Elderly Patients with Atrial Fibrillation: Focus on Comorbidity and Safety of Anticoagulant Therapy

The article discusses issues related to the prescription of anticoagulant therapy to elderly patients with atrial fibrillation (AF), especially those over 70 and 80 years of age. The relevance of the issue is primarily due to the prevalence of AF in this cohort of patients, and the second is due to the higher incidence of comorbidity. The presented material demonstrates the peculiarities of anticoagulant therapy application in groups of patients older than 75, based on the data of randomized clinical trials, and also presents extrapolation of the results of RCTs to the real clinical practice (data of registers and cohort trials). The use of unreasonably low doses of oral anticoagulants in elderly patients is debated. It often leads to a decrease in the efficacy of anticoagulant therapy without improving the drugs safety profile. A new validated scale (ABH) for evaluating of anticoagulant therapy safety is presented in the article. The ABH scale can be used before prescribing to patients exactly direct oral anticoagulants. This scale is simpler and more practical than the HAS-BLED scale. The data for the ABH scale are validated based on direct oral anticoagulants in 21,248 patients from the Norwegian register. The presented results demonstrate a favorable efficiency and safety profile of rivaroxaban in comparison with warfarin in patients 75 years and older. Thus, the overall benefit for the use of rivaroxaban against warfarin in patients > 75 years of age in the subanalysis of the ROCKET-AF study was statistically significantly greater than in younger patients with AF. Data on 11121 patients with AF who were treated with rivaroxaban for the prevention of stroke and systemic embolism are included in the combined analysis of the XANTUS, XANAP and XANTUS-EL registers. 96% of patients in the study did not have serious thromboembolic events. The amount of major bleeding was 1.7 per 100 patient-years, and gastrointestinal bleeding was 0.7 per 100 patient-years. This turned out to be less than in some other registry studies. In addition, patients showed good adherence to rivaroxaban treatment: after a year, 77.4% of patients continued to take the drug.

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The risk of bleeding minimization with direct oral anticoagulants

Atherothrombosis Journal ◽

10.21518/2307-1109-2021-11-1-106-126 ◽

2021 ◽

pp. 106-126

Author(s):

Т. N. Novikova

Keyword(s):

Atrial Fibrillation ◽

Clinical Trials ◽

Anticoagulant Therapy ◽

Randomized Clinical Trials ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Blood Analysis ◽

Systemic Embolism ◽

Risk Of Bleeding ◽

Wide Range

This review is devoted to the safety issues of anticoagulant therapy prescribed for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Direct oral anticoagulants are considered worldwide in accordance with the guidelines for the diagnosis and treatment of atrial fibrillation as the preferred anticoagulant choice for the prevention of stroke and systemic embolism. Direct oral anticoagulants in comparison with vitamin K antagonists generally have similar efficacy, but different safety profiles, primarily, this concerns the risk of large extracranial and, primarily, gastrointestinal hemorrhages. To minimize the risk of bleeding during therapy with direct oral anticoagulants, an individual approach to the choice of the drug for each individual patient is required after assessing the risk of bleeding, searching for a potential bleeding substrate, correcting existing risk factors and eliminating, if possible, the substrate. When choosing an anticoagulant therapy, special attention should be paid to the most vulnerable categories of patients, such as patients of older age groups and patients with concomitant chronic kidney disease. Among the direct oral anticoagulants registered in the Russian Federation, according to meta-analyzes of key randomized clinical trials and real clinical trials, apixaban has the most optimal benefit: risk ratio in a wide range of patients, including vulnerable populations. Dynamic observation, including regular assessment of renal function, control of clinical blood analysis, erythrocyte and platelet levels, after prescribing an individually selected anticoagulant to the patient, ensures the maximum safety of therapy. Small, so-called, annoying bleeding is not a reason for canceling the anticoagulant, but requires a careful search for the causes of bleeding and their correction.

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Anticoagulation Challenges in Hematogeriatrics: Effectiveness and Safety of Direct Oral Anticoagulants Vs Vitamin k Antagonist in Elderly with Atrial Fibrillation

Blood ◽

10.1182/blood-2019-125150 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 1162-1162

Author(s):

Desirée Campoy ◽

Gonzalo Artaza ◽

César A Velasquez ◽

Tania Canals ◽

Erik A Johansson ◽

...

Keyword(s):

Atrial Fibrillation ◽

Elderly Patients ◽

Vitamin K ◽

Major Bleeding ◽

Frail Elderly ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Vitamin K Antagonist ◽

Systemic Embolism ◽

Bleeding Events

BACKGROUND Direct oral anticoagulants (DOAC) are increasingly used in patients with Non Valvular Atrial Fibrillation (NVAF) for stroke prevention. However, Follow-Up (FU) and dosing these agents in the elderly can be challenging due to different factors, such as chronic kidney disease, frailty, falls, multifactorial anemia and concomitant polypharmacy. These factors in elderly patients predisposes to both thromboembolic and bleeding events once atrial fibrillation occurs. Therefore, balancing risks and benefits of antithrombotic strategies in older populations is crucial. Despite recent increases in DOAC use in NVAF, there are still limited data regarding DOACs effectiveness and safety in frail elderly patients. AIM To assess the effectiveness and safety according to DOAC or Vitamin K Antagonist (VKA) in a cohort of elderly patients with NVAF. METHODS From April 2016 to April 2019, we consecutively included NVAF elderly patients (≥80 years-old) treated with DOAC or VKA in a prospective multicenter registry. Demographic, laboratory, frailty risk stratification and antithrombotic therapy data were collected. Patients had a minimum FU of 6 months. VKA patients had a standard FU through digital international normalized ratio (INR) control and the efficacy of therapy was determined by the time in therapeutic range (TTR) values from the preceding 6 months of treatment using Rosendaal's method. FU in DOAC patients was performed through structured and integral assessment following the Tromboc@t Working Group recommendations for management in patients receiving DOAC (Olivera et al, Med Clin 2018). Key practical management aspects are listed in the flow chart (Figure 1). Clinical Frailty Scale (CFS score) was assigned to each patient at the beginning and during the FU; patients were classified into three categories: non-frail (CFS 1-4), mild-to-moderately frail (CFS 5-6), and severely frail (CFS 7-9). RESULTS From a total of 1040 NVAF patients, 690 (63.5%) were treated with DOAC (61 dabigatran, 95 rivaroxaban, 254 edoxaban and 280 apixaban) and 350 with VKA. In the VKA group, the mean TTR was 52.8%. Demographic characteristics and CFS score are summarized in table 1. Kaplan-Meier analysis (median FU: 16.5 months) showed a significantly high incidence of stroke/systemic embolism among VKA patients vs DOAC patients (4.2 vs 0.5 events per 100 patient-years, p<0.001). Major bleeding in the DOAC group was significantly infrequent compared with VKA group (2.2 vs 8.9 events, p=0.001). In the DOAC group, 90% (n=20/22) of the major bleedings were gastrointestinal [16 rivaroxaban and 4 edoxaban]. However, in the VKA group 64% (n = 20/31) were gastrointestinal, 25.8% (n= 8/31) intracranial and 9.7% (n = 3/31) urogenital bleedings. We identified 365 very elderly patients (aged ≥ 90 years) of which 270 (39.1%) were DOAC patients and 95 (27.1%) VKA patients. In this subgroup of patients, after a multivariate regression analysis, the stroke/systemic embolism incidence was similar in both treatment groups regardless of the age, but major bleeding decreased significantly in DOAC group (adjusted HR 0.247, 95% CI 0.091-0.664). CONCLUSIONS Our data indicate that DOACs can be a good therapeutic option for stroke/systemic embolism prevention in frail elderly patients, showing low rates of stroke as well as bleeding events when a structured and integral FU is applied to anticoagulated patients. Further investigations are necessary to analyze the impact in the quality of life and net clinical benefit of anticoagulant therapy when a FU program is applied in elderly patients. Disclosures Sierra: Novartis: Honoraria, Research Funding, Speakers Bureau; Astellas: Honoraria; Pfizer: Honoraria; Daiichi-Sankyo: Honoraria, Speakers Bureau; Abbvie: Honoraria, Speakers Bureau; Roche: Honoraria; Jazz Pharmaceuticals: Honoraria.

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Laboratory bleeding predictors in elderly patients with atrial fibrillation taking direct oral anticoagulants

Medical Council ◽

10.21518/2079-701x-2019-21-40-43 ◽

2020 ◽

pp. 40-43

Author(s):

M. A. Gabitova ◽

P. M. Krupenin ◽

A. A. Sokolova ◽

D. A. Napalkov ◽

V. V. Fomin

Keyword(s):

Atrial Fibrillation ◽

Elderly Patients ◽

Anticoagulant Therapy ◽

Patient Monitoring ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Laboratory Methods ◽

Increased Risk ◽

Hemorrhagic Events ◽

Clinically Significant

Atrial fibrillation (AF) is one of the most common arrhythmias in patients ≥75 years of age. The increased risk of thrombosis due to age and the large number of concomitant diseases makes it evident that anticoagulant therapy is necessary. However, the same factors increase the risk of hemorrhagic complications, which are among the most dangerous side effects of anticoagulant therapy. That is why it is very important to identify patients with the highest probability of bleeding, whether large or small clinically significant and minor. The purpose of our study was to study the prognostic value of laboratory methods of examination with regard to the development of hemorrhagic events in elderly patients with AF taking direct oral anticoagulants (DOAC). The study enrolled 102 patients ≥75 years of age with AF of non-valve etiology taking dabigatran, apixaban, rivaroxaban at full or reduced doses. Anticoagulants were administered by outpatient and inpatient physicians. Both previous experience with DOAC prior to inclusion in the trial (if DOAC was previously prescribed) and prospective patient monitoring after inclusion in the trial were analyzed. The minimum analyzed period of DOAC intake was 18 months. Patients who underwent (n = 19) and did not undergo (n = 83) hemorrhagic events (all events were considered small by ISTH criteria) did not differ in any of the laboratory indicators potentially considered as predictors of hemorrhagic events.

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Anticoagulant Therapy as a Tool for the Prevention of Cognitive Impairment Associated with Atrial Fibrillation

Rational Pharmacotherapy in Cardiology ◽

10.20996/1819-6446-2019-15-5-713-724 ◽

2019 ◽

Vol 15 (5) ◽

pp. 713-724

Author(s):

O. D. Ostroumova ◽

A. I. Kochetkov ◽

S. P. Korchagina ◽

T. M. Ostroumova ◽

M. S. Chernyaeva ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cognitive Impairment ◽

Anticoagulant Therapy ◽

Randomized Clinical Trials ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Additional Risk Factor ◽

Main Hypothesis ◽

Meta Analyses

Atrial fibrillation (AF) is one of the most common cardiac arrhythmias in clinical practice and important additional risk factor for the development of cognitive impairment (CI) and dementia as it has been shown in recent studies. According to the Diagnostic and statistical manual of mental disorders latest revision CI refers to a decrease of one or more higher cortical functions that provide the processes of perception, storage, transformation and transmission of information compared to the premorbid level. The main hypothesis that explains the relationship between AF and dementia is the assumption that in the presence of this arrhythmia a brain substance is damaged due to microembolism and cerebral microbleeding. The high clinical significance of AF as well as CI served as a background for the development by European experts several consensus documents concerning the problem of the relationships between these conditions. In addition, they emphasize the role of anticoagulant therapy as a preventing tool for the development of stroke, which can be a factor in the CI progression in patients with AF, with particular priority to direct oral anticoagulants (DOACs). In randomized clinical trials, meta-analyses and systematic reviews have been shown that the use of DOACs, as compared to vitamin K antagonists, is a more rational strategy for preventing stroke associated with AF. Among the DOAC class, rivaroxaban is worth noticing as a drug that has a favorable efficacy profile for primary and secondary stroke prevention. Rivaroxaban distinguishing characteristics are a once daily administration as well as a calendar package which is practically important for patients with CI.

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Prevention of stroke in elderly patients with a trial fibrillation: possibilities of Apixaban

Russian Journal of Geriatric Medicine ◽

10.37586/2686-8636-2-2020-138-146 ◽

2020 ◽

pp. 138-146

Author(s):

N. M. Vorobyeva ◽

O. N. Tkacheva

Keyword(s):

Elderly Patients ◽

Observational Studies ◽

Clinical Characteristics ◽

Randomized Clinical Trials ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Review Article ◽

Systemic Embolism ◽

Consensus Document ◽

Individualize Treatment

In review article, we discuss the opportunity of use of one of the direct oral anticoagulants – apixaban – for prevention of stroke and/or systemic embolism in elderly patients with non-valvular a trial fibrillation. We consider results of randomized clinical trials of apixaban – ARISTOTLE and AVERROES, including the subgroups analysis in patients in the age of ≥75 years and ≥80 years – in ARISTOTLE, ≥75 years and ≥85 years – in AVERROES. These studies have shown that elderly patients had more benefit from apixaban administration than warfarin (in ARISTOTLE) or acetylsalicylic acid (in AVERROES). The results of two retrospective observational studies confirming the favorable profile of apixaban effectiveness and safety in elderly patients with a trial fibrillation in real clinical practice, and the main provisions of the consensus document FORTA, the purpose of which is to individualize treatment of elderly patients based on clinical characteristics of the patient, are also considered.

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ANTICOAGULANT THERAPY IN CANCER PATIENTS WITH ATRIAL FIBRILLATION. CONSIDERING AGE FACTOR

Успехи геронтологии ◽

10.34922/ae.2020.33.1.013 ◽

2020 ◽

pp. 99-106

Author(s):

В. И. Потиевская ◽

А. А. Ахобеков ◽

М. Ф. Баллюзек

Keyword(s):

Atrial Fibrillation ◽

Cancer Patients ◽

Anticoagulant Therapy ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Current Data ◽

Related Factors ◽

Age Related ◽

Liver And Kidney ◽

After Cancer

Рассматривается современное состояние вопроса выбора антикоагулянтной терапии при фибрилляции предсердий (ФП) у онкологических больных. Отмечается, что сложность выбора антикоагулянта при злокачественных новообразованиях (ЗНО) определяется такими факторами, как коморбидные сердечно-сосудистые заболевания, нарушения функции печени и почек, метаболические дисфункции, свойственные, прежде всего, пациентам старшей возрастной группы. Приводятся актуальные данные по оценке риска геморрагических и тромбоэмболических осложнений ФП при ЗНО в аспекте возраста. Обсуждаются возможные причины увеличения риска развития ФП во время и после лечения ЗНО, в том числе и в связи с возраст-ассоциированностью этих патологий. Рассмотрены вопросы выбора антикоагулянтов у пациентов, находящихся на активной противоопухолевой терапии, особенно на препаратах из группы прямых оральных антикоагулянтов (ПОАК). Согласно данным обсервационных исследований, именно ПОАК являются перспективным, относительно безопасным и эффективным выбором для онкологических пациентов с ФП, в связи с чем их применение должно активно изучаться в рандомизированных клинических исследованиях с учетом фактора возраста. Подчеркивается, что подбор схемы антикоагулянтной терапии у пациентов с ФП и ЗНО требует междисциплинарного участия кардиологов и онкологов, а часто и гериатров, чтобы индивидуализировать лечение и предложить наиболее эффективную терапию. The current issue of the choice of anticoagulant therapy of atrial ﬁbrillation (AF) in cancer patients is considered. It is noted that the difﬁculty of choosing an anticoagulant in malignancies is largely determined by age-related factors, such as comorbid cardiovascular diseases, liver and kidney dysfunction, metabolic disorders common for in elderly patients. Current data on the risk assessment of hemorrhagic and thromboembolic complications of AF in cancer patients in the aspect of age presented. During and after cancer treatment, the risk of developing AF can increase, also in connection with the age-associated pathology. Possible reasons of it are discussed. The choice of different anticoagulants groups in patients treated with anticancer therapy, including direct oral anticoagulants (DOAC) is considered. According to available data from observational studies, it is the DOAC that is a promising, relatively safe and effective choice for cancer patients with AF, and therefore their use should be actively studied in randomized trials, considering the factor of age. It is particularly noted that solving this problem requires the interdisciplinary involvement of cardiologists, oncologists, and sometimes, geriatrics, to individualize treatment for each case and to offer the most effective therapy.

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Features of anticoagulant therapy of atrial fibrillation in combination with impaired renal function

Kardiologiia ◽

10.18087/cardio.2021.10.n1767 ◽

2021 ◽

Vol 61 (10) ◽

pp. 81-88

Author(s):

T. N. Novikova

Keyword(s):

Atrial Fibrillation ◽

Kidney Function ◽

Anticoagulant Therapy ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Alternative Therapy ◽

Favorable Effect ◽

Randomized Controlled ◽

Randomized Controlled Studies ◽

Negative Effect

This review focuses on issues of anticoagulant therapy in patients with atrial fibrillation (AF) associated with chronic kidney disease (CKD). Such patients are at high risk of stroke whereas the choice of an anticoagulant is difficult. A wealth of information about a negative effect of warfarin on the kidney function has accumulated. A need for an alternative therapy to warfarin for patients with stage 3-4 CKD has become imminent. In this regard, rivaroxaban seems to be an appropriate replacement for warfarin in such patients. In randomized, controlled studies that evaluated the efficacy of direct oral anticoagulants in comparison with warfarin, the efficacy and safety profile of a “kidney” dose in moderate disorders of kidney function has been studied only for rivaroxaban. Moreover, both randomized, controlled studies and studies performed in the conditions of clinical practice, have demonstrated a more favorable effect of rivaroxaban on kidney function compared to warfarin. Patients with AF associated with CKD require a comprehensive protection, which, according to results of clinical studies, may be provided by rivaroxaban.

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Recommendations on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation (Based on 2018 European Heart Rhythm Association Practical Guide)

Kardiologiia ◽

10.18087/cardio.2019.5.2633 ◽

2019 ◽

Vol 59 (5) ◽

pp. 68-79

Author(s):

L. V. Popova ◽

T. B. Kondratieva ◽

M. B. Aksenova ◽

T. V. Khlevchuk ◽

M. Z. Kanevskaya

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Randomized Clinical Trials ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Heart Rhythm ◽

Vitamin K Antagonist ◽

Advanced Liver Disease ◽

Clinical Variants

Non-vitamin K antagonist oral anticoagulants (NOACs) – direct oral anticoagulants – are getting the ever-broadening use in clinical practice. However, many problems related to optimal use of NOACs in specific clinical situations remain unresolved. European Heart Rhythm Association in April 2018 issued the renovated recommendations on the use of NOACs in patients with atrial fibrillation. The authors of recommendations presented some specific clinical variants for which they formulated practical advices based on the evidence obtained in randomized clinical trials. They also outlined the indications for use of NOACs, formulated practical start-program and scheme of subsequent follow-up management of patients taking NOACs. Recommendations contain information on pharmacokinetics of NOACs and their interactions with other drugs, consideration of feasibility of NOACs use in patients with chronic renal insufficiency or advanced liver disease. Many other practical problems are covered as well.

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