Evaluation of the predictive performance of bleeding risk scores in patients with non‐valvular atrial fibrillation on oral anticoagulants

2017 ◽  
Vol 43 (2) ◽  
pp. 209-219 ◽  
Author(s):  
S. A. Beshir ◽  
Z. Aziz ◽  
L. B. Yap ◽  
K. H. Chee ◽  
Y. L. Lo
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Predictive Performance ◽  
Bleeding Risk ◽  
Risk Scores

scholarly journals GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation: a Danish nationwide validation study

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e033283 ◽  
Author(s):  
Frederik Dalgaard ◽  
Karen Pieper ◽  
Freek Verheugt ◽  
A John Camm ◽  
Keith AA Fox ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Risk Model ◽  
Oral Anticoagulants ◽  
External Validation ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Secondary Outcome

ObjectivesTo externally validate the accuracy of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) model against existing risk scores for stroke and major bleeding risk in patients with non-valvular AF in a population-based cohort.DesignRetrospective cohort study.SettingDanish nationwide registries.Participants90 693 patients with newly diagnosed non-valvular AF were included between 2010 and 2016, with follow-up censored at 1 year.Primary and secondary outcome measuresExternal validation was performed using discrimination and calibration plots. C-statistics were compared with CHA2DS2VASc score for ischaemic stroke/systemic embolism (SE) and HAS-BLED score for major bleeding/haemorrhagic stroke outcomes.ResultsOf the 90 693 included, 51 180 patients received oral anticoagulants (OAC). Overall median age (Q1, Q3) were 75 (66–83) years and 48 486 (53.5%) were male. At 1-year follow-up, a total of 2094 (2.3%) strokes/SE, 2642 (2.9%) major bleedings and 10 915 (12.0%) deaths occurred. The GARFIELD-AF model was well calibrated with the predicted risk for stroke/SE and major bleeding. The discriminatory value of GARFIELD-AF risk model was superior to CHA2DS2VASc for predicting stroke in the overall cohort (C-index: 0.71, 95% CI: 0.70 to 0.72 vs C-index: 0.67, 95% CI: 0.66 to 0.68, p<0.001) as well as in low-risk patients (C-index: 0.64, 95% CI: 0.59 to 0.69 vs C-index: 0.57, 95% CI: 0.53 to 0.61, p=0.007). The GARFIELD-AF model was comparable to HAS-BLED in predicting the risk of major bleeding in patients on OAC therapy (C-index: 0.64, 95% CI: 0.63 to 0.66 vs C-index: 0.64, 95% CI: 0.63 to 0.65, p=0.60).ConclusionIn a nationwide Danish cohort with non-valvular AF, the GARFIELD-AF model adequately predicted the risk of ischaemic stroke/SE and major bleeding. Our external validation confirms that the GARFIELD-AF model was superior to CHA2DS2VASc in predicting stroke/SE and comparable with HAS-BLED for predicting major bleeding.

Stroke prevention in atrial fibrillation: An Asian perspective

2014 ◽  
Vol 111 (05) ◽  
pp. 789-797 ◽  
Author(s):  
Kang-Ling Wang ◽  
Gregory Y. H. Lip ◽  
Chern-En Chiang
Keyword(s):  
Atrial Fibrillation ◽  
Stroke Prevention ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Asian Patients ◽  
History Of ◽  
Randomised Controlled ◽  
Similar Risk ◽  
Selection Of

SummaryAtrial fibrillation (AF) is the most common sustained cardiac arrhythmia. In 2050, it is estimated that there will be 72 million AF patients in Asia, accounting for almost 2.9 million patients suffering from AF-associated stroke. Asian AF patients share similar risk factor profiles as non-Asians, except that more Asians have a history of previous stroke. Clinical challenges are evident in the field of stroke prevention in AF, amongst Asians. Existing stroke and bleeding risk scores have not been well-validated in Asians. Asians are prone to bleeding when treated with warfarin, and the optimal international normalised ratio (INR) for warfarin use is yet to be determined in Asians, though Asian physicians tend to keep it in a lower range (e.g. INR 1.6–2.6) for elderly patients despite limited evidence to justify this. In general, warfarin is ‘difficult’ to use in Asians due to higher risk of bleeding and higher stroke rate in Asians than in non-Asians, as shown in randomised controlled trials. Excess of bleeding was not found in Asians when novel oral anticoagulants (NOACs) were used. Besides, the superiority of NOACs to warfarin in reducing thromboembolism was maintained in Asians. Therefore NOACs are preferentially indicated in Asians in terms of both efficacy and safety. Also, some preliminary data suggest that Asian patients with AF might not be the same. Future prospective randomised trials are needed for the selection of NOACs according to different ethnic background.Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.

scholarly journals Diagnostic Accuracy of the HAS-BLED Bleeding Score in VKA- or DOAC-Treated Patients With Atrial Fibrillation: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Xinxing Gao ◽  
Xingming Cai ◽  
Yunyao Yang ◽  
Yue Zhou ◽  
Wengen Zhu
Keyword(s):  
Diabetes Mellitus ◽  
Heart Failure ◽  
Atrial Fibrillation ◽  
Congestive Heart Failure ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Risk Scores ◽  
C Statistic ◽  
Ischemic Attack ◽  
Anticoagulated Patients

Background: Several bleeding risk assessment models have been developed in atrial fibrillation (AF) patients with oral anticoagulants, but the most appropriate tool for predicting bleeding remains uncertain. Therefore, we aimed to assess the diagnostic accuracy of the Hypertension, Abnormal liver/renal function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly, Drugs/alcohol concomitantly (HAS-BLED) score compared with other risk scores in anticoagulated patients with AF.Methods: We comprehensively searched the PubMed and Embase databases until July 2021 to identify relevant pieces of literature. The predictive abilities of risk scores were fully assessed by the C-statistic, net reclassification improvement (NRI) and integrated discrimination improvement (IDI) values, calibration data, and decision curve analyses.Results: A total of 39 studies met the inclusion criteria. The C-statistic of the HAS-BLED score for predicting major bleeding was 0.63 (0.61–0.65) in anticoagulated patients regardless of vitamin k antagonists [0.63 (0.61–0.65)] and direct oral anticoagulants [0.63 (0.59–0.67)]. The HAS-BLED had the similar C-statistic to the Hepatic or renal disease, Ethanol abuse, Malignancy, Older, Reduced platelet count or function, Re-bleeding risk, Hypertension (uncontrolled), Anemia, Genetic factors, Excessive fall risk, Stroke (HEMORR2HAGES), the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA), the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT), the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF), or the Age, Biomarkers, Clinical History (ABC) scores, but significantly higher C-statistic than the Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Stroke/transient ischemic attack history (CHADS2) or the Congestive heart failure/left ventricular ejection fraction ≤ 40%, Hypertension, Age ≥75 years, Diabetes mellitus, Stroke/transient ischemic attack/thromboembolism history, Vascular disease, Age 65–74 years, Sex (female) (CHA2DS2-VASc) scores. NRI and IDI values suggested that the HAS-BLED score performed better than the CHADS2 or the CHA2DS2-VASc scores and had similar or superior predictive ability compared with the HEMORR2HAGES, the ATRIA, the ORBIT, or the GARFIELD-AF scores. Calibration and decision curve analyses of the HAS-BLED score compared with other scores required further assessment due to the limited evidence.Conclusion: The HAS-BLED score has moderate predictive abilities for bleeding risks in patients with AF regardless of type of oral anticoagulants. Current evidence support that the HAS-BLED score is at least non-inferior to the HEMORR2HAGES, the ATRIA, the ORBIT, the GARFIELD-AF, the CHADS2, the CHA2DS2-VASc, or the ABC scores.

P6258Direct oral anticoagulants in non-valvular atrial fibrillation: accuracy of traditional bleeding scores in the elderly

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Novello ◽  
A Graceffa ◽  
C Ninivaggi ◽  
G I Greco ◽  
F Bonfante ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Roc Curves ◽  
Bleeding Risk ◽  
Discriminatory Power ◽  
Risk Scores

Abstract Background Due to the fear of increased risk of bleeding, anticoagulation treatment is underutilized in the prevention of stroke in elderly patients with non-valvular atrial fibrillation (NVAF). Although direct oral anticoagulants (DOAC) are safer than VKA, still little is known about the risk factors associated with bleeding in elderly patients treated with DOAC. Furthermore, it is still uncertain whether the risk scores that are currently used can serve to effectively identify higher bleeding risk in elderly subjects. Purpose The aim of this study was to identify predictors of bleeding in a cohort of elderly people affected by NVAF treated with DOAC, and to evaluate the accuracy of risk scores for bleeding used at present. Methods Data on outpatients aged ≥75 years, naïve for DOAC therapy, who started therapy with Dabigatran, Rivaroxaban, Apixaban or Edoxaban for the prevention of thromboembolism during FANV were analyzed. HASBLED, ATRIA, OBRI and ORBIT scores were calculated for each patient. Patients had follow-up for 12 months during which deaths, therapy discontinuation and adverse events such as thromboembolism and bleeding were reported. Potential predictors of bleeding and the predictive value of each bleeding score were tested using univariate Cox regression; testing accuracy was evaluated using ROC curves. Results A total of 291 patients (52.9% female, mean age 82.85±5.18 years) had a median follow-up time of 11 (10–12) months. The incidence rate of major bleeding was 4.7 per 100 patient-years, the rate of intracranial bleeding was 0.4 per 100 patient-years. Patients who had major bleeding were more often affected by heart failure (63.6% vs 25%; p=0.009) and thrombocytopenia (36.4% vs 7.4%; p=0,009). However in the multivariate analysis only heart failure remained statistically associated with major bleeding (HR 3.83, 95% CI 1.06–13.85; p=0.041). None of tested bleeding risk scores was able to predict major bleeding in our cohort. HASBLED and ORBIT scores were able to predict major and non-major clinically relevant bleeding (HR 1.32; 95% CI 1.01–1.71; p=0.042 and HR 1.20; 95% CI 1.00- 1.43; p=0.046); only the ORBIT score was found to be statistically significant, but with weak discriminatory power at ROC curves (AUC 0.59; 95% CI 0.51–0.68; p=0.041). Conclusions In our cohort of elderly patients aged 75 or older, anticoagulated for NVAF, heart failure history was the only effective predictor of major bleeding risk during DOAC treatment. None of the bleeding risk scores used currently have demonstrated a good discriminatory power in our cohort. As predictive factors of bleedings in DOAC-treated patients may not be the same as those for VKA-treated patients and those in elderly may also be differ in younger people, it calls for more investigation on the topic.

Biomarkers Associated with Bleeding Risk in the Setting of Atrial Fibrillation

2019 ◽  
Vol 26 (5) ◽  
pp. 824-836 ◽  
Author(s):  
Skevos Sideris ◽  
Stefanos Archontakis ◽  
George Latsios ◽  
George Lazaros ◽  
Konstantinos Toutouzas ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Large Scale ◽  
Oral Anticoagulants ◽  
Significant Risk ◽  
Bleeding Risk ◽  
Hepatic Function ◽  
Risk Scores ◽  
Current Evidence ◽  
Prognostic Impact ◽  
Increased Risk

Background: Prevention of thromboembolic disease, mainly stroke, with oral anticoagulants remains a major therapeutic goal in patients with atrial fibrillation. Unfortunately, despite the high efficacy, anticoagulant therapy is associated with a significant risk of, frequently catastrophic, and hemorrhagic complications. Among different clinical and laboratory parameters related to an increased risk of bleeding, several biological markers have been recognized and various risk scores for bleeding have been developed. Objectives/Methods: The aim of the present study is to review current evidence regarding the different biomarkers associated with raised bleeding risk in atrial fibrillation. Results: Data originating from large cohorts or the recent large-scale trials of atrial fibrillation have linked numerous individual biomarkers to an increased bleeding risk. Such a relation was revealed for markers of cardiac physiology, such as troponin, BNP and NT-proBNP, markers of renal function, such as GFR and Cystatin or hepatic function, markers involving the system of coagulation, such as D-dimer and Von Willebrand factor, hematologic markers, such as low haemoglobin or low platelets, inflammatory markers, such as interleukin-6, other factors such as GDF-15 and vitamin-E and finally genetic polymorphisms. Many such biomarkers are incorporated in the bleeding risk schemata developed for the prediction of the hemorrhagic risk. Conclusions: Biomarkers were introduced in clinical practice in order to better estimate the potential risk of haemorrhage in these patients and increase the prognostic impact of clinical risk scores. In the last years this concept is gaining significant importance.

Abstract 169: The Role Of Clinical Prediction Factors On Anticoagulant Selection In Atrial Fibrillation

2014 ◽  
Vol 7 (suppl_1) ◽  
Author(s):  
Julie Lauffenburger
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Stroke Risk ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Patient Characteristics ◽  
Treatment Selection ◽  
Risk Scores ◽  
Treatment Benefit ◽  
Risk Treatment

Background: Atrial fibrillation (AF) often benefits from the use of anticoagulants for prevention of stroke or systemic embolism. While novel oral anticoagulants have emerged as possible alternatives to warfarin, it is unknown how treatment selection is determined in practice with clinical guidelines still evolving. This study examined whether and to what extent anticoagulant selection has been driven by clinical predictions of stroke risk (treatment benefit) and bleeding risk (treatment harm) in real-world practice in the US. Methods: A nationwide database of commercial and Medicare Part D supplement claims from 2009-2011 was used to extract a cohort of non-valvular AF patients who were newly-initiating therapy after dabigatran availability in Oct 2010. Patients were excluded if they had claims associated with a reversible AF condition. Risk scores of ischemic stroke (CHADS2 and CHA2DS2-VASc) and bleeding (ATRIA) were used to examine associations with either warfarin or dabigatran use, calculated via claims in the outpatient pharmaceutical, inpatient medical, outpatient, and provider claims files. Baseline demographic and clinical characteristics were also measured as covariates, including concomitant diseases and medications. Multivariable log-binomial regression models assessed the association between each risk score and anticoagulant use, adjusting for the measured covariates. C-statistics were also used to examine the variation in treatment selection explained by inclusion of the risk scores. Results: In total, 37,401 patients were identified with 31% initiating dabigatran. New users of dabigatran were more likely to be younger, male, and have comorbidities. Patients at intermediate stroke risk (CHADS2 or CHA2DS2-VASc =1) were equally likely to receive warfarin and dabigatran (RR, 95% CI: 0.98, 0.93-1.02), while selection for warfarin was significantly associated with high ischemic stroke risk (CHADS2 or CHA2DS2-VASc ≥2) (RR, 95% CI: 0.87, 0.83-0.92). New users of dabigatran were significantly less likely to have high bleeding risk (ATRIA≥5) versus warfarin (RR, 95%: 0.70, 0.66-0.74). The c-statistic of the base model, which included the other measured covariates, was only marginally increased with the addition of any of the risk scores. Conclusions: Despite controlling for other patient characteristics, bleeding risk was strongly associated with the selection of a specific anticoagulant. However, the extent of selection explained by predictions of treatment harm was minimal. Providers appear to base anticoagulant selection on factors other than predictions of treatment benefit, which has implications for studying the anticoagulants’ comparative effectiveness.

scholarly journals Which scores should use cardiologist to predict outcomes in patients with nonvalvular atrial fibrillation?

2020 ◽  
Vol 29 (4) ◽  
pp. 5-16
Author(s):  
S. Moiseev
Keyword(s):  
Atrial Fibrillation ◽  
Stroke Risk ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Nonvalvular Atrial Fibrillation ◽  
High Bleeding Risk ◽  
Medical University ◽  
Risk Symptom

Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia Management of patients with atrial fibrillation (AF) includes anticoagulation for prevention of stroke and systemic embolism, improvement of AF-related symptoms by rate or rhythm control, and treatment for cardiovascular and other comorbidities. The structured characterization of AF should address four AF-related domains, that is, stroke risk, symptom severity, AF burden (type of AF, number and duration of episodes, etc.), and substrate severity. Various scores, i.e.CHA 2 DS 2 -VASc (stroke risk), HAS-BLED (bleeding risk), EHRA (severity of AF-related symptoms), and 2MACE (risk of cardiovascular events), can be used to estimate the risk of outcomes and for treatment decisions. Noteworthy, bleeding risk assessment using HAS-BLED score focuses attention on modifiable risk factors that should be managed to improve safety of anticoagulation, whereas a high bleeding risk score should not lead to withholding oral anticoagulants. New clini- cal and biomarker-based risk scores were developed. However, their potential advantages over existing scores should be confirmed in clinical studies.

P4791Performance of the HAS-BLED, ATRIA, and PRECISE-DAPT Bleeding Risk Scores in Atrial Fibrillation Patients Using Antiplatelet Agents or Oral Anticoagulants

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Y Choi ◽  
M H Kim ◽  
K M Lee ◽  
C H Jang ◽  
J Y Choi
Keyword(s):  
Atrial Fibrillation ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
Oral Anticoagulants ◽  
Antiplatelet Agents ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Bleeding Events ◽  
C Statistic ◽  
Better Than

Abstract Background Various bleeding risk scores have been proposed to assess the risk of bleeding in atrial fibrillation (AF) patients undergoing anticoagulation. PRECISE DAPT score has been developed to assess the out-of hospital bleeding risk in patients receiving dual antiplatelet therapy (DAPT). Our objective was to compare the predictive performance between the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol), ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation), and PRECISE-DAPT (Predicting Bleeding Complication in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet therapy) score in AF patients using antiplatelet agents or anticoagulants Methods We recruited 1,114 consecutive AF patients (51% male; median age, 71 years) receiving antiplatelet agents or oral anticoagulants from January 2014 through December 2018. Major bleeding was defined as according to the Bleeding Academic Research Consortium (BARC) criteria (type 3 or 5: hemodynamic instability, need for transfusion, drop in hemoglobin ≥3 g, and intracranial, intraocular or fatal bleeding). The performance of risk scores were assessed by C-statistic. Results Bleeding events occurred in 135 patients (12.1%) during 30 days, and 72 patients (6.5%) from 30 days till 1-year follow-up. Based on the C-statistic, PRECISE-DAPT score (AUC: 0.72, 95% CI: 0.69–0.75) had a good performance, significantly better than HAS-BLED (AUC: 0.64, 95% CI: 0.61–0.67) (p=0.008) or ATRIA scores (AUC: 0.57, 95% CI: 0.54–0.60) (p<0.001) for 30-days bleeding prediction. Also, PRECISE-DAPT score had a good C-statistic (AUC: 0.72, 95% CI: 0.69–0.75) for 1-year bleeding events compared with HAS-BLED (AUC: 0.64, 95% CI: 0.60–0.67) (p=0.02) or ATRIA (AUC: 0.61, 95% CI: 0.58–0.65) (p=0.01). ROC curve for bleeding Conclusions The PRECISE-DAPT score has been used for assessing bleeding events during DAPT. Also, the PRECISE-DAPT score predicted bleedings better than HAS-BLED or ATRIA scores in AF patients. So, the PRECISE-DAPT score may be considered as bleeding risk score during DAPT or oral anticoagulation in clinical practice.

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