Thursday, November 29, 2012

What a bloody mess! Which bleeding risk score is best?

Numerous publications have come out regarding the validity and utility of currently available bleeding risk scores. Here are some recent studies that looked at 3 commonly used scores:
1) HAS-BLED
2) HEMMORR2HAGES
3) ATRIA

Scores to Predict Major Bleeding Risk During Oral Anticoagulation Therapy: A Prospective Validation Study
AJM August 2012
Prospective cohort study of 515 adult patients taking oral anticoagulants over a 12-month follow-up period comparing the prognostic performance of 7 clinical prediction scores to the first major bleeding event.
  1. OBRI
  2. Kuijer
  3. Shireman
  4. HEMORR2HAGES
  5. RIETE
  6. HAS-BLED
  7. ATRIA 
The performance of 7 clinical scoring systems in predicting major bleeding events in patients receiving oral anticoagulation therapy was poor and not better than physicians' subjective assessments.
RESULTS:
  • the proportions of major bleeding ranged from 3.0% to 5.7% for low-risk, 6.7% to 9.9% for intermediate-risk, and 7.4% to 15.4% for high-risk patients. 
  • The overall predictive accuracy of the scores was poor, with the C statistic ranging from 0.54 to 0.61 and not significantly different from each other (P = .84). 
  • Only the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) score performed slightly better than would be expected by chance (C statistic, 0.61; 95% confidence interval, 0.52-0.70). 
  • The performance of the scores was not statistically better than physicians' subjective risk assessments (C statistic, 0.55; P = .94). 
Predictive value of the HAS-BLED and ATRIA bleeding scores for the risk of serious bleeding in a 'real world' anticoagulated atrial fibrillation population.
Chest. 2012 Jun 21.
Prospective cohort study of anticoagulated AF patients from our out-patient anticoagulation clinic with an INR between 2.0-3.0 during the previous 6 months clinic visits. Authors assessed both bleeding risk scores as quantitative variables or as dichotomized variables (low-moderate vs high risk).
The HAS-BLED score shows significantly better prediction accuracy than the weighted (and more complex) ATRIA score. Our findings reinforce the incremental utility of the simple HAS-BLED score over other published bleeding risk scores in anticoagulated AF patients.
 RESULTS:
  • The HAS-BLED score had a similar model performance (based on c-statistics) to the ATRIA score as a quantitative variable (c-statistics 0.71 vs. 0.68, p=0.356), but was superior to the ATRIA score when analysed as a dichotomized variable (c-statistics, 0.68 vs. 0.59, p=0.035). 
  • The HAS-BLED score more accurately predicted major bleeding episodes than the ATRIA risk score, as reflected in the percentage of events correctly reclassified.

Performance of the HEMORR(2)HAGES, ATRIA, and HAS-BLED bleeding risk-prediction scores in patients with atrial fibrillation undergoing anticoagulation: the AMADEUS (evaluating the use of SR34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation) study.
J Am Coll Cardiol.
2012 Aug 28
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.  

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.

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). 
So which one will you choose?