The various risk stratification schemes classified variable proportions as low , moderate and high risk , but the CHA(2)DS(2)-VASc score classified the smallest proportion of patients as ' low risk ' .
Anticoagulation with vitamin K antagonists and dabigatran is cost-effective in patients at high risk of stroke , but not in patients without any other stroke risk factor beside AF .
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.
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 vali date d 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 central ly 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
The various risk stratification schemes classified variable proportions as low , moderate and high risk , but the CHA(2)DS(2)-VASc score classified the smallest proportion of patients as ' low risk ' .
Anticoagulation with vitamin K antagonists and dabigatran is cost-effective in patients at high risk of stroke , but not in patients without any other stroke risk factor beside AF .