Dataset Information

Predictive ability of scores for bleeding risk in heart disease outpatients on warfarin in Brazil.

ABSTRACT: INTRODUCTION:Bleeding is a common complication in patients taking warfarin. We sought to compare the performance of nine prediction models for bleeding risk in warfarin-treated Brazilian outpatients. METHODS:The dataset was derived from a clinical trial conducted to evaluate the efficacy of an anticoagulation clinic at a public hospital in Brazil. Overall, 280 heart disease outpatients taking warfarin were enrolled. The prediction models OBRI, Kuijer et al., Kearon et al., HEMORR2HAGES, Shireman et al., RIETE, HAS-BLED, ATRIA and ORBIT were compared to evaluate the overall model performance by Nagelkerke's R2 estimation, discriminative ability based on the concordance (c) statistic and calibration based on the Hosmer-Lemeshow goodness-of-fit statistic. The primary outcomes were the first episodes of major bleeding, clinically relevant non-major bleeding and non-major bleeding events within 12 months of follow-up. RESULTS:Major bleeding occurred in 14 participants (5.0%), clinically relevant non-major bleeding in 29 (10.4%), non-major bleeding in 154 (55.0%) and no bleeding at all in 115 (41.1%). Most participants with major bleeding had their risk misclassified. All the models showed low overall performance (R2 0.6-9.3%) and poor discriminative ability for predicting major bleeding (c <0.7), except Shireman et al. and ORBIT models (c 0.725 and 0.719, respectively). Results were not better for predicting other bleedings. All models showed good calibration for major bleeding. CONCLUSIONS:Only two models (Shireman et al. and ORBIT) showed at least acceptable performance in the prediction of major bleeding in warfarin-treated Brazilian patients. Accurate models warrant further investigation to be used in similar populations.

SUBMITTER: Oliveira JAQ

PROVIDER: S-EPMC6195286 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Predictive ability of scores for bleeding risk in heart disease outpatients on warfarin in Brazil.

Oliveira João Antonio de Queiroz JAQ Pinho Ribeiro Antonio Luiz AL Ribeiro Daniel Dias DD Nobre Vandack V Rocha Manoel Otávio da Costa MODC Martins Maria Auxiliadora Parreiras MAP

PloS one 20181019 10

<h4>Introduction</h4>Bleeding is a common complication in patients taking warfarin. We sought to compare the performance of nine prediction models for bleeding risk in warfarin-treated Brazilian outpatients.<h4>Methods</h4>The dataset was derived from a clinical trial conducted to evaluate the efficacy of an anticoagulation clinic at a public hospital in Brazil. Overall, 280 heart disease outpatients taking warfarin were enrolled. The prediction models OBRI, Kuijer et al., Kearon et al., HEMORR2 ...[more]

PMID: 30339702

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Project description:BackgroundThe predictive value of bleeding risk scores for atrial fibrillation in older patients is not as well known. The goal of this study was to evaluate the predictive value of HASBLED, ORBIT and ATRIA for major bleeding (MB) and intracranial hemorrhage (ICH) in patients ≥ 75 years with atrial fibrillation and oral anticoagulation (OAC).MethodsA retrospective unicenter study including patients ≥ 75 years with atrial fibrillation (AF) and OAC. A total of 7613 patients ≥ 75 years with AF and OAC included between 2014 and 2018 (registry: NCT04364516). We analyzed the discriminative value of HASBLED, ATRIA and ORBIT scores for bleeding endpoints (major bleeding as primary endpoint and intracerebral hemorrhage as secondary). Cox regression was used to predict major bleeding with each scale and also for searching other variables potentially predictor of major bleeding. Model discrimination was assessed using Harrell's C-statistic. Calibration was assessed with goodness-of-fit test proposed by Gronnesby and Borgan.ResultsDuring a mean follow up of 4.0 years (IQR: 2.4-5.7 years), 729 patients developed MB (2.61 per 100 patients/year) and 243 patients developed ICH (0.85 per 100 patients/year). Three scores showed a low discrimination for major bleeding, being ORBIT the best (HASBLED C statistic = 0.557; ATRIA C statistic = 0.568; ORBIT C statistic = 0.595) and also a low discrimination for ICH (HASBLED C statistic = 0.509; ATRIA C statistic = 0.522; ORBIT C statistic = 0.526). Among the variables that are part of the scores and other baseline characteristics, after multivariable adjustment only sex (male), dementia, prior admission for bleeding, anemia and liver disease were found as a predictors of MB.ConclusionsIn older patients under oral anticoagulation with atrial fibrillation, the risk scores HASBLED, ATRIA and ORBIT showed a weak discrimination for major bleeding and intracranial hemorrhage. Therefore, other better alternatives should be evaluated for this purpose.

Project description:BackgroundDespite direct oral anticoagulants (DOACs) being safer than warfarin for stroke prevention in atrial fibrillation (AF), major bleeding concerns persist. Most bleeding risk scores predate DOAC approval.ObjectivesThis study aimed to compare the Age, history of Bleeding, and non-bleeding related Hospitalisation [ABH] score's performance-derived for DOAC-treated patients-with those of 5 other scores (Anticoagulation and Risk Factors in Atrial Fibrillation [ATRIA], Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly [>65 years], Drugs/alcohol concomitantly [HAS-BLED], Hepatic, Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke [HEMORR2HAGES], Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT-AF], and Congestive heart failure, Hypertension, Age ≥75 [doubled], Diabetes, Stroke [doubled]-Vascular disease, Age 65-74, Sex category [CHA2DS2-VASc]) in predicting DOAC-related major bleeding in patients with AF.MethodsIn this retrospective study of 2364 patients with nonvalvular AF on rivaroxaban or apixaban (median age, 68.3 years; 32.1% women), International Society on Thrombosis and Haemostasis-defined major bleeding (incidence, 4.1%; n = 97) was analyzed. C-statistics from time-dependent receiver operating characteristic (ROC) curves for continuous risk scores were the primary comparison metric, but other metrics, such as decision curves, were also compared.ResultsAt 100 days, C-statistics were highest for ORBIT-AF and ATRIA (0.62 and 0.61, respectively, with other scores having an area under the ROC curve of <0.60); some significant differences favored ORBIT-AF. At 1100 days, C-statistics remained highest for ORBIT-AF and ATRIA (0.62 and 0.61, respectively, with other scores having an area under the ROC curve of <0.60 again), and ORBIT-AF had significantly higher C-statistics than those for all other risk scores (P < .05), except for ATRIA. At 2100 days, all C-statistics were <0.60 with no significant differences. Decision curves showed the greatest net benefit for ORBIT-AF and ATRIA at 100 days and for ATRIA at 1100 days, with no discernible net benefit for any of the scores at 2100 days.ConclusionORBIT-AF and ATRIA provided the best bleeding risk prediction within the first 1100 days. None of the 6 bleeding risk scores provided predictive benefit over 2100 days of DOAC treatment.

Dataset Information

Predictive ability of scores for bleeding risk in heart disease outpatients on warfarin in Brazil.

Publications

Predictive ability of scores for bleeding risk in heart disease outpatients on warfarin in Brazil.

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