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1.
EClinicalMedicine ; 65: 102305, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37965431

RESUMO

Background: Glibenclamide alleviates brain edema and improves neurological outcomes in experimental models of stroke. We aimed to assess whether glibenclamide improves functional outcomes in patients with acute ischemic stroke treated with recombinant tissue plasminogen activator (rtPA). Methods: In this randomized, double-blind, placebo-controlled trial, patients with acute ischemic stroke were recruited to eight academic hospitals in China. Patients were eligible if they were aged 18-74 years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4-25, and had been treated with rtPA within 4.5 h of symptom onset. We used web-based randomization (1:1) to allocate eligible participants to the glibenclamide or placebo group, stratified according to endovascular treatment and baseline stroke severity. Glibenclamide or placebo was taken orally or via tube feeding at a loading dose of 1.25 mg within 10 h after symptom onset, followed by 0.625 mg every 8 h for 5 days. The primary outcome was the proportion of patients with good outcomes (modified Rankin Scale of 0-2) at 90 days, assessed in all randomly assigned patients who had been correctly diagnosed and had begun study medication. The study is registered with ClinicalTrials.gov, NCT03284463, and is closed to new participants. Findings: Between January 1, 2018, and May 28, 2022, 305 patients were randomly assigned, of whom 272 (142 received glibenclamide and 130 received placebo) were included in the primary efficacy analysis. 103 (73%) patients in the glibenclamide group and 94 (72%) in the placebo group had a good outcome (adjusted risk difference 0.002, 95% CI -0.098 to 0.103; p = 0.96). 12 (8%) patients allocated to glibenclamide and seven (5%) patients allocated to placebo died from any cause at 90 days (p = 0.35). The number and type of adverse events were similar between the two groups. There were no drug-related adverse events and no drug-related deaths. Interpretation: The addition of glibenclamide to thrombolytic therapy did not increase the proportion of patients who achieved good outcomes after stroke compared with placebo, but it did not lead to any safety concerns. Funding: Southern Medical University and Nanfang Hospital.

2.
N Engl J Med ; 388(22): 2025-2036, 2023 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-37256974

RESUMO

BACKGROUND: The effects of the glycoprotein IIb/IIIa receptor inhibitor tirofiban in patients with acute ischemic stroke but who have no evidence of complete occlusion of large or medium-sized vessels have not been extensively studied. METHODS: In a multicenter trial in China, we enrolled patients with ischemic stroke without occlusion of large or medium-sized vessels and with a National Institutes of Health Stroke Scale score of 5 or more and at least one moderately to severely weak limb. Eligible patients had any of four clinical presentations: ineligible for thrombolysis or thrombectomy and within 24 hours after the patient was last known to be well; progression of stroke symptoms 24 to 96 hours after onset; early neurologic deterioration after thrombolysis; or thrombolysis with no improvement at 4 to 24 hours. Patients were assigned to receive intravenous tirofiban (plus oral placebo) or oral aspirin (100 mg per day, plus intravenous placebo) for 2 days; all patients then received oral aspirin until day 90. The primary efficacy end point was an excellent outcome, defined as a score of 0 or 1 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. Secondary end points included functional independence at 90 days and a quality-of-life score. The primary safety end points were death and symptomatic intracranial hemorrhage. RESULTS: A total of 606 patients were assigned to the tirofiban group and 571 to the aspirin group. Most patients had small infarctions that were presumed to be atherosclerotic. The percentage of patients with a score of 0 or 1 on the modified Rankin scale at 90 days was 29.1% with tirofiban and 22.2% with aspirin (adjusted risk ratio, 1.26; 95% confidence interval, 1.04 to 1.53, P = 0.02). Results for secondary end points were generally not consistent with the results of the primary analysis. Mortality was similar in the two groups. The incidence of symptomatic intracranial hemorrhage was 1.0% in the tirofiban group and 0% in the aspirin group. CONCLUSIONS: In this trial involving heterogeneous groups of patients with stroke of recent onset or progression of stroke symptoms and nonoccluded large and medium-sized cerebral vessels, intravenous tirofiban was associated with a greater likelihood of an excellent outcome than low-dose aspirin. Incidences of intracranial hemorrhages were low but slightly higher with tirofiban. (Funded by the National Natural Science Foundation of China; RESCUE BT2 Chinese Clinical Trial Registry number, ChiCTR2000029502.).


Assuntos
Fibrinolíticos , AVC Isquêmico , Tirofibana , Humanos , Aspirina/efeitos adversos , Isquemia Encefálica/tratamento farmacológico , Isquemia Encefálica/etiologia , Fibrinolíticos/efeitos adversos , Fibrinolíticos/uso terapêutico , Hemorragias Intracranianas/induzido quimicamente , AVC Isquêmico/diagnóstico , AVC Isquêmico/tratamento farmacológico , AVC Isquêmico/etiologia , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/uso terapêutico , Tirofibana/efeitos adversos , Tirofibana/uso terapêutico , Resultado do Tratamento , Doenças Arteriais Cerebrais/tratamento farmacológico , Doenças Arteriais Cerebrais/etiologia
3.
Front Neurosci ; 16: 920731, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35911988

RESUMO

Background: The long-term outcomes of acute large vessel occlusion (LVO) in anterior circulation treated by endovascular treatment (EVT) remains to be determined. The aim of this study was to assess the 5-year outcomes of patients with LVO who underwent EVT. Methods: This study was an observational, nationwide registry of consecutive patients with acute LVO who received EVT in 28 comprehensive stroke centers in China. The primary outcome was the proportion of favorable outcome [modified Rankin Scale score (mRS) 0-2] at 5 years. Secondary outcomes included proportions of patients with excellent outcome (mRS 0-1), all-cause mortality and risk of stroke recurrence at 5 years. Results: A total of 807 patients were included into the study and had 90-day follow-up data, 657 patients had 5-year follow-up data. At 90 days, 218 patients (27.0%) had an excellent outcome, 349 patients (43.2%) had a favorable functional outcome. 199 patients (24.7%) died. At 5 years, 190 patients (28.9%) had an excellent outcome, 261 patients (39.7%) had a favorable functional outcome, 317 patients (48.2%) died and 129 (28.2%) had stroke recurrence. Because of missing 5-year follow-up data, among available 269 patients who achieved functional independence at 90 days, 208 (77.3%) maintained favorable outcome, 19 (7.1%) had disability (mRS 3-5) and 42 (15.6%) died at 5 years. Furthermore, among available 189 patients with mRS 3-5 at 90 days, 53 (28.0%) patients achieved favorable functional outcome, 60 (31.7%) patients maintained unfavorable functional outcome and 76 (40.2%) patients died within 5 years. Multivariate analyses identified that younger age [odds ratio (OR): 0.96; 95% CI, 0.93-0.99; P = 0.009], lower mRS at 90 days (OR: 0.15; 95% CI, 0.10-0.23; P < 0.001) and absence of stroke recurrence (OR: 0.001; 95% CI, 0.000-0.006; P < 0.001) were significantly associated with favorable outcome at 5 years. Advanced age (OR: 1.06, 95% CI, 1.04-1.08; P < 0.001), higher mRS at 90 days (OR: 0.84; 95% CI, 0.73-0.98; P = 0.021) and atrial fibrillation (OR: 1.63; 95% CI, 1.02-2.60; P = 0.04) were independent factors for stroke recurrence. Conclusion: Our results indicated that the beneficial effect of EVT in patients with acute LVO can be sustained during the course of at least 5 years. Reducing the risk of stroke recurrence by anticoagulation for atrial fibrillation may be a crucial strategy to improve long-term outcome.

4.
JAMA ; 328(6): 543-553, 2022 08 09.
Artigo em Inglês | MEDLINE | ID: mdl-35943471

RESUMO

Importance: Tirofiban is a highly selective nonpeptide antagonist of glycoprotein IIb/IIIa receptor, which reversibly inhibits platelet aggregation. It remains uncertain whether intravenous tirofiban is effective to improve functional outcomes for patients with large vessel occlusion ischemic stroke undergoing endovascular thrombectomy. Objective: To assess the efficacy and adverse events of intravenous tirofiban before endovascular thrombectomy for acute ischemic stroke secondary to large vessel occlusion. Design, Setting, and Participants: This investigator-initiated, randomized, double-blind, placebo-controlled trial was implemented at 55 hospitals in China, enrolling 948 patients with stroke and proximal intracranial large vessel occlusion presenting within 24 hours of time last known well. Recruitment took place between October 10, 2018, and October 31, 2021, with final follow-up on January 15, 2022. Interventions: Participants received intravenous tirofiban (n = 463) or placebo (n = 485) prior to endovascular thrombectomy. Main Outcomes and Measures: The primary outcome was disability level at 90 days as measured by overall distribution of the modified Rankin Scale scores from 0 (no symptoms) to 6 (death). The primary safety outcome was the incidence of symptomatic intracranial hemorrhage within 48 hours. Results: Among 948 patients randomized (mean age, 67 years; 391 [41.2%] women), 948 (100%) completed the trial. The median (IQR) 90-day modified Rankin Scale score in the tirofiban group vs placebo group was 3 (1-4) vs 3 (1-4). The adjusted common odds ratio for a lower level of disability with tirofiban vs placebo was 1.08 (95% CI, 0.86-1.36). Incidence of symptomatic intracranial hemorrhage was 9.7% in the tirofiban group vs 6.4% in the placebo group (difference, 3.3% [95% CI, -0.2% to 6.8%]). Conclusions and Relevance: Among patients with large vessel occlusion acute ischemic stroke undergoing endovascular thrombectomy, treatment with intravenous tirofiban, compared with placebo, before endovascular therapy resulted in no significant difference in disability severity at 90 days. The findings do not support use of intravenous tirofiban before endovascular thrombectomy for acute ischemic stroke. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR-IOR-17014167.


Assuntos
Procedimentos Endovasculares , AVC Isquêmico , Inibidores da Agregação Plaquetária , Trombectomia , Tirofibana , Administração Intravenosa , Idoso , Arteriopatias Oclusivas/complicações , Arteriopatias Oclusivas/tratamento farmacológico , Arteriopatias Oclusivas/cirurgia , Isquemia Encefálica/tratamento farmacológico , Isquemia Encefálica/etiologia , Isquemia Encefálica/cirurgia , Método Duplo-Cego , Procedimentos Endovasculares/métodos , Feminino , Humanos , Hemorragias Intracranianas/induzido quimicamente , AVC Isquêmico/tratamento farmacológico , AVC Isquêmico/etiologia , AVC Isquêmico/cirurgia , Masculino , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodos , Tirofibana/administração & dosagem , Tirofibana/efeitos adversos , Tirofibana/uso terapêutico , Resultado do Tratamento
5.
Clin Neurol Neurosurg ; 215: 107184, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35272178

RESUMO

BACKGROUND AND PURPOSE: This study aimed to develop a score to predict the risk for symptomatic intracranial haemorrhage (sICH) associated with endovascular treatment (EVT) in patients with acute ischaemic stroke caused by large vessel occlusions (LVOs) in the anterior circulation. METHODS: Between January 2017 and December 2019, acute stroke patients with anterior circulation occlusion and EVT were retrospectively enroled from 11 comprehensive stroke centres in China. Univariate analyses were performed to compare the factors in patients with or without sICH. The predictive value of parameters associated with sICH was evaluated with multivariate logistic regression, and the score was developed according to the magnitude of regression coefficients. We performed external validation in a retrospective stroke registry of EVT for acute anterior circulation ischaemic stroke in 21 comprehensive stroke centres across 10 provinces in China (ACTUAL). RESULTS: Of the 433 patients, 70 (16.2%) patients had sICH. The preoperative predictive factors of sICH were poor collateral circulation, low baseline ASPECTS, cardioembolic stroke and high serum glucose. Using the OR of preoperative predictive factors (collateral circulation status, baseline ASPECTS, TOAST type and serum glucose) in the multivariable model, we derived the ACTS score. In the derivation cohort, the area under the ROC curve (AUC) was 0.797; in the validation cohort, it was 0.727. CONCLUSION: The ACTS score provides a quick and easy-to-perform scale to predict the risk of sICH in acute anterior circulation stroke patients treated with EVT. This score should be further examined and improved in future prospective studies to increase its precision and applicability before it can be recommended to make clinical decisions regarding the performance of EVT.


Assuntos
Isquemia Encefálica , Procedimentos Endovasculares , AVC Isquêmico , Acidente Vascular Cerebral , Isquemia Encefálica/complicações , Isquemia Encefálica/cirurgia , Procedimentos Endovasculares/efeitos adversos , Glucose , Humanos , Hemorragias Intracranianas/complicações , AVC Isquêmico/complicações , AVC Isquêmico/cirurgia , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/complicações , Trombectomia/efeitos adversos , Resultado do Tratamento
6.
Int J Stroke ; 17(10): 1151-1155, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-35083951

RESUMO

BACKGROUND: Tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, has been shown to reduce the risk of thrombotic complications during percutaneous coronary intervention. However, it remains unknown whether tirofiban improves outcomes in large vessel occlusion stroke patients undergoing endovascular treatment. OBJECTIVE: This trial aims to assess whether additional intravenous tirofiban therapy can improve the clinical outcomes in large vessel occlusion stroke patients who undergo endovascular treatment within 24 h of symptom onset. METHODS AND DESIGN: The Endovascular Treatment With versus Without Tirofiban for Stroke Patients With Large Vessel Occlusion (RESCUE BT) Trial is an investigator-initiated, randomized, placebo-controlled, double-blind, multicenter trial. Up to 930 eligible patients will be consecutively randomized to intravenous tirofiban or placebo in 1:1 ratio over 3 years across 50 endovascular-capable stroke centers in China. OUTCOMES: The primary end point is the disability level as measured by overall distribution of the 90-day modified Rankin Scale scores. Primary safety end points include symptomatic intracerebral hemorrhage at 48 h and mortality at 90 days. TRIAL REGISTRY NUMBER: ChiCTR-INR-17014167 (www.chictr.org.cn).


Assuntos
Arteriopatias Oclusivas , Acidente Vascular Cerebral , Humanos , Tirofibana/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Tirosina/uso terapêutico , Método Duplo-Cego , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
7.
Front Aging Neurosci ; 13: 720061, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34483888

RESUMO

Background: Brain atrophy globally reflects the effects of preexisting risk factors and biological aging on brain structures and normally predicts poor outcomes in anterior circulation stroke. However, comparing with these patients, acute basilar artery occlusion (ABAO) impairs infratentorial regions frequently and might benefit from brain atrophy due to the resulting residual space to reduce tissue compression and thus improve prognosis, which raises doubts that current understandings for prognostic roles of brain atrophy are also applicable for ABAO. Therefore, this study aims to evaluate brain atrophy automatically from CT images and investigates its impact on outcomes of ABAO following endovascular treatment (EVT). Methods: A total of 231 ABAO who underwent EVT from the BASILAR registry were enrolled. Brain atrophy was quantified as the ratio of brain parenchymal volume to cerebrospinal fluid volume on baseline CT. The primary outcome was the modified Rankin Scale (mRS) score at 3 months. Results: The frequency of favorable outcomes (90-day mRS ≤ 3) was significantly lower in the severe atrophy group (P = 0.014). Adjusted logistic models revealed that severe brain atrophy was significantly negatively associated with favorable outcome incidence (P = 0.006), with no relationship with either in-hospital or 90-day overall mortality (all P > 0.05). Adding a severe atrophy index into the baseline model obviously enhanced its discriminatory ability in predicting the outcome by obviously increasing areas under the receiver operating characteristic curve, net reclassification improvement algorithm, and integrated discrimination improvement algorithm values (all P < 0.05). Conclusion: Severe brain atrophy did not improve in-hospital or overall mortality but impaired the long-term recovery after EVT. This objective and automated marker has the potential to be incorporated into decision-support methods for treating ABAO.

8.
Ther Adv Neurol Disord ; 14: 17562864211000453, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33912242

RESUMO

BACKGROUND: To date, few data have been reported on clinical outcomes following interventions in elderly populations with acute basilar artery occlusion. Using data from the Endovascular Treatment for Acute Basilar Artery Occlusion Study (BASILAR), we evaluated the efficacy and safety of intervention and determined predictors of outcomes among elderly patients in China. METHODS: Patients from January 2014 to May 2019 were dichotomized into elderly (75 years or older) and nonelderly patients (under 75 years). Pearson's Chi-square test and multivariate logistic regression were performed to assess 90-day favorable functional outcome (defined as a modified Rankin scale score of 0-3), mortality and symptomatic intracranial hemorrhage between intervention and conservative cohorts in elderly patients. RESULTS: Among the 829 patients in the BASILAR, 182 patients aged 75 years or older were analyzed. These patients were divided into intervention (127 patients) and conservative (55 patients) cohorts. Compared with the conservative cohort, the intervention cohort presented more frequently with a favorable functional outcome (28.3% versus 12.7%; p = 0.023) and with a decreased mortality (54.3% versus 76.4%; p = 0.005). There was no difference in symptomatic intracranial hemorrhage (4.7% versus 0, p = 0.235). Multivariate analysis indicated that intervention was associated with favorable functional outcome (adjusted odds ratio, 0.262; 95% confidence interval, 0.088-0.778, p = 0.016) and lower mortality (adjusted odds ratio, 0.257; 95% confidence interval, 0.109-0.606, p = 0.002). In the intervention cohort, initial National Institutes of Health Stroke Scale (NIHSS) score and occlusion site were associated with functional outcome, and initial NIHSS score and recanalization were associated with mortality. CONCLUSIONS: Although the overall outcome following intervention was worse with age, intervention was more effective and safer than conservative treatment for elderly Chinese patients with basilar artery occlusion. Predictors of desirable outcome in elderly patients undergoing intervention included lower initial NIHSS score, occlusion site and successful recanalization.Clinical Trial Registration-URL: http://www.chictr.org. Unique identifier: ChiCTR-1800014759.

9.
JAMA ; 325(3): 234-243, 2021 01 19.
Artigo em Inglês | MEDLINE | ID: mdl-33464335

RESUMO

Importance: For patients with large vessel occlusion strokes, it is unknown whether endovascular treatment alone compared with intravenous thrombolysis plus endovascular treatment (standard treatment) can achieve similar functional outcomes. Objective: To investigate whether endovascular thrombectomy alone is noninferior to intravenous alteplase followed by endovascular thrombectomy for achieving functional independence at 90 days among patients with large vessel occlusion stroke. Design, Setting, and Participants: Multicenter, randomized, noninferiority trial conducted at 33 stroke centers in China. Patients (n = 234) were 18 years or older with proximal anterior circulation intracranial occlusion strokes within 4.5 hours from symptoms onset and eligible for intravenous thrombolysis. Enrollment took place from May 20, 2018, to May 2, 2020. Patients were enrolled and followed up for 90 days (final follow-up was July 22, 2020). Interventions: A total of 116 patients were randomized to the endovascular thrombectomy alone group and 118 patients to combined intravenous thrombolysis and endovascular thrombectomy group. Main Outcomes and Measures: The primary end point was the proportion of patients achieving functional independence at 90 days (defined as score 0-2 on the modified Rankin Scale; range, 0 [no symptoms] to 6 [death]). The noninferiority margin was -10%. Safety outcomes included the incidence of symptomatic intracerebral hemorrhage within 48 hours and 90-day mortality. Results: The trial was stopped early because of efficacy when 234 of a planned 970 patients had undergone randomization. All 234 patients who were randomized (mean age, 68 years; 102 women [43.6%]) completed the trial. At the 90-day follow-up, 63 patients (54.3%) in the endovascular thrombectomy alone group vs 55 (46.6%) in the combined treatment group achieved functional independence at the 90-day follow-up (difference, 7.7%, 1-sided 97.5% CI, -5.1% to ∞)P for noninferiority = .003). No significant between-group differences were detected in symptomatic intracerebral hemorrhage (6.1% vs 6.8%; difference, -0.8%; 95% CI, -7.1% to 5.6%) and 90-day mortality (17.2% vs 17.8%; difference, -0.5%; 95% CI, -10.3% to 9.2%). Conclusions and Relevance: Among patients with ischemic stroke due to proximal anterior circulation occlusion within 4.5 hours from onset, endovascular treatment alone, compared with intravenous alteplase plus endovascular treatment, met the prespecified statistical threshold for noninferiority for the outcome of 90-day functional independence. These findings should be interpreted in the context of the clinical acceptability of the selected noninferiority threshold. Trial Registration: Chinese Clinical Trial Registry: ChiCTR-IOR-17013568.


Assuntos
Fibrinolíticos/administração & dosagem , AVC Isquêmico/tratamento farmacológico , AVC Isquêmico/cirurgia , Trombectomia , Ativador de Plasminogênio Tecidual/administração & dosagem , Doença Aguda , Idoso , Hemorragia Cerebral/etiologia , Terapia Combinada , Procedimentos Endovasculares , Feminino , Fibrinolíticos/efeitos adversos , Estado Funcional , Humanos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Trombectomia/efeitos adversos , Ativador de Plasminogênio Tecidual/efeitos adversos
10.
Int J Stroke ; 16(2): 229-235, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-32448089

RESUMO

BACKGROUND: Eight randomized controlled trials have consistently shown that endovascular treatment plus best medical treatment improves outcome after acute anterior proximal intracranial large vessel occlusion strokes. Whether intravenous thrombolysis prior to endovascular treatment in patients with anterior circulation, large vessel occlusion is of any additional benefits remains unclear. OBJECTIVE: This study compares the safety and efficacy of direct endovascular treatment versus intravenous recombinant tissue-type plasminogen activator bridging with endovascular treatment (bridging therapy) in acute stroke patients with intracranial internal carotid artery or middle cerebral artery-M1 occlusion within 4.5 h of symptom onset. METHODS AND DESIGN: The DEVT study is a randomized, controlled, multicenter trial with blinded outcome assessment. This trial uses a five-look group-sequential non-inferiority design. Up to 194 patients in each interim analysis will be consecutively randomized to direct endovascular treatment or bridging therapy group in 1:1 ratio over three years from about 30 hospitals in China. OUTCOMES: The primary end-point is the proportion of independent neurological function defined as modified Rankin scale score of 0 to 2 at 90 days. The primary safety measure is symptomatic intracerebral hemorrhage at 48 h and mortality at 90 days. TRIAL REGISTRY NUMBER: ChiCTR-IOR-17013568 (www.chictr.org.cn).


Assuntos
Acidente Vascular Cerebral , Hemorragia Cerebral/tratamento farmacológico , Fibrinolíticos/uso terapêutico , Humanos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/tratamento farmacológico , Trombectomia , Ativador de Plasminogênio Tecidual/uso terapêutico
11.
BMC Neurol ; 20(1): 239, 2020 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-32527232

RESUMO

BACKGROUND: Thrombolysis with recombinant tissue plasminogen activator (rtPA) improves outcome for patients with acute ischemic stroke (AIS), but many of them still have substantial disability. Glibenclamide (US adopted name, glyburide), a long-acting sulfonylurea, shows promising result in treating AIS from both preclinical and clinical studies. This study investigates the safety and efficacy of glibenclamide combined with rtPA in treating AIS patients. METHODS: This is a prospective, randomized, double-blind, placebo-controlled, multicenter trial with an estimated sample size of 306 cases, starting in January 2018. Patients aged 18 to 74 years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4 to 25 points and treated with intravenous rtPA within the first 4.5 h of their clinical onsets, are eligible for participation in this study. The target time from the onset of symptoms to receive the study drug is of 10 h. Subjects are randomized 1: 1 to receive glibenclamide or placebo with a loading dose of 1.25 mg, followed by 0.625 mg every 8 h for total 5 days. The primary efficacy endpoint is 90-day good outcome, measured as modified Rankin Scale of 0 to 2. Safety outcomes are all-cause 30-day mortality and early neurological deterioration, with a focus on cardiac- and glucose-related serious adverse events. DISCUSSION: This study will provide valuable information about the safety and efficacy of oral glibenclamide for AIS patients treated with rtPA. This would bring benefits to a large number of patients if the agent is proved to be effective. TRIAL REGISTRATION: The trial was registered on September 14th 2017 at www.clinicaltrials.gov having identifier NCT03284463. Registration was performed before recruitment was initiated.


Assuntos
Glibureto/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/tratamento farmacológico , Ativador de Plasminogênio Tecidual/uso terapêutico , Adolescente , Adulto , Idoso , Isquemia Encefálica/complicações , Constrição Patológica , Método Duplo-Cego , Feminino , Fibrinolíticos/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento , Adulto Jovem
12.
JAMA Neurol ; 77(5): 561-573, 2020 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-32080711

RESUMO

Importance: Several randomized clinical trials have recently established the safety and efficacy of endovascular treatment (EVT) of acute ischemic stroke in the anterior circulation. However, it remains uncertain whether patients with acute basilar artery occlusion (BAO) benefit from EVT. Objective: To evaluate the association between EVT and clinical outcomes of patients with acute BAO. Design, Setting, and Participants: This nonrandomized cohort study, the EVT for Acute Basilar Artery Occlusion Study (BASILAR) study, was a nationwide prospective registry of consecutive patients presenting with an acute, symptomatic, radiologically confirmed BAO to 47 comprehensive stroke centers across 15 provinces in China between January 2014 and May 2019. Patients with acute BAO within 24 hours of estimated occlusion time were divided into groups receiving standard medical treatment plus EVT or standard medical treatment alone. Main Outcomes and Measures: The primary outcome was the improvement in modified Rankin Scale scores (range, 0 to 6 points, with higher scores indicating greater disability) at 90 days across the 2 groups assessed as a common odds ratio using ordinal logistic regression shift analysis, adjusted for prespecified prognostic factors. The secondary efficacy outcome was the rate of favorable functional outcomes defined as modified Rankin Scale scores of 3 or less (indicating an ability to walk unassisted) at 90 days. Safety outcomes included symptomatic intracerebral hemorrhage and 90-day mortality. Results: A total of 1254 patients were assessed, and 829 patients (of whom 612 were men [73.8%]; median [interquartile] age, 65 [57-74] years) were recruited into the study. Of these, 647 were treated with standard medical treatment plus EVT and 182 with standard medical treatment alone. Ninety-day functional outcomes were substantially improved by EVT (adjusted common odds ratio, 3.08 [95% CI, 2.09-4.55]; P < .001). Moreover, EVT was associated with a significantly higher rate of 90-day modified Rankin Scale scores of 3 or less (adjusted odds ratio, 4.70 [95% CI, 2.53-8.75]; P < .001) and a lower rate of 90-day mortality (adjusted odds ratio, 2.93 [95% CI, 1.95-4.40]; P < .001) despite an increase in symptomatic intracerebral hemorrhage (45 of 636 patients [7.1%] vs 1 of 182 patients [0.5%]; P < .001). Conclusions and Relevance: Among patients with acute BAO, EVT administered within 24 hours of estimated occlusion time is associated with better functional outcomes and reduced mortality.


Assuntos
Procedimentos Endovasculares/métodos , AVC Isquêmico/cirurgia , Insuficiência Vertebrobasilar/cirurgia , Idoso , Arteriopatias Oclusivas/complicações , Arteriopatias Oclusivas/cirurgia , China , Estudos de Coortes , Feminino , Humanos , AVC Isquêmico/etiologia , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Terapia Trombolítica , Insuficiência Vertebrobasilar/complicações
13.
J Neurointerv Surg ; 12(3): 271-273, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31530654

RESUMO

PURPOSE: To evaluate the effectiveness and safety of rescue stenting (RS) after failed mechanical thrombectomy (MT) for patients with large artery occlusion in the anterior circulation. METHODS: Consecutive 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. RESULTS: A 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. CONCLUSIONS: RS seems to be an effective safe choice for patients with large vessel occlusion of the anterior circulation who underwent failed MT.


Assuntos
Transtornos Cerebrovasculares/terapia , Pontuação de Propensão , Stents , Acidente Vascular Cerebral/terapia , Trombectomia/efeitos adversos , Idoso , Transtornos Cerebrovasculares/diagnóstico por imagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reperfusão/métodos , Estudos Retrospectivos , Acidente Vascular Cerebral/diagnóstico por imagem , Trombectomia/tendências , Resultado do Tratamento
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