scholarly journals Bleeding risk and healthcare resource utilisation in elderly patients treated with edoxaban or vitamin K antagonists for atrial fibrillation in Italy

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
E Smits ◽  
G Spentzouris ◽  
Y Ingrasciotta ◽  
SS Foti ◽  
C Ferrajolo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Index Date ◽  
Healthcare Resource ◽  
Vitamin K Antagonists ◽  
Age Groups ◽  
Bleeding Risk ◽  
Incidence Rates ◽  
Regression Analyses ◽  
Study Results

Abstract Funding Acknowledgements Type of funding sources: Other. Main funding source(s): Daiichi Sankyo Europe GmbH Background Direct oral anticoagulants (DOACs) have been shown to be non-inferior to vitamin K antagonists (VKA) regarding both efficacy and safety outcomes in patients with atrial fibrillation (AF). However, elderly are underrepresented in the underlying clinical trials. Purpose The aim of this study was to compare risks of major bleeding events and compare healthcare resource utilization (HRU) between AF patients treated with edoxaban or VKA in elderly. Methods A cohort study was conducted using claims databases of Caserta and Palermo Local Heath Units  in Italy. AF patients starting use of edoxaban or VKA between August 1st, 2016 and December 31st, 2018 were included. Date of the first dispensing was defined as the index date. The study population was matched based on a propensity score based on factors associated with the outcome. We restricted to patients aged ≥65, ≥1 year database history, and no use of the index drug in the year before index date. Incidence rates of bleeding outcomes and rates of HRU were assessed per 1,000 and 100 person-years follow-up (PY), respectively. Cox regression analyses to adjust for baseline covariates were used for comparisons of incidence rates of bleeding outcomes among all edoxaban and VKA users. Poisson regression analyses were used for comparisons of rates of HRU among all edoxaban and VKA users. Both analyses were adjusted for age. Sex, region and year of index date were considered for the adjusted models as well, using a backward stepwise approach to select eligible variables. Results 1,317 edoxaban users and 2,924 VKA users were included in the matched population. Mean age was 79 in both treatments groups, and 43% of the edoxaban users and 45% of the VKA users was male. Bleeding risks were significantly lower among edoxaban users compared to VKA users aged ≥65 (adjusted HR 0.39 (95% CI 0.19-0.83)) and among patients aged ≥75 (adjusted HR 0.37 (95% CI 0.16-0.86)). Among patients aged ≥65, edoxaban users were significantly less often hospitalised (RR 0.56 (95% CI 0.46-0.68)) and the total number of hospitalised days were also significant lower (RR 0.58 (95% CI 0.42-0.80)) compared to VKA users. Among patients aged ≥75, similar results were observed for the number of hospitalisations. Edoxaban users had significant less out-patient visits compared to VKA users (among patients aged ≥65 the RR was 0.44 (95% CI 0.39-0.50) and among patients ≥75 this was 0.40 (95% CI 0.35-0.47). Use of out-patient medication use was significantly lower among edoxaban users compared to VKA users among patients aged ≥65 (adjusted RR 0.91 (95% CI 0.88-0.95)) as well as among patients aged ≥75 (adjusted RR 0.91 (95% CI 0.87-0.95)). Conclusion Study results show a decreased bleeding risk of edoxaban compared to VKA in both age groups of patients with AF. Hospital based HRU has shown to be lower among edoxaban users compared to VKA users in both age groups. Out-patient HRU was also lower among edoxaban users.

4037Nurse counseling of patients with atrial fibrillation to improve compliance to oral anticoagulation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Chilian-Hof ◽  
S Schnupp ◽  
C Mahnkopf ◽  
J Brachmann ◽  
C Kleinecke
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Oral Anticoagulation ◽  
Vitamin K Antagonists ◽  
Randomised Trial ◽  
Female Gender ◽  
Bleeding Risk ◽  
Telephone Counseling ◽  
Bleeding Events

Abstract Background Atrial fibrillation (AF) is the most frequent arrhythmia with a prevalence of 1%–2% in the general population. Oral anticoagulation (OAC) is state-of-the art for preventions of thromboembolic events, in particular ischemic stroke, in patients with atrial fibrillation. Despite its proven benefit, numerous studies have documented under use of OAC for a variety of reasons. Purpose To establish a program of nurse counseling in patient with atrial fibrillation and treatment with oral anticoagulation. The program is designed to improve patients satisfaction, compliance to OAC, prevention of medication errors, ischemic and bleeding events. Methods Patients with atrial fibrillation and treatment with oral anticoagulation were prospectively identified at the department of cardiology of our clinic. They received a 30 minutes nurse counseling about oral anticoagulation during the hospital stay and another 30 minutes telephone counseling 3 months after inclusion. Furthermore, they received a brochure to inform about atrial fibrillation, oral anticoagulation and methods to improve medication compliance. Demographic characteristics with stroke and bleeding risk (CHA2DS2-VASc and HAS-BLED scores), as well as procedural data were systematically assessed in a predefined standardized way and captured in a dedicated database. Results Between June 2017 and January 2018, a total of 617 patients (female gender: 43.1%) with atrial fibrillation and oral anticoagulation received nurse counseling. Demographic and follow-up data of 204 patients (female gender: 85/204 (41.7%); mean age 69.7±17.3, CHA2DS2-VASc score 4.2±1.7, HAS-BLED score 2.8±0.37) were assessed in a dedicated database. Indication for OAC was paroxysmal and persistent/permanent AF in 110/204 (53.9%), 93/204 (45.6%) and others 17 (8.3%), respectively. 33/2014 (16.2%) were treated with vitamin K antagonists, and 172/204 (84.3%) with non-vitamin K antagonists. After a follow-up of 0.46±2.9 years and 187 patients-years the rates of cardiovascular death, major bleeding events and all-cause stroke and TIA were 1.07%, 2.14% and 1.61% per 100 patient-years. Conclusion Nurse counseling in patients with atrial fibrillation and treatment with oral anticoagulation has been established at the REGIOMED clinics, Germany. Its effectiveness in terms of quality of live, medication complications and cardiovascular events has to be proven in a randomised trial. Acknowledgement/Funding Daichi-Sankyo

Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation

Heart ◽  
2020 ◽  
pp. heartjnl-2020-317923 ◽  
Author(s):  
Olivier Hanon ◽  
Jean-Sébastien Vidal ◽  
George Pisica-Donose ◽  
Galdric Orvoën ◽  
Jean-Philippe David ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Propensity Score ◽  
Vitamin K ◽  
Lower Risk ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Matched Sample ◽  
Intracerebral Bleeding

ObjectiveDirect oral anticoagulants have been evaluated in the general population, but proper evidence for their safe use in the geriatric population is still missing. We compared the bleeding risk of a direct oral anticoagulant (rivaroxaban) and vitamin K antagonists (VKAs) among French geriatric patients with non-valvular atrial fibrillation (AF) aged ≥80 years.MethodsWe performed a sequential observational prospective cohort study, using data from 33 geriatric centres. The sample comprised 908 patients newly initiated on VKAs between September 2011 and September 2014 and 995 patients newly initiated on rivaroxaban between September 2014 and September 2017. Patients were followed up for up to 12 months. One-year risks of major, intracerebral, gastrointestinal bleedings, ischaemic stroke and all-cause mortality were compared between rivaroxaban-treated and VKA-treated patients with propensity score matching and Cox models.ResultsMajor bleeding risk was significantly lower in rivaroxaban-treated patients (7.4/100 patient-years) compared with VKA-treated patients (14.6/100 patient-years) after multivariate adjustment (HR 0.66; 95% CI 0.43 to 0.99) and in the propensity score–matched sample (HR 0.53; 95% CI 0.33 to 0.85). Intracerebral bleeding occurred less frequently in rivaroxaban-treated patients (1.3/100 patient-years) than in VKA-treated patients (4.0/100 patient-years), adjusted HR 0.59 (95% CI 0.24 to 1.44) and in the propensity score–matched sample HR 0.26 (95% CI 0.09 to 0.80). Major lower bleeding risk was largely driven by lower risk of intracerebral bleeding.ConclusionsOur study findings indicate that bleeding risk, largely driven by lower risk of intracerebral bleeding, is lower with rivaroxaban than with VKA in stroke prevention in patients ≥80 years old with non-valvular AF.

Antikoagulation bei Vorhofflimmern

2012 ◽  
Vol 32 (01) ◽  
pp. 37-39 ◽  
Author(s):  
C. Bode ◽  
M. Moser
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Bleeding Risk ◽  
Coagulation Factors ◽  
Additional Risk ◽  
New Anticoagulants ◽  
Therapeutic Anticoagulation ◽  
Impaired Quality

SummaryAtrial fibrillation is one of the most frequent reasons for therapeutic anticoagulation in everyday practice. Oral vitamin K antagonists such as Marcumar have been state of the art anticoagulants to prevent thrombembolic events in patients with atrial fibrillation and additional risk factors. But these drugs are accompanied by disadvantages such as increased bleeding risk and impaired quality of life caused by interactions with food or other medications as well as frequent controls of INRs.The new anticoagulants apixaban, rivaroxaban and dabigatran are direct antagonists of coagulation factors (FXa or FIIa) and demonstrate a promising risk/benefit profile in large clinical trials compared with vitamin K antagonists.Their approval for clinical use will open up new therapeutic perspectives for patients with atrial fibrillation and indication for anticoagulation.

Selection, management, and outcome of vitamin K antagonist-treated patients with atrial fibrillation not switched to novel oral anticoagulants

2015 ◽  
Vol 114 (11) ◽  
pp. 1076-1084 ◽  
Author(s):  
Franziska Michalski ◽  
Luise Tittl ◽  
Sebastian Werth ◽  
Ulrike Hänsel ◽  
Sven Pannach ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Case Fatality ◽  
Bleeding Risk ◽  
Vitamin K Antagonist ◽  
Bleeding Complications ◽  
Treatment Rate

SummaryAtrial fibrillation (AF) patients treated with well-controlled vitamin K antagonists (VKAs) may benefit less from non-vitamin K antagonist oral anticoagulants (NOACs) because they are supposed to be at low risk of thromboembolic and bleeding complications. However, little is known about the selection, management, and outcome of such “stable” VKA patients in current practice. We assessed characteristics, VKA persistence and 12 months' outcome of AF patients selected for VKA continuation. On March 1, 2013, the Dresden NOAC registry opened recruitment of patients continuing on VKA for sites that had been actively recruiting AF patients treated with NOACs in the prior 18 months. Patient characteristics were compared with those of NOAC patients from the same sites. Four hundred twenty-seven VKA patients had a significantly lower bleeding risk profile compared with 706 patients selected for NOAC treatment. For VKA, international normalised ratio time-in-therapeutic range before enrolment was 71% and increased to 75% during a mean follow-up of 15 months. Rates of stroke/transient ischaemic attack/systemic embolism were 1.3/100 patient-years (intention-to-treat) and 0.94/100 patient-years (as-treated). On-treatment rate of ISTH major bleeding was 4.15/100 patient-years (95% CI 2.60–6.29) with a case-fatality rate of 16.3% (all-cause mortality at day 90 after major bleeding). In conclusion, in daily care, AF patients selected for VKA therapy are healthier than those treated with NOAC, demonstrate a high quality of anticoagulant control and very low stroke rates. However, despite adequate patient selection and INR control, the risk of major VKA bleeding is unacceptably high and bleeding outcome is poor.

scholarly journals Major bleeding risk assessment in atrial fibrillation patients taking vitamin K antagonists

2015 ◽  
Vol 35 (2) ◽  
pp. 99-103
Author(s):  
Fernando Pivatto ◽  
André Luís Ferreira da Silva ◽  
Indira Valente Bezerra ◽  
Leonardo Martins Pires ◽  
Luís Carlos Amon ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Risk Assessment ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Bleeding Risk

scholarly journals 2021 Korean Heart Rhythm Society Guidelines for Stroke Prevention in Atrial Fibrillation

2021 ◽  
Vol 96 (4) ◽  
pp. 296-311
Author(s):  
Ki Hong Lee ◽  
Jin-Bae Kim ◽  
Seung Yong Shin ◽  
Boyoung Joung
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Stroke Prevention ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Optimal Strategies ◽  
Mechanical Valve ◽  
Heart Rhythm ◽  
Bleeding Risk

Atrial fibrillation (AF) is a strong risk factor for ischemic stroke and systemic embolism. To prevent thromboembolic events in patients with AF, anticoagulation therapy is essential. The anticoagulant strategy is determined after stroke and bleeding risk assessments using the CHA2DS2-VASc and HAS-BLED scores, respectively; both consider clinical risk factors. Vitamin K antagonists (VKAs) are the sole anticoagulant option in AF patients with a prosthetic mechanical valve or moderate-severe mitral stenosis; in all other AF patients VKA or non-vitamin K antagonist oral anticoagulants are therapeutic options. However, antiplatelet therapy should not be used for stroke prevention in AF patients. Anticoagulation is not needed in AF patients with low stroke risk but strongly recommended in those with a with low bleeding risk. Left atrial appendage (LAA) occlusion offers an alternative in AF patients in whom long-term anticoagulation is contraindicated. Surgical occlusion or the exclusion of LAA can be considered for stroke prevention in AF patients undergoing cardiac surgery. In this article, we review existing data for stroke prevention and suggest optimal strategies to prevent stroke in AF patients.

Pattern and Management of Intracranial Haemorrhage with Rivaroxaban or Dabigatran Compared to Vitamin K Antagonists - Results of the Prospective Dresden Noac Registry

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1127-1127
Author(s):  
Sandra Marten ◽  
Luise Tittl ◽  
Katharina Daschkow ◽  
Jan Beyer-Westendorf
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Research Funding ◽  
Intracranial Haemorrhage ◽  
Vitamin K Antagonists ◽  
Bleeding Risk ◽  
Interventional Therapy ◽  
Phase Iii ◽  
Bayer Healthcare ◽  
Phase Iii Trials

Abstract Background: In recent phase-III trials, the rate of intracranial haemorrhage (ICH) - the most feared complication of anticoagulant therapy - was around 0.8% per year for patients treated with vitamin K antagonists (VKA) and consistently lower (around 0.3-0.5%) for patients treated with the non-VKA oral anticoagulants (NOACs) rivaroxaban and dabigatran However, patients in clinical trials present a selected population treated under a strict protocol in dedicated academic facilities. Consequently, the risk, management and outcome of ICH need to be evaluated in cohorts of patients treated with NOACs or VKA in daily care. Aim: To evaluate the rate of ICH in patients treated with NOAC compared to VKA patients. Patients and methods: The prospective NOAC registry was initiated in November 2011. A network of more than 230 physicians in the district of Saxony, Germany, enrol up to 3000 patients in the registry, which are prospectively followed by the central registry office for up to 60 months with central outcome event adjudication. For this analysis, every intracranial haemorrhage was identified in the database and ICH management and outcome were evaluated. Results: Until January 31th 2015, 2682 patients were registered and treated with dabigatran (348, mostly treated for atrial fibrillation), Rivaroxaban (1907; 1204 treated for atrial fibrillation and 703 for venous thromboembolism) or vitamin K antagonists (427; treated for atrial fibrillation). VKA patients had lower HAS-BLED scores compared to NOAC patients and were excellently managed with a time-in-therapeutic-range of 75%. During follow-up (mean follow-up duration 25.6 months) ICH occurred in 7/427(1.6%) of VKA treated patients and in 14/2255 (0.6%) of patients treated with NOAC, which translated into an annualized rate of 1.3 events/100 pt. years (95%-CI 0.5-2.7) for VKA and 0.4 events/100 pt. years (95%-CI 0.2-0.6) for NOAC (p=0.0039). Treatment of ICH consisted of PCC in 10 cases, plasma in 3 cases and surgical or interventional therapy in 7 cases (table 1, multiple treatments possible). As indicated, use of factor concentrates, plasma or other hemostatic agents or surgery was much more frequent in VKA patients compared to NOAC patients. Table 1. Cause and treatment of ICH ICH/total Spontaneous vs. traumatic ICH (n) treatment with PCC treatment with fresh frozen plasma treatment with other hemostatic agents no hemostatic treatment surgical or interventional therapy dabigatran 2/348 (0.6%) 2 vs. 0 0 0 0 2/2 (100%) 1/2 (50%) rivaroxaban 12/1907 (0.6%) 4 vs. 8 5/12 (41.7%) 2/12 (16.7%) 2/12 (16.7%) 7/12 (58.3%) 3/12 (25%) VKA 7/427 (1.6%) 2 vs. 5 5/7 (71.4%) 1/7 (14.3%) 4/7 (57.1%) 2/7 (28.6%) 3/7 (42.9%) At Day 90 after ICH, 7/21 patients were dead (2/7 or 28.6% of VKA patients and 5/14 or 35.7% of NOAC patients). The surviving 14 patients received the following antithrombotic agents: 5 (35.7%) rivaroxaban, 3 (21.4%) heparin, 1 (7.1%) apixaban, 1 (7.1%) VKA, 3 (21.4%) aspirin, 1 (7.1%) none.Following ICH, oral anticoagulation therapy was either interrupted (n=7; 6 NOAC vs. 1 VKA) or permanently discontinued (n=10; 6 NOAC vs. 4 VKA). Conclusion: Despite low bleeding risk and excellent INR control in our VKA cohort, the rate of ICH was higher than that of VKA patients treated in recent phase-III trials. Furthermore, ICH rates in our VKA cohort were significantly higher than those seen in our NOAC cohorts, which represented more patients with relevant comorbidities and higher bleeding risk. Consequently, the risk of ICH remains high even in "stable" VKA patients with good INR control and a preventive switch from VKA to NOAC may help to reduce ICH risk and should be discussed with the patient. Disclosures Marten: Bayer HealthCare: Honoraria. Beyer-Westendorf:Pfizer: Honoraria, Research Funding; Boehringer Ingelheim: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; Bayer HealthCare: Honoraria, Research Funding.

scholarly journals Temporal trends in antithrombotic treatment of real-world UK patients with newly diagnosed atrial fibrillation: findings from the GARFIELD-AF registry

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e018905 ◽  
Author(s):  
Patricia N Apenteng ◽  
Haiyan Gao ◽  
FD Richard Hobbs ◽  
David A Fitzmaurice
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Temporal Trends ◽  
Bleeding Risk ◽  
P Value ◽  
Newly Diagnosed ◽  
Antithrombotic Treatment ◽  
The Uk

ObjectiveTo investigate evolving patterns in antithrombotic treatment in UK patients with newly diagnosed non-valvular atrial fibrillation (AF).DesignProspective, multicentre, international registry.Setting186 primary care practices in the UK.Participants3482 participants prospectively enrolled in four sequential cohorts (cohort 2 (C2) n=830, diagnosed September 2011 to April 2013; cohort 3 (C3) n=902, diagnosed April 2013 to June 2014; cohort 4 (C4) n=850, diagnosed July 2014 to June 2015; cohort 5 (C5) n=900, diagnosed June 2015 to July 2016). Participants had newly diagnosed non-valvular AF and at least one risk factor for stroke, were aged ≥18, and provided informed consent.Main outcome measuresAntithrombotic treatment initiated at diagnosis, overall and according to stroke and bleeding risks. Stroke risk was retrospectively calculated using CHA2DS2-VASc (cardiac failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled)–vascular disease, age 65–74 and sex category (female)) and bleeding risk using HAS-BLED (hypertension, abnormal renal/liver function (1 point each), stroke, bleeding history or predisposition, elderly (>65), drugs/alcohol concomitantly (1 point each)).Results42.7% were women and the mean age was 74.5 years. The median CHA2DS2-VASc score was 3 in all cohorts and the median HAS-BLED score was 2 in all cohorts. There was a statistically significant increase in the use of anticoagulant therapy from C2 to C5 (C2 54.7%, C3 60.3%, C4 73.1%, C5 73.9%; P value for trend <0.0001). The increase in the use of anticoagulant was mainly in patients with CHA2DS2-VASc ≥2. The use of vitamin K antagonists (VKAs)±antiplatelet (AP) drugs decreased from C2 to C5 (C2 53.3%, C3 52.1%, C4 50.3%, C5 30.6%), while the use of non-vitamin K antagonist oral anticoagulants (NOACs)±AP increased (C2 1.3%, C3 8.0%, C4 22.7%, C5 43.3%). The use of AP only decreased (C2 36.4%, C3 25.5%, C4 11.9%, C5 10.5%), as did the combination therapy of VKA+AP (C2 13.6%, C3 11.0%, C4 9.6%, C5 5.8%).ConclusionThere has been a progressive increase in the proportion of patients newly diagnosed with AF receiving guideline-recommended therapy in the UK, potentially driven by the availability of NOACs.Trial registration numberNCT01090362; Pre-results.

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