127 results found
Focke JK, Veltkamp R, Bauer P, et al., 2022, Novel heterozygous COL4A2 variant c.2572A > G, p.(I858V) mimicking Sneddon's and Divry van Bogaert Syndrome, JOURNAL OF NEUROLOGY, ISSN: 0340-5354
D'Anna L, Filippidis F, Harvey K, et al., 2022, Ischemic Stroke in orally anticoagulated patients with atrial fibrillation, Acta Neurologica Scandinavica, Vol: 145, Pages: 288-296, ISSN: 0001-6314
BackgroundIschemic strokes in orally anticoagulated patients pose challenges for acute management and secondary prevention but the characteristics of these strokes are poorly understood. We examined the clinical and imaging features, the presumed underlying etiology and the subsequent antithrombotic management.MethodsWe analyzed a consecutive series of patients enrolled into the EIDASAF study, a single center, observational study of ischemic stroke patients with a diagnosis atrial fibrillation (AF) prior to the index event who had been admitted to the Hyperacute Stroke Unit of Imperial College London between 2010 and 2017. We compared patients with oral anticoagulation therapy prior admission (OACprior) with those without anticoagulation (OACnaive). Brain imaging was analyzed centrally.Results763 patients were included in the analysis. 481 (63%) were OACnaive while 282 (37%) were OACprior. Patients with OACprior were younger, more often had a previous history of stroke or transient ischemic attack (TIA), and more often suffered from hypertension and diabetes. In OACnaive, patients, large and deep middle cerebral artery infarcts occurred more often than in OACprior patients. The groups differed significantly in the distribution of competing etiologies underlying their stroke. At discharge, OACprior more frequently were (re)-anticoagulated compared to OACnaive patients. Within the OACprior group, patients with recurrent strokes did not differ from those with a first stroke regarding clinical characteristics and pattern of cerebral infarction but they were less frequently anticoagulated.ConclusionsIschemic strokes on OAC represent a significant proportion of AF-related strokes. There is an unmet need to better understand the causes underlying these strokes and to optimize the medical management.
Best JG, Arram L, Ahmed N, et al., 2022, Optimal timing of anticoagulation after acute ischemic stroke with atrial fibrillation (OPTIMAS): Protocol for a randomized controlled trial, INTERNATIONAL JOURNAL OF STROKE, Vol: 17, Pages: 583-589, ISSN: 1747-4930
D'Anna L, Filippidis F, Nthony S, et al., 2020, EARLY INITIATION OF DIRECT ANTICOAGULATION AFTER STROKE IN PATIENTS WITH ATRIAL FIBRILLATION: THE EIDASAF STUDY., Publisher: SAGE PUBLICATIONS LTD, Pages: 547-547, ISSN: 1747-4930
D'Anna L, Filippidis FT, Antony S, et al., 2020, Early initiation of direct anticoagulation after stroke in patients with atrial fibrillation., European Journal of Neuroscience, Vol: 27, Pages: 2168-2175, ISSN: 0953-816X
BACKGROUND: The safety of early initiation of anticoagulant therapy in patients with ischaemic stroke related to atrial fibrillation (AF) is unknown. We investigated the safety of early initiation of direct oral anticoagulants (DOACs), vitamin K antagonists (VKAs) or no anticoagulation. METHODS: This observational, retrospective, single-centre study included consecutive patients with recent (< 4 weeks) ischaemic stroke and AF. The primary outcome was the rate of major (intra- and extracranial) bleeding in patients on different treatment schemes: DOACs, VKAs and not anticoagulated. We also investigated the rate of ischaemic cerebrovascular events and mortality. RESULTS: We included 959 consecutive patients with AF and ischaemic stroke followed up for an average time of 16.1 days after the index event. 559 patients of 959 (58.3%) were anticoagulated with either VKAs (259) or DOACs (300). Anticoagulation was started after a mean time of 7± 9.4 in the DOACs group and 11.9± 19.7 in the VKAs group. Early initiation of any anticoagulant was not associated with an increased risk of any major bleeding (OR 0.49; CI, 0.21-1.16) and in particular of intracranial bleeding (OR 0.47; CI, 0.17-1.29; p = 0.143) compared with no anticoagulation. In contrast to VKAs (OR 0.78; CI, 0.28-2.13), treatment with DOACs (OR 0.32; CI, 0.10-0.96) reduced the rate of major bleeding compared to no-anticoagulation. Early recurrences of ischaemic stroke did not differ significantly among the three groups. CONCLUSIONS: Starting DOACs within a mean time of 7 days after stroke appears safe. Randomised controlled studies are needed to establish the added efficacy of starting anticoagulation early after stroke.
Shoamanesh A, Hart RG, Connolly SJ, et al., 2020, Microbleeds and the Effect of Anticoagulation in Patients With Embolic Stroke of Undetermined Source An Exploratory Analysis of the NAVIGATE ESUS Randomized Clinical Trial, JAMA NEUROLOGY, Vol: 78, Pages: 11-20, ISSN: 2168-6149
Veltkamp R, Pearce LA, Korompoki E, et al., 2020, Characteristics of recurrent ischemic stroke after embolic stroke of undetermined source: secondary analysis of a randomized clinical trial., JAMA Neurology, Vol: 77, Pages: 1233-1240, ISSN: 2168-6149
Importance: The concept of embolic stroke of undetermined source (ESUS) unifies a subgroup of cryptogenic strokes based on neuroimaging, a defined minimum set of diagnostic tests, and exclusion of certain causes. Despite an annual stroke recurrence rate of 5%, little is known about the etiology underlying recurrent stroke after ESUS. Objective: To identify the stroke subtype of recurrent ischemic strokes after ESUS, to explore the interaction with treatment assignment in each category, and to examine the consistency of cerebral location of qualifying ESUS and recurrent ischemic stroke. Design, Setting, and Participants: The NAVIGATE-ESUS trial was a randomized clinical trial conducted from December 23, 2014, to October 5, 2017. The trial compared the efficacy and safety of rivaroxaban and aspirin in patients with recent ESUS (n = 7213). Ischemic stroke was validated in 309 of the 7213 patients by adjudicators blinded to treatment assignment and classified by local investigators into the categories ESUS or non-ESUS (ie, cardioembolic, atherosclerotic, lacunar, other determined cause, or insufficient testing). Five patients with recurrent strokes that could not be defined as ischemic or hemorrhagic in absence of neuroimaging or autopsy were excluded. Data for this secondary post hoc analysis were analyzed from March to June 2019. Interventions: Patients were randomly assigned to receive rivaroxaban, 15 mg/d, or aspirin, 100 mg/d. Main Outcomes and Measures: Association of recurrent ESUS with stroke characteristics. Results: A total of 309 patients (205 men [66%]; mean [SD] age, 68  years) had ischemic stroke identified during the median follow-up of 11 (interquartile range [IQR], 12) months (annualized rate, 4.6%). Diagnostic testing was insufficient for etiological classification in 39 patients (13%). Of 270 classifiable ischemic strokes, 156 (58%) were ESUS and 114 (42%) were non-ESUS (37 [32%] cardioembolic, 26 [23%] atherosclerotic, 35 [31%] lacu
De Potter T, Yodfat O, Shinar G, et al., 2020, Permanent bilateral carotid filters for stroke prevention in atrial fibrillation., Current Cardiology Reports, Vol: 22, Pages: 144-144, ISSN: 1523-3782
PURPOSE OF REVIEW: A novel permanent carotid filter device for percutaneous implantation was developed for the purpose of stroke prevention. In this review, we cover rationale, existing preclinical and clinical data, and potential future directions for research using such a device. RECENT FINDINGS: The Vine™ filter was assessed for safety in sheep and in 2 observational human studies, the completed CAPTURE 1 (n = 25) and the ongoing CAPTURE 2 (planned n = 100). CAPTURE 1 has shown high procedural and long-term implant safety. A control group was not available for comparison. A mechanical filter for permanent stroke prevention can be implanted bilaterally in the common carotid artery safely and efficiently. A randomized trial is planned for 2021 (n = 3500, INTERCEPT) to demonstrate superiority of a filter + anticoagulation strategy over anticoagulation alone in patients at high risk for ischemic stroke.
Veltkamp R, Pearce LA, Korompoki E, 2020, Characteristics of Recurrent Ischemic Stroke After Embolic Stroke of Undetermined Source: Secondary Analysis of a Randomized Clinical Trial (Jul, 10.1001/jamaneurol.2020.1995, 2020), JAMA NEUROLOGY, Vol: 77, Pages: 1322-1322, ISSN: 2168-6149
Elkind MSV, Veltkamp R, Montaner J, et al., 2020, Natalizumab in acute ischemic stroke (ACTION II): a randomized, placebo-controlled trial, Neurology, Vol: 95, ISSN: 0028-3878
OBJECTIVE: We evaluated the effect of two doses of natalizumab on functional outcomes in acute ischemic stroke (AIS) patients. METHODS: In this double-blind phase 2b trial, AIS patients aged 18-80 years with National Institutes of Health Stroke Scale scores of 5-23 from 53 US and European sites were randomized 1:1:1 to receive a single dose of 300 or 600 mg intravenous natalizumab or placebo, with randomization stratified by treatment window (≤9 or >9 to ≤24 hours from patient's last known normal state). The primary endpoint was a composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95) at day 90 assessed in all patients receiving a full dose. Sample size was estimated from a Bayesian model; p values were not used for hypothesis testing. RESULTS: An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93). There was no effect modification by time to treatment or use of thrombolysis/thrombectomy. For natalizumab 300 mg, 600 mg, or placebo, there were no differences in incidence of adverse events (90%, 92%, and 92%, respectively), serious adverse events (26%, 33%, and 21%, respectively), or deaths (7%, 5%, and 6%, respectively). CONCLUSIONS: Natalizumab administered ≤24 hours after AIS did not improve patient outcomes. CLINICALTRIALSGOV IDENTIFIER: NCT02730455 CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with AIS, an excellent outcome was less likely in patients treated with natalizumab than with placebo.
Pompsch M, Veltkamp C, Veltkamp R, et al., 2020, Proteinase-3-(cANCA)-associated ulcerative Colitis with possible inflammatory leukencephalopathic CNS Involvement, Nervenarzt, Vol: 91, Pages: 737-739, ISSN: 0028-2804
Die Ätiologie der zerebralen Leukenzephalopathie ist vielfältig und reicht von vaskulären Erkrankungen (Mikroangiopathie), über (autoimmun vermittelte) entzündliche und hereditäre Erkrankungen bis zu nicht seltenen unspezifischen Veränderungen (sog. „unknown bright objects“ [UBO]). Bei den autoimmun entzündlichen Erkrankungen des zentralen Nervensystems ist die multiple Sklerose (MS) die mit Abstand häufigste Entität. Jedoch betreffen auch Erkrankungen aus dem rheumatologischen Formenkreis (isolierte zerebrale Vaskulitis, systemische Vaskulitiden, Kollagenosen, Sarkoidose) häufig das zerebrale Marklager.
Mikulik R, Eckstein J, Pearce LA, et al., 2020, Frequency and predictors of major bleeding in patients with embolic strokes of undetermined source NAVIGATE-ESUS trial, Stroke, Vol: 51, Pages: 2139-2147, ISSN: 0039-2499
Background and Purpose:Risks, sites, and predictors of major bleeding during antithrombotic therapies have not been well defined for patients with recent embolic stroke of undetermined source.Methods:Exploratory analysis of major bleeds defined by International Society of Thrombosis and Hemostasis criteria occurring among 7213 participants in international NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial) embolic stroke of undetermined source randomized trial comparing rivaroxaban 15 mg daily with aspirin 100 mg daily.Results:During a median follow-up of 11 months, 85 major bleeds occurred. The most frequent site was gastrointestinal (38%), followed by intracranial (29%). Assignment to rivaroxaban (hazard ratio [HR], 2.7 [95% CI, 1.7–4.3]), East Asia region (HR, 2.5 [95% CI, 1.6–3.9]), systolic blood pressure ≥160 mm Hg (HR, 2.2 [95% CI, 1.2–3.8]), and reduced estimated glomerular filtration rate (HR, 1.2 per 10 mL/min per 1.73 m2 decrease, [95% CI, 1.0–1.3]) were independently associated with presence of major bleeds. Five (6%) were fatal. Among 15 patients with intracerebral hemorrhage, 2 (13%) were fatal. There was no evidence of an early high-risk period following initiation of rivaroxaban. The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2–18.0]). Distribution of bleeding sites was similar for rivaroxaban and aspirin.Conclusions:Among embolic stroke of undetermined source patients participating in an international randomized trial, independent predictors of major bleeding were assignment to rivaroxaban, East Asia region, increased systolic blood pressure, and impaired renal function. East Asia as a region was strongly associated with risk of intracerebral hemorrhage. Estimated glomerular filtration rate should be a consideration for stratifying bleeding risk.Registration:URL: https://www.clinical
Ntaios G, Pearce LA, Veltkamp R, et al., 2020, Potential Embolic Sources and Outcomes in Embolic Stroke of Undetermined Source in the NAVIGATE-ESUS Trial, STROKE, Vol: 51, Pages: 1797-1804, ISSN: 0039-2499
D'Anna L, Kar A, Brown Z, et al., 2020, Automated continuous electrocardiogram monitoring accelerates the detection of atrial fibrillation after ischemic stroke or transient ischemic attack on a hyper acute stroke unit, Journal of Stroke and Cerebrovascular Diseases, Vol: 29, Pages: 1-8, ISSN: 1052-3057
Background and Aim: Rapid and sensitive detection of atrial fibrillation (AF) is of paramount importance for initiation of adequate preventive therapy after stroke. Stroke Unit care includes continuous electrocardiogram monitoring (CEM) but the optimal exploitation of the recorded ECG traces is controversial. In this retrospective single-center study, we investigated whether an automated analysis of continuous electrocardiogram monitoring (ACEM), based on a software algorithm, accelerates the detection of AF in patients admitted to our Stroke Unit compared to the routine CEM. Methods: Patients with acute ischemic stroke or transient ischemic attack were consecutively enrolled. After a 12-channel ECG on admission, all patients received CEM. Additionally, in the second phase of the study the CEM traces of the patients underwent ACEM analysis using a software algorithm for AF detection. Patients with history of AF or with AF on the admission ECG were excluded. Results: The CEM (n = 208) and ACEM cohorts (n= 114) did not differ significantly regarding risk factors, duration of monitoring and length of admission. We found a higher rate of newly-detected AF in the ACEM cohort compared to the CEM cohort (15.8% versus 10.1%, P < .001). Median time to first detection of AF was shorter in the ACEM compared to the CEM cohort [10 hours (IQR 0–23) versus 46.50 hours (IQR 0–108.25), P < .001]. Conclusions: ACEM accelerates the detection of AF in patients with stroke compared with the routine CEM. Further evidences are required to confirm the increased rate of AF detected using ACEM.
D'Anna L, Kar A, Brown Z, et al., 2019, Automated continuous electrocardiogram monitoring to detect atrial fibrillation after ischemic stroke or transient ischemic attack on a hyper acute stroke unit, Publisher: SAGE PUBLICATIONS LTD, Pages: 25-25, ISSN: 1747-4930
Wilson D, Ambler G, Lee K-J, et al., 2019, Cerebral microbleeds and stroke risk after ischaemic stroke or transient ischaemic attack: a pooled analysis of individual patient data from cohort studies, LANCET NEUROLOGY, Vol: 18, Pages: 653-665, ISSN: 1474-4422
Graf J, Schwitalla JC, Albrecht P, et al., 2019, Misdiagnoses and delay of diagnoses in Moyamoya angiopathy-a large Caucasian case series, JOURNAL OF NEUROLOGY, Vol: 266, Pages: 1153-1159, ISSN: 0340-5354
Wutzler A, Krogias C, Grau A, et al., 2019, Stroke prevention in patients with acute ischemic stroke and atrial fibrillation in Germany - a cross sectional survey, BMC Neurology, Vol: 19, ISSN: 1471-2377
BackgroundAtrial fibrillation (AF) is present in 15–20% of patients with acute ischemic stroke. Oral anticoagulation reduces the risk of AF-related recurrent stroke but clinical guideline recommendations are rather vague regarding its use in the acute phase of stroke. We aimed to assess the current clinical practice of medical stroke prevention in AF patients during the acute phase of ischemic stroke.MethodsIn April 2017, a standardized anonymous questionnaire was sent to clinical leads of all 298 certified stroke units in Germany.ResultsOverall, 154 stroke unit leads participated (response rate 52%). Anticoagulation in the acute phase of stroke is considered feasible in more than 90% of AF patients with ischemic stroke. Clinicians assume that about two thirds of all AF patients (range 20–100%) are discharged on oral anticoagulation. According to local preferences, acetylsalicylic acid is given orally in the majority of patients with delayed initiation of oral anticoagulation. A non-vitamin K-dependent oral anticoagulant (NOAC) is more often prescribed than a vitamin K-dependent oral anticoagulant (VKA). VKA is more often chosen in patients with previous VKA intake than in VKA naive patients. In the minority of patients, stroke unit leads discuss the prescription of a specific oral anticoagulant with the treating general practitioner. Adherence to medical stroke prevention after hospital discharge is not assessed on a regular basis in any patient by the majority of participating stroke centers.ConclusionsEarly secondary stroke prevention in AF patients in German stroke units is based on OAC use but prescription modalities vary in clinical practice.
Shoamanesh A, Hart RG, Kasner SE, et al., 2019, Cerebral Microbleeds and the Effect of Anticoagulation on Outcomes in 3699 Patients With Embolic Strokes of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Trial., American-Heart-Association/American-Stroke-Association International Stroke Conference / State-of-the-Science Stroke Nursing Symposium, Publisher: LIPPINCOTT WILLIAMS & WILKINS, ISSN: 0039-2499
Veltkamp R, Uhlmann S, Marinescu M, et al., 2019, Experimental ischaemic stroke induces transient cardiac atrophy and dysfunction, Journal of Cachexia, Sarcopenia and Muscle, Vol: 10, Pages: 54-62, ISSN: 2190-6009
BackgroundStroke can lead to cardiac dysfunction in patients, but the mechanisms underlying the interaction between the injured brain and the heart are poorly understood. The objective of the study is to investigate the effects of experimental murine stroke on cardiac function and molecular signalling in the heart.Methods and resultsMice were subjected to filament‐induced left middle cerebral artery occlusion for 30 or 60 min or sham surgery and underwent repetitive micro‐echocardiography. Left ventricular contractility was reduced early (24–72 h) but not late (2 months) after brain ischaemia. Cardiac dysfunction was accompanied by a release of high‐sensitive cardiac troponin (hsTNT (ng/ml): d1: 7.0 ± 1.0 vs. 25.0 ± 3.2*; d3: 7.3 ± 1.1 vs. 52.2 ± 16.7*; d14: 5.7 ± 0.8 vs. 5.2 ± 0.3; sham vs. 60 min. MCAO; mean ± SEM; *p < 0.05); reduced heart weight (heart weight/tibia length ratio: d1: 6.9 ± 0.2 vs. 6.4 ± 0.1*; d3: 6.7 ± 0.2 vs. 5.8 ± 0.1*; d14: 6.7 ± 0.2 vs. 6.4 ± 03; sham vs. 60 min. MCAO; mean ± SEM; *p < 0.05); resulting from cardiomyocyte atrophy (cardiomyocyte size: d1: 12.8% ± 0.002**; d3: 13.5% ± 0.002**; 14d: 6.3% ± 0.003*; 60 min. MCAO vs. sham; mean ± SEM; **p < 0.01; *p < 0.05), accompanied by increased atrogin‐1 and the E3 ubiquitin ligase murf‐1. Net norepinephrine but not synthesis was increased, suggesting a reduced norepinephrine release or an increase of norepinephrine re‐uptake, resulting in a functional denervation. Transcriptome analysis in cardiac tissue identified the transcription factor peroxisome proliferator‐activated rece
Gill D, Georgakis MK, Laffan M, et al., 2018, Genetically determined FXI (Factor XI) levels and risk of stroke, Stroke, Vol: 49, Pages: 2761-2763, ISSN: 0039-2499
Background and Purpose—FXI (factor XI) is involved in thrombus propagation and stabilization. It is unknown whether lower FXI levels have a protective effect on risk of ischemic stroke (IS) or myocardial infarction. This study investigated the effect of genetically determined FXI levels on risk of IS, myocardial infarction, and intracerebral hemorrhage.Methods—Two-sample Mendelian randomization analysis was performed. Instruments and genetic association estimates for FXI levels were obtained from a genome-wide association study of 16 169 individuals. Genetic association estimates for IS and its etiological subtypes were obtained from a study of 16 851 cases and 32 473 controls. For myocardial infarction, estimates were obtained from a study of 43 676 cases and 123 504 controls and for intracerebral hemorrhage from a study of 1545 cases and 1481 controls.Results—After applying a Bonferroni correction for multiple testing, the Mendelian randomization analysis supported a causal effect of higher, genetically determined FXI levels on risk of any IS (odds ratio [OR] per 1-unit increase in natural logarithm-transformed FXI levels, 2.54; 95% CI, 1.68–3.84; P=1×10−5) but not myocardial infarction (OR, 1.01; 95% CI, 0.76–1.34; P=0.94) or intracerebral hemorrhage (OR, 1.81; 95% CI, 0.44–7.38; P=0.41). Examining IS subtypes, the main results supported an effect of higher, genetically determined FXI levels on risk of cardioembolism (OR, 4.23; 95% CI, 1.94–9.19; P=3×10−4) and IS of undetermined cause (OR, 3.44; 95% CI, 1.79–6.60; P=2×10−4) but not large artery atherosclerosis (OR, 2.73; 95% CI, 1.15–6.45; P=0.02) or small artery occlusion (OR, 1.19; 95% CI, 0.50–2.82; P=0.69). However, the statistically significant result for IS of undetermined cause was not replicated in all sensitivity analyses.Conclusions—We find Mendelian randomization evidence supporting FXI as a possible t
Tsivgoulis G, Wilson D, Katsanos AH, et al., 2018, Neuroimaging and clinical outcomes of oral anticoagulant-associated intracerebral hemorrhage, ANNALS OF NEUROLOGY, Vol: 84, Pages: 694-704, ISSN: 0364-5134
Van Mieghem NM, Unverdorben M, Valgimigli M, et al., 2018, Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation-Rationale and design of the ENVISAGE-TAVI AF trial, AMERICAN HEART JOURNAL, Vol: 205, Pages: 63-69, ISSN: 0002-8703
Haeusler KG, Groeschel K, Koehrmann M, et al., 2018, Expert opinion paper on atrial fibrillation detection after ischemic stroke, CLINICAL RESEARCH IN CARDIOLOGY, Vol: 107, Pages: 871-880, ISSN: 1861-0684
Purrucker J, Wolf M, Haas K, et al., 2018, MICROBLEEDS IN ISCHEMIC VS. HEMORRHAGIC STROKES ON NOVEL ORAL ANTICOAGULANTS, INTERNATIONAL JOURNAL OF STROKE, Vol: 13, Pages: 84-84, ISSN: 1747-4930
Purrucker JC, Wolf M, Haas K, et al., 2018, Microbleeds in ischemic vs hemorrhagic strokes on novel oral anticoagulants, ACTA NEUROLOGICA SCANDINAVICA, Vol: 138, Pages: 163-169, ISSN: 0001-6314
Charidimou A, Shams S, Romero JR, et al., 2018, Clinical significance of cerebral microbleeds on MRI: A comprehensive meta-analysis of risk of intracerebral hemorrhage, ischemic stroke, mortality, and dementia in cohort studies (v1), INTERNATIONAL JOURNAL OF STROKE, Vol: 13, Pages: 454-468, ISSN: 1747-4930
Hart RG, Sharma M, Mundl H, et al., 2018, Rivaroxaban for stroke prevention after embolic stroke of undetermined source, New England Journal of Medicine, Vol: 378, Pages: 2191-2201, ISSN: 0028-4793
BackgroundEmbolic strokes of undetermined source represent 20% of ischemic strokes and are associated with a high rate of recurrence. Anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, may result in a lower risk of recurrent stroke than aspirin.MethodsWe compared the efficacy and safety of rivaroxaban (at a daily dose of 15 mg) with aspirin (at a daily dose of 100 mg) for the prevention of recurrent stroke in patients with recent ischemic stroke that was presumed to be from cerebral embolism but without arterial stenosis, lacune, or an identified cardioembolic source. The primary efficacy outcome was the first recurrence of ischemic or hemorrhagic stroke or systemic embolism in a time-to-event analysis; the primary safety outcome was the rate of major bleeding.ResultsA total of 7213 participants were enrolled at 459 sites; 3609 patients were randomly assigned to receive rivaroxaban and 3604 to receive aspirin. Patients had been followed for a median of 11 months when the trial was terminated early because of a lack of benefit with regard to stroke risk and because of bleeding associated with rivaroxaban. The primary efficacy outcome occurred in 172 patients in the rivaroxaban group (annualized rate, 5.1%) and in 160 in the aspirin group (annualized rate, 4.8%) (hazard ratio, 1.07; 95% confidence interval [CI], 0.87 to 1.33; P=0.52). Recurrent ischemic stroke occurred in 158 patients in the rivaroxaban group (annualized rate, 4.7%) and in 156 in the aspirin group (annualized rate, 4.7%). Major bleeding occurred in 62 patients in the rivaroxaban group (annualized rate, 1.8%) and in 23 in the aspirin group (annualized rate, 0.7%) (hazard ratio, 2.72; 95% CI, 1.68 to 4.39; P<0.001).ConclusionsRivaroxaban was not superior to aspirin with regard to the prevention of recurrent stroke after an initial embolic stroke of undetermined source and was associated with a higher risk of bleeding. (Funded by Bayer and Janssen Research and Development; NAVIGATE
Kasner SE, Lavados P, Sharma M, et al., 2018, Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial, JOURNAL OF STROKE & CEREBROVASCULAR DISEASES, Vol: 27, Pages: 1673-1682, ISSN: 1052-3057
Perera KS, Swaminathan B, Veltkamp R, et al., 2018, Frequency and features of embolic stroke of undetermined source in young adults, EUROPEAN STROKE JOURNAL, Vol: 3, Pages: 110-116, ISSN: 2396-9873
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