Golden Hour Thrombolysis in Acute Ischemic Stroke: The Changing Pattern in South Korea.
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ABSTRACT:
SUBMITTER: Kim H
PROVIDER: S-EPMC7900393 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Tenecteplase is a fibrinolytic drug with higher fibrin specificity and longer half-life than the standard stroke thrombolytic, alteplase, permitting the convenience of single bolus administration. Tenecteplase, at 0.5 mg/kg, has regulatory approval to treat ST-segment-elevation myocardial infarction, for which it has equivalent 30-day mortality and fewer systemic hemorrhages. Investigated as a thrombolytic for ischemic stroke over the past 15 years, tenecteplase is currently being studied in several phase 3 trials. Based on a systematic literature search, we provide a qualitative synthesis of published stroke clinical trials of tenecteplase that (1) performed randomized comparisons with alteplase, (2) compared different doses of tenecteplase, or (3) provided unique quantitative meta-analyses. Four phase 2 and one phase 3 study performed randomized comparisons with alteplase. These and other phase 2 studies compared different tenecteplase doses and effects on early outcomes of recanalization, reperfusion, and substantial neurological improvement, as well as symptomatic intracranial hemorrhage and 3-month disability on the modified Rankin Scale. Although no single trial prospectively demonstrated superiority or noninferiority of tenecteplase on clinical outcome, meta-analyses of these trials (1585 patients randomized) point to tenecteplase superiority in recanalization of large vessel occlusions and noninferiority in disability-free 3-month outcome, without increases in symptomatic intracranial hemorrhage or mortality. Doses of 0.25 and 0.4 mg/kg have been tested, but no advantage of the higher dose has been suggested by the results. Current clinical practice guidelines for stroke include intravenous tenecteplase at either dose as a second-tier option, with the 0.25 mg/kg dose recommended for large vessel occlusions, based on a phase 2 trial that demonstrated superior recanalization and improved 3-month outcome relative to alteplase. Ongoing randomized phase 3 trials may better define the comparative risks and benefits of tenecteplase and alteplase for stroke thrombolysis and answer questions of tenecteplase efficacy in the >4.5-hour time window, in wake-up stroke, and in combination with endovascular thrombectomy.
| S-EPMC7606819 | biostudies-literature
Project description:Background: Thrombolysis with r-tPA is recommended for patients after acute ischemic stroke (AIS) within 4.5 h of symptom onset. However, only a few patients benefit from this therapeutic regimen. Thus, we aimed to develop an interpretable machine learning (ML)-based model to predict the thrombolysis effect of r-tPA at the super-early stage. Methods: A total of 353 patients with AIS were divided into training and test data sets. We then used six ML algorithms and a recursive feature elimination (RFE) method to explore the relationship among the clinical variables along with the NIH stroke scale score 1 h after thrombolysis treatment. Shapley additive explanations and local interpretable model-agnostic explanation algorithms were applied to interpret the ML models and determine the importance of the selected features. Results: Altogether, 353 patients with an average age of 63.0 (56.0-71.0) years were enrolled in the study. Of these patients, 156 showed a favorable thrombolysis effect and 197 showed an unfavorable effect. A total of 14 variables were enrolled in the modeling, and 6 ML algorithms were used to predict the thrombolysis effect. After RFE screening, seven variables under the gradient boosting decision tree (GBDT) model (area under the curve = 0.81, specificity = 0.61, sensitivity = 0.9, and F1 score = 0.79) demonstrated the best performance. Of the seven variables, activated partial thromboplastin clotting time (time), B-type natriuretic peptide, and fibrin degradation products were the three most important clinical characteristics that might influence r-tPA efficiency. Conclusion: This study demonstrated that the GBDT model with the seven variables could better predict the early thrombolysis effect of r-tPA.
| S-EPMC8762247 | biostudies-literature
Project description:Background and purposeTimely intravenous (IV) thrombolysis for acute ischemic stroke is associated with better clinical outcomes. Acute stroke care implemented with "Stroke Code" (SC) may increase IV tissue plasminogen activator (tPA) administration. The present study aimed to investigate the impact of SC on thrombolysis.MethodsThe study period was divided into the "pre-SC era" (January 2006 to July 2010) and "SC era" (August 2010 to July 2013). Demographics, critical times (stroke symptom onset, presentation to the emergency department, neuroimaging, thrombolysis), stroke severity, and clinical outcomes were recorded and compared between the two eras.ResultsDuring the study period, 5957 patients with acute ischemic stroke were admitted; of these, 1301 (21.8%) arrived at the emergency department within 3 h of stroke onset and 307 (5.2%) received IV-tPA. The number and frequency of IV-tPA treatments for patients with an onset-to-door time of <3 h increased from the pre-SC era (n?=?91, 13.9%) to the SC era (n?=?216, 33.3%) (P<0.001). SC also improved the efficiency of IV-tPA administration; the median door-to-needle time decreased (88 to 51 min, P<0.001) and the percentage of door-to-needle times ?60 min increased (14.3% to 71.3%, P<0.001). The SC era group tended to have more patients with good outcome (modified Rankin Scale ?2) at discharge (49.5 vs. 39.6%, P?=?0.11), with no difference in symptomatic hemorrhage events or in-hospital mortality.ConclusionThe SC protocol increases the percentage of acute ischemic stroke patients receiving IV-tPA and decreases door-to-needle time.
| S-EPMC4128738 | biostudies-literature
Project description:ObjectiveThe objective of this study was to investigate the safety and efficacy of remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT) in the treatment of acute ischemic stroke (AIS).MethodsPatients with AIS who underwent IVT were enrolled and 1:1 randomized to the RIC group and sham-RIC group in this study. RIC (or sham-RIC) was performed twice within 6-24 h of IVT. The subjects in the two groups were followed up for 90 days. The safety outcome included the ratio of hemorrhagic transformation (HT), adverse events during the follow-up, blood pressure within the first 24 h after IVT, and laboratory tests 24 h after IVT. The efficacy outcome included the modified Rankin Scale (mRS) score, National Institute of Health Stroke Scale (NIHSS) score during the follow-up, and level of high-sensitivity C-reactive protein (hs-CRP) tested 24 h after IVT.ResultsForty-nine patients (24 in the RIC group and 25 in the sham-RIC group) were recruited. No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups. In addition, there was no significant difference in mRS score and NIHSS score during the follow-up between groups. However, patients in the RIC group exhibited a significant lower level of hs-CRP compared with the control group (P = 0.048).InterpretationRIC combined with IVT is safe in the treatment of AIS. The neuroprotective and anti-inflammatory effects of this therapy warrant further study on a larger scale.
| S-EPMC7318096 | biostudies-literature
Project description:The initial therapeutic approach to acute ischemic stroke consists of thrombolytic therapy and early initiation of supportive care, usually commenced prior to the determination of the underlying stroke etiology. Varying stroke mechanisms may call for specific, etiology-based treatment. The majority of strokes result from cardioembolism, large-vessel atherothromboembolism, and small-vessel occlusive disease. There are scant data to support the use of acute anticoagulation therapy over anti-platelet therapy in cardioembolic stroke and large-vessel atherosclerosis, although it may be reasonable in a certain subset of patients. However, augmentation of blood flow with early surgery, stenting, or induced hypertension, may play a role in patients with large artery stenosis. The less commonly identified stroke mechanisms may warrant special consideration in treatment. Controversy remains regarding the optimal anti-thrombotic treatment of arterial dissection. Reversible cerebral vasoconstriction syndrome may benefit from therapy with calcium channel blockers, high-dose steroids, or magnesium, although spontaneous recovery may occur. Inflammatory vasculopathies, such as isolated angiitis of the central nervous system and temporal arteritis, require prompt diagnosis as the mainstay of therapy is immunosuppression. Cerebral venous thrombosis is a rare cause of stroke, but one that needs early identification and treatment with anticoagulation. Rapid determination of stroke mechanism is essential for making these critical early treatment decisions.
| S-EPMC3250267 | biostudies-literature
Project description:ObjectivesThis study examined the neurologists' perspective toward intravenous thrombolysis for the treatment of acute ischemic stroke and the influencing factors in a Chinese Province.MethodsA cross-sectional study was conducted from 1 October 2014 to 31 January 2015. A total of 719 neurologists from 66 hospitals in Hubei Province were included. A questionnaire was designed, and multivariable logistic regression models were used to identify the factors associated with the neurologists' perspective toward intravenous thrombolysis.ResultsAmong the responding neurologists, 67.3% reported using intravenous thrombolysis and 32.9% believed the treatment was unsafe. Approximately 51.4% reported deficits in their knowledge of intravenous thrombolysis and 45.8% felt unconfident about their ability to employ the treatment. The majority (90.1%) supported hospitals in performing intravenous thrombolysis for eligible patients. Their safety concern was associated with hospital grade (odds ratio[OR] = 2.3; 95% confidence interval [CI], 1.4-3.7) and previous experiences with thrombolysis (OR = 3.1; 95% CI, 2.1-4.6). Their confidence was associated with their educational background (OR = 2.5; 95% CI, 1.3-4.5), knowledge mastery (OR = 10.4; 95% CI, 6.6-16.3), and previous experiences with thrombolysis (OR = 3.3; 95% CI, 2.1-5.3). Their attitudes were associated with gender (OR = 0.6; 95% CI, 0.3-1.0) and previous experiences with thrombolysis (OR = 4.9; 95% CI, 2.5-9.4).ConclusionsMost neurologists in Hubei Province, China, identified with intravenous thrombolysis for the treatment of acute ischemic stroke. However, they were weak in knowledge and lack confidence. Therefore, training, especially practical training, is needed to promote the use of thrombolysis in the region.
| S-EPMC5853636 | biostudies-literature
Project description:It is uncertain whether previous ischemic stroke within 3 months of receiving intravenous thrombolysis (tPA [tissue-type plasminogen activator]) for acute ischemic stroke (AIS) is associated with an increased risk of adverse outcomes.Using administrative claims data, we identified adults with AIS who received intravenous tPA at California, New York, and Florida hospitals from 2005 to 2013. Our primary outcome was intracerebral hemorrhage, and our secondary outcomes were unfavorable discharge disposition and inpatient mortality. We used logistic regression to compare rates of outcomes in patients with and without previous ischemic stroke within 3 months of intravenous tPA for AIS.We identified 36 599 AIS patients treated with intravenous tPA, of whom 568 (1.6%) had a previous ischemic stroke in the past 3 months. Of all patients who received intravenous tPA, the rate of intracerebral hemorrhage was 4.9% (95% confidence interval [CI], 4.7%-5.1%), and death occurred in 10.7% (95% CI, 10.4%-11.0%). After adjusting for demographics, vascular risk factors, and the Elixhauser Comorbidity Index, previous ischemic stroke within 3 months of thrombolysis for AIS was not associated with an increased risk of intracerebral hemorrhage (odds ratio, 0.9; 95% CI, 0.6-1.4; P=0.62), but was associated with an increased risk of death (odds ratio, 1.5; 95% CI, 1.2-1.9; P=0.001) and unfavorable discharge disposition (odds ratio, 1.3; 95% CI, 1.0-1.7; P=0.04).Among patients who receive intravenous tPA for AIS, recent ischemic stroke is not associated with an increased risk of intracerebral hemorrhage but is associated with a higher risk of death and unfavorable discharge disposition.
| S-EPMC5663184 | biostudies-literature
Project description:ObjectiveWe sought to determine the safety of IV thrombolysis (IVT) in acute ischemic stroke (AIS) patients harboring unruptured intracranial aneurysm (UIA) in a multicenter study and a comprehensive meta-analysis of available case series.MethodsWe analyzed prospectively collected data from consecutive AIS patients treated with IVT during a 4-year period at 4 tertiary-care stroke centers. All patients routinely underwent CT or magnetic resonance angiography during hospitalization. The presence of UIA was documented on the basis of neuroradiology reports. Symptomatic intracranial hemorrhage (sICH) was defined as imaging evidence of ICH combined with an increase in NIH Stroke Scale score of ?4 points. A systematic meta-analysis of case series reporting safety of IVT in AIS with concomitant UIA was conducted according to PRISMA recommendations.ResultsAmong 1,398 AIS patients treated with IVT, we identified 42 cases (3.0%) harboring a total of 48 UIAs. The rates of symptomatic and asymptomatic ICH were 2.4% (95% confidence interval [CI] by adjusted Wald method: 0%-12.6%) and 7.1% (95% CI: 1.8%-19.7%), respectively. A total of 5 case series met our inclusion criteria for meta-analysis, and the pooled rate of sICH among 120 IVT-treated AIS patients harboring UIA was 6.7% (95% CI: 3.1%-13.7%). In the overall analysis of 5 case-series studies, the risk ratio of sICH did not differ between AIS patients with and without UIA (risk ratio = 1.60; 95% CI: 0.54-4.77; p = 0.40) with no evidence of heterogeneity across included studies (I(2) = 22% and p = 0.27 for Cochran Q test).ConclusionsOur prospectively collected multicenter data, coupled with the findings of the meta-analysis, indicate the potential safety of IVT in AIS patients with UIA.
| S-EPMC4631074 | biostudies-literature
Project description:BackgroundThrombolysis for acute ischemic stroke has remained controversial. The Canadian Alteplase for Stroke Effectiveness Study, a national prospective cohort study, was conducted to assess the effectiveness of alteplase therapy for ischemic stroke in actual practice.MethodsThe study was mandated by the federal government as a condition of licensure of alteplase for the treatment of stroke in Canada. A registry was established to collect data over 2.5 years for stroke patients receiving such treatment from Feb. 17, 1999, through June 30, 2001. All centres capable of administering thrombolysis therapy according to Canadian guidelines were eligible to submit patient data to the registry. Data collection was prospective, and follow-up was completed at 90 days after stroke. Copies of head CT scans obtained at baseline and at 24-48 hours after the start of treatment were submitted to a central panel for review.ResultsA total of 1135 patients were enrolled at 60 centres in all major hospitals across Canada. The registry collected data for an estimated 84% of all treated ischemic stroke patients in the country. An excellent clinical outcome was observed in 37% of the patients. Symptomatic intracranial hemorrhage occurred in only 4.6% of the patients (95% confidence interval [CI] 3.4%-6.0%); however, 75% of these patients died in hospital. An additional 1.3% (95% CI 0.7%-2.2%) of patients had hemiorolingual angioedema.ConclusionsThe outcomes of stroke patients undergoing thrombolysis in Canada are commensurate with the results of clinical trials. The rate of symptomatic intracranial hemorrhage was low. Stroke thrombolysis is a safe and effective therapy in actual practice.
| S-EPMC557101 | biostudies-literature
Project description:Background and Purpose: The association between stress hyperglycemia and clinical outcomes in patients with acute ischemic stroke treated with intravenous thrombolysis (IVT) is uncertain. We sought to analyze the association between the stress hyperglycemia ratio (SHR) using different definitions and clinical outcomes in acute patients with ischemic stroke undergoing IVT. Methods: A total of 341 patients with ischemic stroke receiving IVT were prospectively enrolled in this study. The SHR was evaluated using different equations: SHR1, fasting glucose (mmol/L)/glycated hemoglobin (HbA1c) (%); SHR2, fasting glucose (mmol/L)/[(1.59 × HbA1c)-2.59]; SHR3, admission blood glucose (mmol/L)/[(1.59 × HbA1c)-2.59]. A poor functional outcome was defined as a modified Rankin scale score of 3-6 at 3 months. Multivariate logistic regression analysis was used to identify the relationship between different SHRs and clinical outcomes after IVT. Results: A total of 127 (37.2%) patients presented with poor functional outcomes at 3 months. The predictive value of SHR1 for poor functional outcomes was better than that of SHR2 and SHR3 in receiver operating characteristic analyses. On multivariate analysis, SHR1 [odds ratio (OR) 14.639, 95% CI, 4.075-52.589; P = 0.000] and SHR2 (OR, 19.700; 95% CI; 4.475-86.722; P = 0.000) were independently associated with an increased risk of poor functional outcome but not SHR3. Conclusions: Our study confirmed that the SHR, as measured by SHR1 and SHR2, is independently associated with worse clinical outcomes in patients with ischemic stroke after intravenous thrombolysis. Furthermore, SHR1 has a better predictive performance for outcomes than other SHR definitions.
| S-EPMC8793935 | biostudies-literature