, in a cohort of 7,329 anticoagulated patients with atrial fibrillation participating in the SPORTIF III and V clinical trials. The research identified significant predictors of bleeding, such as concurrent aspirin use and renal impairment, to help clinicians balance the risks of antithrombotic therapy. Because managing bleeding risk is paramount in any anticoagulant therapy, understanding these clinical predictors is theoretically relevant to the systemic and local effects of hirudin delivered during hirudotherapy. However, the study's limitation is that it is exclusively focused on oral pharmaceutical anticoagulants (warfarin and ximelagatran). It lacks any direct investigation of leeches, the leech secretome, or topical hirudin application.
Citation
Reference (Vancouver style)
Lip GY, Frison L, Halperin JL, Lane DA. 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. J Am Coll Cardiol. 2011;57(2):173-180. doi:10.1016/j.jacc.2010.09.024. PMID: 21111555
Bibliographic details (authors, volume, pages, DOI) are taken from the PubMed record.
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