Author/Authors :
Wann، نويسنده , , L. Samuel and Curtis، نويسنده , , Anne B. and January، نويسنده , , Craig T. and Ellenbogen، نويسنده , , Kenneth A. and Lowe، نويسنده , , James E. and Estes III، نويسنده , , N.A. Mark and Page، نويسنده , , Richard L. and Ezekowitz، نويسنده , , Michael D. and Slotwiner، نويسنده , , David J. and Jackman، نويسنده , , Warren M. and Stevenson، نويسنده , , William G. and Tracy، نويسنده , , Cynthia M. and Fuster، نويسنده , , Valentin and Rydén، نويسنده , , Lars E. and Cannom، نويسنده , , David S. and Le Heuzey، نويسنده , , Jean-Yves and Crijns، نويسنده , , Harry J. and Lowe، نويسنده , , James E. and Curtis، نويسنده , , Anne B. and Olsson، نويسنده , , S. Bertil and Ellenbogen، نويسنده , , Kenneth A. and Prystowsky، نويسنده , , Eric N. and Halperin، نويسنده , , Jonathan L. and Tamargo، نويسنده , , Juan Luis and Kay، نويسنده , , G. Neal and Wann، نويسنده , , L. Samuel، نويسنده ,
Abstract :
Objectives
rpose 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.
ound
sk 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.
s
estigated 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.
s
tivariate 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 (ptrend <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).
sions
nalysis 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.
Keywords :
ACCF/AHA Practice Guidelines , Antiplatelet therapy , atrial fibrillation , Catheter Ablation , rate control , Thromboembolism , rhythm control , Anticoagulant therapy , Antithrombotic agents