156 Rivaroxaban in very elderly patients with atrial fibrillation

Abstract Aims The incidence of atrial fibrillation (AF) increases with age. The risk of stroke is increased 4- to 5-fold in old patients with AF. In the Framingham Study, 23.5% of strokes in patients aged 80 and older were attributable to AF. Advanced age is also associated with a progressive increase in the risk of major bleeding in subjects ≥85 years, particularly if treated by oral anticoagulants (OAC). Only 20% of patients >75 years were included in randomized controlled trials (RCTs) involving OACs in AF, due to the high risk of falls and bleeding, especially intracranial haemorrhage (ICH). The management of anticoagulation in the very elderly represents a challenging issue because they are at high thromboembolic risk, and also at high haemorrhagic risk. The aim of our study was to describe the use and tolerability of rivaroxaban in very old patients with heart failure with reduced ejection fraction. The average age of enrolled patients is 76.0 ± 8.4 years with a significant prevalence of the elderly (16.0% with age ≥85 years with a slight male prevalence). Methods We analysed retrospective data from 50 patients from June 2016 to June 2018 and taking rivaroxaban 20 mg. The average age of enrolled patients was 76 ± 8.2 years and 40% were females. The inclusion criteria were patients with at least one episode of documented AF of any duration in the preceding 12 months. The average CHA2DS2-VASc of these subjects is 3.2 ± 1.4, while the haemorrhagic risk expressed by the HAS-BLED appears more contained (2.7 ± 1.1). The risk profile of these patients was complex as documented by an older age, by a CHA2DS2-VASc higher and by the prevalence of comorbidities such as heart failure, valvular disease, peripheral vasculopathy and diabetes mellitus. Follow-up, characterized by clinical examination and blood analysis, was performed at 3, 6, and 12 months. The AF patients were followed for the effectiveness outcome of thromboembolism (ischaemic stroke and/or systemic embolism) and bleeding outcomes (composite of major bleeding, gastrointestinal bleeding, and intracranial Haemorrhage), as well as bleeding requiring hospitalization. A secondary safety endpoint was total minor bleedings. Standard two-dimensional transthoracic echocardiographic examination was performed. Left ventricular end-diastolic volume, end-systolic volume, and ejection fraction (LVEF) were measured using the modified Simpson’s rule from the apical view. Results During follow-up, we observed no major bleedings, strokes, or cardiovascular deaths. Only two minor haemorrhages (one epistaxis and one haematuria, none of which required blood transfusion or hospital admission) observed with no differences observed in LVEF or left atrial dimension at echocardiography, body mass index, and the thrombotic and haemorrhagic risk profile. Conclusions Such data confirm that the new oral anticoagulants, and in particular rivaroxaban, are considered safe even in the most population frail and above all elderly, allowing for enlargement the use of anticoagulant therapy. Results are expected of long-term follow-up to confirm the benefits of that therapeutic choice.

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

European Heart Journal ◽

10.1093/eurheartj/ehz746.0858 ◽

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.

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Reasons for and consequences of oral anticoagulant underuse in atrial fibrillation with heart failure

Heart ◽

10.1136/heartjnl-2017-312720 ◽

2018 ◽

Vol 104 (13) ◽

pp. 1093-1100 ◽

Cited By ~ 15

Author(s):

Gianluigi Savarese ◽

Ulrik Sartipy ◽

Leif Friberg ◽

Ulf Dahlström ◽

Lars H Lund

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Major Bleeding ◽

Oral Anticoagulants ◽

Bleeding Risk ◽

Patients With Heart Failure ◽

Unit Increase ◽

History Of ◽

Logistic Regressions

ObjectiveAtrial fibrillation (AF) is common in patients with heart failure (HF), and oral anticoagulants (OAC) are indicated. The aim was to assess prevalence of, predictors of and consequences of OAC non-use.MethodsWe included patients with AF, HF and no previous valve replacement from the Swedish Heart Failure Registry. High and low CHA2DS2-VASc and HAS-BLED scores were defined as above/below median. Multivariable logistic regressions were used to assess the associations between baseline characteristics and OAC use and between CHA2DS2-VASc and HAS-BLED scores and OAC use. Multivariable Cox regressions were used to assess associations between CHA2DS2-VASc and HAS-BLED scores, OAC use and two composite outcomes: all-cause death/stroke and all-cause death/major bleeding.ResultsOf 21 865 patients, only 12 659 (58%) received OAC. Selected predictors of OAC non-use were treatment with platelet inhibitors, less use of HF treatments, paroxysmal AF, history of bleeding, no previous stroke, planned follow-up in primary care, older age, living alone, lower income and variables associated with more severe HF. For each 1-unit increase in CHA2DS2-VASc and HAS-BLED, the ORs (95% CI) of OAC use were 1.24 (1.21–1.27) and 0.32 (0.30–0.33), and the HRs for death/stroke were 1.08 (1.06–1.10) and for death/major bleeding 1.18 (1.15–1.21), respectively. For high versus low CHA2DS2-VASc and HAS-BLED, the ORs of OAC use were 1.23 (1.15–1.32) and 0.20 (0.19–0.21), and the HRs for death/stroke were 1.25 (1.19–1.30) and for death/major bleeding 1.28 (1.21–1.34), respectively.ConclusionsPatients with AF and concomitant HF do not receive OAC on rational grounds. Bleeding risk inappropriately affects decision-making more than stroke risk.

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Edoxaban treatment of elderly patients with atrial fibrillation in routine clinical practice: 1-year results of the non-interventional Global ETNA-AF program

European Heart Journal ◽

10.1093/ehjci/ehaa946.0663 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

T Yamashita ◽

C.C Wang ◽

Y.-H Kim ◽

R De Caterina ◽

P Kirchhof ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Major Bleeding ◽

Intracranial Haemorrhage ◽

Clinical Care ◽

Oral Anticoagulants ◽

Clinical Event ◽

Funding Source ◽

Private Company ◽

All Cause Mortality

Abstract Background The prevalence of atrial fibrillation (AF) and the need for appropriate anticoagulation increase with age. The benefit/risk profile of direct oral anticoagulants such as edoxaban in elderly population with AF in regular clinical practice is therefore of particular interest. Purpose Analyses of Global ETNA-AF data were performed to report patient characteristics, edoxaban treatment, and 1-year clinical events by age subgroups. Methods Global ETNA-AF is a multicentre, prospective, noninterventional program conducted in Europe, Japan, Korea, Taiwan, and other Asian countries. Demographics, baseline characteristics, and 1-year clinical event data were analysed in four age subgroups. Results Of 26,823 patients included in this analysis, 50.4% were ≥75 years old and 11.6% were ≥85 years. Increase in age was generally associated with lower body weight, lower creatinine clearance, higher CHA2DS2-VASc and HAS-BLED scores, and a higher percentage of patients receiving the reduced dose of 30 mg daily edoxaban. At 1-year, rates of ISTH major bleeding and ischaemic stroke were generally low across all age subgroups. The proportion of intracranial haemorrhage within major bleeding events was similar across age groups. All-cause mortality increased with age more than cardiovascular mortality. Conclusion Data from Global ETNA-AF support the safety and effectiveness of edoxaban in elderly AF patients (including ≥85 years) in routine clinical care with only a small increase in intracranial haemorrhage. The higher all-cause mortality with increasing age is not driven by cardiovascular causes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo

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Plasma natriuretic peptide level is an independent determinant of major clinical outcomes in atrial fibrillation patients without heart failure: the Fushimi AF Registry

European Heart Journal ◽

10.1093/ehjci/ehaa946.0673 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

Y Hamatani ◽

M Iguchi ◽

Y Aono ◽

K Ishigami ◽

S Ikeda ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Chronic Kidney Disease ◽

Kidney Disease ◽

Clinical Outcomes ◽

Prognostic Marker ◽

Oral Anticoagulants ◽

Systemic Embolism ◽

The Mean

Abstract Background Atrial fibrillation (AF) increases the risk of death, stroke/systemic embolism and heart failure (HF). Plasma natriuretic peptide (NP) level is an important prognostic marker in HF patients. However, little is known regarding the prognostic significance of plasma NP level in AF patients without HF. Purpose The aim of this study is to investigate the relationship between plasma NP level and clinical outcomes such as all-cause death, stroke/systemic embolism and HF hospitalization during follow-up period in AF patients without HF. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in our city. The inclusion criterion of the registry is the documentation of AF at 12-lead electrocardiogram or Holter monitoring at any time, and there are no exclusion criteria. We started to enroll patients from March 2011, and follow-up data were available for 4,466 patients by the end of November 2019. From the registry, we excluded 1,220 patients without a pre-existing HF (defined as having one of the following; prior hospitalization for HF, New York Heart Association class ≥2, or left ventricular ejection fraction <40%). Among 3,246 AF patients without HF, we investigated 1,189 patients with the data of plasma BNP (n=401) or N-terminal pro-BNP (n=788) level at the enrollment. We divided the patients according to the quartile of each plasma BNP or NT-pro BNP level and compared the backgrounds and outcomes between these 4 groups stratified by plasma NP level. Results Of 1,189 patients, the mean age was 72.1±10.2 years, 454 (38%) were female and 684 (58%) were paroxysmal AF. The mean CHADS2 and CHA2DS2-VASc score were 1.6±1.1 and 2.9±1.5, respectively. Oral anticoagulants were prescribed in 671 (56%) at baseline. The median (interquartile range) BNP and N-terminal pro-BNP level were 84 (38, 176) and 500 (155, 984) pg/ml, respectively. Patients with high plasma NP level were older, and demonstrated lower prevalence of paroxysmal AF, higher CHADS2 and CHA2DS2-VASc scores and higher prevalence of chronic kidney disease and oral anticoagulants prescription (all P<0.01). A total of 165 all-cause death, 114 stroke/systemic embolism and 103 HF hospitalization occurred during the median follow-up period of 5.0 years. Kaplan-Meier curves demonstrated that higher plasma NP level was significantly associated with the incidences of all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF (Figure 1A). Multivariable Cox regression analysis revealed that plasma NP level could stratify the risk of clinical outcomes even after adjustment by type of AF, CHA2DS2-VASc score, chronic kidney disease and oral anticoagulant prescription (Figure 1B). Conclusion Plasma NP level is a significant prognostic marker for all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF, suggesting the importance of measuring plasma NP level in AF patients even without HF. Figure 1 Funding Acknowledgement Type of funding source: None

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Catheter ablation of atrial fibrillation in patients with heart failure with preserved ejection fraction: a systematic review and meta-analysis

European Heart Journal ◽

10.1093/ehjci/ehaa946.0582 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

O.M Aldaas ◽

F Lupercio ◽

C.L Malladi ◽

P.S Mylavarapu ◽

D Darden ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Systematic Review ◽

Catheter Ablation ◽

Ejection Fraction ◽

Meta Analysis ◽

Preserved Ejection Fraction ◽

Patients With Heart Failure ◽

One Year

Abstract Background Catheter ablation improves clinical outcomes in symptomatic atrial fibrillation (AF) patients with heart failure (HF) with reduced ejection fraction (HFrEF). However, the role of catheter ablation in HF patients with a preserved ejection fraction (HFpEF) is less clear. Purpose To determine the efficacy of catheter ablation of AF in patients with HFpEF relative to those with HFrEF. Methods We performed an extensive literature search and systematic review of studies that compared AF recurrence at one year after catheter ablation of AF in patients with HFpEF versus those with HFrEF. Risk ratio (RR) 95% confidence intervals were measured using the Mantel-Haenszel method for dichotomous variables, where a RR<1.0 favors the HFpEF group. Results Four studies with a total of 563 patients were included, of which 312 had HFpEF and 251 had HFrEF. All patients included were undergoing first time catheter ablation of AF. Patients with HFpEF experienced similar recurrence of AF one year after ablation on or off antiarrhythmic drugs compared to those with HFrEF (RR 0.87; 95% CI 0.69–1.10, p=0.24), as shown in Figure 1. Recurrence of AF was assessed with electrocardiography, Holter monitoring, and/or event monitoring at scheduled follow-up visits and final follow-up. Conclusion Based on the results of this meta-analysis, catheter ablation of AF in patients with HFpEF appears as efficacious in maintaining sinus rhythm as in those with HFrEF. Funding Acknowledgement Type of funding source: None

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The Number of Concomitant Drugs and the Safety of Direct Oral Anticoagulants in Routine Care Patients with Atrial Fibrillation

TH Open ◽

10.1055/s-0040-1721499 ◽

2020 ◽

Vol 04 (04) ◽

pp. e417-e426

Author(s):

Carline J. van den Dries ◽

Sander van Doorn ◽

Patrick Souverein ◽

Romin Pajouheshnia ◽

Karel G.M. Moons ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Major Bleeding ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Routine Care ◽

P Value ◽

Risk Of Mortality ◽

Mortality Effect

Abstract Background The benefit of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) on major bleeding was less prominent among atrial fibrillation (AF) patients with polypharmacy in post-hoc randomized controlled trials analyses. Whether this phenomenon also exists in routine care is unknown. The aim of the study is to investigate whether the number of concomitant drugs prescribed modifies safety and effectiveness of DOACs compared with VKAs in AF patients treated in general practice. Study Design Adult, nonvalvular AF patients with a first DOAC or VKA prescription between January 2010 and July 2018 were included, using data from the United Kingdom Clinical Practice Research Datalink. Primary outcome was major bleeding, secondary outcomes included types of major bleeding, nonmajor bleeding, ischemic stroke, and all-cause mortality. Effect modification was assessed using Cox proportional hazard regression, stratified for the number of concomitant drugs into three strata (0–5, 6–8, ≥9 drugs), and by including the continuous variable in an interaction term with the exposure (DOAC vs. VKA). Results A total of 63,600 patients with 146,059 person-years of follow-up were analyzed (39,840 person-years of DOAC follow-up). The median age was 76 years in both groups, the median number of concomitant drugs prescribed was 7. Overall, the hazard of major bleeding was similar between VKA-users and DOAC-users (hazard ratio [HR] 0.98; 95% confidence interval [CI] 0.87–1.11), though for apixaban a reduction in major bleeding was observed (HR 0.81; 95% CI 0.68–0.98). Risk of stroke was comparable, while risk of nonmajor bleeding was lower in DOAC users compared with VKA users (HR 0.92; 95% CI 0.88–0.97). We did not observe any evidence for an impact of polypharmacy on the relative risk of major bleeding between VKA and DOAC across our predefined three strata of concomitant drug use (p-value for interaction = 0.65). For mortality, however, risk of mortality was highest among DOAC users, increasing with polypharmacy and independent of the type of DOAC prescribed (p-value for interaction <0.01). Conclusion In this large observational, population-wide study of AF patients, risk of bleeding, and ischemic stroke were comparable between DOACs and VKAs, irrespective of the number of concomitant drugs prescribed. In AF patients with increasing polypharmacy, our data appeared to suggest an unexplained yet increased risk of mortality in DOAC-treated patients, compared with VKA recipients.

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Abstract 14344: Prognostic Factors of Atrial Fibrillation Patients With Coronary Artery Disease: The Fushimi Af Registry

Circulation ◽

10.1161/circ.142.suppl_3.14344 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Nobutoyo Masunaga ◽

Hisashi Ogawa ◽

Yuya Aono ◽

Syuhei Ikeda ◽

KOSUKE DOI ◽

...

Keyword(s):

Diabetes Mellitus ◽

Heart Failure ◽

Atrial Fibrillation ◽

Prognostic Factors ◽

Major Bleeding ◽

Cardiac Death ◽

Cardiovascular Events ◽

Factors Associated ◽

Artery Disease

Background: Atrial fibrillation (AF) patients are likely to have concomitant coronary artery disease (CAD). A new strategy of antithrombotic therapy in AF patients with stable CAD was demonstrated in recent randomized clinical trials. Now that antithrombotic therapy for AF patients with CAD has reached a major turning point, it is important to know the prognostic factors in those patients. Purpose: In this study, we investigated clinical characteristics, cardiovascular events and prognostic factors in AF patients with CAD. Methods: The Fushimi AF Registry, a community-based prospective survey, was designed to enroll all of the AF patients who visited the participating medical institutions in Fushimi-ku, Kyoto, Japan. Follow up data including prescription status were available in 4,441 patients from March 2011 to November 2019. Of 4,441 patients, 645 patients had a history of CAD at enrollment. Results: The mean age was 76.4±8.6 and 65.9% were male. Averages of CHA 2 DS 2 -VASc score and HAS-BLED score were 4.41 and 2.35, respectively. Oral anticoagulant (OAC) was prescribed in 52.9% of those patients and antiplatelet drug (APD) was prescribed in 70.4%. The combination of OAC and APD was prescribed in 36.0%. During follow-up period (median 1,495 days), cardiac death occurred in 51 patients, composite of cardiac death, myocardial infarction (MI) and stroke in 136, and major bleeding in 77 (1.8, 5.1 and 2.9 per 100 person-years, respectively). In multivariate analysis, factors associated with composite of cardiac death, MI and stroke in AF patients with CAD were low body weight (<=50kg) (hazard ratio [95% confidence interval]; 1.62 [1.07-2.47]), previous stroke (1.69 [1.13-2.52]), heart failure (1.47 [1.02-2.11]), hypertension (0.60 [0.41-0.87]) and diabetes mellitus (1.62 [1.13-2.32]). Furthermore, factors associated with major bleeding in AF patients with CAD were anemia (male: hemoglobin<12 g/dl, female: hemoglobin<11 g/dl) (1.82 [1.09-3.04]) and thrombocytopenia (<150,000 /μL) (3.02 [1.29-7.03]). Conclusion: In Japanese AF patients with CAD, low body weight, previous stroke, heart failure, hypertension and diabetes mellitus were associated with cardiovascular events, and anemia and thrombocytopenia were associated with major bleeding.

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Impacts of off-label dosing noacs on clinical outcomes in very elderly patients with atrial fibrillation

European Heart Journal ◽

10.1093/eurheartj/ehab724.0565 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

T Chao ◽

Y.H Chan ◽

G.Y.H Lip ◽

S.A Chen

Keyword(s):

Atrial Fibrillation ◽

Clinical Outcomes ◽

Major Bleeding ◽

Lower Risk ◽

Oral Anticoagulants ◽

Systemic Embolism ◽

Very Elderly ◽

Off Label ◽

Funding Sources ◽

Clinical Events

Abstract Background Studies about the comparisons of on-label and off-label dosing non-vitamin K antagonist oral anticoagulants (NOACs) regarding the risks of clinical outcomes among atrial fibrillation (AF) patients have been published. However, data among the very elderly AF patients were limited. In the present study, we aimed to investigate the impacts of inappropriate dosing of NOACs on clinical outcomes in AF patients aged ≥85 years of age. Methods We used medical data from a multi-center healthcare system in Taiwan enrolling 1,836 and 268 AF patients aged ≥85 years treated with NOACs and warfarin, respectively. Among 1,836 patients receiving NOACs, underdosing, overdosing and on-label dosing NOACs were prescribed in 248, 149 and 1439 patients, respectively. The risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding were compared between warfarin and NOACs in different dosing groups. Also, the risks of clinical events of underdosing and overdosing NOACs were comapred to on-labeling dosing. Results Compared to warfarin, underdosing NOACs were associated with a higher risk of IS/SE (aHR 2.39; p=0.048) without a lower risk of major bleeding; while overdosing NOACs were not associated with a lower risk of IS/SE (aHR 0.74, p=0.604) (Figure 1). Compared to on-label dosing NOACs, underdosing NOACs were associated with a higher risk of IS/SE, while the risk was not lower for overdoing NOACs (Figure 2). Conclusions Even for very elderly AF patients aged ≥85 years, NOACs should still be prescribed at the dosing following the criteria defined in clinical trials and guideline recommendations. FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Figure 2

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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 ◽

10.1161/circ.132.suppl_3.17152 ◽

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.

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

BMJ Open ◽

10.1136/bmjopen-2019-033283 ◽

2019 ◽

Vol 9 (11) ◽

pp. e033283 ◽

Cited By ~ 3

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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