Real‐world data on the incidence, mortality, and cost of ischaemic stroke and major bleeding events among non‐valvular atrial fibrillation patients in England

Abstract Background Anticoagulant therapy is recommended in patients with non-valvular atrial fibrillation (NVAF) for those with CHADS2 ≥2. However, there have been significant number of subjects with CHADS2 ≥2 who receive no anticoagulation. Most of reported real world data have been collected mainly before wide spread use of DOAC. This study evaluated the clinical outcome of no anticoagulant drug therapy in NVAF. Methods This study is a non-interventional, observational, retrospective cohort study of NVAF patients in Mie-LIP Database, which is a regional clinical database joining 1 university hospital and 8 general hospitals in Mie prefecture in Japan. Patient enrolment was conducted from 1st Jan. 2016 to 31st Dec. 2018. The primary outcome events are ischemic stroke, systemic embolism, and bleeding events (bleeding to need a blood transfusion, intracranial bleeding, intraocular bleeding, and gastrointestinal bleeding). Results 7001 patients were included in the current analysis, 2550 patients, 36.4% were treated without any anticoagulant drug therapy. Table 1 shows patients with no anticoagulant drug therapy, mean age was 75.4 years and 42.2% of patients were female. The most frequent comorbidities included hypertension (50.0%), diabetes mellitus (28.2%), heart failure (14.0%), ischemic stroke (12.7%), vascular disease (14.4%) respectively. The annual incidence of ischemic stroke, systemic embolism per 100 person-years is 3.7, and that in each CHADS2 group is 0: 1.4, 1: 1.4, 2: 3.2, 3–6: 8, respectively in Figure 1. The annual incidence of bleeding events is 1.5, and that in each CHADS2 group is 0: 0.7, 1: 1.0, 2: 1.2, 3–6: 2.9, respectively. Conclusions Approximately one-thirds of subjects have not received any anticoagulation in the modern DOAC in daily clinical practice in Japan. The rate of ischemic stroke and systemic embolism increased by CHADS2. Stroke or SEE rate was very low in subjects with CHADS2 ≤1, supporting no indication of anticoagulation in current guidelines. Regarding subjects with CHADS2>2, considering the higher risk of stroke, use of anticoagulant drug therapy is recommended. Funding Acknowledgement Type of funding source: None

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A Systematic Review of Network Meta-Analyses and Real-World Evidence Comparing Apixaban and Rivaroxaban in Nonvalvular Atrial Fibrillation

Clinical and Applied Thrombosis/Hemostasis ◽

10.1177/1076029619898764 ◽

2020 ◽

Vol 26 ◽

pp. 107602961989876 ◽

Cited By ~ 1

Author(s):

Nathan R. Hill ◽

Belinda Sandler ◽

Evelien Bergrath ◽

Dušan Milenković ◽

Ajibade O. Ashaye ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Real World ◽

Health Care Expenditure ◽

Bleeding Events ◽

Nonvalvular Atrial Fibrillation ◽

Real World Evidence ◽

Evidence Review ◽

Major Bleeding Events ◽

Meta Analyses

There is no direct evidence comparing the 2 most commonly prescribed direct oral anticoagulants, apixaban and rivaroxaban, used for stroke prevention in nonvalvular atrial fibrillation (NVAF). A number of network meta-analyses (NMAs) of randomized control trials and real-world evidence (RWE) studies comparing the efficacy, effectiveness, and safety of apixaban and rivaroxaban have been published; however, a comprehensive evidence review across the available body of evidence is lacking. In this study, we aimed to systematically review and evaluate the clinical outcomes of apixaban and rivaroxaban using a combination of data gleaned from both NMAs and RWE studies. The review identified 21 NMAs and 5 RWE studies. The data demonstrated that apixaban was associated with fewer major bleeding events compared to rivaroxaban. There was no difference in the efficacy/effectiveness profiles between these treatments. Bleeding is a serious complication of anticoagulation therapy for the management of NVAF, and is associated with increased rates of hospitalization, morbidity, mortality, and health-care expenditure. The majority of studies in this comprehensive evidence review suggests that apixaban has a lower risk of major bleeding events compared to rivaroxaban in patients with NVAF.

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Residual risks of ischaemic stroke and systemic embolism among atrial fibrillation patients with anticoagulation: large-scale real-world data (F-CREATE project)

Heart ◽

10.1136/heartjnl-2020-317299 ◽

2020 ◽

pp. heartjnl-2020-317299

Author(s):

Toshiki Maeda ◽

Takumi Nishi ◽

Shunsuke Funakoshi ◽

Kazuhiro Tada ◽

Masayoshi Tsuji ◽

...

Keyword(s):

Risk Factors ◽

Atrial Fibrillation ◽

Ischaemic Stroke ◽

Real World ◽

Large Scale ◽

Oral Anticoagulants ◽

Modifiable Risk Factors ◽

Systemic Embolism ◽

Real World Data ◽

World Data

ObjectiveAmong patients with atrial fibrillation, the risks of ischaemic stroke and systemic embolism (IS/SE) are high even with effective anticoagulation. Using large-scale, real-world data from Japan, this study aims to clarify residual risks of IS/SE attributable to modifiable risk factors among patients with atrial fibrillation who are taking oral anticoagulants.MethodsThe study design we employed was a retrospective cohort. Health check-ups and insurance claims data of Japanese health insurance companies were accumulated from January 2005 to June 2017. We identified 11 848 participants with atrial fibrillation who were on oral anticoagulants during the study period. We set the modifiable risk factors as hypertension, diabetes and dyslipidaemia. A Cox proportional hazards model was used to obtain the effects of the risk factors for IS/SE.ResultsDuring an average of 3 years’ follow-up, 200 cases of IS/SE occurred (incidence rate 0.57 per 100 person-years). In multivariable analyses, older age (65–74 vs <65 years; adjusted HR 2.02 (95% CI 1.49 to 2.73)), hypertension (adjusted HR 1.41 (1.04 to 1.92)) and dyslipidaemia (adjusted HR 1.46 (1.07 to 1.98)) were significantly associated with increased risk of IS/SE. Percentage of IS/SE risk attributable to modifiable risk factors (hypertension, diabetes and dyslipidaemia) was 30.0% (16.1% to 41.6%).ConclusionAmong patients with atrial fibrillation on anticoagulant therapy, approximately one-third of the residual risks were estimated to be attributable to modifiable risk factors such as hypertension, diabetes and dyslipidaemia.

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

Thrombosis and Haemostasis ◽

10.1055/a-1477-3760 ◽

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.

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“Unreal world” or “real world” data in oral anticoagulant treatment of atrial fibrillation

Thrombosis and Haemostasis ◽

10.1160/th16-08-0658 ◽

2016 ◽

Vol 116 (10) ◽

pp. 587-589 ◽

Cited By ~ 41

Author(s):

Gregory Y. H. Lip ◽

Ben Freedman

Keyword(s):

Atrial Fibrillation ◽

Real World ◽

Oral Anticoagulant ◽

Review Process ◽

Anticoagulant Treatment ◽

Real World Data ◽

Oral Anticoagulant Treatment ◽

World Data

Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.

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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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