scholarly journals Prospective Observational Study of Safety of Early Treatment with Edoxaban in Patients with Ischemic Stroke and Atrial Fibrillation (SATES Study)

2020 ◽  
Vol 11 (1) ◽  
pp. 30
Author(s):  
Giovanni Frisullo ◽  
Paolo Profice ◽  
Valerio Brunetti ◽  
Irene Scala ◽  
Simone Bellavia ◽  
...  

New direct oral anticoagulants are recommended for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). However, no data are available regarding the optimal time to start oral anticoagulation after acute stroke. The aim of our study was to evaluate the occurrence of symptomatic bleedings within 90 days from acute cardioembolic stroke in patients who received early treatment with Edoxaban. The study was conducted according to an observational prospective uncontrolled design. Secondary endpoints were the incidence of major bleeding (MB), hemorrhagic transformation within the first week of Edoxaban treatment, minor bleeding, and recurrent stroke. We included patients with Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥ 6, NVAF, no previous treatment with any other anticoagulant, preserved swallowing function. Patients with estimated Glomerular Filtration Rate < 50 mL/min, body weight < 60 kg, receiving cyclosporine, dronedarone, erythromycin, ketoconazole, or previous treatment with any other anticoagulant were excluded. We enrolled 75 elderly patients with moderate disability. We did not observe any symptomatic intracranial bleeding or recurrent stroke after 3 months of treatment with early administration of Edoxaban, while two gastrointestinal MB, and 11 minor bleedings were reported. Asymptomatic bleeding was evaluated with a brain Magnetic Resonance Imaging performed 5 days after starting anticoagulant treatment with Edoxaban. Specifically, we observed small petechiae in 12% of the patients, confluent petechiae in 6.6% of the patients, and small hematoma of the infarcted area in 2.7% of the patients. No intralesional hematoma or hemorrhagic lesion outside the infarcted area were observed. According to our data, the early use of Edoxaban seems to be safe in patients after cardioembolic stroke. However, due to the small size of the study sample, and the short follow-up period, further studies are needed.

Author(s):  
Kristaps Jurjāns ◽  
Santa Sabeļnikova ◽  
Evija Miglāne ◽  
Baiba Luriņa ◽  
Oskars Kalējs ◽  
...  

Abstract Atrial fibrillation is one of major risk factors of cerebral infarction. The use of oral anticoagulants is the only evidence-based method of reducing the risk of cardioembolic accidents. The guidelines of oral anticoagulant admission and usage have been available since 2012. The results of this study show that of 550 stroke patients that were admitted to Pauls Stradiņš Clinical University Hospital, Rīga, Latvia, from 1 January 2014 until 1 July 2014, atrial fibrillation was diagnosed in 247 (45%) cases, and of these patients, only 8.5% used oral anticoagulants before the onset of stroke. Six months after discharge of 111 (44.9%) stroke survivors, five (4.5%) used no secondary prevention medication, 27 (24.3%) used antiplatelet agents, 54 (48.6%) warfarin, and 25 (22.5%) used target specific oral anticoagulants (TSOACs). The mortality rate was significantly higher in the patient group that used no secondary prevention medication or antiplatelet agents compared to the patient group that used oral anticoagulants. The use of oral anticoagulants for primary stroke prevention in Latvia is insufficient. The mortality of cardioembolic stroke in 180 days is very high - 40.4%. Secondary prevention is essential to prevent recurrent cardioembolic accidents.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Abdul Shokor Parwani ◽  
Daniel Blaschke ◽  
Alexander Wutzler ◽  
Martin Huemer ◽  
Phillip Attanasio ◽  
...  

Introduction: Thromboembolic events are the most feared complication of radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF). The traditional periprocedural anticoagulation approach is discontinuation of vitamin K antagonist and bridging with heparin. Newly procedures are done under therapeutic INR 2-3. Recent studies used periprocedural new direct oral anticoagulants (NOACs). Hypothesis: We evaluated the available evidence on the efficacy and safety of NOACs for periprocedural anticoagulation during RFCA of AF. Methods: Pubmed, Embase and Cochrane Central were searched. Retrospective and prospective studies published as peer-reviewed full-size articles were included if they reported embolic events and major and minor bleeding. Results: Fifteen studies were identified (14 observational studies, 1 small randomized trial). A total of 7050 patients were included (NOACs group: 2887 ). A total of 37 thromboembolic complications occurred (0,5%) with 17 events in the NOAC group (0,6%) and 20 in the warfarin group (0,5%) (odds ratio 0.97, 95% confidence interval (CI) 0.48 to 1.99). Major bleeding were numerically higher in the warfarin group compared to the NOACs group. However, the difference did not reach statistical significance (odds ratio 0.69, CI 0.43 to 1.10). Subgroup analysis did not reveal any differences in event rates. Conclusions: Our review suggests that dabigatran etexilate and rivaroxaban are as effective and safe as warfarin for periprocedural anticoagulation in patients undergoing RFCA of AF. However, it has to be acknowledged that the current evidence is mainly based on observational studies.


2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Mariacarla Gallù ◽  
Giulia Marrone ◽  
Jacopo Maria Legramante ◽  
Antonino De Lorenzo ◽  
Nicola Di Daniele ◽  
...  

Sex-specific differences have been definitively demonstrated in cardiovascular (CV) diseases. These differences can also impact on the effects of CV therapies. Female sex is recognized as an independent predictor of thromboembolic risk, particularly in older patients. Most of strokes are due to atrial fibrillation (AF). Women affected by AF have higher stroke risk compared to men. The introduction of novel oral anticoagulants (NOACs) for long-term anticoagulation completely changed the anticoagulant therapeutic approach and follow-up of patients affected by nonvalvular atrial fibrillation (NVAF). CHA2DS2-VASc stroke risk scoring in use in the current international guidelines attributes 1 point to “female sex”. Besides, no anticoagulation is indicated for AF female patients without other risk factors. Interestingly, NOACs seem to normalize the differences between males and females both in terms of safety and efficacy, whereas residual higher stroke risk and systemic embolism persist in AF women treated with vitamin K antagonist anticoagulants VKA with optimal time in therapeutic range. Based on the CHA2DS2-VASc score, NOACs represent the preferred choice in NVAF patients. Moreover, complete evaluation of apparently lower risk factor along with concomitant clinical conditions in AF patients appears mandatory, particularly for female patients, in order to achieve the most appropriate anticoagulant treatment, either in male or in female patients. The present review was performed to review sex differences in AF-related thromboembolic risk reported in the literature and possibly highlight current knowledge gaps in prevention and management that need further research.


2020 ◽  
pp. 7-16
Author(s):  
L. A. Geraskina ◽  
M. M. Alieva ◽  
A. V. Fonyakin ◽  
M. Yu. Maximova ◽  
N. I. Garabova ◽  
...  

Introduction. For the prevention of recurrent ischemic stroke (IS) in patients with atrial fibrillation (AF), oral anticoagulants (OAC) are considered a priority. The comorbidity of AF patients raises a discussion about the non-alternative feasibility and exceptional clinical efficacy of OAC. The validity of the choice of a specific antithrombotic agent can be assessed using a dynamic assessment of the causes of the first and recurrent stroke in patients with AF.Aim. To assess the frequency recurrent IS and quality of medicament prevention therapy in patients with AF depend on heterogeneity of stroke leading pathogenetic mechanism.Materials and methods. The data from the register of 200 patients with IS and AF were analyzed. 55 (27.5%) patients suffered recurrent IS (24 (43,6%) men, 31 (56,4%) women, mean age 72,3 ± 10,2 years). The pathogenetic subtype of recurrent IS was determined, including a retrospective assessment of the pathogenetic subtype of a previous IS. We studied the presence and nature of antithrombotic therapy (ATT) preceding a second stroke.Results. The first IS was due to cardiogenic embolism in 36.4% of patients, the atherothrombotic subtype occurred in 18.2%, and the lacunar subtype in 34.5% of patients. Embolic stroke from an undetermined source (ESUS) - in 10.9% of patients. OACs were prescribed only to 31.7% of patients, antiplatelet agents - to 14.6% of patients, 53.7% of patients did not receive ATT. The leading pathogenetic subtype of recurrent stroke was cardiogenic embolism (70.7%), the frequency of lacunar stroke decreased (4.9%), and the frequency of atherothrombotic stroke remained unchanged. In 14 patients with recurrent stroke, AF was first detected, including all patients with ESUS.Conclusion. The proportion of recurrent stroke in patients with AF is 27.5%. Compared with the first stroke, recurrent stroke in patients with AF is characterized by an increase in the proportion of cardiogenic embolism up to 70.7%, which is due to the insufficient prescription of OAC, which must be recommended, including for patients with non-cardioembolic subtypes of stroke.


Medicina ◽  
2019 ◽  
Vol 55 (9) ◽  
pp. 586
Author(s):  
Kristaps Jurjans ◽  
Baiba Vikmane ◽  
Janis Vetra ◽  
Evija Miglane ◽  
Oskars Kalejs ◽  
...  

Background and Objectives: Oral anticoagulants are the hallmark of cardioembolic stroke prevention, but they are frequently underused, especially in elderly patients and patients with paroxysmal atrial fibrillation. In our paper, we analyzed the long-term outcome of severely disabled cardioembolic stroke survivors depending on the prescribed antithrombotic secondary prevention medication. Materials and Methods: In our study, we retrospectively collected data for ischemic stroke (IS) patients treated in P. Stradins Clinical University hospital, Riga, Latvia, from 2014 until 2017. Patients’ clinical data were collected using local stroke registry, including patients’ demographic data, vascular risk factors, clinical findings, and laboratory results. Severely disabled stroke survivors were followed up by phone at 30/90/180/365 days after discharge. Patients’ functional outcomes were assessed using the adapted version of The Rankin Focused Assessment–Ambulation. The collected data were compared in 4 groups according to prescribed secondary prevention medication. Results: A total of 682 (91.42%) patients were followed up and included in data analysis. The median age of patients was 80 (IQR = 75–85) years. Of these patients, 231 (31%) were males and 515 (69%) were females. One-year probability of survival of patients not taking any preventive medication was 53% (IQR = 29–76), while in patients taking antiplatelet agents it was 57% (IQR = 37–78), 78% (IQR = 68–88) of patients on Vitamin K antagonists (VKA) and 81% (IQR = 72–90) in patients on direct oral anticoagulants (DOACs). One year after discharge 73 (31%) had mRS 0–2, 50 (20.9%), 29 (12.1%) were still severely disabled, and 87 (36.4%) had died. Conclusions: Anticoagulant use in secondary prevention predicts better functional outcome and higher survival rate in patients with severe cardioembolic stroke due to non-valvular atrial fibrillation (NVAF), therefore severe neurological deficit must not be a reason of restriction of anticoagulation.


2019 ◽  
pp. 55-58 ◽  
Author(s):  
A. S. Mukhin ◽  
A. P. Mеdvedev ◽  
Ya. A. Ivanova ◽  
S. A. Fedorov

A stroke develops due to ineffective anticoagulant therapy or the lack of such therapy. With the advent of new oral anticoagulants, everything has changed. This is what the latest research on this topic shows. According to available literature sources, it is known that atherogenic dyslipidemia is a risk factor for plaque failure in the coronary arteries. Persistent atrial fibrillation, diagnosed with Holter's long-term monitoring, is also a risk factor for stroke. One of the methods for diagnosing embolism is transcranial Doppler scanning. Also, the method helps in choosing the tactics of endovascular closure of the left atrial appendage. As for the etiology, embolism is one of the common causes of cardioembolic stroke. The term embolism of an unspecified source (ESUS), a study of the causes currently underway, was introduced for the embolism that happened in the remote period after a myocardial infarction. Recent clinical trials have shown that ESUS can occur in patients with subclinical atrial fibrillation (AF). Evidence suggests that a left atrial thrombus can lead to thromboembolism even in the absence of AF. Many aspects for the sensible management of patients at risk of developing car dioembolic stroke are ref lected in this review.


Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Shadi Yaghi ◽  
Yeseon P Moon ◽  
Consuelo Mora-McLaughlin ◽  
Joshua Z Willey ◽  
Marco R Di Tullio ◽  
...  

Background: While left atrial (LA) enlargement increases incident stroke risk, the association with recurrent stroke is unclear. Our aim was to determine the association of LA enlargement (LAE) with stroke recurrence risk and recurrent stroke subtypes likely related to embolism (cryptogenic or cardioembolic). Methods: We enrolled 655 first ischemic stroke patients in the Northern Manhattan Stroke Study. LA size was measured by two-dimensional echocardiogram as part of the clinical evaluation and patients were followed annually for up to 5 years. LA size adjusted for sex and body surface area was categorized into three groups: normal (52.7%), mild LAE (31.6%), and moderate to severe LAE (15.7%). The outcomes were total recurrent stroke, and recurrent combined cryptogenic or cardioembolic stroke. Cox proportional hazard models assessed the association between LA size and risk of stroke recurrence. Results: Of 655 patients, LA size data was present in 529 (81%). Mean age was 69 ± 13 years; 46% were male and 18% had atrial fibrillation. Over a median of 4 years, recurrent stroke occurred in 83 patients (16%), 29 were cardioembolic or cryptogenic stroke. After adjusting for baseline demographics and risk factors including atrial fibrillation and congestive heart failure, compared to normal LA size, moderate to severe LAE was associated with greater risk of recurrent combined cardioembolic or cryptogenic stroke (adjusted HR 2. 99, 95% CI 1. 10 to 8.13), but not with risk of total stroke recurrence (adjusted HR 1.18, 95% CI 0.60 to 2.32). Mild LAE was not associated with either total stroke recurrence or the combined recurrent cryptogenic or cardioembolic stroke subtypes. Conclusion: Moderate to severe LAE is an independent marker of recurrent cardioembolic or cryptogenic stroke in a multiethnic cohort of ischemic stroke patients. Future research is needed to determine if anticoagulant use reduces the risk of recurrence in ischemic stroke patients with moderate to severe LAE.


2019 ◽  
Vol 8 (12) ◽  
pp. 2228 ◽  
Author(s):  
Jiesuck Park ◽  
So-Ryoung Lee ◽  
Eue-Keun Choi ◽  
Soonil Kwon ◽  
Jin-Hyung Jung ◽  
...  

We investigated the effectiveness and safety of direct oral anticoagulants (DOACs) for secondary prevention in patients with atrial fibrillation (AF), particularly focusing on subgroups of patients with severe, disabling, and recent stroke. Using the Korean National Health Insurance Service claims database between January 2010 and April 2018, we selected OAC-naïve patients with non-valvular AF and a history of stroke. Cumulative risks for recurrent stroke, major bleeding, composite outcome (recurrent stroke + major bleeding), and mortality were compared between DOAC and warfarin groups. Among 61,568 patients, 28,839 and 32,729 received warfarin and DOACs, respectively. Compared with warfarin, DOACs were associated with lower risks of recurrent stroke (hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.62–0.72), major bleeding (HR 0.73, 95% CI 0.66–0.80), composite outcome (HR 0.69, 95% CI 0.65–0.73), and mortality. DOAC use resulted in a consistent trend of improved outcomes in the subgroups of patients with severe, disabling, and recent stroke. In conclusion, DOACs were associated with lower risks of recurrent stroke, major bleeding, composite clinical outcomes, and mortality in patients with AF and a history of stroke. These results were consistent across all types of DOACs and subgroups of patients with severe, disabling, and recent stroke.


2021 ◽  
Vol 8 (4) ◽  
pp. 222-232
Author(s):  
V. I. Petrov ◽  
A. S. Gerasimenko ◽  
V. S. Gorbatenko ◽  
O. V. Shatalova

Background. Every fifth ischemic stroke is caused by a patient’s history of atrial fibrillation. Nowadays, direct and indirect oral anticoagulants are widely used to prevent thromboembolic complications in patients with atrial fibrillation. However, despite the prescription of this group of drugs, every year 1–2% of patients with atrial fibrillation have an ischemic stroke. In this situation, a number of questions take rise: if it is possible to carry out thrombolytic therapy in the patients who have been taking anticoagulants; if it is worth resuming anticoagulant therapy after a stroke; when exactly this should be done; and what drugs should be used to prevent another stroke.The aim of this review was to summarize the available clinical guidelines and research results on the study of the anticoagu- lant therapy characteristics in patients with atrial fibrillation after an ischemic stroke.Materials and methods. For this review, the information presented in the scientific literature from open and available sourc- es, has been used. The information had been placed in the following electronic databases: PubMed, Scopus, Web of Sci- ence Core Collection, Cochrane Library, ClinicalTrials.gov; Elibrary, Cyberleninka, Google Academy. The covering period was 1997–2020. The search queries were: “ischemic stroke + atrial fibrillation + anticoagulants”; “ischemic stroke + atrial fibrillation + direct oral coagulants” and “atrial fibrillation + ischemic stroke + warfarin” in both Russian and English equivalents.Results and conclusion. Currently, the problem of the use of anticoagulants for the prevention of recurrent thromboembolic complications in patients with AF in the acute period of a stroke, is studied insufficiently. The difficulties are caused by the delivery of TLT in the patients who have been taking DOACs, first of all, due to the impossibility of an accurate assessment of the hemostasis state because of the unavailability of routine specific tests; and second, as a result of the lack of registered antidotes for most drugs, and their high costs. Besides, there are no RCTs dedicated to the study of the optimal time for the resumption or initiation of anticoagulant therapy in the acute period of an IS, and the optimal drugs for this group of patients. Most of the existing recommendations on these aspects, are based on the consensus of experts, and this fact indicates the need for further research in the area under review.


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