scholarly journals Safety and Effectiveness of Edoxaban in Atrial Fibrillation Patients in Routine Clinical Practice: One-Year Follow-Up from the Global Noninterventional ETNA-AF Program

2021 ◽  
Vol 10 (4) ◽  
pp. 573
Author(s):  
Raffaele De Caterina ◽  
Young-Hoon Kim ◽  
Yukihiro Koretsune ◽  
Chun-Chieh Wang ◽  
Takeshi Yamashita ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Major Bleeding ◽  
Stroke Prevention ◽  
Oral Anticoagulants ◽  
Routine Clinical Practice ◽  
Bleeding Events ◽  
Major Bleeding Events ◽  
One Year

Non-vitamin K antagonist oral anticoagulants such as edoxaban are the standard of care for stroke prevention in patients with atrial fibrillation (AF). The Global Edoxaban Treatment in routiNe clinical prActice (ETNA)-AF program integrates prospective, observational, noninterventional regional studies from Europe, Japan, and other Asian countries, collecting data on patient characteristics and clinical outcomes in unselected patients treated with edoxaban for stroke prevention in AF. Overall, 26,823 patients completed a 1-year follow-up and were treated with edoxaban; either 60 or 30 mg once daily. The majority (82.6%) of patients received the recommended doses according to the local label. At baseline, the median (interquartile range) age was 75 (68, 80) years, the CHA2DS2-VASc score was 3.0 (2.0, 4.0), and the hypertension, abnormal renal and liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs, or alcohol (HAS-BLED) score was 2.0 (2.0, 3.0). At one year, there were 273 (1.12%/year) major bleeding events, including 75 (0.31%/year) intracranial hemorrhages and 140 (0.57%/year) major gastrointestinal (GI) bleeds. There were 214 ischemic strokes (0.87%/year). Mortality was 3.03%/year (745 deaths), and cardiovascular mortality accounted for 40% of all deaths (1.22%/year, 299 cardiovascular deaths). In conclusion, stroke, intracranial hemorrhage, and other major bleeding events were low in patients with AF treated with edoxaban in routine care. Even on anticoagulation, cardiovascular death remained common.

Abstract 17152: Frequency and Management of Major Bleeding in Atrial Fibrillation Patients Treated With Warfarin and Non-vitamin K Oral Anticoagulants in Community Practice: Results From the ORBIT-AF II Registry

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Benjamin A Steinberg ◽  
DaJuanicia N Simon ◽  
Laine Thomas ◽  
Jack Ansell ◽  
Gregg C Fonarow ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Recurrent Bleeding ◽  
Bleeding Events ◽  
Reversal Agents ◽  
Major Bleeding Events

Background: Non-vitamin K oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the frequency of major bleeds on NOACs and how these events are managed in clinical practice. Methods: We assessed the rates, management, and outcomes of ISTH major bleeding events among AF patients in the ORBIT-AF II registry (mean follow-up 213 days). Results: Overall, 103 patients experienced 110 major bleeding events during follow-up n=90/4986 (1.8%) on NOAC, and n=20/1320 (1.5%) on warfarin. Patients with bleeding events on NOAC were slightly younger than those on warfarin (median age 76 vs. 80; p=0.2). Among mutually-exclusive bleeding types, intracranial bleeding was more common in warfarin treated patients than NOAC-treated (15% vs 6.7%), whereas GI bleeding was more common on NOACs (56% vs. 40%, overall p=0.1 for bleeding type). Management of bleeding differed by anticoagulation type: blood products and reversal agents were more commonly used in patients on warfarin (Table). No patient received prothrombin complexes, recombinant factor VIIa, aminocaproic acid, tranexamic acid, aprotinin, or desmopressin. Out of 90 major bleeding events in NOAC patients, only 1 was fatal (1%). Within 30 days following bleeding, there were no strokes and 1 TIA (NOAC). Following a major bleed, the recurrent bleeding rate in NOAC patients in the next 30-days was 4% and the death rate was 4%. Conclusions: Rates of major bleeding with NOACs in clinical practice are comparable to those reported in clinical trials. Compared with warfarin, bleeding among NOAC users was less likely intracranial and more likely to be GI. Management of bleeding in the setting of NOAC rarely includes reversal agents.

scholarly journals Edoxaban for stroke prevention in atrial fibrillation in routine clinical care: 1-year follow-up of the prospective observational ETNA-AF-Europe study

2020 ◽  
Author(s):  
Joris R de Groot ◽  
Thomas W Weiss ◽  
Peter Kelly ◽  
Pedro Monteiro ◽  
Jean Claude Deharo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Stroke Prevention ◽  
Clinical Care ◽  
Oral Anticoagulants ◽  
Routine Care ◽  
European Medicines Agency ◽  
Systemic Embolism ◽  
Bleeding Events

Abstract Aims Non-vitamin K oral anticoagulants are safe and effective for stroke prevention in patients with atrial fibrillation (AF). Data on the safety and efficacy of edoxaban in routine care are limited in Europe. We report 1-year outcomes in patients with AF treated with edoxaban in routine care. Methods and results ETNA-AF-Europe is a prospective, multicentre, post-authorization, observational study enrolling patients treated with edoxaban in 10 European countries, the design of which was agreed with the European Medicines Agency as part of edoxaban’s post-approval safety plan. Altogether 13 092 patients in 852 sites completed the 1-year follow-up [mean age: 73.6 ± 9.5 years; 57% male, mean follow-up: 352 ± 49 days (median: 366 days)]. Most patients had associated comorbidities (mean CHA2DS2-VASc score: 3.1 ± 1.4). Stroke or systemic embolism was reported in 103 patients (annualized event rate: 0.82%/year), and major bleeding events were reported in 132 patients (1.05%/year). Rates of intracranial haemorrhage were low [30 patients (0.24%/year)]. Death occurred in 442 patients (3.50%/year); cardiovascular (CV) death occurred in 206 patients (1.63%/year). The approved dosing of edoxaban was chosen in 83%. All-cause and CV mortality were higher in patients receiving edoxaban 30 mg vs. 60 mg, in line with the higher age and more frequent comorbidities of the 30 mg group. Major bleeding was also numerically more common in patients receiving edoxaban 30 mg vs. 60 mg. Conclusion The rates of stroke, systemic embolism, and major bleeding are low in this large unselected cohort of high-risk AF patients routinely treated with edoxaban.

P4742Evaluation of the HAS-BLED, ATRIA and ORBIT bleeding risk scores in newly diagnosed non-valvular atrial fibrillation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Bergamaschi ◽  
A Stefanizzi ◽  
M Coriano ◽  
P Paolisso ◽  
I Magnani ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Independent Predictor ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Newly Diagnosed ◽  
Bleeding Events ◽  
Hemorrhagic Events ◽  
Major Bleeding Events

Abstract Background Several risk scores have been proposed to assess the bleeding risk in patients with Atrial Fibrillation. Purpose To compare the efficacy of HAS-BLED, ATRIA and ORBIT scores to predict major bleedings in newly diagnosed non-valvular AF (NV-AF) treated with vitamin K antagonists (VKAs) or new oral anticoagulants (NOACs). Methods We analyzed all consecutive patients with AF at our outpatient clinic from January to December 2017. Only those with new diagnosed NV-AF starting new anticoagulant therapy were enrolled. Major hemorrhagic events were defined according to the ISTH definition in non-surgical patients. Results Out of the 820 patients admitted with AF, 305 were newly diagnosed with NV-AF starting oral anticoagulation. Overall, 51.3% were male with a mean age of 72.6±13.7 years. Thirty-six patients (11.8%) started VKAs whereas 269 (88.2%) patients were treated with NOACs. The median follow-up time was 10.4±3.4 months. During follow-up, 123 (32.2%) bleeding events were recorded, 21 (17,1%) in the VKA group and 102 (82,9%) in the NOAC group. Eleven (2.9%) major bleeding events occurred: 5 (45.5%) in the VKA group and 6 (54.5%) in the NOAC group. Overall, patients with major hemorrhagic events showed a mean value of the scores significantly higher when compared to patients without such bleeding complications (HASBLED 3.4 vs 2.4 p=0.007; ATRIA 5.6 vs 2.4 p<0.001; ORBIT 3.6 vs 1.8 p<0,001). Conversely, when analyzing the VKA subgroup, only the ATRIA score was significantly higher in patients with major adverse events (7.4 vs 3.5 p<0.001; HAS-BLED: 4.4 vs 3.6 p=0.27; ORBIT 4.4 vs 2.9 p=0.13). An ATRIA score ≥4 identified patients at high risk of bleeding (29.4% vs. 0% events. respectively, p=0.04). In the NOAC group, patients with major bleeding events had higher mean values of ATRIA (4.0 vs 2.3 p=0.02) and ORBIT (2.8 vs 1.6 p=0,04) but not the HAS-BLED (2.5 vs 2.3 p=0.57) scores. Similarly, patients on NOACs with an ATRIA score ≥4 had higher rates of major bleedings (8.1% vs. 1.6% p=0,02). Comparing the single elements of the ATRIA score, only glomerular filtration rate <30 ml/min/1.73 mq was associated with major bleedings in the VKA group (p<0.001) whereas, in the NOAC group, anemia was strongly associated with bleeding events (p=0,02). In fact, multivariate analysis in the NOAC group showed that hemoglobin level at admission was an independent predictor for major bleeding events (OR 0.41, 95% CI 0.23–0.75, P=0.003). Conversely, in the VKA group, baseline creatinine level was an independent predictor for these events (OR 12.76, 95% CI 1.6–101.7, P=0.016). Conclusions The ATRIA score showed the best efficacy in predicting major bleeding events. Hemoglobin and creatinine levels at admission were independent predictors for major hemorrhagic events in the NOAC and in the VKA groups, respectively. The latter finding might be helpful in stratifying the hemorrhagic risk at the beginning of treatment.

scholarly journals Temporal trend of clinical events in patients with atrial fibrillation on edoxaban therapy: results from the non-interventional global ETNA-AF program

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
L Dinshaw ◽  
C Chen ◽  
R De Caterina ◽  
W Jiang ◽  
Y.-H Kim ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Temporal Trend ◽  
Routine Clinical Practice ◽  
Clinical Event ◽  
Clinical Events ◽  
Baseline Characteristics

Abstract Background Patients with atrial fibrillation (AF) who initiated vitamin K antagonist (VKA) were at highest risk of stroke and bleeding in the first few months of therapy. Understanding of the temporal trend of clinical events in AF patients on non-VKA oral anticoagulant (NOAC) therapy should aid therapeutic decisions. Purpose To evaluate the temporal trend of clinical events in AF patients receiving edoxaban in routine clinical practice in the Global ETNA-AF program. Methods Global ETNA-AF is a multicentre, prospective, noninterventional program evaluating the safety and effectiveness of edoxaban in patients from European and Asian countries. Thromboembolic, bleeding and death events were analysed separately for the 1st and 2nd year of the follow-up period, using a time-to-first-event estimation of cumulative incidence and annual rate via Kaplan-Meier method. Results A total of 27,617 patients were included in this analysis, 48.6% from Europe and 51.4% from Japan, Korea, and Taiwan. Baseline characteristics were consistent with typical AF population in real world studies (Table 1). Approximately 83% of patients received the recommended edoxaban dose. Annualized rates of ischaemic stroke and major bleeding (ISTH) were lower in the 2nd year than in the 1st year: ischaemic stroke 0.59% (95% CI, 0.50–0.70) vs 0.86% (95% CI, 0.75–0.98), p=0.015; major bleeding 0.87% (95% CI, 0.75–1.00) vs 1.15% (95% CI, 1.02–1.29), p=0.036. The trend toward lower rates of ischaemic stroke and major bleeding in the 2nd year was consistent across regions. All-cause mortality increased slightly from the 1st year to the 2nd year, which was not statistically significant and was not driven by cardiovascular (CV) mortality (Table 2). Conclusion In routine clinical practice in the Global ETNA-AF program, major bleeding and ischaemic stroke rates in &gt;27,000 patients on edoxaban therapy declined from 1st year to 2nd year. Further analyses will investigate whether such trend is influenced by selection for healthier patients over time. Longer follow-up is needed to better understand long-term trends. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Table 1. Baseline characteristics Table 2. Annualised clinical event rates

Novel bleeding prediction model in atrial fibrillation patients on new oral anticoagulants

Heart ◽  
2021 ◽  
pp. heartjnl-2021-319702
Author(s):  
Ofra Barnett-Griness ◽  
Nili Stein ◽  
Antonio Kotler ◽  
Walid Saliba ◽  
Naomi Gronich
Keyword(s):  
Atrial Fibrillation ◽  
Health Services ◽  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Bleeding Event ◽  
New Oral Anticoagulants ◽  
Selection Algorithm ◽  
Bleeding Events ◽  
Major Bleeding Events

ObjectiveClinical models such as the HAS-BLED (standing for Hypertension, Abnormal liver/renal function, Stroke history, Bleeding history or predisposition, Labile INR, Elderly, Drug/alcohol usage) were developed to predict risk of major bleeding on vitamin K antagonists/antiplatelet therapy. We aimed to develop a model that will improve the ability to predict major bleeding events in patients with non-valvular atrial fibrillation (AF) treated with new oral anticoagulants (NOACs).MethodsClalit Health Services is the largest of four integrated healthcare organisations in Israel, which insures 4.7 million patients (53% of the population). We identified in Clalit Health Services all patients with AF, new users of an NOAC (2013–2017), and followed them until first occurrence of a major bleeding event, death, switch to another oral anticoagulant, 30 days after discontinuation of NOAC or end of follow-up (31 December 2019). Importance of the candidate model variables was estimated by inclusion frequencies across forward selection algorithm applied to 50 bootstrap samples. Then, backward selection algorithm using the modified Bayesian Information Criterion for competing risks was applied to select predictors for the final model.Results47 623 patients with AF prescribed NOAC were studied. 28 055 patients with AF, initiators of apixaban (mean age 78.7, SD 9.0), were included in the first phase and had 662 major bleeding events. Nine variables were selected for inclusion in a final points-based risk-scoring system: male sex, anaemia, thrombocytopaenia (<99×103/µL), concurrent antiplatelet therapy, hypertension, prior major bleeding, risk factors for a fall, low cholesterol level and low estimated glomerular filtration rate, with apparent area-under-curve (AUC) of 0.6546. Applicability of the model was then shown for 14 118 and 5450 patients with AF, initiators of dabigatran and rivaroxaban, where the score achieved c indices of 0.62 and 0.61, respectively.ConclusionsWe present a novel and simple risk score for prediction of major bleeding in patients with non-valvular AF treated with NOACs. Validation in additional cohorts is warranted.

scholarly journals A single institution’s experience with using dabigatran, rivaroxaban and warfarin for prevention of thromboembolism in atrial fibrillation

2017 ◽  
Vol 27 (1) ◽  
pp. 20-25 ◽  
Author(s):  
Li Xin Chan ◽  
Yee May Wong ◽  
Pow-Li Chia ◽  
Zhen Liang Kek
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Oral Anticoagulants ◽  
Tertiary Hospital ◽  
Minor Bleeding ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Warfarin Group ◽  
One Year

Background: Although non-vitamin K antagonist oral anticoagulants (NOACs) are approved for stroke prevention in atrial fibrillation (AF) patients, their use in the local clinical setting has not been well studied. This study aims to evaluate the clinical outcomes of dabigatran, rivaroxaban and warfarin in a tertiary hospital in Singapore. Methods: This is a retrospective cohort study with one-year follow-up. A total of 383 patients recruited between June 2011 and December 2014 were studied. Incidents of stroke, systemic embolism and clinically relevant bleeding events were compared between dabigatran, rivaroxaban and warfarin. Results: Stroke rates were 5.47% per year with warfarin, 7.27% per year with dabigatran (HR=1.32; 95% CI 0.48−3.64; p=0.591) and 2.76% per year with rivaroxaban (HR=0.49; 95% CI 0.14−1.69; p=0.261). The warfarin group had significantly higher incidence of minor bleeding (62.4% vs 3.64% for dabigatran vs 13.79% for rivaroxaban; p<0.001), major bleeding (3.91% for warfarin, 0.91% for dabigatran, 0% for rivaroxaban; p=0.028) and other adverse events (51.18% for warfarin, 3.64% for dabigatran, 8.28% for rivaroxaban; p<0.001). Incidence of dyspepsia was higher in both NOAC groups compared to warfarin (0% for warfarin, 7.27% for dabigatran, 5.52% for rivaroxaban; p=0.003). Conclusion: Stroke and venous thromboembolism rates after one year were comparable among dabigatran, rivaroxaban and warfarin. Warfarin was associated with more bleeding and adverse events while both NOACs were associated with higher rates of dyspepsia. Further study is needed to assess the clinical benefit of NOACs in the Singaporean population.

Patterns of oral anticoagulation use with cardioversion in clinical practice

Heart ◽  
2020 ◽  
pp. heartjnl-2019-316315
Author(s):  
Kyle Geurink ◽  
DaJuanicia Holmes ◽  
Michael D Ezekowitz ◽  
Karen Pieper ◽  
Gregg Fonarow ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Inclusion Criteria ◽  
Related Hospitalisation ◽  
Informed Treatment ◽  
Ischaemic Attack

BackgroundCardioversion is common among patients with atrial fibrillation (AF). We hypothesised that novel oral anticoagulants (NOAC) used in clinical practice resulted in similar rates of stroke compared with vitamin K antagonists (VKA) for cardioversion.MethodsUsing the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II, patients with AF who had a cardioversion, follow-up data and an AF diagnosis within 6 months of enrolment were identified retrospectively. Clinical outcomes were compared for patients receiving a NOAC or VKA for 1 year following cardioversion.ResultsAmong 13 004 patients with AF, 2260 (17%) underwent cardioversion. 1613 met the inclusion criteria for this analysis. At the time of cardioversion, 283 (17.5%) were receiving a VKA and 1330 (82.5%) a NOAC. A transoesophageal echocardiogram (TOE) was performed in 403 (25%) cardioversions. The incidence of stroke/transient ischaemic attack (TIA) at 30 days was the same for patients having (3.04 per 100 patient-years) or not having (3.04 per 100 patient-years) a TOE (p=0.99). There were no differences in the incidence of death (HR 1.19, 95% CI 0.62 to 2.28, p=0.61), cardiovascular hospitalisation (HR 1.02, 95% CI 0.76 to 1.35, p=0.91), stroke/TIA (HR 1.18, 95% CI 0.30 to 4.74, p=0.81) or bleeding-related hospitalisation (HR 1.29, 95% CI 0.66 to 2.52, p=0.45) at 1 year for patients treated with either a NOAC or VKA.ConclusionsCardioversion was a low-risk procedure for patients treated with NOAC, and there were statistically similar rates of stroke/TIA 30 days after cardioversion as for patients treated with VKA. There were no statically significant differences in death, stroke/TIA or major bleeding at 1 year among patients treated with NOAC compared with VKA after cardioversion.

scholarly journals Assessment of Predicted Rate and Associated Factors of Dabigatran-induced Bleeding Events in Malaysian Patients with Non-Valvular Atrial Fibrillation

2017 ◽  
Vol 20 (1) ◽  
pp. 365 ◽  
Author(s):  
Semira Abdi Beshir ◽  
Lok Bin Yap ◽  
Szyuin Sim ◽  
Kok Han Chee ◽  
Yoke Lin Lo
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Congestive Heart Failure ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Laboratory Test Results ◽  
Major Bleeding Events

Purpose: To assess the predicted rate and the factors associated with bleeding events among patients with non-valvular atrial fibrillation (NVAF) receiving dabigatran therapy. Methods: This retrospective cohort study includes adult patients of two tertiary hospitals in Malaysia. Potential study subjects were identified using pharmacy supply database or novel oral anticoagulant (NOAC) registry. Demographics, clinical data and laboratory test results were extracted from the medical records of the patients or electronic databases. The main outcome measure is the occurrence of a bleeding event. Bleeding events were classified into major bleeding, clinically relevant non-major bleeding, or minor bleeding, according to the International Society on Thrombosis and Haemostasis criteria. We consider clinically relevant non-major bleeding events or major bleeding events as clinically relevant bleeding events. An occurrence of any bleeding event was recorded from the initiation of NOAC therapy until the death of a patient, or the date of permanent discontinuation of NOAC use, or the last day of data collection. The predicted rate of dabigatran-induced bleeding events per 100 patient-years was estimated. Results: During a median follow-up period of 18 months, 73 patients experienced 90 bleeding events. Among these patients, 25 including 4 fatal cases, experienced major bleeding events. The predicted rate per 100 patient-years of follow-up of any bleeding events was 9.0 [95% CI 6.9 to 11.1]; clinically relevant bleeding events 6.0 [95% CI 4.8 to 8.3], and major bleeding events 3.0 [95% CI 1.9 to 4.2]. The independent risk factor for clinically relevant bleeding events is prior bleeding. While prior bleeding or congestive heart failure is linked with major bleeding events. Conclusions: The predicted rate for dabigatran-induced major bleeding episodes is low but these adverse events carry a high fatality risk. Preventive measures should target older patients who have prior bleeding or congestive heart failure. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

Bleeding risks with frailty and multimorbidity in patients with atrial fibrillation. A nationwide analysis of 1.4 million subjects

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Fauchier ◽  
A Bisson ◽  
A Bodin ◽  
J Herbert ◽  
N Clementy ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Frailty Index ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Bleeding Events ◽  
Frailty Phenotype ◽  
One Year

Abstract Background Frailty and multimorbidity are common in patients with atrial fibrillation (AF). The quantifiable frailty phenotype has been validated as predictive of mortality and disability, and patients can be categorised as frail and non-frail using the Claims-based Frailty Index (CFI). The Charlson comorbidity index (CCI) is a tool to quantify multimorbidity and also a strong estimator of mortality. We evaluated whether frailty and multimorbidity are associated with the risk of major bleeding in patients with AF. Methods Based on the administrative hospital-discharge database, we collected information for all patients with AF between 2010 and 2019 in France. CCI and CFI were calculated for each patient, and their associated risks of bleeding compared to 4 bleeding risk scores (HAS-BLED, HEMORR2HAGES, ATRIA and ORBIT). The analysis focused on patients with events or with at least one year of follow-up. Predictive abilities of the scores were compared in the whole population, and then separately in the subgroup of elderly patients (&gt;75 yo). Results Among 1,372,567 patients with AF, 131,535 major bleeding events were recorded during a follow-up of 3.5±2.1 years (median 3.1, IQR 1.8–4.9) (yearly rate 2.7%). Bleeding occurred more commonly in patients with higher HAS-BLED, ATRIA, CCI and CFI scores. Those with high frailty and multimorbidity had markedly higher yearly incidences of bleeding events of 13.0% and 14.7%, respectively (vs low frailty and multimorbidity: 4.3%% and 4.1%, respectively; p&lt;0.001). The 4 bleeding risk scores significantly had lower c-statistics than CCI and CFI for predicting major bleeding (table). In elderly patients (n=853,833), the c-statistics were all lower than in the whole population and were lower for the 4 scores than for the CCI and CFI scores (0.463, 0.473, 0.443, 0.445, 0.622 and 0.620 for HAS-BLED, ATRIA, ORBIT, HEMORR2HAGES, CCI and CFI, respectively). Conclusion Multimorbidity and frailty, respectively assessed with CCI and CFI, demonstrated statistically better performances in predicting major bleeding than the 4 established bleeding risk scores in AF. Funding Acknowledgement Type of funding source: None

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