HAS-BLED. Ron Pisters, MD Maastricht University Medical Centre (NL) No conflict of interest

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1 HAS-BLED Ron Pisters, MD Maastricht University Medical Centre (NL) No conflict of interest

2 Background major bleeding risk High stroke risk frequently warrants use of oral anticoagulation Oral anticoagulation use is (inherently) associated with (major) bleeding No user-friendly counterpart of the CHADS 2 score exists Fear of (starting) oral anticoagulation 2006 AHJ, BF Gage

3 2006 ACC/AHA/ESC AF guidelines?

4 Study objective Develop a practical scoring system to assess risk of major bleeding in patients with atrial fibrillation

5 Methods Patients of the Euro Heart Survey on AF: baseline & 1 yr follow-up For 3978 patients we had information on the occurrence of major bleeding during 1 yr Multivariate model consisted of all potential univariate bleed risk factors combined with historical bleed risk factors Regression coefficient based allocation of points to variables of the final model Current available bleed risk schema (HEMOR 2 RHAGES) was assessed C-statistic was calculated for both HASBLED and HEMOR 2 RHAGES regarding the occurrence of major bleeding

6 Study population 3978 AF patients Mean age (SD) 66 (13) Female 41.4% Prior Stroke/TIA 9.7% Coronary artery disease 33.6% Prior major bleeding 2.0% Hypertension 63.1% Diabetes mellitus 17.8% Heart failure 31.9% Mean SBP mmhg (SD) 136 (22) Oral anticoagulation 66% Only antiplatelet 21% SD, standard deviation; TIA, transient ischemic attack; SBP, systolic blood pressure;

7 HAS-BLED H A S B L E D Clinical characteristic* Hypertension Abnormal liver/renal function Stroke Prior major bleeding or predisposition Labile INR Elderly (>65) Drugs/alcohol concomitantly Points awarded * Hypertension is defined as systolic blood pressure >160 mmhg. Abnormal kidney function is defined as the presence of chronic dialysis or renal transplantation or serum creatinine 200μmol/L. Abnormal liver function is defined as chronic hepatic disease (eg. cirrhosis) or biochemical evidence of significant hepatic derangement (eg. bilirubin >2x upper limit of normal, in association with AST/ALT/ALP >3x upper limit normal, etc). Bleeding refers to previous bleeding history and/or predisposition to bleeding eg. bleeding diathesis, anaemia, etc. Labile INRs refers to unstable/high INRs or poor time in therapeutic range(eg. <60%). Drugs/alcohol use refers to concomitant use of drugs, such as antiplatelet agents, non-steroidal antiinflammatory drugs, etc.

8 Major bleeding at 1y using HAS-BLED HAS-BLED* score Number of patients Number of bleedings Bleeds per 100 patient years Total 3, P value for trend.007 *HAS-BLED, acronym: Hypertension [uncontrolled, >160 mmhg systolic), Abnormal renal/liver function, Stroke, Bleeding history or predisposition [anemia], Labile INR [i.e. therapeutic time in range <60%], Elderly (>65 years) and Drugs/alcohol concomitantly [antiplatelet agents, non-steroidal anti-inflammatory drugs;

9 Head-to-head: prediction of major bleeding HEMOR 2 RHAGES C-statistic 0.66 vs. HAS-BLED C-statistic 0.72

10 Predictive power of HAS-BLED Antithrombotic treatment Bleed risk score N C-statistic (CI) Overall group Derivation cohort* HAS-BLED** HEMORRHAGES^ ( ) 0.72 ( ) 0.66 ( ) Oral anticoagulation alone Derivation cohort* HAS-BLED** HEMORRHAGES^ ( ) 0.72 ( ) 0.66 ( ) OAC + antiplatelet therapy Derivation cohort* HAS-BLED** HEMORRHAGES^ ( ) 0.78 ( ) 0.83 ( ) Antiplatelet alone Derivation cohort* HAS-BLED** HEMORRHAGES^ ( ) 0.91 ( ) 0.83 ( ) No antithrombotic therapy Derivation cohort* HAS-BLED** HEMORRHAGES^ ( ) 0.85 ( ) 0.81 ( ) N, number of patients included in analysis; CI, confidence interval; OAC, oral anticoagulation). *Derivation cohort risk factors: Bleeding history, Age>65 years, Clopidogrel use and Kidney failure **HAS-BLED, acronym: Hypertension [uncontrolled, >160 mmhg systolic), Abnormal renal/liver function, Stroke, Bleeding history or predisposition [anemia], Labile INR [i.e. therapeutic time in range <60%], Elderly (>65 years) and Drugs/alcohol concomitantly [antiplatelet agents, non-steroidal anti-inflammatory drugs; ^HEMOR 2 RHAGES, acronym: Hepatic or renal disease, Ethanol abuse, Malignancy, Older age (>75years), Re-bleeding, Reduced platelet count or function, Hypertension (uncontrolled), Anemia, Genetic factors, Excessive fall risk and Stroke. [NB. Classifying bleeding risk by antithrombotic therapy use with thehemor 2 RHAGES model resulted in mean scores of 1.17, 1.17, 1.31, 1.24 and 1.07, respectively.]

11 HAS-BLED in summary - Short and snappy - Readily available characteristics within contemporary cohort - Limited overlap with CHADS 2 index - Similar predictive power compared to HEMOR 2 RHAGES

12 Future direction Major bleeding Clinical prediction rule Stroke Score HASBLED bleed risk (%) CHADS 2 stroke risk (%) Potentially preventing 4/33 (12.1%) of the major bleedings EHS-AF population: NO oral anticoagulation IF HAS-BLED > CHADS 2 score however IF HAS-BLED >2 in CHADS 2 score 0/1 IF HAS-BLED >3 in CHADS 2 score 2

13 Acknowledgements Harry J Crijns Maastricht University Medical Centre, the Netherlands Cees B de Vos Maastricht University Medical Centre, the Netherlands Robby Nieuwlaat McMaster University, Canada Gregory YH Lip University of Birmingham, United Kingdom Deirdre A Lane University of Birmingham, United Kingdom

Objectives. Falling Down on Warfarin Therapy. CHADS 2 Score. CHADS 2 & CHA 2 DS 2 -VASc Score. HAS-BLED Score 04/08/2014. Real World Application

Objectives. Falling Down on Warfarin Therapy. CHADS 2 Score. CHADS 2 & CHA 2 DS 2 -VASc Score. HAS-BLED Score 04/08/2014. Real World Application Falling Down on Warfarin Therapy David Andrew Jacob, PharmD Pharmacy Resident 2013-2014 Dayton VA Medical Center Dayton, Ohio Objectives Describe CHADS 2 score and the decision to anticoagulate patients