Predicting Bleeding Events in Anticoagulated Patients With Atrial Fibrillation: A Comparison Between the HAS‐BLED and GARFIELD‐AF Bleeding Scores

Abstract

BackgroundPatients with atrial fibrillation (AF) treated with oral anticoagulants may be exposed to an increased risk of bleeding events. The HAS‐BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INRs, Elderly, Drugs or alcohol) score is a simple, well‐established, clinical bleeding‐risk prediction score. Recently, a new algorithm‐based score was proposed, the GARFIELD‐AF (Global Anticoagulant in the Field–AF) bleeding score. We compared HAS‐BLED and GARFIELD‐AF scores in predicting adjudicated bleeding events in a clinical trial cohort of patients with AF taking anticoagulants, in the first external comparative validation of both scores.Methods and ResultsWe analyzed patients from the SPORTIF (Stroke Prevention Using an Oral Thrombin Inhibitor in Patients With AF) III and V trials. All patients assigned to the warfarin arm with information to calculate the scores were considered. Outcomes were major, major/clinically relevant nonmajor, and any bleeding. A total of 3550 warfarin‐treated patients were available for analysis. Of these patients, 2519 (71.0%) had a HAS‐BLED score ≥3, whereas based on GARFIELD‐AF median value, 2056 (57.9%) were categorized as “high score.” Both HAS‐BLED and GARFIELD‐AF C‐indexes showed modest predictive value (C‐index [95% confidence interval] for major bleeding, 0.58 [0.56–0.60] and 0.56 [0.54–0.57], respectively); however, GARFIELD‐AF was not predictive of any bleeding. The GARFIELD‐AF bleeding score had a significantly lower sensitivity and a negative reclassification for any bleeding compared with HAS‐BLED, assessed by integrated discrimination improvement and net reclassification improvement (both P<0.001). HAS‐BLED showed a 5% net benefit for any bleeding occurrence.ConclusionsThe algorithm‐based GARFIELD‐AF bleeding score did not show any significant improvement in major and major/clinically relevant nonmajor prediction compared with the simple HAS‐BLED score. For clinical usefulness in prediction of any bleeding, the HAS‐BLED score showed a significant net benefit compared with the GARFIELD‐AF.

Bleeding Risk Scores in Atrial Fibrillation: Helpful or Harmful?

“…First, the patients in the study by Lip and colleagues were from the SPORTIF III and V controlled clinical trials, a more constrained population with strict inclusion and exclusion factors. As expected, the time in the therapeutic range in these controlled patients was 68.2%7 compared with the time in the therapeutic range of patients in GARFIELD‐AF, a real‐world registry, of 55% 8. Additionally, the patients in the SPORTIF III and V cohorts were sicker compared with GARFIELD‐AF.…”

“…This study did show modest predictive value for major bleeding in both bleeding scores (C index: 0.58 HAS‐BLED versus 0.56 GARFIELD‐AF) 7. The high‐risk HAS‐BLED score (>3) patients had higher risk of major bleeding, clinically relevant nonmajor bleeding, and any bleeding in comparison to low‐risk HAS‐BLED patients 7.…”

“…The high‐risk HAS‐BLED score (>3) patients had higher risk of major bleeding, clinically relevant nonmajor bleeding, and any bleeding in comparison to low‐risk HAS‐BLED patients 7. In contrast, except for the major clinically relevant bleeding outcomes metric, the GARFIELD‐AF score did not show a statistically significant difference for major bleeding and any bleeding in the high‐risk patients compared with the low‐risk patients.…”

“…In contrast, except for the major clinically relevant bleeding outcomes metric, the GARFIELD‐AF score did not show a statistically significant difference for major bleeding and any bleeding in the high‐risk patients compared with the low‐risk patients. Lastly, there was a net benefit of 5% of any bleeding with HAS‐BLED in comparison to GARFIELD‐AF 7. The authors concluded GARFIELD‐AF was not superior to HAS‐BLED, specifically in predicting any bleeding.…”

“…In the past, HAS‐BLED bas been found to be superior at determining any clinically relevant bleeding risk by receiver‐operating characteristic analysis and decision curve analysis (C index: HAS‐BLED: 0.6 versus HEMORR2HAGES: 0.55 versus ATRIA: 0.50) 2. However, more recently, the GARFIELD‐AF risk model has been shown to be superior in major bleeding in comparison to HAS‐BLED (C index: 0.66 GARFIELD‐AF versus 0.64 HAS‐BLED) 4, 7. Proietti and colleagues sought to challenge GARFIELD‐AF's superiority in this issue of the Journal of the American Heart Association ( JAHA ) and compared the predictive value of HAS‐BLED with GARFIELD‐AF risk model in the SPORTIF (Stroke Prevention Using the Oral Direct Thrombin Inhibitor Ximelagatran in Patients With Atrial Fibrillation Trial III and V) population 7…”