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  • Ovid Technologies (Wolters Kluwer Health)  (8)
  • Sobesky, Jan  (8)
  • 1
    Online Resource
    Online Resource
    Association of Intraventricular Fibrinolysis With Clinical Outcomes in Intracerebral Hemorrhage: An Individual Participant Data Meta-Analysis
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Stroke Vol. 53, No. 9 ( 2022-09), p. 2876-2886
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 53, No. 9 ( 2022-09), p. 2876-2886
    Abstract: In patients with intracerebral hemorrhage (ICH), the presence of intraventricular hemorrhage constitutes a promising therapeutic target. Intraventricular fibrinolysis (IVF) reduces mortality, yet impact on functional disability remains unclear. Thus, we aimed to determine the influence of IVF on functional outcomes. Methods: This individual participant data meta-analysis pooled 1501 patients from 2 randomized trials and 7 observational studies enrolled during 2004 to 2015. We compared IVF versus standard of care (including placebo) in patients treated with external ventricular drainage due to acute hydrocephalus caused by ICH with intraventricular hemorrhage. The primary outcome was functional disability evaluated by the modified Rankin Scale (mRS; range: 0–6, lower scores indicating less disability) at 6 months, dichotomized into mRS score: 0 to 3 versus mRS: 4 to 6. Secondary outcomes included ordinal-shift analysis, all-cause mortality, and intracranial adverse events. Confounding and bias were adjusted by random effects and doubly robust models to calculate odds ratios and absolute treatment effects (ATE). Results: Comparing treatment of 596 with IVF to 905 with standard of care resulted in an ATE to achieve the primary outcome of 9.3% (95% CI, 4.4–14.1). IVF treatment showed a significant shift towards improved outcome across the entire range of mRS estimates, common odds ratio, 1.75 (95% CI, 1.39–2.17), reduced mortality, odds ratio, 0.47 (95% CI, 0.35–0.64), without increased adverse events, absolute difference, 1.0% (95% CI, −2.7 to 4.8). Exploratory analyses provided that early IVF treatment (≤48 hours) after symptom onset was associated with an ATE, 15.2% (95% CI, 8.6–21.8) to achieve the primary outcome. Conclusions: As compared to standard of care, the administration of IVF in patients with acute hydrocephalus caused by intracerebral and intraventricular hemorrhage was significantly associated with improved functional outcome at 6 months. The treatment effect was linked to an early time window 〈 48 hours, specifying a target population for future trials.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.121.038455
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
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  • 2
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    Characteristics in Non–Vitamin K Antagonist Oral Anticoagulant–Related Intracerebral Hemorrhage
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Stroke Vol. 50, No. 6 ( 2019-06), p. 1392-1402
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 50, No. 6 ( 2019-06), p. 1392-1402
    Abstract: Given inconclusive studies, it is debated whether clinical and imaging characteristics, as well as functional outcome, differ among patients with intracerebral hemorrhage (ICH) related to vitamin K antagonists (VKA) versus non–vitamin K antagonist (NOAC)-related ICH. Notably, clinical characteristics according to different NOAC agents and dosages are not established. Methods— Multicenter observational cohort study integrating individual patient data of 1328 patients with oral anticoagulation–associated ICH, including 190 NOAC-related ICH patients, recruited from 2011 to 2015 at 19 tertiary centers across Germany. Imaging, clinical characteristics, and 3-months modified Rankin Scale (mRS) outcomes were compared in NOAC- versus VKA-related ICH patients. Propensity score matching was conducted to adjust for clinically relevant differences in baseline parameters. Subgroup analyses were performed regarding NOAC agent, dosing and present clinically relevant anticoagulatory activity (last intake 〈 12h/24h or NOAC level 〉 30 ng/mL). Results— Despite older age in NOAC patients, there were no relevant differences in clinical and hematoma characteristics between NOAC- and VKA-related ICH regarding baseline hematoma volume (median [interquartile range]: NOAC, 14.7 [5.1–42.3] mL versus VKA, 16.4 [5.8–40.6] mL; P =0.33), rate of hematoma expansion (NOAC, 49/146 [33.6%] versus VKA, 235/688 [34.2%] ; P =0.89), and the proportion of patients with unfavorable outcome at 3 months (mRS, 4–6: NOAC 126/179 [70.4%] versus VKA 473/682 [69.4%] ; P =0.79). Subgroup analyses revealed that NOAC patients with clinically relevant anticoagulatory effect had higher rates of intraventricular hemorrhage (n/N [%]: present 52/109 [47.7%] versus absent 9/35 [25.7%]; P =0.022) and hematoma expansion (present 35/90 [38.9%] versus absent 5/30 [16.7%] ; P =0.040), whereas type of NOAC agent or different NOAC-dosing regimens did not result in relevant differences in imaging characteristics or outcome. Conclusions— If effectively anticoagulated, there are no differences in hematoma characteristics and functional outcome among patients with NOAC- or VKA-related ICH. Clinical Trial Registration— URL: https://www.clinicaltrials.gov . Unique identifier: NCT03093233.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.118.023492
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
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  • 3
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    Outcome and Symptomatic Bleeding Complications of Intravenous Thrombolysis Within 6 Hours in MRI-Selected Stroke Patients : Comparison of a German Multicenter Study With the Pooled Data of ATLANTIS, ECASS, and NINDS tPA Trials
    Ovid Technologies (Wolters Kluwer Health) ; 2006
    In:  Stroke Vol. 37, No. 3 ( 2006-03), p. 852-858
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 37, No. 3 ( 2006-03), p. 852-858
    Abstract: Background and Purpose— We compared outcome and symptomatic bleeding complications of intravenous tissue plasminogen activator (IV-tPA) within 6 hours of symptom onset in MRI-selected patients with acute middle cerebral artery infarction with the pooled data of the large stroke tPA trials. Methods— Patients were examined by perfusion-weighted and diffusion-weighted imaging ≤6 hours. Within 3 hours, patients were treated according to Second European-Australasian Acute Stroke Study (ECASS II) criteria. After 3 to 6 hours, treatment with IV-tPA was performed based on MRI findings. Favorable outcome was assessed after 90 days using a dichotomized modified Rankin scale score of 0 to 1. Intracerebral bleeding complications were assessed on follow-up MRI or computed tomography. Data were compared with the pooled placebo and pooled tPA patients of the ATLANTIS, ECASS, and National Institute of Neurological Disorders and Stroke (NINDS) tPA trials. Results— From 174 MRI-selected tPA patients, 62% (n=108) were treated in ≤3 hours and 38% (n=66) after 3 to 6 hours. Favorable outcome was more frequent in MRI-selected tPA patients (48% [95% CI, 39 to 54]) compared with pooled placebo (33% [95% CI, 31 to 36] ; P 〈 0.001) and pooled tPA patients (40% [95% CI, 37 to 42]; P =0.046). Odds ratios for favorable outcome in the MRI-selected tPA group were 1.82 (1.32 to 2.51) compared with the pooled placebo and 1.39 (1.01 to 1.92) compared with the pooled tPA group. The rate of symptomatic intracerebral hemorrhage in MRI-selected tPA patients (3% [95% CI, 0 to 5]) was lower than in the pooled tPA group (8% [95% CI, 7 to 10] ; P =0.012) and comparable to the pooled placebo group (2% [95% CI, 1 to 3]; P =0.392). Conclusions— This study supports that it is safe and effective to expand the time window for IV-tPA up to 6 hours in patients with tissue at risk as defined by MRI.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/01.STR.0000204120.79399.72
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2006
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  • 4
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    Pretreatment Diffusion-Weighted Imaging Lesion Volume Predicts Favorable Outcome After Intravenous Thrombolysis With Tissue-Type Plasminogen Activator in Acute Ischemic Stroke
    Ovid Technologies (Wolters Kluwer Health) ; 2011
    In:  Stroke Vol. 42, No. 5 ( 2011-05), p. 1251-1254
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 42, No. 5 ( 2011-05), p. 1251-1254
    Abstract: Stroke magnetic resonance imaging with perfusion and diffusion weighting has shown its potential to select patients likely to benefit from intravenous thrombolysis with tissue-type plasminogen activator (IV-tPA). We aimed to determine the predictors of favorable outcome in magnetic resonance imaging–selected, acute stroke patients treated with IV-tPA. Methods— We analyzed the data of acute ischemic stroke patients from a prospective, multicenter, observational study of magnetic resonance imaging–based IV-tPA treatment initiated ≤6 hours from symptom onset. Neurologic deficit on admission was assessed by the National Institutes of Health Stroke Scale. Clinical outcome was assessed after 90 days according to the modified Rankin Scale. Favorable outcome was defined as a modified Rankin Scale score of 0 to 1. Patients were compared regarding baseline parameters. Multivariate regression analysis was used to identify predictors of favorable outcome. Results— Of 174 patients, 83 (48%) reached a favorable outcome. They were younger (median age, 62 versus 67 years; P =0.001), had a lower National Institutes of Health Stroke Scale score on admission (median, 11 versus 15; P 〈 0.001), and had smaller diffusion-weighted imaging lesions (median, 12.9 versus 20 mL; P =0.001). Perfusion-weighted imaging lesion volumes and onset-to-treatment time were comparable between the groups. Age ( P =0.017), National Institutes of Health Stroke Scale score on admission ( P 〈 0.001), and diffusion-weighted imaging lesion volume ( P =0.047) were identified as independent predictors of favorable outcome. Conclusions— A lower age, lower National Institutes of Health Stroke Scale score on admission, and smaller pretreatment diffusion-weighted imaging lesion volume were found to be associated with a favorable outcome after treatment with IV-tPA. Pretreatment perfusion lesion volume and onset-to-treatment time were not associated with outcome when patients were selected for IV-tPA by magnetic resonance imaging within 6 hours of symptom onset.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.110.600148
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2011
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  • 5
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    Transcranial Laser Therapy in Acute Stroke Treatment : Results of Neurothera Effectiveness and Safety Trial 3, a Phase III Clinical End Point Device Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2014
    In:  Stroke Vol. 45, No. 11 ( 2014-11), p. 3187-3193
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. 11 ( 2014-11), p. 3187-3193
    Abstract: On the basis of phase II trials, we considered that transcranial laser therapy could have neuroprotective effects in patients with acute ischemic stroke. Methods— We studied transcranial laser therapy in a double-blind, sham-controlled randomized clinical trial intended to enroll 1000 patients with acute ischemic stroke treated ≤24 hours after stroke onset and who did not undergo thrombolytic therapy. The primary efficacy measure was the 90-day functional outcome as assessed by the modified Rankin Scale, with hierarchical Bayesian analysis incorporating relevant previous data. Interim analyses were planned after 300 and 600 patients included. Results— The study was terminated on recommendation by the Data Monitoring Committee after a futility analysis of 566 completed patients found no difference in the primary end point (transcranial laser therapy 140/282 [49.6%] versus sham 140/284 [49.3%] for good functional outcome; modified Rankin Scale, 0–2). The results remained stable after inclusion of all 630 randomized patients (adjusted odds ratio, 1.024; 95% confidence interval, 0.705–1.488). Conclusions— Once the results of the interim futility analysis became available, all study support was immediately withdrawn by the capital firms behind PhotoThera, and the company was dissolved. Proper termination of the trial was difficult but was finally achieved through special efforts by former employees of PhotoThera, the CRO Parexel and members of the steering and the safety committees. We conclude that transcranial laser therapy does not have a measurable neuroprotective effect in patients with acute ischemic stroke when applied within 24 hours after stroke onset. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01120301.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.114.005795
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
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  • 6
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    Two Tales: Hemorrhagic Transformation but Not Parenchymal Hemorrhage After Thrombolysis Is Related to Severity and Duration of Ischemia : MRI Study of Acute Stroke Patients Treated With Intravenous Tissue Plasminogen Activator Within 6 Hours
    Ovid Technologies (Wolters Kluwer Health) ; 2007
    In:  Stroke Vol. 38, No. 2 ( 2007-02), p. 313-318
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 38, No. 2 ( 2007-02), p. 313-318
    Abstract: Background and Purpose— Intracerebral hemorrhage represents the most feared complication of treatment with intravenous tissue plasminogen activator. We studied whether perfusion-weighted imaging and diffusion-weighted imaging has the potential to identify patients at risk of severe intracerebral hemorrhage after treatment with intravenous tissue plasminogen activator. Methods— We analyzed data of prospectively studied MRI selected acute ischemic stroke patients treated with intravenous tissue plasminogen activator within 6 hours. All patients were examined by perfusion- and diffusion-weighted imaging ≤6 hours. Perfusion- and diffusion-weighted imaging lesion volumes were calculated. Hemorrhagic transformation was assessed on follow-up CT or MRI and diagnosed as hemorrhagic transformation, parenchymal hemorrhage, or symptomatic intracerebral hemorrhage according to ECASS II criteria. Results— Of 152 patients, hemorrhagic transformation was seen in 60 (39.5%), parenchymal hemorrhage in 15 (9.9%), and symptomatic intracerebral hemorrhage in 4 (2.6%). Multiple logistic regression analysis identified onset to treatment time after 3 to 6 hours ( P 〈 0.001), a larger perfusion-weighted imaging lesion volume ( P =0.002), and, as a tendency, a higher score on the National Institutes of Health Stroke Scale on admission ( P =0.068) as independent predictors of hemorrhagic transformation. Neither MRI lesion volumes nor severity of symptoms, but rather only an older age tended to be associated with parenchymal hemorrhage ( P =0.087). Conclusion— Our results further support the concept of a different pathogenesis for hemorrhagic transformation and parenchymal hemorrhage. Whereas hemorrhagic transformation should be regarded as a clinically irrelevant epiphenomenon of ischemic damage and reperfusion, parenchymal hemorrhage appears to be related to biologic effects of tissue plasminogen activator and other pre-existing pathologic conditions, which deserve further investigation.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/01.STR.0000254565.51807.22
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2007
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  • 7
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    MRI-Based and CT-Based Thrombolytic Therapy in Acute Stroke Within and Beyond Established Time Windows : An Analysis of 1210 Patients
    Ovid Technologies (Wolters Kluwer Health) ; 2007
    In:  Stroke Vol. 38, No. 10 ( 2007-10), p. 2640-2645
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 38, No. 10 ( 2007-10), p. 2640-2645
    Abstract: Background and Purpose— The use of intravenous thrombolysis is restricted to a minority of patients by the rigid 3-hour time window. This window may be extended by using modern imaging-based selection algorithms. We assessed safety and efficacy of MRI-based thrombolysis within and beyond 3 hours compared with standard CT-based thrombolysis. Methods— Five European stroke centers pooled the core data of their CT- and MRI-based prospective thrombolysis databases. Safety outcomes were predefined as symptomatic intracranial hemorrhage and mortality. Primary efficacy outcome was a favorable outcome (modified Rankin Scale 0 to 1). We performed univariate and multivariate analyses for all end points, including age, National Institutes of Health Stroke Scale, treatment group (CT 〈 3 hours, MRI 〈 3 hours and 〉 3 hours), and onset to treatment time as variables. Results— A total of 1210 patients were included (CT 〈 3 hours: N=714; MRI 〈 3 hours: N=316; MRI 〉 3 hours: N=180). Median age, National Institutes of Health Stroke Scale, and onset to treatment time were 69, 67, and 68.5 years ( P =0.66); 12, 13, and 14 points ( P =0.019); and 130, 135, and 240 minutes ( P 〈 0.001). Symptomatic intracranial hemorrhage rates were 5.3%, 2.8%, and 4.4% ( P =0.213); mortality was 13.7%, 11.7%, and 13.3% ( P =0.68). Favorable outcome occurred in 35.4%, 37.0%, and 40% ( P =0.51). Age and National Institutes of Health Stroke Scale were independent predictors for all safety and efficacy outcomes. The overall use of MRI significantly reduced symptomatic intracranial hemorrhage (OR: 0.520, 95% CI: 0.270 to 0.999, P =0.05). Beyond 3 hours, the use of MRI significantly predicted a favorable outcome (OR: 1.467; 95% CI: 1.017 to 2.117, P =0.040). Within 3 hours and for all secondary end points, there was a trend in favor of MRI-based selection over standard 〈 3-hour CT-based treatment. Conclusion— Despite significantly longer time windows and significantly higher baseline National Institutes of Health Stroke Scale scores, MRI-based thrombolysis is safer and potentially more efficacious than standard CT-based thrombolysis.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.107.483255
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2007
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  • 8
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    Stroke Lesion Volumes and Outcome Are Not Different in Hemispheric Stroke Side Treated With Intravenous Thrombolysis Based on Magnetic Resonance Imaging Criteria
    Ovid Technologies (Wolters Kluwer Health) ; 2015
    In:  Stroke Vol. 46, No. 4 ( 2015-04), p. 1004-1008
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 46, No. 4 ( 2015-04), p. 1004-1008
    Abstract: Patients with right hemispheric stroke (RHS) have been reported to have fewer good outcomes after thrombolysis. We aimed at evaluating outcome after stroke thrombolysis with regards to the affected hemisphere controlling for stroke lesion volume as a potential confounder. Methods— We retrospectively analyzed data from a prospective study of patients with acute stroke treated with intravenous tissue-type plasminogen activator, based on magnetic resonance imaging criteria within 6 hours of symptom onset. Neurological deficit was assessed by the National Institutes of Health Stroke Scale. Lesion volume on acute perfusion imaging, diffusion-weighted imaging (DWI) and perfusion imaging/DWI mismatch were measured. Clinical outcome was assessed after 90 days using the modified Rankin Scale, and relation to affected hemisphere was studied by multivariate analysis. Results— Of 173 patients, 55 (32%) presented with RHS, whereas 118 (68%) had left HS. Baseline National Institutes of Health Stroke Scale was lower in RHS (11.7 versus 13.6; P =0.031). There were no differences in DWI lesion volume (11.0 versus 17.8 mL; P =0.519), perfusion imaging lesion volume (98.9 versus 118.3 mL; P =0.395), perfusion imaging/DWI mismatch (60 versus 85.05 mL; P =0.283). Clinical outcome was also comparable for both groups (modified Rankin Scale, 0–1; P =0.327). In multivariate analysis, DWI lesion volume ( P 〈 0.001) and age were associated with modified Rankin Scale at day 90, whereas affected hemisphere was not. Conclusions— We did not find differences between RHS and left HS with regards to stroke lesions volumes or outcome after thrombolysis. Previously reported hemisphere-related differences in stroke outcome may partly results from imbalances in stroke lesion volume between RHS and left HS.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.114.007292
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
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