Clinical Prediction Guide
In anticoagulated patients with AF, HAS-BLED predicted major bleeding better than CHADS2 and CHA2DS2-VASc
Roldán V, Marín F, Manzano-Fernández S, et al. The HAS-BLED score has better prediction accuracy for major bleeding than CHADS2 or CHA2DS2-VASc scores in anticoagulated patients with atrial fibrillation. J Am Coll Cardiol. 2013;62:2199-204.
Clinical impact ratings: F ★★★★★★✩ C ★★★★★✩✩ H ★★★★★✩✩ N ★★★★★✩✩ Question
Source of funding: In part, Sociedad Española de Cardiología.
In patients with atrial fibrillation (AF) who are receiving stable oral anticoagulants, does a bleeding risk score (HAS-BLED) predict major bleeding better than stroke risk scores (CHADS2 or CHA2DS2-VASc)?
For correspondence: Professor Gregory Y. Lip, University of Birmingham Centre for Cardiovascular Sciences, Birmingham, England, UK. E-mail [email protected]. ■
Commentary
Methods Design: Retrospective cohort study to compare HAS-BLED with CHADS2 and CHA2DS2-VASc. Setting: Outpatient anticoagulation clinic. Patients: 1370 patients (median age 76 y, 53% women, median follow-up 996 d) who had permanent or paroxysmal AF, were receiving oral anticoagulation therapy with acenocoumarol, and had an international normalized ratio (INR) of 2 to 3 over the past 6 months. Exclusion criteria were prosthetic heart valves, an acute coronary syndrome, stroke (ischemic or embolic), valvular AF, hemodynamic instability, or hospital admission or surgery in the past 6 months. Description of prediction guides: HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history, labile INR, age ≥ 65 y, and drugs/alcohol concomitantly); CHADS2 (congestive heart failure, hypertension, age ≥ 75 y, diabetes, and previous stroke or transient ischemic attack); and CHA2DS2VASc (CHADS2 plus vascular disease, age 65 to 74 y, and sex). For HAS-BLED, all patients had a score of 0 for labile INR (based on inclusion criteria). Outcomes: Major bleeding events (according to 2005 International Society on Thrombosis and Hemostasis criteria).
Main results 114 patients (3%/y) had a major bleeding event. HAS-BLED better predicted risk for major bleeding than CHADS2 and CHA2DS2-VASc (P < 0.001) (Table).
Conclusion In patients with atrial fibrillation who were receiving stable oral anticoagulants, the HAS-BLED bleeding risk score better predicted major bleeding than the stroke risk scores CHADS2 and CHA2DS2-VASc.
Roldán and colleagues showed that CHADS2 and CHA2DS2VASc are not very good at predicting major bleeding in patients with AF who are receiving stable anticoagulants. Similar data were simultaneously reported in an independent population of a randomized controlled trial (1). The clear take-home message is not to rely on CHADS2 or CHA2DS2-VASc to assess risk for bleeding but to use a dedicated bleeding score like HAS-BLED. Many clinicians might say that they never use CHADS2 or CHA2DS2-VASc to assess risk for bleeding. Fewer would deny that they are more comfortable prescribing anticoagulants to patients with low rather than high risk for stroke, because the latter patients are also perceived as having a high risk for bleeding. Generally, the risk for bleeding is not high enough to withhold a beneficial therapy. On the other hand, the main drawback of CHADS2 and CHA2DS2-VASc compared with HAS-BLED is the absence of important risk factors, such as previous bleeding. This difference resulted in > 30% of patients with major bleeding having low CHADS2 and CHA2DS2-VASc scores that were correctly reclassified as high risk with HAS-BLED, whereas only 5% to 7% of patients without a bleeding event scored high on CHADS2 and CHA2DS2-VASc and were reclassified as low risk with HAS-BLED. Therefore, clinicians guided only by CHADS2 or CHA2DS2-VASc are more likely to underestimate rather than overestimate risk for bleeding, and some patients with low CHADS2 and CHA2DS2-VASc scores will, indeed, bleed. The study results encourage an individualized risk–benefit assessment using well-performing prediction models for both stroke and bleeding, ideally adjusted for patient values. Preferably, models should be calibrated for the new oral anticoagulants for which such risk factors as renal failure, current or potential, might deserve more weight than currently assigned by HAS-BLED. Maura Marcucci, MD University of Milan Milan, Italy
Test characteristics of risk scores for major bleeding in patients with atrial fibrillation who were receiving stable oral anticoagulants* C-statistic (95% CI) HAS-BLED 0.69 (0.67 to 0.72)
CHADS2 0.59 (0.56 to 0.62)
0.69 (0.67 to 0.72)
NRI
Events correctly reclassified
Nonevents correctly reclassified
38%
34%
4.6%
0.58 (0.55 to 0.60) 38%
31%
6.6%
CHA2DS2-VASc
Reference 1. Apostolakis S, Lane DA, Buller H, Lip GY. Comparison of the CHADS2, CHA2DS2-VASc and HAS-BLED scores for the prediction of clinically relevant bleeding in anticoagulated patients with atrial fibrillation: the AMADEUS trial. Thromb Haemost. 2013;110:1074-9.
*NRI = net reclassification improvement.
20 May 2014 | ACP Journal Club | Volume 160 • Number 10
© 2014 American College of Physicians
Downloaded From: http://annals.org/pdfaccess.ashx?url=/data/journals/aim/930210/ by a NYU Medical Center Library User on 02/20/2017
JC13
In anticoagulated patients with AF, HAS-BLED predicted major bleeding better than CHADS2 and CHA2DS2-VASc
Roldán V, Marín F, Manzano-Fernández S, et al. The HAS-BLED score has better prediction accuracy for major bleeding than CHADS2 or CHA2DS2-VASc scores in anticoagulated patients with atrial fibrillation. J Am Coll Cardiol. 2013;62:2199-204.
Clinical impact ratings: F ★★★★★★✩ C ★★★★★✩✩ H ★★★★★✩✩ N ★★★★★✩✩ Question
Source of funding: In part, Sociedad Española de Cardiología.
In patients with atrial fibrillation (AF) who are receiving stable oral anticoagulants, does a bleeding risk score (HAS-BLED) predict major bleeding better than stroke risk scores (CHADS2 or CHA2DS2-VASc)?
For correspondence: Professor Gregory Y. Lip, University of Birmingham Centre for Cardiovascular Sciences, Birmingham, England, UK. E-mail [email protected]. ■
Commentary
Methods Design: Retrospective cohort study to compare HAS-BLED with CHADS2 and CHA2DS2-VASc. Setting: Outpatient anticoagulation clinic. Patients: 1370 patients (median age 76 y, 53% women, median follow-up 996 d) who had permanent or paroxysmal AF, were receiving oral anticoagulation therapy with acenocoumarol, and had an international normalized ratio (INR) of 2 to 3 over the past 6 months. Exclusion criteria were prosthetic heart valves, an acute coronary syndrome, stroke (ischemic or embolic), valvular AF, hemodynamic instability, or hospital admission or surgery in the past 6 months. Description of prediction guides: HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history, labile INR, age ≥ 65 y, and drugs/alcohol concomitantly); CHADS2 (congestive heart failure, hypertension, age ≥ 75 y, diabetes, and previous stroke or transient ischemic attack); and CHA2DS2VASc (CHADS2 plus vascular disease, age 65 to 74 y, and sex). For HAS-BLED, all patients had a score of 0 for labile INR (based on inclusion criteria). Outcomes: Major bleeding events (according to 2005 International Society on Thrombosis and Hemostasis criteria).
Main results 114 patients (3%/y) had a major bleeding event. HAS-BLED better predicted risk for major bleeding than CHADS2 and CHA2DS2-VASc (P < 0.001) (Table).
Conclusion In patients with atrial fibrillation who were receiving stable oral anticoagulants, the HAS-BLED bleeding risk score better predicted major bleeding than the stroke risk scores CHADS2 and CHA2DS2-VASc.
Roldán and colleagues showed that CHADS2 and CHA2DS2VASc are not very good at predicting major bleeding in patients with AF who are receiving stable anticoagulants. Similar data were simultaneously reported in an independent population of a randomized controlled trial (1). The clear take-home message is not to rely on CHADS2 or CHA2DS2-VASc to assess risk for bleeding but to use a dedicated bleeding score like HAS-BLED. Many clinicians might say that they never use CHADS2 or CHA2DS2-VASc to assess risk for bleeding. Fewer would deny that they are more comfortable prescribing anticoagulants to patients with low rather than high risk for stroke, because the latter patients are also perceived as having a high risk for bleeding. Generally, the risk for bleeding is not high enough to withhold a beneficial therapy. On the other hand, the main drawback of CHADS2 and CHA2DS2-VASc compared with HAS-BLED is the absence of important risk factors, such as previous bleeding. This difference resulted in > 30% of patients with major bleeding having low CHADS2 and CHA2DS2-VASc scores that were correctly reclassified as high risk with HAS-BLED, whereas only 5% to 7% of patients without a bleeding event scored high on CHADS2 and CHA2DS2-VASc and were reclassified as low risk with HAS-BLED. Therefore, clinicians guided only by CHADS2 or CHA2DS2-VASc are more likely to underestimate rather than overestimate risk for bleeding, and some patients with low CHADS2 and CHA2DS2-VASc scores will, indeed, bleed. The study results encourage an individualized risk–benefit assessment using well-performing prediction models for both stroke and bleeding, ideally adjusted for patient values. Preferably, models should be calibrated for the new oral anticoagulants for which such risk factors as renal failure, current or potential, might deserve more weight than currently assigned by HAS-BLED. Maura Marcucci, MD University of Milan Milan, Italy
Test characteristics of risk scores for major bleeding in patients with atrial fibrillation who were receiving stable oral anticoagulants* C-statistic (95% CI) HAS-BLED 0.69 (0.67 to 0.72)
CHADS2 0.59 (0.56 to 0.62)
0.69 (0.67 to 0.72)
NRI
Events correctly reclassified
Nonevents correctly reclassified
38%
34%
4.6%
0.58 (0.55 to 0.60) 38%
31%
6.6%
CHA2DS2-VASc
Reference 1. Apostolakis S, Lane DA, Buller H, Lip GY. Comparison of the CHADS2, CHA2DS2-VASc and HAS-BLED scores for the prediction of clinically relevant bleeding in anticoagulated patients with atrial fibrillation: the AMADEUS trial. Thromb Haemost. 2013;110:1074-9.
*NRI = net reclassification improvement.
20 May 2014 | ACP Journal Club | Volume 160 • Number 10
© 2014 American College of Physicians
Downloaded From: http://annals.org/pdfaccess.ashx?url=/data/journals/aim/930210/ by a NYU Medical Center Library User on 02/20/2017
JC13
