Composite risk scores and composite endpoints in the risk prediction of outcomes in anticoagulated patients with atrial fibrillation

2014 ◽  
Vol 111 (03) ◽  
pp. 549-556 ◽  
Author(s):  
Amitava Banerjee ◽  
Laurent Fauchier ◽  
Anne Bernard-Brunet ◽  
Nicolas Clementy ◽  
Gregory Y. H. Lip
Keyword(s):  
Atrial Fibrillation ◽  
Risk Prediction ◽  
Major Bleeding ◽  
Predictive Value ◽  
Risk Scores ◽  
Chads2 Score ◽  
Net Reclassification Improvement ◽  
Composite Endpoints ◽  
Composite Risk ◽  
Anticoagulated Patients

SummarySeveral validated risk stratification schemes for prediction of ischaemic stroke (IS)/thromboembolism (TE) and major bleeding are available for patients with non-valvular atrial fibrillation (NVAF). On the basis for multiple common risk factors for IS/TE and bleeding, it has been suggested that composite risk prediction scores may be more practical and user-friendly than separate scores for bleeding and IS/TE. In a long-term prospective hospital registry of anticoagulated patients with newly diagnosed AF, we compared the predictive value of existing risk prediction scores as well as composite risk scores, and also compared these risk scoring systems using composite endpoints. Endpoint 1 was the simple composite of IS and major bleeds. Endpoint 2 was based on a composite of IS plus intracerebral haemorrhage (ICH). Endpoint 3 was based on weighted coefficients for IS/TE and ICH. Endpoint 4 was a composite of stroke, cardiovascular death, TE and major bleeding. The incremental predictive value of these scores over CHADS2 (as reference) for composite endpoints was assessed using c-statistic, net reclassification improvement (NRI) and integrated discrimination improvement (IDI). Of 8,962 eligible individuals, 3,607 (40.2%) had NVAF and were on OAC at baseline. There were no statistically significant differences between the c-statistics of the various risk scores, compared with the CHADS2 score, regardless of the endpoint. For the various risk scores and various endpoints, NRI and IDI did not show significant improvement (≥1%), compared with the CHADS2 score. In conclusion, composite risk scores did not significantly improve risk prediction of endpoints in patients with NVAF, regardless of how endpoints were defined. This would support individualised prediction of IS/TE and bleeding separately using different separate risk prediction tools, and not the use of composite scores or endpoints for everyday ‘real world’ clinical practice, to guide decisions on thromboprophylaxis.Note: The review process for this paper was fully handled by Christian Weber, Editor in Chief.

Use of Simplified HAS-BLED Score for Predicting Bleeding Events in Anticoagulated Patients with Atrial Fibrillation

2021 ◽  
Vol 104 (5) ◽  
pp. 802-806
Keyword(s):  
Atrial Fibrillation ◽  
Risk Prediction ◽  
Major Bleeding ◽  
Predictive Value ◽  
Statistical Significance ◽  
Bleeding Risk ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Sensitivity Specificity ◽  
Anticoagulated Patients

Objective: To demonstrate bleeding risk prediction of simplified HAS-BLED (sHAS-BLED) score in anticoagulated patients with atrial fibrillation (AF). Materials and Methods: AF patients receiving warfarin were retrospectively recruited in Central Chest Institute of Thailand between October 2012 and December 2017. The main outcome was total bleeding including major bleeding, clinically relevant non-major bleeding or minor bleeding. The chi-square test or Fisher’s exact test was used to compare the main outcome between sHAS-BLED and conventional HAS-BLED (cHAS-BLED) scores. A sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of sHAS-BLED were calculated. The discrimination performances of sHAS-BLED and cHAS-BLED scores were demonstrated with c-statistics. Results: One hundred ten patients were recruited. The mean age was 70.53±9.58 years. The average sHAS-BLED and cHAS-BLED scores were 2.23±0.79 and 1.95±0.83, respectively. The patients with sHAS-BLED score of 3 or more had 15 total bleeding events (37.50%) while those with score of less than 3 had 13 total bleeding events (18.57%). Those with sHAS-BLED score of 3 or more had more total bleeding than those with score of less than 3 with statistical significance (odds ratio 2.63; 95% CI 1.09 to 6.25; p=0.049). A sensitivity, specificity, PPV, and NPV of sHAS-BLED score were 53.57%, 69.51%, 37.50%, and 81.43%, respectively. The discrimination performances of sHAS-BLED and cHAS-BLED scores were demonstrated with c-statistics of 0.65 and 0.67, respectively. Conclusion: The sHAS-BLED score can be used for bleeding risk prediction in anticoagulated AF patients compared with cHAS-BLED score. Keywords: Simplified HAS-BLED, Atrial fibrillation, Anticoagulant, Bleeding, SAMe-TT₂R₂

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

2013 ◽  
Vol 110 (11) ◽  
pp. 1074-1079 ◽  
Author(s):  
Stavros Apostolakis ◽  
Deirdre A. Lane ◽  
Harry Buller ◽  
Gregory Y. H. Lip
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Risk Assessment ◽  
Risk Score ◽  
Stroke Risk ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Net Reclassification Improvement ◽  
Anticoagulated Patients ◽  
Discriminatory Performance

SummaryMany of the risk factors for stroke in atrial fibrillation (AF) are also important risk factors for bleeding. We tested the hypothesis that the CHADS2 and CHA2DS2-VASc scores (used for stroke risk assessment) could be used to predict serious bleeding, and that these scores would compare well against the HAS-BLED score, which is a specific risk score designed for bleeding risk assessment. From the AMADEUS trial, we focused on the trial’s primary safety outcome for serious bleeding, which was “any clinically relevant bleeding”. The predictive value of HAS-BLED/CHADS2/CHA2DS2-VASc were compared by area under the curve (AUC, a measure of the c-index) and the Net Reclassification Improvement (NRI). Of 2,293 patients on VKA, 251 (11%) experienced at least one episode of “any clinically relevant bleeding” during an average 429 days follow up period. Incidence of “any clinically relevant bleeding” rose with increasing HAS-BLED/CHADS2/CHA2DS2-VASc scores, but was statistically significant only for HAS-BLED (p<0.0001). Only HAS-BLED demonstrated significant discriminatory performance for “any clinically relevant bleeding” (AUC 0.60, p<0.0001). There were significant AUC-differences between HAS-BLED (which had the highest AUC) and both CHADS2 (p<0.001) and CHA2DS2VASc (p=0.001). The HAS-BLED score also demonstrated significant NRI for the outcome of “any clinically relevant bleeding” when compared with CHADS2 (p=0.001) and CHA2DS2-VASc (p=0.04). In conclusion, the HAS-BLED score demonstrated significant discriminatory performance for “any clinically relevant bleeding” in anticoagulated patients with AF, whilst the CHADS2 and CHA2DS2-VASc scores did not. Bleeding risk assessment should be made using a specific bleeding risk score such as HAS-BLED, and the stroke risk scores such as CHADS2 or CHA2DS2-VASc scores should not be used.

scholarly journals Incremental Value of Genotype Bins over the HAS-BLED Score for the Prediction of Bleeding Risk in Warfarin-Treated Patients with Atrial Fibrillation

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Jia Liu ◽  
Guanyun Wang ◽  
Liu’an Qin ◽  
Yangxun Wu ◽  
Yuting Zou ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Risk Prediction ◽  
Major Bleeding ◽  
Bleeding Risk ◽  
Carrier Status ◽  
Predictive Values ◽  
Net Reclassification Improvement ◽  
C Statistic ◽  
Incremental Value ◽  
Highly Sensitive

Background. This study aimed to analyse the role of the HAS-BLED score with the addition of genotype bins for bleeding risk prediction in warfarin-treated patients with atrial fibrillation (AF). Methods and Results. Consecutive patients with AF on initial warfarin treatment were recruited. For each patient, CYP2C9 ∗ 3 and VKORC1-1639 A/G genotyping was performed to create 3 genotype functional bins. The predictive values of the HAS-BLED score with or without the addition of genotype bins were compared. According to the carrier status of the genotype bins, the numbers of normal, sensitive, and highly sensitive responders among 526 patients were 64 (12.17%), 422 (80.23%), and 40 (7.60%), respectively. A highly sensitive response was independently associated with clinically relevant bleeding (HR: 3.85, 95% CI: 1.88–7.91, P = 0.001 ) and major bleeding (HR:3.75, 95% CI: 1.17–11.97, P = 0.03 ). With the addition of genotype bins, the performance of the HAS-BLED score for bleeding risk prediction was significantly improved (c-statistic from 0.60 to 0.64 for clinically relevant bleeding and from 0.64 to 0.70 for major bleeding, P < 0.01 ). Using the integrated discriminatory, net reclassification improvement, and decision curve analysis, the HAS-BLED score plus genotype bins could perform better in predicting any clinically relevant bleeding than the HAS-BLED score alone. Conclusions. Genotypes have an incremental predictive value when combined with the HAS-BLED score for the prediction of clinically relevant bleeding in warfarin-treated patients with AF.

Abstract 18028: Inclusion of B-type Natriuretic Peptide into Existing Atrial Fibrillation (AF) Risk Scores Improves Identification of Patients with Recurrence of Atrial Fibrillation after Pulmonary Vein Isolation

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Amir Y Shaikh ◽  
Nada Esa ◽  
Menhel Kinno ◽  
William Martin-Doyle ◽  
Kevin C Floyd ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Natriuretic Peptide ◽  
Pulmonary Vein Isolation ◽  
Predictive Value ◽  
Risk Scores ◽  
Discriminative Ability ◽  
Composite Risk ◽  
Af Recurrence

AIMS: Pre-procedural identification of patients with atrial fibrillation (AF) who will remain free from AF after pulmonary vein isolation (PVI) remains challenging. Clinical risk scores, including CHADS2, CHA2DS2-VASc, R2CHADS2, and HATCH scores show modest discriminative ability with respect to AF recurrence. B-type natriuretic peptide (BNP) is associated with risk for AF and AF recurrence but is not currently included in existing AF risk scores. We sought to evaluate the incremental benefit of adding pre-operative BNP to existing risk scores in predicting AF recurrence within 6-months after PVI. METHODS AND RESULTS: One hundred and fifty one patients (105 men, age 60 ± 10 years) with paroxysmal or persistent AF underwent an index PVI procedure between 2010-2014. Seventy-seven patients had an AF recurrence (51%) over the 6-month follow-up period. BNP level of >100 units was significantly associated with 6-month AF recurrence in univariate models (p<0.001). A composite risk score including BNP to the existing scores significantly improved their predictive value and net AF recurrence reclassification (net reclassification index, 63.4%; p<0.001) (Table 1). CONCLUSIONS: Addition of BNP to existing AF risk scores enhanced their predictive value and discriminative ability in predicting AF recurrence after PVI. Further research is needed including large and diverse cohorts of patients undergoing ablation and monitored for AF recurrence over extended periods to further validate the performance of this composite score.

A Systematic Review of Anticoagulation Strategies for Patients With Atrial Fibrillation in Critical Care.

2021 ◽  
Author(s):  
Alexandra Jayne Nelson ◽  
Brian W Johnston ◽  
Alicia Achiaa Charlotte Waite ◽  
Gedeon Lemma ◽  
Ingeborg Dorothea Welters
Keyword(s):  
Atrial Fibrillation ◽  
Critical Care ◽  
Critically Ill ◽  
Major Bleeding ◽  
Critically Ill Patients ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Major Bleeding Events ◽  
The Impact ◽  
Anticoagulated Patients

Background. Atrial fibrillation (AF) is the most common cardiac arrhythmia in critically ill patients. There is a paucity of data assessing the impact of anticoagulation strategies on clinical outcomes for general critical care patients with AF. Our aim was to assess the existing literature to evaluate the effectiveness of anticoagulation strategies used in critical care for AF. Methodology. A systematic literature search was conducted using MEDLINE, EMBASE, CENTRAL and PubMed databases. Studies reporting anticoagulation strategies for AF in adults admitted to a general critical care setting were assessed for inclusion. Results. Four studies were selected for data extraction. A total of 44087 patients were identified with AF, of which 17.8-49.4% received anticoagulation. The reported incidence of thromboembolic events was 0-1.4% for anticoagulated patients, and 0-1.3% in non-anticoagulated patients. Major bleeding events were reported in three studies and occurred in 7.2-8.6% of the anticoagulated patients and up to 7.1% of the non-anticoagulated patients. Conclusions. There was an increased incidence of major bleeding events in anticoagulated patients with AF in critical care compared to non-anticoagulated patients. There was no significant difference in the incidence of reported thromboembolic events within studies, between patients who did and did not receive anticoagulation. However, the outcomes reported within studies were not standardised, therefore, the generalisability of our results to the general critical care population remains unclear. Further data is required to facilitate an evidence-based assessment of the risks and benefits of anticoagulation for critically ill patients with AF.

Abstract 274: Prevalence of undiagnosed non-valvular atrial fibrillation in the United States

2014 ◽  
Vol 7 (suppl_1) ◽  
Author(s):  
Mintu P Turakhia ◽  
Jason Shafrin ◽  
Katalin Bognar ◽  
Jeffrey B Brown ◽  
Jeffrey Trocio ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
The Elderly ◽  
The United States ◽  
Risk Scores ◽  
Chads2 Score ◽  
Aged Patients ◽  
Number Of Patients ◽  
Working Age ◽  
Back Calculation

Background: Because atrial fibrillation (AF) is often asymptomatic, clinically silent and therefore undiagnosed, the prevalence of AF is difficult to estimate. In fact, ischemic stroke is often the first clinical sign of AF among previously undiagnosed patients. In this study, we estimated the prevalence of undiagnosed AF using a back-calculation approach that relies on the fact that AF causes stroke but causality generally does not run from stroke to AF. Methods: We first estimated the prevalence of diagnosed non-valvular AF in the elderly (65+) and working age (18-64) U.S. population from a 5% Medicare sample and an OptumInsight commercial claims database from 2004-2010 using validated ICD9 algorithms. To estimate the prevalence of undiagnosed non-valvular AF, our back-calculation methodology used two measured inputs: (i) the number of patients who are diagnosed with new non-valvular AF in the current or subsequent quarter after a stroke; (ii) the probability that patients with non-valvular AF have a stroke, based on CHADS2 risk scores. We confirmed calibration by comparing our prevalence estimates of diagnosed AF with prior Medicare and commercial claims analyses. Results: Between 2005 and 2009, the estimated prevalence of AF gradually increased, reaching 9.9% of the elderly U.S. population and 0.88% of the working aged population by 2009. Among the Medicare AF cases in 2009, 11% of these cases (1.1% out of 9.9%) were undiagnosed; among working aged patients with AF, 8% of cases (0.07% out of 0.88%) were undiagnosed. In addition, a large share of the undiagnosed cases was at high risk of stroke. Among the undiagnosed AF cases for elderly and working age adults, 26% and 37%, respectively have a CHADS2 score of 1, and 68% and 26% have a CHADS2 score of 2+. Conclusions: Among elderly and working adult U.S. populations, a substantial proportion of individuals with undiagnosed AF have moderate to high risk of stroke. Screening for AF could favorably impact the disease burden.

scholarly journals Association between clinical risk scores and mortality in atrial fibrillation: Systematic review and network meta-regression of 669,000 patients

2018 ◽  
Vol 27 (6) ◽  
pp. 633-644 ◽  
Author(s):  
Marco Proietti ◽  
Alessio Farcomeni ◽  
Giulio Francesco Romiti ◽  
Arianna Di Rocco ◽  
Filippo Placentino ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Predictive Ability ◽  
Risk Scores ◽  
Clinical Risk ◽  
Increased Risk ◽  
High Negative Predictive Value ◽  
Meta Regression

Aims Many clinical scores for risk stratification in patients with atrial fibrillation have been proposed, and some have been useful in predicting all-cause mortality. We aim to analyse the relationship between clinical risk score and all-cause death occurrence in atrial fibrillation patients. Methods We performed a systematic search in PubMed and Scopus from inception to 22 July 2017. We considered the following scores: ATRIA-Stroke, ATRIA-Bleeding, CHADS2, CHA2DS2-VASc, HAS-BLED, HATCH and ORBIT. Papers reporting data about scores and all-cause death rates were considered. Results Fifty studies and 71 scores groups were included in the analysis, with 669,217 patients. Data on ATRIA-Bleeding, CHADS2, CHA2DS2-VASc and HAS-BLED were available. All the scores were significantly associated with an increased risk for all-cause death. All the scores showed modest predictive ability at five years (c-indexes (95% confidence interval) CHADS2: 0.64 (0.63–0.65), CHA2DS2-VASc: 0.62 (0.61–0.64), HAS-BLED: 0.62 (0.58–0.66)). Network meta-regression found no significant differences in predictive ability. CHA2DS2-VASc score had consistently high negative predictive value (≥94%) at one, three and five years of follow-up; conversely it showed the highest probability of being the best performing score (63% at one year, 60% at three years, 68% at five years). Conclusion In atrial fibrillation patients, contemporary clinical risk scores are associated with an increased risk of all-cause death. Use of these scores for death prediction in atrial fibrillation patients could be considered as part of holistic clinical assessment. The CHA2DS2-VASc score had consistently high negative predictive value during follow-up and the highest probability of being the best performing clinical score.

Abstract 17617: History of Bleeding and Outcomes with Apixaban versus Warfarin in Patients with Atrial Fibrillation in the ARISTOTLE Trial

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Raffaele De Caterina ◽  
Ulrika Andersson ◽  
John H Alexander ◽  
M.Cecilia Bahit ◽  
Patrick J Commerford ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Body Weight ◽  
Major Bleeding ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Channel Blockers ◽  
Chads2 Score ◽  
History Of

Background: History of bleeding is important in decisions for anticoagulation. We analyzed outcomes in relation to history of bleeding and randomized treatments in patients with atrial fibrillation (AF) in the ARISTOTLE trial. Methods: The on-treatment safety population included 18,140 patients receiving ≥1 dose of study drug, apixaban 5 mg bd (2.5 mg bd if 2 of the following: age >80 yrs; body weight <60 kg; or creatinine >133 μmol/L) or warfarin aiming for INR 2.0-3.0 (median TTR 66%), for a median of 1.8 yrs. Adjudicated outcomes in relation to randomization and history of bleeding were analyzed using a Cox proportional hazards model. Efficacy endpoints were analyzed in the intention-to-treat population. Results: A history of bleeding was reported in 3033 patients (16.7%), who more often were male (68% vs 64%, p <0.0005); with a history of prior stroke/TIA/systemic embolism (23% vs 19%, p <0.0001); diabetes (27% vs 24%, p=0.0010); higher CHADS2 score (CHADS2 >3: 35% vs 29%), age (mean [SD] 71 [9] vs 69 [10], p <0001) and body weight (86 [21] vs 84 [21], p <0.0001); lower creatinine clearance (77 [33] vs 80 [33], p=0.0007) and mean systolic blood pressure (131 [17] vs 132 [16], p=0.0027). Calcium channel blockers, statins, non-steroidal anti-inflammatory drugs and proton pump inhibitors were used more often in patients with vs without a history of bleeding. Major bleeding was the only outcome event occurring more frequently in patients with vs without a history of bleeding, HR 1.7 (95% CI 1.4-2.3) with apixaban and 1.5 (1.2-1.0) with warfarin. Primary efficacy and safety outcomes in relation to randomization, see Table. Conclusions: In patients with AF, a history of bleeding was associated with several risk factors for stroke and bleeding and, accordingly, a higher bleeding risk during anticoagulation. Benefits with apixaban vs warfarin as to stroke, mortality and major bleeding, are however consistent irrespective of bleeding history.

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.

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