Objectives:
The objective of this study was to compare the predictive performance of bleeding risk-estimation tools in a cohort of patients with atrial fibrillation (af) undergoing anticoagulation.
Background:
Three bleeding risk-prediction schemes have been derived for and validated in patients with af: hemorr(2)hages (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), atria (anticoagulation and risk factors in atrial fibrillation), and has-bled (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol). τhe relative predictive values of these bleeding scores have not previously been compared.
Methods:
We analyzed the dataset from the amadeus (evaluating the use of sr34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation) trial, a multicenter, randomized, open-label noninferiority study that compared fixed-dose idraparinux with adjustable-dose oral vitamin k antagonist therapy in patients with af. the principal safety outcome was any clinically relevant bleeding event, which was a composite of major bleeding plus clinically relevant nonmajor bleeding.
Results:
The has-bled score performed best in predicting any clinically relevant bleeding, reflected both in net reclassification improvement (10.3% and 13% improvement compared with hemorr(2)hages and atria, respectively) and receiver-operating characteristic (roc) analyses (c-indexes: 0.60 vs. 0.55 and 0.50 for has-bled vs. hemorr(2)ages and atria, respectively). using decision-curve analysis, the has-bled score demonstrated superior performance compared with atria and hemorr(2)hages at any threshold probability for clinically relevant bleeding. has-bled was the only score that demonstrated a significant predictive performance for intracranial hemorrhage (c-index: 0.75; p = 0.03). an atria score >3 was not significantly associated with the risk for any clinically relevant bleeding on cox regression or on roc analysis (c-index: 0.50; p = 0.87).
Conclusions:
All 3 tested bleeding risk-prediction scores demonstrated only modest performance in predicting any clinically relevant bleeding, although the has-bled score performed better than the hemorr(2)hages and atria scores, as reflected by roc analysis, reclassification analysis, and decision-curve analysis. only has-bled demonstrated a significant predictive performance for intracranial hemorrhage. given its simplicity, the has-bled score may be an attractive method for the estimation of oral anticoagulant-related bleeding risk for use in clinical practice, supporting recommendations in international guidelines.