| 1. |
- Ahmed, N, et al.
(author)
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The SITS-UTMOST: A registry-based prospective study in Europe investigating the impact of regulatory approval of intravenous Actilyse in the extended time window (3-4.5 h) in acute ischaemic stroke
- 2016
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In: European stroke journal. - : SAGE Publications. - 2396-9881 .- 2396-9873. ; 1:3, s. 213-221
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Journal article (peer-reviewed)abstract
- The SITS-UTMOST (Safe Implementation of Thrombolysis in Upper Time window Monitoring Study) was a registry-based prospective study of intravenous alteplase used in the extended time window (3–4.5 h) in acute ischaemic stroke to evaluate the impact of the approval of the extended time window on routine clinical practice. Patients and methods Inclusion of at least 1000 patients treated within 3–4.5 h according to the licensed criteria and actively registered in the SITS-International Stroke Thrombolysis Registry was planned. Prospective data collection started 2 May 2012 and ended 2 November 2014. A historical cohort was identified for 2 years preceding May 2012. Clinical management and outcome were contrasted between patients treated within 3 h versus 3–4.5 h in the prospective cohort and between historical and prospective cohorts for the 3 h time window. Outcomes were functional independency (modified Rankin scale, mRS) 0–2, favourable outcome (mRS 0–1), and death at 3 months and symptomatic intracerebral haemorrhage (SICH) per SITS. Results 4157 patients from 81 centres in 12 EU countries were entered prospectively ( N = 1118 in the 3–4.5 h, N = 3039 in the 0–3 h time window) and 3454 retrospective patients in the 0–3 h time window who met the marketing approval conditions. In the prospective cohort, median arrival to treatment time was longer in the 3–4.5 h than 3 h window (79 vs. 55 min). Within the 3 h time window, treatment delays were shorter for prospective than historical patients (55 vs. 63). There was no significant difference between the 3–4.5 h versus 3 h prospective cohort with regard to percentage of reported SICH (1.6 vs. 1.7), death (11.6 vs. 11.1), functional independency (66 vs. 65) at 3 months or favourable outcome (51 vs. 50). Discussion Main weakness is the observational design of the study. Conclusion This study neither identified negative impact on treatment delay, nor on outcome, following extension of the approved time window to 4.5 h for use of alteplase in stroke.
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| 2. |
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| 3. |
- Hart, Robert G., et al.
(author)
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Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source : Design of the NAVIGATE ESUS randomized trial
- 2016
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In: European Stroke Journal. - : SAGE Publications. - 2396-9873 .- 2396-9881. ; 1:3, s. 146-154
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Journal article (peer-reviewed)abstract
- Background: Embolic strokes of undetermined source comprise up to 20% of ischemic strokes. The stroke recurrence rate is substantial with aspirin, widely used for secondary prevention. The New Approach riVaroxaban Inhibition of Factor Xa in a Global trial versus ASA to prevenT Embolism in Embolic Stroke of Undetermined Source international trial will compare the efficacy and safety of rivaroxaban, an oral factor Xa inhibitor, versus aspirin for secondary prevention in patients with recent embolic strokes of undetermined source. Main hypothesis: In patients with recent embolic strokes of undetermined source, rivaroxaban 15 mg once daily will reduce the risk of recurrent stroke (both ischemic and hemorrhagic) and systemic embolism (primary efficacy outcome) compared with aspirin 100 mg once daily. Design: Double-blind, randomized trial in patients with embolic strokes of undetermined source, defined as nonlacunar cryptogenic ischemic stroke, enrolled between seven days and six months from the qualifying stroke. The planned sample size of 7000 participants will be recruited from approximately 480 sites in 31 countries between 2014 and 2017 and followed for a mean of about two years until at least 450 primary efficacy outcome events have occurred. The primary safety outcome is major bleeding. Two substudies assess (1) the relative effect of treatments on MRI-determined covert brain infarcts and (2) the biological underpinnings of embolic strokes of undetermined source using genomic and biomarker approaches. Summary: The New Approach riVaroxaban Inhibition of Factor Xa in a Global trial versus ASA to prevenT Embolism in Embolic Stroke of Undetermined Source trial is evaluating the benefits and risks of rivaroxaban for secondary stroke prevention in embolic strokes of undetermined source patients. Main results are anticipated in 2018.
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| 4. |
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| 5. |
- Norrving, Bo, et al.
(author)
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Introducing the European Stroke Journal
- 2016
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In: European Stroke Journal. - : SAGE Publications. - 2396-9873 .- 2396-9881. ; 1:1, s. 3-3
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Journal article (peer-reviewed)
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| 6. |
- Ntaios, G, et al.
(author)
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Small-vessel occlusion versus large-artery atherosclerotic strokes in diabetics: Patient characteristics, outcomes, and predictors of stroke mechanism
- 2016
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In: European Stroke Journal. - : SAGE Publications. - 2396-9873 .- 2396-9881. ; 1:2, s. 108-113
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Journal article (peer-reviewed)abstract
- Abstract Introduction: Diabetes mellitus exerts a detrimental effect on cerebral vasculature affecting both macrovasculature and microvasculature. However, although ischaemic stroke is typically included among macrovascular diabetic complications, it is frequently omitted from microvascular diabetic complications. We aimed to compare the proportion of large-artery atherosclerotic and small-vessel occlusion strokes among diabetic stroke patients, explore their differences and outcomes, and assess potential mechanisms which may determine why some diabetic patients suffer large-artery atherosclerotic stroke whereas others suffer small-vessel occlusion stroke. Methods: We pooled data of diabetic patients from four prospective ischaemic stroke registries (Acute Stroke Registry and Analysis of Lausanne (ASTRAL), Athens, Austrian, and Helsinki Stroke Thrombolysis Registries). Stroke severity and prognosis were assessed with National Institutes of Health Stroke Scale (NIHSS) and ASTRAL scores, respectively; functional outcome with three-month modified Rankin score (0–2 considered as favourable outcome). Logistic- regression analysis identified independent predictors of large-artery atherosclerotic stroke. Results: Among 5412 patients, 1069 (19.8%) were diabetics; of them, 232 (21.7%) had large-artery atherosclerotic and 205 (19.2%) small-vessel occlusion strokes. Large-artery atherosclerotic stroke had higher severity than small-vessel occlusion stroke (median NIHSS: 6 vs. 3, p < 0.001), worse prognosis (median ASTRAL score: 23 vs. 19, p < 0.001), and worse three-month outcome (60.3% vs. 83.4% with favourable outcome, p < 0.001). In logistic-regression analysis, peripheral artery disease (odds ratio: 4.013, 95% confidence interval: 1.667–9.665, p < 0.01) and smoking (odds ratio: 1.706, 95% confidence interval: 1.087–2.675, p < 0.05) were independently associated with large-artery atherosclerotic strokes. Conclusion: In the diabetic stroke population, small-vessel occlusion and large-artery atherosclerotic strokes occur with similar frequency. Large-artery atherosclerotic strokes are more severe and have worse outcome than small-vessel occlusion strokes. The presence of peripheral artery disease and smoking independently predicted large-artery athero- sclerotic stroke.
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| 7. |
- Persson, Hanna C, 1979, et al.
(author)
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Upper extremity recovery after ischaemic and haemorrhagic stroke: Part of the SALGOT study
- 2016
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In: European Stroke Journal. - : SAGE Publications. - 2396-9873 .- 2396-9881. ; 1:4, s. 310-19
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Journal article (peer-reviewed)abstract
- Introduction The purpose was to explore if there are differences in extent of change in upper extremity motor function and activity capacity, in persons with ischaemic versus haemorrhagic stroke, during the first year post stroke. Patients and methods One hundred seventeen persons with stroke (ischaemic n=98, haemorrhagic n=19) and reduced upper extremity function 3 days after onset were consecutively included to the Stroke Arm Longitudinal Study at the University of Gothenburg (SALGOT) from a stroke unit. Upper extremity motor function (Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)) and activity capacity (Action Research Arm Test (ARAT)) were assessed at 6 assessments during the first year; age and initial stroke severity were recorded. Differences between groups in extent of change over time of upper extremity motor function and activity capacity were analysed with mixed models repeated measurements method. Results Significant improvements were found in function and activity in both groups within the first month (p=0.001). Higher age and more severe stroke had a negative impact on recovery in both groups. Larger improvements of function and activity were seen in haemorrhagic stroke compared to ischaemic, both from 3 days to 3- and 12 months, and from 1 month to 3 months. Both groups reached similar levels of function and activity at 3 months post stroke. Conclusion Although persons with haemorrhagic stroke had initially lower scores than those with ischaemic stroke, they had a larger improvement within the first 3 months, and thereafter both groups had similar function and activity.
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| 8. |
- Sjölander, Maria, et al.
(author)
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Inequalities in medication adherence to statin treatment after stroke : A nationwide observational study
- 2016
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In: European Stroke Journal. - : Sage Publications. - 2396-9873 .- 2396-9881. ; 1:2, s. 101-107
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Journal article (peer-reviewed)abstract
- Introduction: The objective was to investigate differences in adherence to statins after stroke based on age, sex, socioeconomic status and country of birth.Patients and methods: Patients with ischemic stroke in 2009–2010 were included from the Swedish stroke register. Adherence to statin treatment was measured over two years as proportion of days covered with 80% as cut-off for adherence. Income, education, and country of birth were obtained from official registers. Factors associated with adherence were controlled for in multivariable logistic regression.Results: Of 15,192 included patients, 73.9% had an adherence rate 80%. The oldest (85þ years) and youngest (18–54 years) had the lowest adherence, and a smaller proportion of women were adherent (odds ratio (OR) 0.84; 95% confidence interval (CI) 0.77–0.92). Adherence was less common in patients born in Nordic countries (OR 0.82; 95% CI (0.68–0.97), Europe (OR 0.78; 95% CI 0.65–0.93), and in non-European countries (OR 0.65; 95% CI 0.50–0.84) compared to Sweden-born. Patients with university education were to a lower extent adherent compared to patients with primary school education (OR 0.81; 95% CI 0.72–0.91). There was no association between adherence and income.Discussion: The study was based on individual level real-life data with national coverage. Adherence was estimated from data on filled prescriptions, but filled prescription does not mean that drugs are used as intended.Conclusion: Adherence to statin treatment over two years was suboptimal, and adherence was less common among women, patients born outside of Sweden and patients with university education.
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| 9. |
- Ullberg, Teresa, et al.
(author)
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Doctor’s follow-up after stroke in the south of Sweden : An observational study from the Swedish stroke register (Riksstroke)
- 2016
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In: European Stroke Journal. - : SAGE Publications. - 2396-9873 .- 2396-9881. ; 1:2, s. 114-121
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Journal article (peer-reviewed)abstract
- Introduction: Information on follow-up practices after stroke in clinical routine are sparse. We studied the probability of doctor’s follow-up within 90, 120, 180, and 365 days after hospital discharge, and how patient characteristics were associated with the probability of follow-up, in a large unselected stroke cohort. Patients and methods: Data on patients living in southern Sweden, hospitalized with acute ischemic stroke or intracerebral hemorrhage 1 January 2008 to 31 December 2010, were obtained from the Swedish stroke register (Riksstroke) and merged with administrative data on doctor’s visits during the year following stroke. Results: Complete data were registered in 8164 patients. The cumulative probability of a doctor’s follow-up was 76.3% within 90 days, 83.6% within 120 days, 88.7% within 180 days, and 93.1% within 365 days. Using Cox regression calculating hazard ratios (HR), factors associated with 90-day follow-up were: female sex HR = 1.066 (95%CI: 1.014–1.121), age: ages 65–74 HR = 0.928 (95%CI: 0.863–0.999), ages 75–84 HR = 0.943 (95%CI: 0.880–1.011), ages 85 + HR = 0.836 (95%CI: 0.774–0.904), pre-stroke dependency in activities of daily living (ADL): HR = 0.902 (95%CI = 0.819–0.994), prior stroke HR = 0.902 (95%CI: 0.764–0.872), and severe stroke HR = 0.506 (95%CI: 0.407–0.629). In patients discharged to assisted living, the following factors were associated with lower follow-up probability: living alone pre-stroke HR = 0.836 (95%CI: 0.736–0.949), and pre-stroke dependency HR = 0.887 (95%CI: 0.775–0.991). Discussion: This study was based on hospital administrative data of post-stroke doctor’s visits, but may be confounded by attendance for other conditions than stroke. Conclusions: One in four stroke patients was not followed up within three months after hospital discharge. Vulnerable patients with high age, pre-stroke ADL dependency, and prior stroke were less likely to receive doctor’s follow-up.
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| 10. |
- Wu, Teddy, et al.
(author)
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Impact of pre-stroke sulphonylurea and metformin use on mortality of intracerebral haemorrhage
- 2016
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In: European Stroke Journal. - : SAGE Publications. - 2396-9873 .- 2396-9881. ; 1:4, s. 302-309
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Journal article (peer-reviewed)abstract
- Introduction: Few proven therapies for intracerebral haemorrhage exist. Preliminary observational evidence suggests that sulphonylurea and metformin may be protective in ischaemic stroke. We assessed the association of pre-intracerebral haemorrhage sulphonylurea and metformin use on outcome in diabetic patients. Methods: We merged datasets from the consecutive single-centre Helsinki ICH Study, the intracerebral haemorrhage arm of the Virtual International Stroke Trials Archive (VISTA-ICH) and the Royal Melbourne Hospital ICH Study. Logistic regression adjusting for known predictors of intracerebral haemorrhage outcome (age, sex, baseline Glasgow Coma Scale, National Institutes of Health Stroke Scale, intracerebral haemorrhage volume, infratentorial location, intraven- tricular extension, and pre-intracerebral haemorrhage warfarin use) estimated the association of metformin and sulpho- nylurea with all-cause 90-day mortality. Results: From a dataset of 2404 consecutive intracerebral haemorrhage patients, we included 374 (16%) patients with diabetes. Of these, 113 (30%) died by 90 days. Metformin was used in 148 (40%) patients and sulphonylurea in 115 (31%) patients at intracerebral haemorrhage onset. After adjusting for baseline characteristics, metformin use was associated with lower 90-day mortality (OR 0.51; 95% CI 0.26–0.97; p ¼ 0.041) irrespective of whether the drug was continued or not during the admission, while sulphonylurea use was not associated with mortality (OR 0.96; 95% CI 0.49–1.88; p ¼ 0.906). Haematoma location or evacuation did not modify the association between metformin and mortality; neither did adding insulin use, baseline glucose and serum creatinine into the model (OR 0.50; 95% CI 0.25–0.99; p ¼ 0.047). Conclusion: Pre-intracerebral haemorrhage metformin use was associated with improved outcome in diabetic intracer- ebral haemorrhage patients. Our results generate hypotheses which after further validation could be tested in clinical trials.
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| 11. |
- Zelano, Johan, 1981, et al.
(author)
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Association between poststroke epilepsy and death : A nationwide cohort study
- 2016
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In: European Stroke Journal. - : SAGE PUBLICATIONS LTD. - 2396-9873 .- 2396-9881. ; 1:4, s. 272-278
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Journal article (peer-reviewed)abstract
- Introduction: Poststroke epilepsy (PSE) is the most common form of acquired epilepsy after middle age. The primary aim of this study was to study the impact of PSE on prognosis. A secondary aim was to validate recent findings from smaller studies on the risk of developing PSE on a nationwide scale.Patients and methods: We performed a nationwide cohort study based on comprehensive national registries and included patients without a prior epilepsy diagnosis surviving more than 2 months after stroke, identified by the Swedish Stroke Register (Riksstroke) and linked to the National Patient Register and Cause of Death Register. Cox proportional time-updated hazard model was used to assess the risk of death, with or without multivariable adjustment for possible confounders, and multiple Cox regression was used to examine associations between PSE and clinical characteristics.Results: In 106,455 patients, PSE (defined as a seizure diagnosis more than 7 days after stroke) was detected in 7.3%, with lower cumulative incidence after ischemic stroke (6.4%) than after intracerebral haemorrhage (12.4%). Stroke severity, intracerebral haemorrhage and young age were associated with a risk of PSE. The risk of death was increased in patients with PSE (hazard ratio: 1.68, 95% confidence interval: 1.25-1.53). Also with adjustments for age, comorbidities and stroke severity, an increased risk of death associated with PSE remained.Discussion: Studies are needed on potential causes of increased mortality in PSE, such as a direct seizure-related mortality, less ambitious secondary stroke prophylaxis or rehabilitation, or impact of antiepileptic drugs on cardiovascular risk.
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