scholarly journals The SITS Open Study

Stroke ◽  
2021 ◽  
Author(s):  
Niaz Ahmed ◽  
Kennedy R. Lees ◽  
Rudiger von Kummer ◽  
Staffan Holmin ◽  
Irene Escudero-Martinez ◽  
...  

Background and Purpose: We designed SITS (Safe Implementation of Treatment in Stroke) Open to determine benefit and safety of thrombectomy in clinical practice for large artery occlusion stroke, using selected stent retrievers plus standard care versus standard care alone. Methods: SITS Open was a prospective, open, blinded evaluation, international, multicenter, controlled, nonrandomized registry study. Centers lacking access to thrombectomy contributed controls. Primary end point was categorical shift in modified Rankin Scale score at 3 months in the per protocol (PP) population. Principal secondary outcomes were symptomatic intracranial hemorrhage, functional independency (modified Rankin Scale score 0–2) and death at 3 months. Patients independently evaluated by video-recorded modified Rankin Scale interviews blinded to treatment or center identity by central core laboratory were regarded as PP population. Propensity score matching with covariate adjusted analysis was performed. Results: During 2014 to 2017, 293 patients (257 thrombectomy, 36 control) from 26 centers in 10 countries fulfilled intention-to-treat and 200 (170 thrombectomy, 30 control) PP criteria; enrollment of controls was limited by rapid uptake of thrombectomy. In PP analysis, median age was 71 versus 71 years, and baseline National Institutes of Health Stroke Scale 17 versus 17 in the thrombectomy and control arms, respectively. The propensity score matching analysis for PP showed a significant shift for modified Rankin Scale at 3 months favoring the thrombectomy group (odds ratio, 3.8 [95% CI, 1.61–8.95]; P =0.002). Regarding safety, there were 4 cases of symptomatic intracranial hemorrhage in the thrombectomy group (2.4%) and none in the control group. Conclusions: In clinical practice, thrombectomy for patients with large artery occlusion stroke is superior to standard of care in our study. REGISTRATION: URL: https://www.clinicaltrials.gov . Unique Identifier: NCT02326428.

2011 ◽  
Vol 114 (4) ◽  
pp. 1008-1013 ◽  
Author(s):  
Muhammad Zeeshan Memon ◽  
Sabareesh K. Natarajan ◽  
Jitendra Sharma ◽  
Marlon S. Mathews ◽  
Kenneth V. Snyder ◽  
...  

Object Experience with the use of platelet glycoprotein (GP) IIb–IIIa inhibitor eptifibatide in patients with ischemic stroke is limited. The authors report the off-label use of intraarterial eptifibatide during endovascular ischemic stroke revascularization procedures for reocclusion after documented recanalization or formed fresh thrombi in distal vessels that were inaccessible to endovascular devices. Methods Patients who received intraarterial eptifibatide were identified from a prospectively collected database of patients in whom endovascular revascularization for acute ischemic stroke was attempted between 2005 and 2008. Data were analyzed retrospectively. The intraarterial eptifibatide dose was a single-bolus dose of 180 μg/kg body weight. Primary outcome measures were angiographic recanalization (Thrombolysis in Myocardial Infarction Grade 2 or 3), symptomatic intracranial hemorrhage rate, overall mortality rate, and favorable 3-month modified Rankin Scale score (≤ 2). Results The study included 35 patients (mean age 62 years, range 18–85 years). The median presenting National Institutes of Health Stroke Scale score was 13. Two patients received intravenous tissue plasminogen activator before endovascular therapy. The median time from symptom onset to therapy initiation was 230 minutes (range 90–1370 minutes). Twelve patients (34%) received intraarterial tissue plasminogen activator without mechanical measures. Mechanical revascularization measures used were Merci retriever in 19 (54%), Penumbra device in 1 (3%), balloon angioplasty in 15 (43%), and stent placement in 22 (63%) patients. The mean dose of intraarterial eptifibatide was 11.6 mg (range 5–16.6 mg). Partial-to-complete recanalization (Thrombolysis in Myocardial Infarction Grade 2 or 3) was achieved in 27 patients (77%). Postprocedure intracranial hemorrhage occurred in 13 patients (37%), causing symptoms in 5 (14%). In the 5 symptomatic intracranial hemorrhage cases, all patients but one presented more than 8 hours after symptom onset and all received intraarterial recombinant tissue plasminogen activator. The median discharge National Institutes of Health Stroke Scale score was 7 (range 0–17). At 3 months postprocedure, 21 patients (60%) had a modified Rankin Scale score ≤ 2, and 8 patients (23%) had died. Conclusions Adjunctive intraarterial eptifibatide is a feasible option for salvage of reocclusion and thrombolysis of distal inaccessible thrombi during endovascular stroke revascularization. Its safety and efficacy need to be studied further in larger, multicenter, controlled studies.


Stroke ◽  
2021 ◽  
Vol 52 (2) ◽  
pp. 603-610
Author(s):  
Russell P. Sawyer ◽  
Eunji Yim ◽  
Elisheva Coleman ◽  
Stacie L. Demel ◽  
Padmini Sekar ◽  
...  

Background and Purpose: In intracerebral hemorrhage (ICH), preexisting cognitive impairment has been identified as a risk factor for increased mortality and morbidity. However, previous studies examined predominantly White populations; therefore, the prevalence and effect of preICH cognitive impairment has not been studied in a multiethnic cohort. This limits the generalizability of previous findings. We sought to investigate the role of preexisting cognitive impairment in a multiethnic population on short-term mortality and functional outcomes after ICH. Methods: Patients with ICH were prospectively enrolled as cases for the GERFHS III (Genetic and Environmental Risk Factors for Hemorrhagic Stroke) Study and the Ethnic/Racial Variations of ICH (ERICH) Study. Cognitive impairment before ICH was defined as positive history of dementia or treatment with donepezil, galantamine, memantine, or rivastigmine on chart abstraction or baseline interview. Specific outcomes—modified Rankin Scale score at 3 months (0–2 versus ≥3), Barthel Index score (<100 versus 100) at 3 months, and withdrawal of care—were analyzed using multivariable logistic regression. Propensity score matching and analysis was done because of imbalances between cognitively impaired and cognitively intact groups. Results: Of the 3537 cases of ICH, 304 patients had cognitive impairment predating ICH. Cognitively impaired subjects were more likely to experience withdrawal of care during hospitalization, and for survivors, greater disability (modified Rankin Scale score of ≥3) and lower Barthel scores after ICH. After propensity score matching, preexisting cognitive impairment was associated with a lower modified Rankin Scale at 3 months in the White, Black, and Hispanic subgroups. Conclusions: Preexisting cognitive impairment was associated with loss of independence 3-month post-ICH, when matching for risk factors of cognitive impairment, in the White, Black, and Hispanic subgroups. This suggests that preexisting cognitive impairment has a negative effect in obtaining functional independence following ICH, irrespective of race/ethnicity.


Neurosurgery ◽  
2004 ◽  
Vol 54 (1) ◽  
pp. 39-46 ◽  
Author(s):  
Eric C. Bourekas ◽  
Andrew P. Slivka ◽  
Rajul Shah ◽  
Robert W. Tarr ◽  
Jeffrey Sunshine ◽  
...  

Abstract OBJECTIVE The National Institute of Neurological Disorders and Stroke (NINDS) Recombinant Tissue Plasminogen Activator Stroke Study Group showed that recombinant tissue plasminogen activator (rt-PA) administered intravenously within 3 hours of the onset of ischemic stroke can improve clinical outcome. Intraarterial (IA) thrombolysis has been shown to offer advantages over intravenous (IV) thrombolysis, but experience with this type of therapy within 3 hours of the onset of symptoms has not been reported previously. This study is the first retrospective analysis of a two-institution experience with IA thrombolysis within 3 hours of stroke onset. METHODS A total of 36 patients with angiographically demonstrated occlusions were treated with urokinase or rt-PA within 3 hours of stroke onset. Outcome measures included the percentage of patients with no or minimal neurological disability at 30 to 90 days as measured by the modified Rankin Scale, percentage recanalization, incidence of symptomatic intracranial hemorrhage, and mortality rate. The results were compared with those of the NINDS rt-PA study. RESULTS The median admission National Institutes of Health Stroke Scale score was 14. Fifty percent of treated patients had a modified Rankin Scale score of 0 or 1 indicating no or little disability at 1 to 3 months compared with 39% of treated patients in the NINDS trial. Recanalization was 75%, symptomatic intracranial hemorrhage was 11% (versus 6.4% with IV rt-PA in the NINDS trial), and the mortality rate was 22% (versus 17% with IV rt-PA in the NINDS trial). CONCLUSION The results suggest that IA thrombolysis administered within 3 hours of stroke onset is a feasible and viable alternative to IV rt-PA on the basis of improved clinical outcomes, high recanalization percentage, and comparable mortality rate and despite increased symptomatic intracranial hemorrhage. Whether IA thrombolysis is superior to IV therapy awaits further study.


2021 ◽  
Vol 12 ◽  
Author(s):  
Lingxin Cai ◽  
Xiaobo Yu ◽  
Jun Yu ◽  
Jing Xu ◽  
Liang Xu ◽  
...  

Objective: To evaluate the efficacy and safety of tirofiban for patients with acute ischemic stroke (AIS), especially posterior circulation stroke (PCS).Methods: We enrolled consecutive patients with AIS who suffered large artery occlusion (LAO) and underwent mechanical thrombectomy (MT) between January 2016 and May 2020. Patients were divided into two groups according to whether tirofiban was used during MT. The primary efficacy outcome was a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0–2 at 3 months. The safety outcomes were the rate of mortality at 3 months and the presence of intracranial hemorrhage (ICH) and symptomatic intracranial hemorrhage (sICH). Cohorts were balanced using 1:1 propensity score matching (PSM). Subgroup analysis was further performed to compare the efficacy and safety of tirofiban between the anterior circulation stroke (ACS) and PCS groups.Results: A total of 292 patients were eligible for this study and divided into the tirofiban group (n = 51) and the no-tirofiban group (n = 241). In the propensity-score-matched cohort, the tirofiban group had a higher rate of favorable outcomes than the no-tirofiban group (49.0 vs. 25.5%, p = 0.014), and the mortality at 3 months showed a greater downward trend in the tirofiban group than the no-tirofiban group (15.6 vs. 33.3% p = 0.064). The risk of sICH and ICH was the same between the tirofiban and control groups (17.6 vs. 27.4% p = 0.236, 31.3 vs. 45.1% p = 0.154, respectively). Tirofiban use was predictive of favorable outcomes [adjusted odds ratio (aOR) = 2.87, 95% confidence interval (CI) 1.52–6.44, p = 0.043] after multiple logistic regression analysis. Subgroup analysis revealed that tirofiban use was significantly associated with favorable outcomes in ACS (aOR = 3.66, 95% CI 1.24–5.22, p = 0.019) but not in PCS (aOR = 1.12, 95% CI 0.47–7.52, p = 0.570).Conclusion: We demonstrated that tirofiban may be associated with improving favorable outcome for the AIS patients who underwent MT, without increasing ICH or sICH. Furthermore, our results indicated that for PCS patients tirofiban may not be associated with favorable outcome, and more comprehensive randomized controlled trials are needed to confirm this finding.


2019 ◽  
Vol 12 (3) ◽  
pp. 271-273 ◽  
Author(s):  
Feng Peng ◽  
Junfang Wan ◽  
Wenhua Liu ◽  
Wenguo Huang ◽  
Li Wang ◽  
...  

PurposeTo evaluate the effectiveness and safety of rescue stenting (RS) after failed mechanical thrombectomy (MT) for patients with large artery occlusion in the anterior circulation.MethodsConsecutive patients who experienced failed reperfusion and subsequently did or did not undergo RS at 16 comprehensive stroke centers were enrolled from January 2015 to June 2018. Propensity score matching was used to achieve baseline balance between the patient groups. Symptomatic intracranial hemorrhage (sICH) at 48 hours and the modified Rankin Scale scores and mortality at 3 months in the two groups were compared.ResultsA total of 90 patients with RS and 117 patients without RS after failed MT were enrolled. Propensity score matching analysis selected 132 matched patients. The good outcome rate was significantly higher in matched patients with RS than in those without RS (36.4% vs 19.7%, p=0.033), whereas the sICH (13.6% vs 21.2%, p=0.251) and mortality (31.9% vs 43.9%, p=0.151) were not significantly different between the groups.ConclusionsRS seems to be an effective safe choice for patients with large vessel occlusion of the anterior circulation who underwent failed MT.


Stroke ◽  
2020 ◽  
Vol 51 (7) ◽  
pp. 2051-2057 ◽  
Author(s):  
Ilaria Casetta ◽  
Enrico Fainardi ◽  
Valentina Saia ◽  
Giovanni Pracucci ◽  
Marina Padroni ◽  
...  

Background and Purpose: To evaluate outcome and safety of endovascular treatment beyond 6 hours of onset of ischemic stroke due to large vessel occlusion in the anterior circulation, in routine clinical practice. Methods: From the Italian Registry of Endovascular Thrombectomy, we extracted clinical and outcome data of patients treated for stroke of known onset beyond 6 hours. Additional inclusion criteria were prestroke modified Rankin Scale score ≤2 and ASPECTS score ≥6. Patients were selected on individual basis by a combination of CT perfusion mismatch (difference between total hypoperfusion and infarct core sizes) and CT collateral score. The primary outcome measure was the score on modified Rankin Scale at 90 days. Safety outcomes were 90-day mortality and the occurrence of symptomatic intracranial hemorrhage. Data were compared with those from patients treated within 6 hours. Results: Out of 3057 patients, 327 were treated beyond 6 hours. Their mean age was 66.8±14.9 years, the median baseline National Institutes of Health Stroke Scale 16, and the median onset to groin puncture time 430 minutes. The most frequent site of occlusion was middle cerebral artery (45.1%). Functional independence (90-day modified Rankin Scale score, 0–2) was achieved by 41.3% of cases. Symptomatic intracranial hemorrhage occurred in 6.7% of patients, and 3-month case fatality rate was 17.1%. The probability of surviving with modified Rankin Scale score, 0–2 (odds ratio, 0.58 [95% CI, 0.43–0.77]) was significantly lower in patients treated beyond 6 hours as compared with patients treated earlier No differences were found regarding recanalization rates and safety outcomes between patients treated within and beyond 6 hours. There were no differences in outcome between people treated 6-12 hours from onset (278 patients) and those treated 12 to 24 hours from onset (49 patients). Conclusions: This real-world study suggests that in patients with large vessel occlusion selected on the basis of CT perfusion and collateral circulation assessment, endovascular treatment beyond 6 hours is feasible and safe with no increase in symptomatic intracranial hemorrhage.


Stroke ◽  
2021 ◽  
Author(s):  
Kyohei Fujita ◽  
Kanta Tanaka ◽  
Hiroshi Yamagami ◽  
Takeshi Yoshimoto ◽  
Kazutaka Uchida ◽  
...  

Background and Purpose: Outcomes in patients ≥90 years of age with stroke due to large vessel occlusion were compared between endovascular therapy (EVT) and medical management. Methods: Of 2420 acute ischemic stroke patients with large vessel occlusion in a prospective, multicenter, nationwide registry in Japan, patients aged ≥90 years with occlusion of the internal carotid artery or M1 segment of the middle cerebral artery were included. The primary effectiveness outcome was a favorable outcome at 3 months, defined as achieving a modified Rankin Scale score of 0 to 2 or return to at least the prestroke modified Rankin Scale score at 3 months. Safety outcomes included symptomatic intracranial hemorrhage within 72 hours after onset. Intergroup biases were adjusted by multivariable adjustment with inverse probability of treatment weighting. Results: A total of 150 patients (median age, 92 [interquartile range, 90–94] years; median prestroke modified Rankin Scale score, 2 [interquartile range, 0–4]) were analyzed. EVT was performed in 49 patients (32.7%; mechanical thrombectomy, n=43). The EVT group showed shorter time from onset to hospital arrival ( P =0.03), higher Alberta Stroke Program Early Computed Tomography Score ( P <0.01), and a higher rate of treatment with intravenous thrombolysis ( P <0.01) than the medical management group. The favorable outcome was seen in 28.6% of the EVT group and 6.9% of the medical management group ( P <0.01). EVT was associated with the favorable outcome (adjusted odds ratio, 8.44 [95% CI, 1.88–37.97]). Rates of symptomatic intracranial hemorrhage were similar between the EVT group (0.0%) and the medical management group (3.9%; P =0.30). Conclusions: Patients who underwent EVT showed better functional outcomes than those with medical management without increased symptomatic intracranial hemorrhages. Given proper patient selection, withholding EVT solely on the basis of the age of patients may not offer the best chance of good outcome. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02419794.


Stroke ◽  
2021 ◽  
Vol 52 (2) ◽  
pp. 611-619
Author(s):  
Anne Mrochen ◽  
Maximilian I. Sprügel ◽  
Stefan T. Gerner ◽  
Jochen A. Sembill ◽  
Stefan Lang ◽  
...  

Background and Purpose: The impact of platelets on hematoma enlargement (HE) of intracerebral hemorrhage (ICH) is not yet sufficiently elucidated. Especially the role of reduced platelet counts on HE and clinical outcomes is still poorly understood. This study investigated the influence of thrombocytopenia on HE, functional outcome, and mortality in patients with ICH with or without prior antiplatelet therapy (APT). Methods: Individual participant data of multicenter cohort studies (multicenter RETRACE program [German-Wide Multicenter Analysis of Oral Anticoagulation-Associated Intracerebral Hemorrhage] and single-center UKER-ICH registry [Universitätsklinikum Erlangen Cohort of Patients With Spontaneous ICH]) were grouped into APT and non-APT ICH patients according to the platelet count, that is, with or without thrombocytopenia (cells <150×10 9 /L). Of all patients, 51.5% (1124 of 2183) were on vitamin K antagonist. Imbalances in baseline characteristics including proportions of vitamin K antagonist patients were addressed using propensity score matching. Outcome analyses included HE (>33%), as well as mortality and functional outcome, after 3 months using the modified Rankin Scale, dichotomized into favorable (modified Rankin Scale score, 0–3) and unfavorable (modified Rankin Scale score, 4–6). Results: Of overall 2252 ICH patients, 11.4% (52 of 458) under APT and 14.0% (242 of 1725) without APT presented with thrombocytopenia on admission. The proportion of patients with HE was not significantly different between patients with or without thrombocytopenia among APT and non-APT ICH patients after propensity score matching (HE: APT patients: 9 of 40 [22.5%] thrombocytopenia versus 27 of 115 [23.5%] nonthrombocytopenia, P =0.89; non-APT patients: 54 of 174 [31.0%] thrombocytopenia versus 106 of 356 [29.8%] nonthrombocytopenia, P =0.77). In both (APT and non-APT) propensity score matching cohorts, there were no significant differences regarding functional outcome. Mortality after 3 months did not differ among non-APT patients, whereas the mortality rate was significantly higher for APT patients with thrombocytopenia versus APT patients with normal platelet count (APT: 29 of 46 [63.0%] thrombocytopenia versus 58 of 140 [41.4%] nonthrombocytopenia, P =0.01; non-APT: 95 of 227 [41.9%] thrombocytopenia versus 178 of 455 [39.1%] nonthrombocytopenia, P =0.49). Conclusions: Our study implies that thrombocytopenia does not affect rates of HE and functional outcome among ICH patients, neither in patients with nor without APT. In light of increased mortality, the significance of platelet transfusions for ICH patients with thrombocytopenia and previous APT should be explored in future studies.


Stroke ◽  
2020 ◽  
Vol 51 (11) ◽  
pp. 3215-3223
Author(s):  
Leon A. Rinkel ◽  
T. Truc My Nguyen ◽  
Valeria Guglielmi ◽  
Adrien E. Groot ◽  
Laura Posthuma ◽  
...  

Background and Purpose: High-serum glucose on admission is a predictor of poor outcome after stroke. We assessed the association between glucose concentrations and clinical outcomes in patients who underwent endovascular treatment. Methods: From the MR CLEAN Registry, we selected consecutive adult patients with a large vessel occlusion of the anterior circulation who underwent endovascular treatment and for whom admission glucose levels were available. We assessed the association between admission glucose and the modified Rankin Scale score at 90 days, symptomatic intracranial hemorrhage and successful reperfusion rates. Hyperglycemia was defined as admission glucose ≥7.8 mmol/L. We evaluated the association between glucose and modified Rankin Scale using multivariable ordinal logistic regression and assessed whether successful reperfusion (extended Thrombolysis in Cerebral Infarction 2b-3) modified this association. Results: Of 3637 patients in the MR CLEAN Registry, 2908 were included. Median admission glucose concentration was 6.8 mmol/L (interquartile range, 5.9–8.1) and 882 patients (30%) had hyperglycemia. Hyperglycemia on admission was associated with a shift toward worse functional outcome (median modified Rankin Scale score 4 versus 3; adjusted common odds ratio, 1.69 [95% CI, 1.44–1.99]), increased mortality (40% versus 23%; adjusted odds ratio, 1.95 [95% CI, 1.60–2.38]), and an increased risk of symptomatic intracranial hemorrhage (9% versus 5%; adjusted odds ratio, 1.94 [95% CI, 1.41–2.66]) compared with nonhyperglycemic patients. The association between admission glucose levels and poor outcome (modified Rankin Scale score 3–6) was J -shaped. Hyperglycemia was not associated with the rate of successful reperfusion nor did successful reperfusion modify the association between glucose and functional outcome. Conclusions: Increased admission glucose is associated with poor functional outcome and an increased risk of symptomatic intracranial hemorrhage after endovascular treatment.


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