P471Experience with the use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation and a high risk of hemorrhagic complications

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
E Emelina ◽  
G Gendlin ◽  
I Nikitin
Keyword(s):  
Atrial Fibrillation ◽  
Anterior Chamber ◽  
Oral Anticoagulants ◽  
Lymphocytic Leukemia ◽  
Hemorrhagic Complication ◽  
Minimum Dose ◽  
Gingival Bleeding ◽  
Life Threatening ◽  
History Of ◽  
Persistent Thrombocytopenia

Abstract Background. The use of NOACs in patients with chronic lymphocytic leukemia (CLL) is a difficult task due to the tendency to hemorrhage in these patients associated with CLL. The use of targeted ibrutinib (Ib) therapy in the treatment of CLL patients increases the risk of bleeding due to thrombocytopathy. A feature of targeted Ib therapy is the need for daily and lifelong use. One of the cardiotoxic effects of Ib is the development of atrial fibrillation (AF). Some patients receiving Ib have a history of AF. Warfarin is contraindicated in patients taking Ib, so all patients received NOACs. Purpose. To evaluate the possibility of using NOACs in CLL patients receiving Ib, taking into account the frequency and severity of hemorrhagic manifestations, the need to cancel, reduce the dose and replace with another NOACs. Methods. We examined and observed the dynamics of 224 patients with CLL receiving Ib from 5 to 56 months at a dose of 420 mg per day as 1, 2, 3, and 4 lines of CLL therapy. Patients with CLL aged 32 to 91 years (66.0 (59.0-72.0) years) were Included, of whom 82 are women aged 39 to 83 years (64.0 (54.0-71.0 ) years) and 142 men aged 32 to 91 years (66.0 (60.0-72.0) years). All hemorrhagic manifestations in patients receiving Ib and NOACs were evaluated, taking into account the glomerular filtration rate and platelet count. Results. AF were revealed in 51 patients with CLL receiving Ib. AF was registered in 32 patients during the treatment with Ib, in 19 patients AF was before prescribing of Ib. The need for NOACs because of AF arose in 38 patients with CLL who were prescribed rivaroxaban (n = 11), dabigatran (n = 6), apixaban (n = 21). Hemorrhages were observed in 88.2% of patients receiving NOACs and Ib, represented by hematomas (n = 32), petechiae (n = 4), nosebleeds (n = 6), gingival bleeding (n = 7), hemorrhage in the anterior chamber of the eye (n = 1), hemorrhage in the sclera of the eye (n = 3) and macrohematuria (n = 4). A combination of several hemorrhagic manifestations (combined hemorrhages) was observed in 40.7% of CLL patients receiving NOACs. 10 patients were transferred to the minimum dose of apixaban 2.5 mg twice a day due to the development of recurring nosebleeds (n = 5), macrohematuria (n = 3), large, recurring hematomas with localization on the neck and face (n = 1 ), hemorrhages in the anterior chamber of the eye (n = 1). Cancellation of NOACs in 1 patient was associated with recurrent macrohematuria. Rivaroxaban 20 mg per day was canceled in 6 patients due to the development of persistent thrombocytopenia of less than 50 × 109/L. Conclusions. There were no life-threatening hemorrhages. The main reason for the withdrawal of NOACs was persistent thrombocytopenia. Due to hemorrhagic complication, NOACs was canceled only in 1 patient, 10 patients (26.3%) required a transfer to the minimum dose of apixaban. The arising hemorrhages did not require hospitalization of patients.

scholarly journals Severe gastrointestinal bleeding in patients with atrial fibrillation receiving oral anticoagulants (based on REGistry of long-term AnTithrombotic TherApy – REGATTA)

2021 ◽  
Vol 93 (9) ◽  
pp. 1037-1043
Author(s):  
Ekaterina S. Kropacheva ◽  
Mariia B. Khakimova ◽  
Elena N. Krivosheeva ◽  
Oksana A. Zemlyanskaya ◽  
Elizaveta P. Panchenko
Keyword(s):  
Atrial Fibrillation ◽  
Gastrointestinal Bleeding ◽  
Antithrombotic Therapy ◽  
Oral Anticoagulants ◽  
Clinical Predictors ◽  
Gastrointestinal Ulcer ◽  
Hemorrhagic Complications ◽  
Life Threatening ◽  
History Of

Background. The rate of major bleeding in patients with atrial fibrillation receiving oral anticoagulants is 25% per year. Gastrointestinal bleedings are at least a half of major hemorrhagic complications. Currently, there is no optimal scale to calculate the risk of bleeding, and therefore the search for clinical predictors of gastrointestinal bleeding remains relevant. Aim. To assess the frequency and structure of large gastrointestinal bleeding, as well as to identify clinical predictors of their development based on long-term prospective observation of patients with atrial fibrillation receiving oral anticoagulants. Materials and methods. Data were obtained from single center prospective REGistry of long-term AnTithrombotic TherApy (REGATTA NCT043447187). Investigation based on a 20-year follow-up with 510 patients with atrial fibrillation with a high thromboembolic risk (median CHA2DS2-VASc was 4 points). The REGATTA registry assessed the frequency and structure of major gastrointestinal bleeding. Predictors of the development of 32 large gastrointestinal bleeding were identified based on the analysis of pairs with univariate and multivariate analyses. Results. The frequency of major gastrointestinal bleeding in patients with atrial fibrillation receiving oral anticoagulants at 1 year was 1.42 per 100 patients; the predominant localization was upper gastrointestinal tract. Predictors of the development of major gastrointestinal bleeding according to multiple regression data analysis were hemoglobin level 14.55 g/dL, body mass index 28.4 kg/m2, gastrointestinal ulcer or erosive lesion and major hemorrhagic complications in history of disease. In 1/2 cases the sourse of bleeding remained unclear. Conclusion. Searching for clinical predictors of gastrointestinal bleeding can identify patients receiving oral anticoagulants who is need of intensive monitoring risk factors to prevent the development of life-threatening bleeding and to provide with adequate anticoagulant therapy.

Comparison Of Drugs in Patients Using New Generation Anticoagulants

2021 ◽  
Vol 6 (14) ◽  
pp. 56-67
Author(s):  
Arslan Say ◽  
Abdülkadir ÇAKMAK ◽  
Gökhan KESKİN ◽  
Erdinç PELİT ◽  
Yılmaz ÖZBAY
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Oral Anticoagulants ◽  
Recurrent Venous Thromboembolism ◽  
Anticoagulant Drugs ◽  
History Of ◽  
The Mean ◽  
N 93 ◽  
New Generation

Aim: New generation anticoagulants rapidly find a wider area of use in the clinic due to the use problems of other oral anticoagulants. Anticoagulants such as Dabigatran, Rivaroxaban, and Apixaban with safer treatment intervals have been accepted in clinical practice guidelines and have taken their place as preferred drugs. In this study, we aimed to retrospectively examine the effects of three new-generation anticoagulant drugs on a group of patients. Material and Methods: In this retrospectively planned study, patients diagnosed with atrial fibrillation (n = 522) were divided into three groups according to the drugs used for treatment (Dabigatran, Rivaroxaban, and Apixaban). Routine blood values of the patients in each group were retrospectively scanned according to age, gender, time of drug initiation and presence of chronic disease. Results: According to the results obtained, it was found that the mean HCT, BUN, AST, ALT, MPV, Iron, and Ferritin were higher in patients using Apixaban than those using Dabigatran and Rivaroxaban drugs, but the age, average values of Hgb1 Hgb2, Hgb1, PLT, CrCl, Gfr and INR of the patients using Apixaban lower than those using Dabigatran and Rivaroxaban. The highest rate (22.5%) was found in the group of patients taking apixaban (n=93) when people taking the drugs were examined in terms of mortality. Conclusion: It has been observed that Rivaroxaban can be used more safely in patients with a history of acute cancer and thrombosis, patients with recurrent venous thromboembolism, and patients with high frailty, three drugs should be preferred instead of oral anticoagulants.

6072Risk of stroke in hypertensive patients with atrial fibrillation treated with oral anticoagulants

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R E Harskamp ◽  
W A M Lucassen ◽  
R D Lopes ◽  
H C Van Weert
Keyword(s):  
Atrial Fibrillation ◽  
Blood Pressure ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Haemorrhagic Stroke ◽  
Uncontrolled Hypertension ◽  
P Value ◽  
Systemic Embolism ◽  
History Of

Abstract Background Hypertension is common in patients with atrial fibrillation (AF) and carries an additional risk for complications, most notably stroke and bleeding. We assessed the history of hypertension, level of blood pressure control, and an interaction with the choice of oral anticoagulants on clinical outcomes. Purpose To gain insights into the risks of hypertension in the setting of AF and explore possible interactions with the safety and efficacy of non-vitamin K oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs). Methods We performed a systematic review and meta-analysis of studies that randomised patients to NOACs or VKAs and reported outcomes stratified by presence of hypertension. Collected outcomes included: ischaemic stroke or systemic embolism (SE), death from any cause, hemorrhagic stroke, major bleeding, and intracranial hemorrhage. Log adjusted hazard ratios (HR) and corresponding standard error were calculated, and HRs were compared using Mantel-Haenszel random effects. Quality of the evidence was assessed with Cochrane risk of bias tool. Results Five high-quality studies were eligible, including 71,602 participants who received NOACs (apixaban, dabigatran, edoxaban, rivaroxaban) or VKAs, with median follow-up of 1.8–2.8 years. 89.2% of participants had a history of hypertension. Compared with patients without hypertension, those with controlled and uncontrolled hypertension had higher risk for stroke/SE (HR: 1.21 [1.04–1.41] and HR: 1.50 [1.12–2.01], respectively) and haemorrhagic stroke (HR: 1.78 [1.06, 3.00] and HR: 1.66 [0.99–4.01], respectively). On a continuous scale, the risk of stroke increased 7% per 10mmHg increase in systolic blood pressure. As shown in the Table, no interactions were found between hypertension status and the efficacy or safety of NOACs versus VKAs. Table 1. Interaction of presence of hypertension on the comparative efficacy and safety of NOAC versus VKA Hypertension (n=63,869) No hypertension (n=7,733) P-value (int) Adjusted HR, 95% CI Adjusted HR, 95% CI Stroke or systemic embolism 080, 0.72–0.89 0.79, 0.53–1.19 0.98 Haemorrhagic stroke 0.55, 0.41–0.74 0.24, 0.04–1.37 0.36 Death from any cause 0.91, 0.84–0.98 0.89, 0.76–1.04 0.82 Major bleeding 0.90, 0.76–1.07 0.84, 0.69–1.01 0.57 Intracranial haemorrhage 0.41, 0.24-.068 0.48, 0.14–1.69 0.81 Major or clinically relevant non-major bleed 0.90, 0.68–1.18 0.91, 0.55–1.53 0.96 Conclusions Adequate blood pressure management is vital to optimally reduce the risk of stroke in patients with atrial fibrillation. The benefits of NOACs over VKAs, also apply to patients with elevated blood pressure.

Stroke prevention in atrial fibrillation: An Asian perspective

2014 ◽  
Vol 111 (05) ◽  
pp. 789-797 ◽  
Author(s):  
Kang-Ling Wang ◽  
Gregory Y. H. Lip ◽  
Chern-En Chiang
Keyword(s):  
Atrial Fibrillation ◽  
Stroke Prevention ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Asian Patients ◽  
History Of ◽  
Randomised Controlled ◽  
Similar Risk ◽  
Selection Of

SummaryAtrial fibrillation (AF) is the most common sustained cardiac arrhythmia. In 2050, it is estimated that there will be 72 million AF patients in Asia, accounting for almost 2.9 million patients suffering from AF-associated stroke. Asian AF patients share similar risk factor profiles as non-Asians, except that more Asians have a history of previous stroke. Clinical challenges are evident in the field of stroke prevention in AF, amongst Asians. Existing stroke and bleeding risk scores have not been well-validated in Asians. Asians are prone to bleeding when treated with warfarin, and the optimal international normalised ratio (INR) for warfarin use is yet to be determined in Asians, though Asian physicians tend to keep it in a lower range (e.g. INR 1.6–2.6) for elderly patients despite limited evidence to justify this. In general, warfarin is ‘difficult’ to use in Asians due to higher risk of bleeding and higher stroke rate in Asians than in non-Asians, as shown in randomised controlled trials. Excess of bleeding was not found in Asians when novel oral anticoagulants (NOACs) were used. Besides, the superiority of NOACs to warfarin in reducing thromboembolism was maintained in Asians. Therefore NOACs are preferentially indicated in Asians in terms of both efficacy and safety. Also, some preliminary data suggest that Asian patients with AF might not be the same. Future prospective randomised trials are needed for the selection of NOACs according to different ethnic background.Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.

scholarly journals Atrial fibrillation and clinical outcomes 1 to 3 years after myocardial infarction

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001726
Author(s):  
Anthony P Carnicelli ◽  
Ruth Owen ◽  
Stuart J Pocock ◽  
David B Brieger ◽  
Satoshi Yasuda ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Adverse Outcomes ◽  
Increased Risk ◽  
History Of ◽  
The Impact

ObjectiveAtrial fibrillation (AF) and myocardial infarction (MI) are commonly comorbid and associated with adverse outcomes. Little is known about the impact of AF on quality of life and outcomes post-MI. We compared characteristics, quality of life and clinical outcomes in stable patients post-MI with/without AF.Methods/resultsThe prospective, international, observational TIGRIS (long Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease) registry included 8406 patients aged ≥50 years with ≥1 atherothrombotic risk factor who were 1–3 years post-MI. Patient characteristics were summarised by history of AF. Quality of life was assessed at baseline using EQ-5D. Clinical outcomes over 2 years of follow-up were compared. History of AF was present in 702/8277 (8.5%) registry patients and incident AF was diagnosed in 244/7575 (3.2%) over 2 years. Those with AF were older and had more comorbidities than those without AF. After multivariable adjustment, patients with AF had lower self-reported quality-of-life scores (EQ-5D UK-weighted index, visual analogue scale, usual activities and pain/discomfort) than those without AF. CHA2DS2-VASc score ≥2 was present in 686/702 (97.7%) patients with AF, although only 348/702 (49.6%) were on oral anticoagulants at enrolment. Patients with AF had higher rates of all-cause hospitalisation (adjusted rate ratio 1.25 [1.06–1.46], p=0.008) over 2 years than those without AF, but similar rates of mortality.ConclusionsIn stable patients post-MI, those with AF were commonly undertreated with oral anticoagulants, had poorer quality of life and had increased risk of clinical outcomes than those without AF.Trial registration numberClinicalTrials: NCT01866904.

scholarly journals The role of edoxaban in preventing thromboembolic complications in patients with atrial fibrillation

2020 ◽  
pp. 28-43
Author(s):  
O. O. Shakhmatova
Keyword(s):  
Atrial Fibrillation ◽  
Drug Interactions ◽  
Dose Reduction ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Factor Xa ◽  
Extensive Study ◽  
Thromboembolic Complications ◽  
Nonvalvular Atrial Fibrillation ◽  
Life Threatening

Edoxaban is a selective direct factor Xa inhibitor. Edoxaban in a dose of 60 mg per day is an effective and safe option in the prevention of thromboembolic complications in patients with nonvalvular atrial fibrillation, including in combination therapy in patients after percutaneous coronary interventions. ENGAGE AF-TIMI 48 is currently the most extensive study comparing direct oral anticoagulants and warfarin in patients with atrial fibrillation, both in terms of number of participants and duration of observation. For edoxaban, an adequate approach to dose reduction has been developed in patients with alikely increase in plasma concentration due to renal impairment, low body weight or inter-drug interactions. Such dose reduction does notlead to an increase in the frequency of ischemic complications.Edoxaban is characterized by an optimal safety profile in patients with chronic moderate kidney disease, a small number of drug interactions and a convenient mode of administration. In patients with atrial fibrillation and concomitant ischemic heart disease, the use of Edoxaban is associated with a decrease in the frequency of myocardial infarctions, as well as strokes and episodes of systemic thromboembolism in comparison with warfarin. The drug can be successfully used as anticoagulant support for cardioversion and catheter ablation for atrial fibrillation.Edoxaban intake does not require routinelaboratory control. In case of unexpected situations (life-threatening bleeding, urgent surgical intervention) in patients receiving edoxaban, to assess the degree of anticoagulation should use the determination of anti-Xa activity. Clinical studies of a specific antidote of edoxaban - andexanet alfa are ongoing. Before approval of the specific antidote in severe andlife-threatening bleedings against the background of edoxaban administration, the use of prothrombin complex concentrate should be considered. Data on the effective and safe use of edoxaban in routine clinical practice have been accumulated.

scholarly journals COVID-19 Pneumonia in Patients with Chronic Myocarditis (HBV-Associated with InfarctLike Debute): Specifics of the Diseases Course, the Role of the Basic Therapy (Part II)

2020 ◽  
Vol 16 (5) ◽  
pp. 730-736
Author(s):  
O. V. Blagova ◽  
N. V. Varionchik ◽  
M. M. Beraia ◽  
V. A. Zaidenov ◽  
E. A. Kogan ◽  
...  
Keyword(s):  
Immunosuppressive Therapy ◽  
Troponin T ◽  
Oral Anticoagulants ◽  
Adverse Outcomes ◽  
Interleukin 17 ◽  
Chronic Myocarditis ◽  
Life Threatening ◽  
History Of ◽  
Therapy Withdrawal

Chronic infectious-immune myocarditis of severe course can potentially be considered as a factor that aggravates the course of new coronavirus disease (COVID-19) and increases the risk of adverse outcomes. The interaction of chronic myocarditis and COVID-19 during long-term immunosuppressive therapy has not been studied. We present a description of a 35-year-old female patient with chronic infectious-immune myocarditis (morphologically confirmed, with a history of infarction-like onset and thromboembolic complications), who had continuous immunosuppressive therapy with methylprednisolone and mycophenolate mofetil. The patient also received new oral anticoagulants and tenofovir (for chronic HBV infection). COVID-19 (SARS-Cov-2 RNA+) was diagnosed in May 2020. Risk factors for the adverse course of coronavirus infection included severe obesity, heart failure, and life-threatening ventricular arrhythmias. Correction of immunosuppressive therapy (withdrawal of the cytostatic agent, administration of hydroxychloroquine) and therapy with levofloxacin, an interleukin-17 inhibitor (netakimab) were performed. The severity of pneumonia and respiratory failure was moderate despite high fever and high levels of inflammatory markers in the blood (including interleukin-6). Signs of exacerbation of myocarditis, increased levels of troponin T and anticardial antibodies (compared with the initial ones) were not found. It can be assumed that supportive immunosuppressive therapy for myocarditis has a positive effect on the course of coronavirus pneumonia and avoids exacerbation of myocarditis. Careful continuation of immunosuppressive therapy with temporary withdrawal of aggressive cytostatics can be recommended in chronic myocarditis. Further study of the features of the course of previous myocarditis and COVID-19 pneumonia is necessary.

scholarly journals The Therapy with Oral Anticoagulants in Patients with Atrial Fibrillation in Outpatient and Hospital Settings (Data from RECVASA Registries)

2019 ◽  
Vol 15 (4) ◽  
pp. 538-545 ◽  
Author(s):  
M. M. Loukianov ◽  
S. Yu. Martsevich ◽  
O. M. Drapkina ◽  
S. S. Yakushin ◽  
A. N. Vorobyev ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Hospital Treatment ◽  
Pronounced Difference ◽  
Period 2 ◽  
Significant Difference ◽  
History Of ◽  
Low Incidence ◽  
Outpatient Settings

Aim. To evaluate an incidence of oral anticoagulants (OAC) administration during longterm follow-up period in patients with atrial fibrillation (AF) enrolled in outpatient and hospital RECVASA registries.Material and methods. 3169 patients with AF were enrolled in outpatient registries RECVASA (Ryazan), RECVASA AF-Yaroslavl and hospital registries RECVASA AF (Moscow, Kursk, Tula), age 70.9±10.7 years, 43.1% men. The incidence of OAC administration was evaluated in hospital and outpatient settings, including longterm follow-up period (2-6 years).Results. OAC were administrated only in 42.2% of cases (1335 from 3169 patients; age 69.1±10.4 years, 43% men), including warfarin (817 patients; 26%) and non-vitamin K antagonist oral anticoagulants (NOAC) – 518 (16%). Patients with permanent and persistant types of AF had lower incidence of OAC administration (43% and 40%) than in cases of paroxysmal type (47.6%, p<0.05), despite of the higher СНА2DS2-VASc risk score (4.69±1.66 and 4.23±1.57 vs 3.81±1.69; р<0.05). Patients with and without history of stroke received OAC in 42.5% and 40% of cases that means no significant difference (p>0.05) contrary to the pronounced difference of thromboembolic risk in these groups (6.14±1.34 and 3.77±1.39; р<0.001). The incidence of OAC administration in hospitals (54.1%) was 2.3 times higher than before hospitalization (23.8%) and was 4.1 times higher than in outpatient registries (13.5%). During follow-up period after hospital treatment (2.3±0.9 years) this parameter decreased from 54.1% to 41.2%, but was still 1.8 times higher than before admission to the hospital. After 4 years follow-up in RECVASA (Ryazan) registry we revealed 4.4 times higher incidence of OAC administration compared with enrollment data (4.2% and 18.3%, р<0.0001). This data was confirmed by the information from outpatient medical cards of accidentally generated group (75 from 297 patients survived during follow-up period): 5.3% at baseline and 22.7% six years later.Conclusions. RECVASA registries in 5 regions of Russia revealed low incidence of OAC administration. The risk of thromboembolic events was higher in patients with AF and no OAC administration compared with patients who received OAC. Patients with paroxysmal type of AF received OAC more often than those with permanent type. There were no significant differences of incidence of OAC therapy in patients with and without history of stroke. Both questioning of patients with AF and analysis of medical cards in outpatient clinics revealed higher incidence of OAC administration after 4-6 years of follow-up compared with the stage of enrollment in registries.

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