Risk score to predict serious bleeding in stable outpatients with or at risk of atherothrombosis

INSERM U-698 'Recherche Clinique en Athérothrombose', Department of Cardiology, Centre Hospitalier Universitaire Bichat-Claude Bernard, 46 rue Henri Huchard, Paris Cedex, France.
European Heart Journal (Impact Factor: 15.2). 02/2010; 31(10):1257-65. DOI: 10.1093/eurheartj/ehq021
Source: PubMed


To develop a risk score to quantify bleeding risk in outpatients with or at risk of atherothrombosis.
We studied patients in the REACH Registry, a cohort of 68 236 patients with/at risk of atherothrombosis. The outcome of interest was serious bleeding (non-fatal haemorrhagic stroke or bleeding leading to hospitalization and transfusion) over 2 years. Risk factors for bleeding were assessed using modified regression analysis. Multiple potential scoring systems based on the least complex models were constructed. Competing scores were compared on their discriminative ability via logistic regression. The score was validated externally using the CHARISMA population. From a final cohort of 56 616 patients, 804 (1.42%, 95% confidence interval 1.32-1.52) experienced serious bleeding between baseline and 2 years. A nine-item bleeding risk score (0-23 points) was constructed (age, peripheral arterial disease, congestive heart failure, diabetes, hypertension, smoking, antiplatelets, oral anticoagulants, hypercholesterolaemia). Observed incidence of bleeding at 2 years was: 0.46% (score < or = 6); 0.95% (7-8); 1.25% (9-10); 2.76% (> or = 11). The score's discriminative performance was consistent in CHARISMA and REACH (c-statistics 0.64 and 0.68, respectively); calibration in the CHARISMA population was very good (modified Hosmer-Lemeshow c(2) = 4.74; P = 0.69).
Bleeding risk increased substantially with a score >10. This score can assist clinicians in predicting the risk of serious bleeding and making decisions on antithrombotic therapy in outpatients.

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Available from: Philippe Ravaud
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    • "At the time this study was designed, the AFib risk-specific HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly [>65 years], Drugs/alcohol concomitantly) [20] and atherothrombotic risk-specific REACH (REduction of Atherothrombosis for Continued Health) [21] bleeding algorithms had not yet been published. Bleeding risk factors were identified from the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study [22] and from other studies [23, 24]. "
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    ABSTRACT: Objectives The aims of the study were to evaluate usage rates of warfarin in stroke prophylaxis and the association with assessed stages of stroke and bleeding risk in long-term care (LTC) residents with atrial fibrillation (AFib). Methods A cross-sectional analysis of two LTC databases (the National Nursing Home Survey [NNHS] 2004 and an integrated LTC database: AnalytiCare) was conducted. The study involved LTC facilities across the USA (NNHS) and within 19 states (AnalytiCare). It included LTC residents diagnosed with AFib (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] diagnostic code 427.3X). Consensus guideline algorithms were used to classify residents by stroke risk categories: low (none or 1+ weak stroke risk factors), moderate (1 moderate), high (2+ moderate or 1+ high). Residents were also classified by number of risk factors for bleeding (0–1, 2, 3, 4+). Current use of warfarin was assessed. A logistic regression model predicted odds of warfarin use associated with the stroke and bleeding risk categories. Results The NNHS and AnalytiCare databases had 1,454 and 3,757 residents with AFib, respectively. In all, 34 % and 45 % of residents with AFib in each respective database were receiving warfarin. Only 36 % and 45 % of high-stroke-risk residents were receiving warfarin, respectively. In the logistic regression model for the NNHS data, when compared with those residents having none or 1+ weak stroke risk and 0–1 bleeding risk factors, the odds of receiving warfarin increased with stroke risk (odds ratio [OR] = 1.93, p = 0.118 [1 moderate risk factor]; OR = 3.19, p = 0.005 [2+ moderate risk factors]; and OR = 8.18, p ≤ 0.001 [1+ high risk factors]) and decreased with bleeding risk (OR = 0.83, p = 0.366 [2 risk factors]; OR = 0.47, p ≤ 0.001 [3 risk factors]; OR = 0.17, p ≤ 0.001 [4+ risk factors]). A similar directional but more constrained trend was noted for the AnalytiCare data: only 3 and 4+ bleeding risk factors were significant. Conclusions The results from two LTC databases suggest that residents with AFib have a high risk of stroke. Warfarin use increased with greater stroke risk and declined with greater bleeding risk; however, only half of those classified as appropriate warfarin candidates were receiving guideline-recommended anticoagulant prophylaxis.
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