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  • 1
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    Solitaire™ with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Trial: Protocol for a Randomized, Controlled, Multicenter Study Comparing the Solitaire Revascularization Device with IV tPA with IV tPA Alone in Acute Ischemic Stroke
    SAGE Publications ; 2015
    In:  International Journal of Stroke Vol. 10, No. 3 ( 2015-04), p. 439-448
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 10, No. 3 ( 2015-04), p. 439-448
    Abstract: Early reperfusion in patients experiencing acute ischemic stroke is critical, especially for patients with large vessel occlusion who have poor prognosis without revascularization. Solitaire™ stent retriever devices have been shown to immediately restore vascular perfusion safely, rapidly, and effectively in acute ischemic stroke patients with large vessel occlusions. Aim The aim of the study was to demonstrate that, among patients with large vessel, anterior circulation occlusion who have received intravenous tissue plasminogen activator, treatment with Solitaire revascularization devices reduces degree of disability 3 months post stroke. Design The study is a global multicenter, two-arm, prospective, randomized, open, blinded end-point trial comparing functional outcomes in acute ischemic stroke patients who are treated with either intravenous tissue plasminogen activator alone or intravenous tissue plasminogen activator in combination with the Solitaire device. Up to 833 patients will be enrolled. Procedures Patients who have received intravenous tissue plasminogen activator are randomized to either continue with intravenous tissue plasminogen activator alone or additionally proceed to neurothrombectomy using the Solitaire device within six-hours of symptom onset. Study Outcomes The primary end-point is 90-day global disability, assessed with the modified Rankin Scale (mRS). Secondary outcomes include mortality at 90 days, functional independence (mRS ≤ 2) at 90 days, change in National Institutes of Health Stroke Scale at 27 h, reperfusion at 27 h, and thrombolysis in cerebral infarction 2b/3 flow at the end of the procedure. Analysis Statistical analysis will be conducted using simultaneous success criteria on the overall distribution of modified Rankin Scale (Rankin shift) and proportions of subjects achieving functional independence (mRS 0–2).
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12459
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
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  • 2
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    Clinical effectiveness of endovascular stroke treatment in the early and extended time windows
    SAGE Publications ; 2022
    In:  International Journal of Stroke Vol. 17, No. 4 ( 2022-04), p. 389-399
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 17, No. 4 ( 2022-04), p. 389-399
    Abstract: The clinical efficacy of mechanical thrombectomy has been unequivocally demonstrated in multiple randomized clinical trials. However, these studies were performed in carefully selected centers and utilized strict inclusion criteria. Aim We aimed to assess the clinical effectiveness of mechanical thrombectomy in a prospective registry. Methods A total of 2008 patients from 76 sites across 12 countries were enrolled in a prospective open-label mechanical thrombectomy registry. Patients were categorized into the corresponding cohorts of the SWIFT-Prime, DAWN, and DEFUSE 3 trials according to the basic demographic and clinical criteria without considering specific parenchymal imaging findings. Baseline and outcome variables were compared across the corresponding groups. Results As compared to the treated patients in the actual trials, registry-derived patients tended to be younger and had lower baseline ASPECTS. In addition, time to treatment was earlier and the use of intravenous tissue plasminogen activator (IV-tPA) and general anesthesia were higher in DAWN- and DEFUSE-3 registry derived patients versus their corresponding trials. Reperfusion rates were higher in the registry patients. The rates of 90-day good outcome (mRS0-2) in registry-derived patients were comparable to those of the patients treated in the corresponding randomized clinical trials (SWIFT-Prime, 64.5% vs. 60.2%; DAWN, 50.4% vs. 48.6%; Beyond-DAWN: 52.4% vs. 48.6%; DEFUSE 3, 52% vs. 44.6%, respectively; all P  〉  0.05). Registry-derived patients had significant less disability than the corresponding randomized clinical trial controls (ordinal modified Rankin Scale (mRS) shift odds ratio (OR), P  〈  0.05 for all). Conclusion Our study provides favorable generalizability data for the safety and efficacy of thrombectomy in the “real-world” setting and supports that patients may be safely treated outside the constraints of randomized clinical trials.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/17474930211005740
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
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  • 3
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    Intra-Arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Patients with Moderate to Severe Middle Cerebral Artery Acute Ischemic Stroke
    SAGE Publications ; 2012
    In:  Cell Transplantation Vol. 21, No. 1_suppl ( 2012-01), p. 13-21
    Details
    In: Cell Transplantation, SAGE Publications, Vol. 21, No. 1_suppl ( 2012-01), p. 13-21
    Abstract: Transplantation of autologous bone marrow mononuclear cells (BMMCs) has been proven safe in animal and human studies. However, there are very few studies in stroke patients. In this study, intra-arterial autologous BMMCs were infused in patients with moderate to severe acute middle cerebral artery infarcts. The subjects of this study included 20 patients with early or late spontaneous recanalization but with persistent deficits, in whom treatment could be initiated between 3 and 7 days after stroke onset. Mononuclear cells were isolated from bone marrow aspirates and infused at the proximal middle cerebral artery of the affected hemisphere. Safety analysis (primary endpoint) during the 6-month follow-up assessed death, any serious clinical events, neurological worsening with ≥ 4-point increase in National Institutes of Health Stroke Scale (NIHSS) scores, seizures, epileptogenic activity on electroencephalogram, and neuroimaging complications including new ischemic, hemorrhagic, or neoplastic lesions. Satisfactory clinical improvement (secondary endpoint) at 90 days was defined according to the pretreatment NIHSS scores as follows: modified Rankin Scale score of 0 in patients with NIHSS 〈 8, modified Rankin Scale scores of 0–1 in patients with NIHSS 8–14, or modified Rankin Scale scores 0–2 in patients with NIHSS 〉 14. Good clinical outcome was defined as mRS ≤2 at 90 days. Serial clinical, laboratory, electroencephalogram, and imaging evaluations showed no procedure-related adverse events. Satisfactory clinical improvement occurred in 6/20 (30%) patients at 90 days. Eight patients (40%) showed a good clinical outcome. Infusion of intra-arterial autologous BMMCs appears to be safe in patients with moderate to severe acute middle cerebral artery strokes. No cases of intrahospital mortality were seen in this pilot trial. Larger prospective randomized trials are warranted to assess the efficacy of this treatment approach.
    Type of Medium: Online Resource
    ISSN: 0963-6897 , 1555-3892
    URL: Article
    DOI: 10.3727/096368912X612512
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2012
    detail.hit.zdb_id: 2020466-8
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  • 4
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    Randomization of endovascular treatment with stent-retriever and/or thromboaspiration versus best medical therapy in acute ischemic stroke due to large vessel occlusion trial: Rationale and design
    SAGE Publications ; 2021
    In:  International Journal of Stroke Vol. 16, No. 1 ( 2021-01), p. 100-109
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 16, No. 1 ( 2021-01), p. 100-109
    Abstract: RESILIENT is a prospective, multicenter, randomized phase III trial to test the safety, efficacy, and cost-effectiveness of mechanical thrombectomy as compared to medical treatment alone in patients treated under the less than ideal conditions typically found in the public healthcare system of a developing country. Methods Subjects must fulfill the following main inclusion criteria: symptom onset ≤8 h, age ≥18 years, baseline NIHSS ≥8, evidence of intracranial ICA or proximal MCA (M1 segment) occlusion, ASPECTS ≥6 on CT or 〉 5 on DWI-MRI and be either ineligible for or unresponsive to intravenous alteplase. The primary end-point is the distribution of disability levels (on the modified Rankin Scale, mRS) at 90 days under the intention-to-treat principle. Randomization Randomization is performed under a minimization process using age, baseline NIHSS, intravenous alteplase use, occlusion site and center. Design The trial is designed with an expectation of a 10% difference in the proportion of favorable outcome (mRS 0–2 at 90 days) common odds ratio of 1.615. Primary outcome Projected sample size is 690 subjects with pre-planned interim analyses at 174, 346, and 518 subjects. Secondary outcomes Secondary end-points include: 90-day functional independence (mRS ≤2), mRS shift stratified for treatment with IV rt-PA at 90 days, infarct volume on 24 h CT or MRI, early dramatic response (NIHSS 0–2 or improvement ≥8 points) at 24 h, vessel recanalization evaluated by CTA or MRA at 24 h, and the post-procedure rate of successful reperfusion (defined as a modified Treatment in Cerebral Infarction 2b or greater). Safety variables are mortality at 90 days, symptomatic intracranial hemorrhage at 24 h and procedure-related complications.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493019890700
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
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  • 5
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    Global impact of COVID-19 on stroke care
    SAGE Publications ; 2021
    In:  International Journal of Stroke Vol. 16, No. 5 ( 2021-07), p. 573-584
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 16, No. 5 ( 2021-07), p. 573-584
    Abstract: The COVID-19 pandemic led to profound changes in the organization of health care systems worldwide. Aims We sought to measure the global impact of the COVID-19 pandemic on the volumes for mechanical thrombectomy, stroke, and intracranial hemorrhage hospitalizations over a three-month period at the height of the pandemic (1 March–31 May 2020) compared with two control three-month periods (immediately preceding and one year prior). Methods Retrospective, observational, international study, across 6 continents, 40 countries, and 187 comprehensive stroke centers. The diagnoses were identified by their ICD-10 codes and/or classifications in stroke databases at participating centers. Results The hospitalization volumes for any stroke, intracranial hemorrhage, and mechanical thrombectomy were 26,699, 4002, and 5191 in the three months immediately before versus 21,576, 3540, and 4533 during the first three pandemic months, representing declines of 19.2% (95%CI, −19.7 to −18.7), 11.5% (95%CI, −12.6 to −10.6), and 12.7% (95%CI, −13.6 to −11.8), respectively. The decreases were noted across centers with high, mid, and low COVID-19 hospitalization burden, and also across high, mid, and low volume stroke/mechanical thrombectomy centers. High-volume COVID-19 centers (−20.5%) had greater declines in mechanical thrombectomy volumes than mid- (−10.1%) and low-volume (−8.7%) centers (p  〈  0.0001). There was a 1.5% stroke rate across 54,366 COVID-19 hospitalizations. SARS-CoV-2 infection was noted in 3.9% (784/20,250) of all stroke admissions. Conclusion The COVID-19 pandemic was associated with a global decline in the volume of overall stroke hospitalizations, mechanical thrombectomy procedures, and intracranial hemorrhage admission volumes. Despite geographic variations, these volume reductions were observed regardless of COVID-19 hospitalization burden and pre-pandemic stroke/mechanical thrombectomy volumes.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493021991652
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
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  • 6
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    Pittsburgh response to endovascular therapy score as a pre-treatment prognostic tool: External validation in Trevo2
    SAGE Publications ; 2017
    In:  International Journal of Stroke Vol. 12, No. 5 ( 2017-07), p. 494-501
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 12, No. 5 ( 2017-07), p. 494-501
    Abstract: Optimal patient selection is needed to maximize the therapeutic benefit of endovascular therapy for large vessel occlusion stroke. Aims To validate the Pittsburgh response to endovascular therapy (PRE) score in a randomized controlled trial (Trevo2) comparing stent retriever (Trevo) to the Merci device. Methods Trevo2 participants with internal carotid, M1 and M2 middle cerebral artery occlusions with prospectively collected baseline stroke severity (NIHSS), degree of hypodensity (CT ASPECTS), and three-month modified Rankin Scale (mRS) were included. Multivariable regression was used to confirm association between PRE score variables (age, NIHSS, and ASPECTS), medical comorbidities, randomization arm, and reperfusion status (mTICI2B/3) with good outcome (three-month modified Rankin Scale 0–2). Predictive power (area under the receiver operating characteristic curve) for good outcome of pre-treatment prognostic scores (PRE, THRIVE, HIAT2) was compared. Rates of good outcome were compared between successfully reperfused (mTICI2B/3) and non-reperfused (mTICI0-2A) patients across previously identified PRE score risk groups. Results Age, NIHSS, ASPECTS, reperfusion status, and randomization arm were independent predictors of good outcome. PRE score had moderate predictive power (AUC = 0.75) for good outcome and was comparable to other pre-treatment scores. Reperfusion resulted in maximal treatment benefit in patients with PRE score 0–24 (60% vs. 12.5%, p = 0.002) but not in those with PRE ≥50 (11.8% vs. 0.0%, p = 0.49). Conclusion The PRE score is a validated predictor of functional outcome and a tool for patient selection for endovascular therapy in anterior large vessel occlusion stroke. Our finding of limited benefit of reperfusion in patients with PRE score ≥50 needs to be prospectively validated.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493016677984
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2017
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  • 7
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    Endotheliitis and cytokine storm as a mechanism of clot formation in COVID-19 ischemic stroke patients: A histopathologic study of retrieved clots
    SAGE Publications ; 2023
    In:  Interventional Neuroradiology
    Details
    In: Interventional Neuroradiology, SAGE Publications
    Abstract: Studies during the COVID-19 pandemic have demonstrated an association between COVID-19 virus infection and the development of acute ischemic stroke, particularly large vessel occlusion (LVO). Studying the characteristics and immunohistochemistry of retrieved stroke emboli during mechanical thrombectomy for LVO may offer insights into the pathogenesis of LVO in COVID-19 patients. We examined retrieved COVID-19 emboli from the STRIP, EXCELLENT, and RESTORE registries and compared their characteristics to a control group. Methods We identified COVID-positive LVO patients from the STRIP, RESTORE, and EXCELLENT studies who underwent mechanical thrombectomy. These patients were matched to a control group controlling for stroke etiology based on Trial of Org 10172 in Acute Stroke Treatment criteria. All clots were stained with Martius Scarlet Blue (MSB) along with immunohistochemistry for interleukin-6 (IL-6), C-reactive protein (CRP), von Willebrand factor (vWF), CD66b, fibrinogen, and citrullinated Histone H3. Clot composition was compared between groups. Results Nineteen COVID-19-positive patients and 38 controls were included. COVID-19-positive patients had a significantly higher percentage of CRP and vWF. There was no difference in IL-6, fibrin, CD66b, or citrullinated Histone H3 between groups. Based on MSB staining, there was no statistically significant difference regarding the percentage of red blood cells, white blood cells, fibrin, and platelets. Conclusions Our study found higher concentrations of CRP and vWF in retrieved clots of COVID-19-positive stroke patients compared to COVID-19-negative controls. These findings support the potential role of systemic inflammation as indicated by elevated CRP and endothelial injury as indicated by elevated vWF as precipitating factors in thrombus development in these patients.
    Type of Medium: Online Resource
    ISSN: 1591-0199 , 2385-2011
    URL: Article
    DOI: 10.1177/15910199231185804
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2571161-1
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  • 8
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    Response to: Basilar artery occlusion and unwarranted clinical trials
    SAGE Publications ; 2020
    In:  Interventional Neuroradiology Vol. 26, No. 1 ( 2020-02), p. 7-9
    Details
    In: Interventional Neuroradiology, SAGE Publications, Vol. 26, No. 1 ( 2020-02), p. 7-9
    Type of Medium: Online Resource
    ISSN: 1591-0199 , 2385-2011
    URL: Article
    DOI: 10.1177/1591019919872402
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
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  • 9
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    The THRIVE Score Strongly Predicts Outcomes in Patients Treated with the Solitaire Device in the SWIFT and STAR Trials
    SAGE Publications ; 2014
    In:  International Journal of Stroke Vol. 9, No. 6 ( 2014-08), p. 698-704
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 9, No. 6 ( 2014-08), p. 698-704
    Abstract: The Totaled Health Risks in Vascular Events (THRIVE) score strongly predicts clinical outcome, mortality, and risk of thrombolytic haemorrhage in ischemic stroke patients, and performs similarly well in patients receiving intravenous tissue plasminogen activator, endovascular stroke treatment, or no acute treatment. It is not known if the THRIVE score predicts outcomes with the Solitaire endovascular stroke treatment device. Aims To validate the relationship between the THRIVE score and outcomes after treatment with the Solitaire endovascular stroke treatment device. Methods The study conducted a retrospective analysis of the prospective SWIFT and STAR trials to examine the relationship between THRIVE and outcomes after treatment with the Solitaire device. We examined the relationship between THRIVE and clinical outcomes (good outcome or death at 90 days) among patients in SWIFT and STAR. Receiver-operator characteristics curve analysis was used to compare THRIVE score performance with other stroke prediction scores. Multivariable modeling was used to confirm the independence of the THRIVE score from procedure-specific predictors (successful recanalization or device used) and other predictors of functional outcome. Results The THRIVE score strongly predicts good outcome and death among patients treated with the Solitaire device in SWIFT and STAR (Mantel-Haenszel chi-square test for trend P 〈 0·001 for good outcome, P = 0·01 for death). In receiver-operator characteristics (ROC) curve comparisons, totaled health risks in vascular events score is superior to Stroke Prognostication using Age and NIH Stroke Scale score-100 ( P 〈 0·001) and performed similarly to Houston Intra-Arterial Therapy score (HIAT) ( P = 0·98) and HIAT-2 ( P = 0·54). In multivariable models, THRIVE's prediction of good outcome is not altered after controlling for recanalization or after controlling for device used. The THRIVE score remains a strong independent predictor after controlling for the above predictors together with time to procedure, rate of symptomatic haemorrhage, and use of general anesthesia. Of note, use of general anesthesia was not an independent predictor of outcome in SWIFT + STAR after controlling for totaled health risks in vascular events and other factors. Conclusions The THRIVE score strongly predicts clinical outcome and mortality in patients treated with the Solitaire device in the SWIFT and STAR trials. The lack of interaction between THRIVE and procedure-specific elements such as vessel recanalization or device choice makes the THRIVE score a reasonable candidate for use as a patient selection criterion in stroke clinical trials.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12292
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2014
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  • 10
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    Cerebrovascular events and outcomes in hospitalized patients with COVID-19: The SVIN COVID-19 Multinational Registry
    SAGE Publications ; 2021
    In:  International Journal of Stroke Vol. 16, No. 4 ( 2021-06), p. 437-447
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 16, No. 4 ( 2021-06), p. 437-447
    Abstract: Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) has been associated with a significant risk of thrombotic events in critically ill patients. Aim To summarize the findings of a multinational observational cohort of patients with SARS-CoV-2 and cerebrovascular disease. Methods Retrospective observational cohort of consecutive adults evaluated in the emergency department and/or admitted with coronavirus disease 2019 (COVID-19) across 31 hospitals in four countries (1 February 2020–16 June 2020). The primary outcome was the incidence rate of cerebrovascular events, inclusive of acute ischemic stroke, intracranial hemorrhages (ICH), and cortical vein and/or sinus thrombosis (CVST). Results Of the 14,483 patients with laboratory-confirmed SARS-CoV-2, 172 were diagnosed with an acute cerebrovascular event (1.13% of cohort; 1130/100,000 patients, 95%CI 970–1320/100,000), 68/171 (40.5%) were female and 96/172 (55.8%) were between the ages 60 and 79 years. Of these, 156 had acute ischemic stroke (1.08%; 1080/100,000 95%CI 920–1260/100,000), 28 ICH (0.19%; 190/100,000 95%CI 130–280/100,000), and 3 with CVST (0.02%; 20/100,000, 95%CI 4–60/100,000). The in-hospital mortality rate for SARS-CoV-2-associated stroke was 38.1% and for ICH 58.3%. After adjusting for clustering by site and age, baseline stroke severity, and all predictors of in-hospital mortality found in univariate regression (p  〈  0.1: male sex, tobacco use, arrival by emergency medical services, lower platelet and lymphocyte counts, and intracranial occlusion), cryptogenic stroke mechanism (aOR 5.01, 95%CI 1.63–15.44, p  〈  0.01), older age (aOR 1.78, 95%CI 1.07–2.94, p = 0.03), and lower lymphocyte count on admission (aOR 0.58, 95%CI 0.34–0.98, p = 0.04) were the only independent predictors of mortality among patients with stroke and COVID-19. Conclusions COVID-19 is associated with a small but significant risk of clinically relevant cerebrovascular events, particularly ischemic stroke. The mortality rate is high for COVID-19-associated cerebrovascular complications; therefore, aggressive monitoring and early intervention should be pursued to mitigate poor outcomes.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493020959216
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
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