scholarly journals Alteplase for Acute Ischemic Stroke in Patients Aged >80 Years

Stroke ◽  
2020 ◽  
Vol 51 (8) ◽  
pp. 2322-2331 ◽  
Author(s):  
Erich Bluhmki ◽  
Thierry Danays ◽  
Gabriele Biegert ◽  
Werner Hacke ◽  
Kennedy R. Lees
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Controlled Trial ◽  
Risk Profile ◽  
Routine Practice ◽  
Stroke Outcome ◽  
Modified Rankin Scale ◽  
Treatment Allocation ◽  
European Regulatory ◽  
Open Control

Background/Purpose: Expert guidelines specify no upper age limit for alteplase for thrombolysis of acute ischemic stroke (AIS) but, until recently, European regulatory criteria restricted its use to patients aged 18 to 80 years. We performed pooled analyses of randomized controlled trial (RCT) and registry data to evaluate the benefit-risk profile of alteplase for AIS among patients aged >80 years to support a regulatory application to lift the upper age restriction. Methods: Individual patient data were evaluated from 7 randomized trials of alteplase (0.9 mg/kg) versus placebo or open control for AIS, and the European SITS-UTMOST registry database. Clinical outcomes, including good functional outcome (score 0–1, modified Rankin Scale day 90 or Oxford Handicap Score day 180), were evaluated in the full RCT and registry populations, and specified age-based subgroups (≤80 or >80 years) who met existing European regulatory criteria for alteplase, excluding upper age restriction. Results: Regardless of treatment allocation, 90-day mortality was lower among RCT patients aged ≤80 versus >80 years who otherwise met existing European regulatory criteria (246/2405 [10.2%] versus 307/1028 [29.9%], respectively). Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome (modified Rankin Scale score 0–1; 99/518 [19.1%] versus 67/510 [13.1%]; P =0.0109) and similar 90-day mortality (153/518 [29.5%] versus 154/510 [30.2%]; P =0.8382). The odds of a good stroke outcome following alteplase allocation in the full RCT population were independent of age ( P =0.7383). Good stroke outcome was reported for almost half (4821/11 169 [43.2%]) of the patients who received alteplase in routine practice. Outcomes in routine practice supported those achieved in RCTs. Conclusions: Alteplase for AIS has a positive benefit-risk profile among patients aged >80 years when administered according to other regulatory criteria. Alteplase for AIS should be evaluated on an individual benefit-risk basis.

NIHSS cut point for predicting outcome in supra- vs infratentorial acute ischemic stroke

Neurology ◽  
2018 ◽  
Vol 91 (18) ◽  
pp. e1695-e1701 ◽  
Author(s):  
Sohei Yoshimura ◽  
Richard I. Lindley ◽  
Cheryl Carcel ◽  
Shoichiro Sato ◽  
Candice Delcourt ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Functional Outcome ◽  
Controlled Trial ◽  
Additional Treatment ◽  
Clinical Severity ◽  
Stroke Outcome ◽  
Operating Characteristics ◽  
Cut Point ◽  
Significant Difference

ObjectiveTo determine the optimal cut point on the NIH Stroke Scale (NIHSS) for predicting poor 90-day clinical outcome in patients with supratentorial and infratentorial acute ischemic stroke (AIS).MethodsData are from participants of the alteplase-dose arm of the randomized controlled trial, Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED). Associations between baseline characteristics of clinically defined supratentorial and infratentorial AIS patients and poor functional outcome, defined by scores 3–6 on the modified Rankin Scale, were evaluated in logistic regression models, with area under the curve (AUC) receiver operating characteristics defining the optimal NIHSS predictor cut point.ResultsPatients with infratentorial AIS (n = 289) had lower baseline NIHSS scores than those with supratentorial AIS (n = 2,613) (median 7 vs 9; p < 0.001). NIHSS cut points for poor outcome were 10 (AUC 76, sensitivity 65%, specificity 73%) and 6 (AUC 69, sensitivity 72%, specificity 56%) in supratentorial and infratentorial AIS, respectively. There was no significant difference in functional outcome or symptomatic intracranial hemorrhage between AIS types.ConclusionsIn thrombolysis-eligible AIS patients, the NIHSS may underestimate clinical severity for infratentorial compared to supratentorial lesions for a similar prognosis for recovery. Because thrombolysis treatment has low effect on stroke outcome in patients with infratentorial AIS when baseline NIHSS score is more than 6, additional treatment such as endovascular treatment should be considered to improve stroke outcome.Clinicaltrials.gov identifierNCT01422616.

scholarly journals PENGARUH KADAR INTERLEUKIN-6 DAN NEURON SPECIFIC ENOLASE TERHADAP LUARAN STROKE ISKEMIK AKUT

2020 ◽  
Vol 35 (4) ◽  
Author(s):  
Al Rasyid ◽  
Salim Harris ◽  
Muhammad Kurniawan ◽  
Taufik Mesiano ◽  
Rakhmad Hidayat
Keyword(s):  
Ischemic Stroke ◽  
High Density Lipoprotein ◽  
Acute Ischemic Stroke ◽  
Interleukin 6 ◽  
Low Density Lipoprotein ◽  
Neuron Specific Enolase ◽  
Density Lipoprotein ◽  
Low Density ◽  
Stroke Outcome ◽  
Modified Rankin Scale

     THE EFFECT OF INTERLEUKIN-6 AND NEURON SPECIFIC ENOLASE LEVEL ON ACUTE ISCHEMIC STROKE OUTCOME WITH PACS AND LACS SUBTYPEABSTRACTIntroduction: Brain blood flow disruption  in ischemic stroke will trigger  cells damage  cascade  and  caused infarction. Interleukin-6 (IL-6) and neuron specific enolase (NSE) are brain cells damage marker that can be markers of acute ischemic stroke outcome.Aim: To investigate the effect of IL-6 and NSE levels on acute ischemic stroke outcome and its interacting factors.Methods: An observational cohort study on ischemic stroke patients with onset ≤3 days in several hospitals in Jakarta and Depok in 2014. Medical history and physical examination were carried out as well as laboratory parameters; hematocrit, fibrinogen, low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride, IL-6, and NSE. The National Institute of Health Stroke Scale (NIHSS) were assessed ≤72 hours of onset and 7 days along with Modified Rankin Scale (mRS) at 1 month of onset. Bivariate and multivariate logistic regression were done to investigate the association of IL-6 and NSE with stroke outcome and other factors.Results: One-hundred thirty-five subjects were included, mostly male (62%), with age mean 59,4±10,7 years and subtype PACS (76%). Interleukin-6 and NSE level were elevated in 61,5% and 21,5% subjects. Interleukin-6 and fibrinogen influenced the mRS, while diabetes and fibrinogen influenced the NIHSS. NSE serum didn’t show any association with mRS nor NIHSS, but influenced by dyslipidemia.Discussion: There was a tendency of worse outcome on high IL-6 level patients, although by multivariate analysis IL-2 alone was not sufficient enough as prognostic marker in acute ischemic stroke outcome. Neuron specific enolase serum didn’t show any association with acute stroke outcome due to also influenced by sex, smoking, and fibrinogen levels.Keywords: Acute ischemic stroke, IL-6, NSE, outcomeABSTRAKPendahuluan: Gangguan aliran darah otak pada stroke iskemik akut akan memicu kaskade kerusakan sel otak yang menyebabkan infark dan inflamasi. Interleukin-6 (IL-6) dan neuron specific enolase (NSE) merupakan penanda kerusakan sel otak yang dapat menjadi penanda luaran stroke iskemik akut.Tujuan: Mengetahui pengaruh kadar IL-6 dan NSE pada luaran stroke iskemik akut serta faktor-faktor yang memengaruhinya.Metode: Penelitian kohort observasional terhadap pasien stroke iskemik akut dengan awitan ≤3 hari yang dirawat di beberapa RS di Jakarta dan Depok pada tahun 2014. Dilakukan anamnesis dan pemeriksaan fisik serta pemeriksaan hematokrit, fibrinogen, low density lipoprotein (LDL), high density lipoprotein  (HDL), trigliserida, IL-6, dan NSE serum. Dilakukan pemeriksaan National Institute of Health Stroke Scale (NIHSS) awal awitan ≤72 jam dan 7 hari serta modified rankin scale (mRS) pada 1 bulan. Analisis statistik bivariat dan regresi logistik multivariat dilakukan untuk mengetahui hubungan kadar IL-6 dan NSE dengan luaran stroke serta hubungannya terhadap faktor-faktor lainnya.Hasil: Didapatkan 135 subjek yang mayoritas laki-laki (62%) dengan rerata usia 59,4±10,7 tahun dan subtipe PACS (76%). Peningkatan kadar IL-6 dan NSE ditemukan pada 61,5% dan 21,5% subjek. Luaran berdasarkan skor mRS dipengaruhi oleh kadar IL-6 dan fibrinogen, sedangkan  berdasarkan NIHSS dipengaruhi oleh diabetes melitus dan fibrinogen. Kadar NSE tidak berhubungan dengan mRS dan NIHSS, namun dipengaruhi oleh status dislipidemia.Diskusi: Terdapat kecenderungan luaran buruk pada kadar IL-6 tinggi, namun dengan analisis multivariat IL-6 belum bisa menjadi penanda prognosis luaran stroke iskemik akut. Kadar NSE serum tidak berperan terhadap luaran stroke iskemik akut, oleh karena juga dipengaruhi oleh jenis kelamin, merokok, dan kadar fibrinogen.Kata kunci: Stroke iskemik akut, IL-6, neuron specirefic enolase, luaran

Pre Hospital Interventions to Improve Acute Ischemic Stroke Outcome in Urban Settings

2020 ◽  
Vol 112 (5) ◽  
pp. S34
Author(s):  
Shannon Anderson ◽  
Danielle Thompson ◽  
Erin Adams ◽  
Marcus Spady ◽  
Efosa Aghimien ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Stroke Outcome ◽  
Urban Settings

Pre-Stroke Cholinesterase Inhibitor Treatment Is Beneficially Associated with Functional Outcome in Patients with Acute Ischemic Stroke and Pre-Stroke Dementia: The Fukuoka Stroke Registry

2021 ◽  
pp. 1-7
Author(s):  
Yoshinobu Wakisaka ◽  
Ryu Matsuo ◽  
Kuniyuki Nakamura ◽  
Tetsuro Ago ◽  
Masahiro Kamouchi ◽  
...  
Keyword(s):  
Cohort Study ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Functional Outcome ◽  
Neurological Deterioration ◽  
Stroke Outcome ◽  
Matched Cohort ◽  
Poor Functional Outcome ◽  
Stroke Registry ◽  
Chei Treatment

Introduction: Pre-stroke dementia is significantly associated with poor stroke outcome. Cholinesterase inhibitors (ChEIs) might reduce the risk of stroke in patients with dementia. However, the association between pre-stroke ChEI treatment and stroke outcome remains unresolved. Therefore, we aimed to determine this association in patients with acute ischemic stroke and pre-stroke dementia. Methods: We enrolled 805 patients with pre-stroke dementia among 13,167 with ischemic stroke within 7 days of onset who were registered in the Fukuoka Stroke Registry between June 2007 and May 2019 and were independent in basic activities of daily living (ADLs) before admission. Primary and secondary study outcomes were poor functional outcome (modified Rankin Scale [mRS] score: 3–6) at 3 months after stroke onset and neurological deterioration (≥2-point increase in the NIH Stroke Scale [NIHSS] during hospitalization), respectively. Logistic regression analysis was used to evaluate associations between pre-stroke ChEI treatment and study outcomes. To improve covariate imbalance, we further conducted a propensity score (PS)-matched cohort study. Results: Among the participants, 212 (26.3%) had pre-stroke ChEI treatment. Treatment was negatively associated with poor functional outcome (odds ratio: 0.68 [95% confidence interval: 0.46–0.99]) and neurological deterioration (0.52 [0.31–0.88]) after adjusting for potential confounding factors. In the PS-matched cohort study, the same trends were observed between pre-stroke ChEI treatment and poor functional outcome (0.61 [0.40–0.92]) and between the treatment and neurological deterioration (0.47 [0.25–0.86]). Conclusions: Our findings suggest that pre-stroke ChEI treatment is associated with reduced risks for poor functional outcome and neurological deterioration after acute ischemic stroke in patients with pre-stroke dementia who are independent in basic ADLs before the onset of stroke.

Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot)

2016 ◽  
Vol 12 (2) ◽  
pp. 211-215
Author(s):  
Verónica V Olavarría ◽  
Hisatomi Arima ◽  
Craig S Anderson ◽  
Alejandro Brunser ◽  
Paula Muñoz-Venturelli ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Statistical Analysis ◽  
Pilot Study ◽  
Acute Ischemic Stroke ◽  
Transcranial Doppler ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Head Position ◽  
Process Of Care ◽  
Anterior Circulation

Background The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. A feature of this trial was that patients were randomized to a certain position according to the month of admission to hospital. Objective To outline in detail the predetermined statistical analysis plan for HEADPOST Pilot study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be classified, and for each item, appropriate descriptive statistical analyses are planned with comparisons made between randomized groups. For the outcomes, statistical comparisons to be made between groups are planned and described. Results This statistical analysis plan was developed for the analysis of the results of the HEADPOST Pilot study to be transparent, available, verifiable, and predetermined before data lock. Conclusions We have developed a statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. Trial registration The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.

scholarly journals A multicenter randomized controlled trial of endovascular therapy following imaging evaluation for ischemic stroke (DEFUSE 3)

2017 ◽  
Vol 12 (8) ◽  
pp. 896-905 ◽  
Author(s):  
Gregory W Albers ◽  
Maarten G Lansberg ◽  
Stephanie Kemp ◽  
Jenny P Tsai ◽  
Phil Lavori ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Ischemic Stroke ◽  
Magnetic Resonance ◽  
Primary Endpoint ◽  
Endovascular Therapy ◽  
Symptom Onset ◽  
Medical Management ◽  
Controlled Trial ◽  
Modified Rankin Scale ◽  
Computed Tomography Perfusion

Rationale Early reperfusion in patients experiencing acute ischemic stroke is effective in patients with large vessel occlusion. No randomized data are available regarding the safety and efficacy of endovascular therapy beyond 6 h from symptom onset. Aim The aim of the study is to demonstrate that, among patients with large vessel anterior circulation occlusion who have a favorable imaging profile on computed tomography perfusion or magnetic resonance imaging, endovascular therapy with a Food and Drug Administration 510 K-cleared mechanical thrombectomy device reduces the degree of disability three months post stroke. Design The study is a prospective, randomized, multicenter, phase III, adaptive, blinded endpoint, controlled trial. A maximum of 476 patients will be randomized and treated between 6 and 16 h of symptom onset. Procedures Patients undergo imaging with computed tomography perfusion or magnetic resonance diffusion/perfusion, and automated software (RAPID) determines if the Target Mismatch Profile is present. Patients who meet both clinical and imaging selection criteria are randomized 1:1 to endovascular therapy plus medical management or medical management alone. The individual endovascular therapist chooses the specific device (or devices) employed. Study outcomes The primary endpoint is the distribution of scores on the modified Rankin Scale at day 90. The secondary endpoint is the proportion of patients with modified Rankin Scale 0–2 at day 90 (indicating functional independence). Analysis Statistical analysis for the primary endpoint will be conducted using a normal approximation of the Wilcoxon–Mann–Whitney test (the generalized likelihood ratio test).

scholarly journals Dysphagia in Patients with Acute Ischemic Stroke: Early Dysphagia Screening May Reduce Stroke-Related Pneumonia and Improve Stroke Outcomes

2016 ◽  
Vol 42 (1-2) ◽  
pp. 81-89 ◽  
Author(s):  
Mohamed Al-Khaled ◽  
Christine Matthis ◽  
Andreas Binder ◽  
Jonas Mudter ◽  
Joern Schattschneider ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Case Fatality ◽  
National Institutes Of Health ◽  
Modified Rankin Scale ◽  
Stroke Patients ◽  
Stroke Outcomes ◽  
Increased Risk ◽  
Reduced Risk

Background: Dysphagia is associated with poor outcome in stroke patients. Studies investigating the association of dysphagia and early dysphagia screening (EDS) with outcomes in patients with acute ischemic stroke (AIS) are rare. The aims of our study are to investigate the association of dysphagia and EDS within 24 h with stroke-related pneumonia and outcomes. Methods: Over a 4.5-year period (starting November 2007), all consecutive AIS patients from 15 hospitals in Schleswig-Holstein, Germany, were prospectively evaluated. The primary outcomes were stroke-related pneumonia during hospitalization, mortality, and disability measured on the modified Rankin Scale ≥2-5, in which 2 indicates an independence/slight disability to 5 severe disability. Results: Of 12,276 patients (mean age 73 ± 13; 49% women), 9,164 patients (74%) underwent dysphagia screening; of these patients, 55, 39, 4.7, and 1.5% of patients had been screened for dysphagia within 3, 3 to <24, 24 to ≤72, and >72 h following admission. Patients who underwent dysphagia screening were likely to be older, more affected on the National Institutes of Health Stroke Scale score, and to have higher rates of neurological symptoms and risk factors than patients who were not screened. A total of 3,083 patients (25.1%; 95% CI 24.4-25.8) had dysphagia. The frequency of dysphagia was higher in patients who had undergone dysphagia screening than in those who had not (30 vs. 11.1%; p < 0.001). During hospitalization (mean 9 days), 1,271 patients (10.2%; 95% CI 9.7-10.8) suffered from stroke-related pneumonia. Patients with dysphagia had a higher rate of pneumonia than those without dysphagia (29.7 vs. 3.7%; p < 0.001). Logistic regression revealed that dysphagia was associated with increased risk of stroke-related pneumonia (OR 3.4; 95% CI 2.8-4.2; p < 0.001), case fatality during hospitalization (OR 2.8; 95% CI 2.1-3.7; p < 0.001) and disability at discharge (OR 2.0; 95% CI 1.6-2.3; p < 0.001). EDS within 24 h of admission appeared to be associated with decreased risk of stroke-related pneumonia (OR 0.68; 95% CI 0.52-0.89; p = 0.006) and disability at discharge (OR 0.60; 95% CI 0.46-0.77; p < 0.001). Furthermore, dysphagia was independently correlated with an increase in mortality (OR 3.2; 95% CI 2.4-4.2; p < 0.001) and disability (OR 2.3; 95% CI 1.8-3.0; p < 0.001) at 3 months after stroke. The rate of 3-month disability was lower in patients who had received EDS (52 vs. 40.7%; p = 0.003), albeit an association in the logistic regression was not found (OR 0.78; 95% CI 0.51-1.2; p = 0.2). Conclusions: Dysphagia exposes stroke patients to a higher risk of pneumonia, disability, and death, whereas an EDS seems to be associated with reduced risk of stroke-related pneumonia and disability.

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