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1.
Am J Emerg Med ; 86: 78-82, 2024 Oct 02.
Artículo en Inglés | MEDLINE | ID: mdl-39383769

RESUMEN

INTRODUCTION: Intravenous thrombolysis remains the primary treatment for acute ischemic stroke (AIS); however, administration is time sensitive. Teleneurology services have increased in popularity in recent years due to their ability to aid in triaging patients with neurological conditions. Teleneurology services were implemented at this comprehensive stroke center, in August 2023 to aid in streamlining the administration of tenecteplase in AIS patients. Currently, there are no studies assessing whether the implementation of teleneurology services at a comprehensive stroke center influences tenecteplase door-to-needle time. The purpose of this study is to evaluate the difference in door-to-needle times when tenecteplase is administered with versus without a teleneurology consult. METHODS: This was an institutional review board approved, retrospective cohort study conducted at a single comprehensive stroke center. Adult patients who presented to the emergency department between January 1st, 2022 and April 1st, 2023 were included if they received tenecteplase for the treatment of AIS. The primary outcome was door-to-needle time, defined as the moment the patient first enters the door of the emergency department to the moment the IV bolus of fibrinolytic is administered. Secondary outcomes included the proportion of patients with door-to-needle time within 45 min, neurological improvement at 24 h and discharge, and rate of hemorrhagic conversion. RESULTS: A total of 93 patients were included with 43 patients in the pre-teleneurology group and 50 patients in the post-teleneurology group. Baseline characteristics were comparable between both treatment groups. The median door-to-needle time was significantly reduced in the post-teleneurology group (49 minutes [IQR, 40.0-70.0] preintervention vs. 34.5 minutes [IQR, 23.8-43.0] postintervention, p < 0.01). For secondary outcomes, the post-teleneurology group had more patients with a door-to-needle time within 45 minutes (44.2% vs. 80.0%, p < 0.01). There was no significant difference in early neurological improvement (58.1% vs. 54.0%), neurological improvement at discharge (60.5% vs. 62.0%), or hemorrhagic conversion (7.0% vs. 12.0%). CONCLUSION: Among patients who received tenecteplase for the treatment of AIS, there was a significant reduction in door-to-needle time with the use of teleneurology services. There was no difference in neurological improvement or rate of hemorrhagic conversion.

3.
J Am Heart Assoc ; : e036393, 2024 Oct 11.
Artículo en Inglés | MEDLINE | ID: mdl-39392168

RESUMEN

BACKGROUND: The aim of this study was to investigate the efficacy and safety of tenecteplase versus alteplase in patients with acute ischemic stroke, considering their diabetes history and admission hyperglycemia status. METHODS AND RESULTS: This was a post hoc analysis of the TRACE-2 (Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-2) randomized clinical trial that enrolled patients in China between June 2021 and May 2022. Eligible patients with acute ischemic stroke for standard intravenous thrombolysis, but ineligible for endovascular thrombectomy, were randomly assigned (1:1) to tenecteplase or alteplase within 4.5 hours of symptom onset. Admission hyperglycemia was defined as plasma glucose >7.8 mmol/L. The primary efficacy and safety outcome were excellent functional outcome at 90 days (modified Rankin Scale score of 0-1) and symptomatic intracranial hemorrhage within 36 hours, respectively. The Cochran-Mantel-Haenszel χ2 test was used for the outcomes. Of the 1382 patients included, 369 (26.7%) had a history of diabetes, and 482 (34.9%) experienced admission hyperglycemia. The primary efficacy outcome, comparing tenecteplase to alteplase, was achieved in 93 (56.7%) versus 97 (48.3%) among patients with a history of diabetes (P=0.11) and 335 (64.6%) versus 300 (62.2%) among those without diabetes (P=0.45), respectively. The primary efficacy outcome for tenecteplase versus alteplase was comparable among patients with and without admission hyperglycemia (57.5% versus 53.9%, P = 0.44; 65.4% versus 60.4%, P=0.12, respectively). No significant difference in the risk of symptomatic intracranial hemorrhage within 36 hours was observed between tenecteplase and alteplase, regardless of diabetes history or admission hyperglycemia. CONCLUSIONS: This study demonstrated that intravenous tenecteplase exhibits similar clinical outcomes compared with alteplase, irrespective of the patient's glucose metabolism status. REGISTRATION: URL: https://clinicaltrials.gov; Unique identifier: NCT04797013.

4.
Heliyon ; 10(18): e37660, 2024 Sep 30.
Artículo en Inglés | MEDLINE | ID: mdl-39309924

RESUMEN

Intravenous thrombolysis is an effective treatment for acute ischemic stroke. The ESO recommends that tenecteplase be used for thrombolytic therapy in stroke within 4.5h of onset. However, there are few reports on the complications of intravenous thrombolysis with tenecteplase in stroke, and spinal hematomas are rare. Herein, we report the first case of spinal subdural hematoma secondary to tenecteplase treatment for stroke. A 71-year-old male patient arrived at the stroke center because of left limb weakness that had persisted for 105 min. After intravenous thrombolysis with tenecteplase, the patient experienced unbearable pain in the neck and left shoulder, progressive limb weakness, and sensory disturbance. MRI revealed a spinal subdural hematoma of the cervical vertebrae, and the prognosis was poor after surgical treatment. Once patients develop pain around the spine with intravenous thrombolysis, physicians should be aware of the possibility of a spinal subdural hematoma and promptly perform MRI.

5.
Cerebrovasc Dis Extra ; 14(1): 134-140, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39226883

RESUMEN

INTRODUCTION: Tenecteplase is a thrombolytic with higher fibrin affinity and is potentially better in clot lysis. A higher spontaneous recanalisation rate for large vessel occlusion (LVO) strokes had been shown in comparison studies with alteplase. Results of the LVO studies reflect the composite effect of the thrombolytic and thrombectomy, as patients would be treated by thrombectomy had they not been recanalised by intravenous thrombolysis alone. Thrombectomy is not readily available in many parts of the world. Our study aimed to compare the outcomes of suspected LVO patients treated with tenecteplase versus alteplase only, without the confounding effect of thrombectomy. METHODS: This is a retrospective review. Data of patients given tenecteplase from May 2020 to August 2023 and those given alteplase 0.9 mg/kg from January 2019 to August 2023 were retrieved. Due to fluctuation in supply of tenecteplase during the COVID pandemic, some LVO patients were given alteplase. Patients with anterior circulation, clinically suspected LVO strokes (defined as National Institutes of Health Stroke Scale (NIHSS) score ≥6, plus cortical signs or hyperdense vessel sign), with thrombolysis given within 4.5 h of stroke onset were analysed. Patients with thrombectomy done were excluded. Safety and efficacy outcomes were compared. RESULTS: There were 245 tenecteplase-treated patients treated between May 1, 2020, and August 31, 2023, and 732 patients were treated with alteplase between January 1, 2019, to August 31, 2023. Out of these, 148 tenecteplase patients and 138 alteplase 0.9 mg/kg patients fulfilled the study criteria. The symptomatic intracerebral haemorrhage rate was non-significantly lower in the tenecteplase group (2.1% vs. 5.8%, p = 0.13). There were no significant differences in the rate of ≥8-point NIHSS improvement (23.6% vs. 23.7%, p = 1) or the ≥4-point improvement (40.5% vs. 40.7%, p = 1) at 24 h. At 3 months, 21.6% of tenecteplase patients had good functional outcome (modified Rankin scale [mRS] 0-2), compared to 26.3% in the alteplase group (p = 0.40). CONCLUSION: In this pragmatic study of clinically suspected anterior circulation LVO patients without thrombectomy, outcome solely reflects the effects of tenecteplase. Tenecteplase showed comparable safety and efficacy to alteplase, but the result should be interpreted with caution in view of its small sample size and non-randomised study design.


Asunto(s)
Fibrinolíticos , Accidente Cerebrovascular Isquémico , Tenecteplasa , Terapia Trombolítica , Activador de Tejido Plasminógeno , Humanos , Tenecteplasa/administración & dosificación , Tenecteplasa/efectos adversos , Fibrinolíticos/administración & dosificación , Fibrinolíticos/efectos adversos , Estudios Retrospectivos , Masculino , Femenino , Anciano , Resultado del Tratamiento , Persona de Mediana Edad , Accidente Cerebrovascular Isquémico/tratamiento farmacológico , Accidente Cerebrovascular Isquémico/diagnóstico , Terapia Trombolítica/efectos adversos , Activador de Tejido Plasminógeno/administración & dosificación , Activador de Tejido Plasminógeno/efectos adversos , Factores de Tiempo , Anciano de 80 o más Años , Recuperación de la Función , Evaluación de la Discapacidad , Trombectomía/efectos adversos
7.
Eur Stroke J ; : 23969873241286983, 2024 Sep 30.
Artículo en Inglés | MEDLINE | ID: mdl-39345180

RESUMEN

RATIONALE: Adjunct intra-arterial alteplase has been shown to potentially improve clinical outcomes in patients with large vessel occlusion (LVO) stroke who have undergone successful endovascular thrombectomy. Tenecteplase, known for its enhanced fibrin specificity and extended activity duration, could potentially enhance outcomes in stroke patients after successful reperfusion when used as an adjunct intra-arterial therapy. AIM: To explore the safety and efficacy of intra-arterial tenecteplase after successful endovascular thrombectomy in patients with LVO stroke. SAMPLE SIZE: To randomize 498 participants 1:1 to receive intra-arterial tenecteplase or no intra-arterial adjunctive thrombolysis therapy. METHODS AND DESIGN: An investigator-initiated, prospective, randomized, open-label, blind-endpoint multicenter clinical trial. Eligible patients with anterior circulation LVO stroke presenting within 24 h from symptom onset (time last known well) and excellent to complete reperfusion (expanded Thrombolysis In Cerebral Infarction (eTICI) scale 2c-3) at endovascular thrombectomy are planned to be randomized. OUTCOMES: The primary outcome is freedom from disability (modified Rankin Scale, mRS, of 0-1) at 90 days. The primary safety outcomes are mortality through 90 days and symptomatic intracranial hemorrhage within 48 h. DISCUSSION: The POST-TNK trial will evaluate the efficacy and safety of intra-arterial tenecteplase in patients with LVO stroke and excellent to complete reperfusion.

8.
J Neurol ; 2024 Sep 23.
Artículo en Inglés | MEDLINE | ID: mdl-39312003

RESUMEN

INTRODUCTION: Intravenous thrombolysis (IVT) with alteplase (TPA) in hyperglycemic stroke patients is associated with an increased risk of symptomatic intracranial hemorrhage (sICH) and poor functional outcomes. We aimed to explore the association between admission hyperglycemia and sICH in large vessel occlusion stroke (LVOS) patients treated with TNK versus TPA before endovascular thrombectomy (EVT). METHODS: We reviewed consecutive LVOS patients treated with TPA or TNK before EVT from 01/2020 to 06/2023. EVT was performed across five comprehensive stroke centers (CSCs) in Pennsylvania. Of 569 patients, 462 met inclusion criteria: LVOS, pre-stroke modified Rankin Scale (mRS) 0-2, and last-known-well to IVT (LKW-to-IVT) ≤ 4.5 h. The rates of sICH and parenchymal hematomas (PHs) between TPA and TNK cohorts were assessed. RESULTS: Of 462 patients, 254 (55%) received TNK, and 208 (45%) received TPA. Admission hyperglycemia (≥ 140 mg/dl) was present in 153 (33.1%) patients. Hyperglycemic patients were more frequently diabetic (p < 0.001). Admission hyperglycemia was associated with a significantly increased rate of sICH (5.9% versus 1.6%, p = 0.019) and PH (20.3% versus 11.3%, p = 0.010). Hyperglycemic patients had a significantly higher degree of overall disability as compared to normoglycemic patients (90d-mRS shift aOR 0.611, p = 0.007). Comparable rates of sICH and PH were observed in the hyperglycemic and normoglycemic cohorts among both TNK and TPA groups. CONCLUSION: In LVOS patients receiving IVT before EVT, admission hyperglycemia significantly increased the risk of sICH and PH and was associated with worse outcomes at 90 days. No differences in sICH or PH were observed between TNK and TPA groups.

9.
Cureus ; 16(8): e67392, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-39310476

RESUMEN

The coronavirus 2019 (COVID-19) pandemic has brought renewed attention to thrombotic complications arising from respiratory viral infections, driven by inflammatory responses and activation of the coagulation cascade. While influenza typically resolves on its own, information about its thromboembolic risks remains limited. The persistence of symptoms and the similarity between influenza symptoms and those of pulmonary embolism (PE) often lead to diagnostic delays, which can significantly impact patient outcomes. We discuss a case of a 62-year-old woman with a history of hypertension and hyperlipidemia who presented with dyspnea, syncope, and persistent symptoms following influenza A infection. Despite initial treatment with Tamiflu and subsequent antibiotics for presumed pneumonia, her condition worsened, leading to syncope and admission to the hospital. A diagnostic workup revealed saddle pulmonary emboli with right ventricular strain. She was treated with a half-dose of tenecteplase, resulting in significant clinical improvement and a notable reduction in thrombus burden on follow-up imaging. The thromboembolic complications of influenza A are not extensively documented compared to COVID-19, yet they can present with severe outcomes. Submassive PE, characterized by hemodynamic stability with signs of right ventricular strain, poses treatment challenges. While full-dose thrombolytics are generally avoided in intermediate-risk PE due to bleeding risks, half-dose thrombolytics such as tenecteplase can offer a safer alternative. Though not FDA-approved specifically for PE, tenecteplase has shown efficacy and was effectively used in this case. Half-dose thrombolytics, including tenecteplase, may be a viable treatment option for certain cases of PE, offering a balance between efficacy and safety. This case highlights the importance of considering PE in patients with persistent respiratory symptoms post-influenza and demonstrates the potential of tenecteplase in managing submassive PE.

10.
J Stroke Cerebrovasc Dis ; 33(11): 107985, 2024 Aug 31.
Artículo en Inglés | MEDLINE | ID: mdl-39222700

RESUMEN

OBJECTIVES: There are limited data available demonstrating the safety and efficacy of intravenous tenecteplase versus alteplase in patients with acute ischemic stroke in the posterior circulation. MATERIALS AND METHODS: This is a post-hoc analysis of the Alteplase compared to Tenecteplase (AcT) pragmatic, phase 3, registry-linked randomized controlled trial. Patients with any posterior circulation vessel occlusion on baseline imaging were included. Study outcomes included 90-day modified Rankin Scale (mRS) 0-1, mRS 0-2, ordinal mRS, death within 90 days, 24 h symptomatic intracerebral haemorrhage (sICH) and successful reperfusion/recanalization. Mixed effects regression adjusting for age, sex and stroke severity was used to analyze differences in outcomes between patients administered tenecteplase vs. alteplase. Further, sensitivity analysis was conducted for basilar artery occlusion (BAO) alone. RESULTS: Of 1577 patients, 136 (8.6 %, 77:alteplase, 59:tenecteplase) had posterior circulation stroke. Baseline characteristics were similar[median age 71 (IQR 60-81) vs. 72 (IQR 65-82) years, 57.1 % vs. 67.8 % males, median baseline NIHSS 7 (IQR 4-12) vs. 7 (IQR 4-16) in alteplase vs. tenecteplase arms, respectively]. 28 patients (20.6 %, 16:alteplase, 12:tenecteplase arm) underwent EVT. The median 90-120 days mRS was 2 (IQR 1-4). There were no differences between alteplase and tenecteplase for 90-d mRS 0-1 (adjRR 0.93;95 %CI 0.63-1.36), 90-day mRS 0-2 (adjRR 0.95; 95 %CI 0.72-1.26), sICH (RR 0.65; 95 %CI 0.06-7.02) and mortality (RR 1.21; 95 %CI 0.61-2.38). Successful reperfusion eTICI 2b-3 and successful recanalization rAOL 2b-3 was achieved in 23/28 (82 %, 12:alteplase, 11:tenecteplase) and in 16/28 (57 %, 14:alteplase, 12:tenecteplase), respectively. Similar results were seen in 31 patients (22.8 %) with BAO. CONCLUSION: Intravenous tenecteplase has a similar effect on outcome as alteplase, without increased safety concerns in patients with acute posterior circulation strokes.

11.
Cureus ; 16(8): e67186, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-39295695

RESUMEN

We report a case of a 51-year-old female who presented to the emergency department with stroke symptoms within the time window for intravenous (IV) thrombolytic therapy. Her initial CT head imaging showed no evidence of acute changes and her CT perfusion demonstrated an area of ischemia in the left parieto-occipital region. While she had no absolute contraindications for IV tenecteplase (TNK), she was actively menstruating at the time, which could represent a relative contraindication due to increased bleeding risk from a site that would not be easily compressible. She elected to receive TNK and did not experience any adverse events after treatment was administered. At her follow-up clinic visit, her neurological deficits were completely resolved. In the context of increasingly widespread usage of TNK, this case report highlights an uncommon but important consideration when treating acute ischemic strokes with IV thrombolytic in the female population. While no definitive conclusions should be drawn from this case, it would hopefully encourage the continued usage of TNK in menstruating females who present with stroke symptoms within the therapeutic window and with no other contraindications.

12.
J Emerg Med ; 67(5): e432-e441, 2024 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-39237444

RESUMEN

BACKGROUND: Pulmonary embolism (PE) leads to many emergency department visits annually. Thrombolytic agents, such as alteplase, are currently recommended for massive PE, but genetically modified tenecteplase (TNK) presents advantages. Limited comparative studies exist between TNK and alteplase in PE treatment. OBJECTIVE: The aim of this study was to assess the safety and mortality of TNK compared with alteplase in patients with PE using real-world evidence obtained from a large multicenter registry. Primary outcomes included mortality, intracranial hemorrhage, and blood transfusions. METHODS: This retrospective cohort study used the TriNetX Global Health Research Network. Patients aged 18 years or older with a PE diagnosis (International Classification of Diseases, 10th Revision, Clinical Modification code I26) were included. The following two cohorts were defined: TNK-treated (29 organizations, 266 cases) and alteplase-treated (22,864 cases). Propensity matching controlled for demographic characteristics, anticoagulant use, pre-existing conditions, and vital sign abnormalities associated with PE severity. Patients received TNK or alteplase within 7 days of diagnosis and outcomes were measured at 30 days post thrombolysis. RESULTS: Two hundred eighty-three patients in each cohort were comparable in demographic characteristics and pre-existing conditions. Mortality rates at 30 days post thrombolysis were similar between TNK and alteplase cohorts (19.4% vs 19.8%; risk ratio 0.982; 95% CI 0.704-1.371). Rates of intracerebral hemorrhages and transfusion were too infrequent to analyze. CONCLUSIONS: This study found TNK to exhibit a similar mortality rate to alteplase in the treatment of PE with hemodynamic instability. The results necessitate prospective evaluation. Given the cost-effectiveness and ease of administration of TNK, these findings contribute to the ongoing discussion about its adoption as a primary thrombolytic agent for stroke and PE.


Asunto(s)
Fibrinolíticos , Embolia Pulmonar , Tenecteplasa , Activador de Tejido Plasminógeno , Humanos , Tenecteplasa/uso terapéutico , Embolia Pulmonar/tratamiento farmacológico , Embolia Pulmonar/mortalidad , Femenino , Masculino , Activador de Tejido Plasminógeno/uso terapéutico , Estudios Retrospectivos , Fibrinolíticos/uso terapéutico , Fibrinolíticos/farmacología , Persona de Mediana Edad , Anciano , Resultado del Tratamiento , Estudios de Cohortes , Puntaje de Propensión , Sistema de Registros/estadística & datos numéricos , Adulto , Anciano de 80 o más Años
13.
Clin Ther ; 2024 Sep 11.
Artículo en Inglés | MEDLINE | ID: mdl-39266330

RESUMEN

PURPOSE: Acute ischemic stroke (AIS) is a life-threatening condition demanding prompt reperfusion to salvage brain tissue. Thrombolytic drugs, like tenecteplase (TNK), offer clot dissolution, but time constraints and contraindications limit their use. Mechanical thrombectomy (MT) revolutionized AIS treatment, especially for large vessel occlusions (LVO). Recent evidence suggests that administering TNK before MT improves recanalization and outcomes, challenging the dominance of alteplase. METHODS: Relevant articles focusing on TNK before MT were retrieved from PubMed, Scopus, and Web of Science, looking for randomized controlled trials (RCT), clinical trials, and meta-analyses in humans until 2024. FINDINGS: TNK, a genetically engineered thrombolytic, exhibits superior fibrin specificity and a longer half-life than alteplase. Clinical trials comparing TNK and alteplase before MT showcase enhanced recanalization, functional outcomes, and safety with TNK. Advanced neuroimaging aids patient selection, though its cost-effectiveness warrants consideration. Dosing studies favor a 0.25 mg/kg dose for efficacy and reduced complications. Clinical guidelines from various associations acknowledge TNK's potential as an alteplase alternative for AIS treatment, particularly for LVOs eligible for thrombectomy. IMPLICATIONS: In conclusion, TNK emerges as a promising option for bridging therapy in AIS, displaying efficacy and safety benefits, especially when administered before MT. Its fibrin specificity, longer half-life, and potential for improved outcomes position TNK as a viable alternative to alteplase, potentially transforming the landscape of AIS treatment strategies. While limitations like small sample sizes and variations in protocols exist, future research should focus on large-scale RCT, subgroup analyses, and cost-effectiveness evaluations to further elucidate TNK's role in optimizing AIS management.

14.
Mol Oncol ; 2024 Sep 05.
Artículo en Inglés | MEDLINE | ID: mdl-39234921

RESUMEN

In this paper, we have modified the workflow of the traditional light transmission aggregometry (LTA) protocol to characterize tumor cell clusters in vitro in a quantifiable and multifaceted manner. Circulating tumor cell (CTC) clusters have high metastatic potential compared to single tumor cells traveling in the bloodstream. Thus, engineering new therapeutic strategies that specifically target this CTC population is essential. To accomplish this, quantifiable methods to characterize their therapeutic effect on tumor cell clusters is a prerequisite. The method presented here enables the user to precisely quantify the dissociation of cancer cell clusters in the presence of clinically relevant fibrinolytic agents, such as alteplase and tenecteplase. The efficacy of the fibrinolytic agents can be quantified using this in vitro assay, prior to conducting preclinical studies. Here, we have obtained the fibrinolytic activity data in terms of lag time to the initiation of tumor cell dissociation, time to 25% dissociation, and trend of dissociation over time. To validate the assay, cell counts and phase-contrast microscopy images were recorded over time. Further, we explored an LTA-assisted preparation of platelet-tumor-cell clusters of calibrated size for potential downstream testing/applications. To assess whether the assay is applicable to characterize the dissociation of cancer cell clusters in the presence of platelets, we added low (50 000 platelets·µL-1), normal (200 000 platelets·µL-1) and high (450 000 platelets·µL-1) concentrations of platelets to the tumor cell clusters. In addition to dissociation parameters, microcopy images were recorded over time to validate the assay and enabled the enumeration of clusters and single cells. The correlative light electron microscopy (CLEM) technique was utilized to visualize the morphology and composition of platelet-tumor cell clusters.

15.
J Stroke Cerebrovasc Dis ; 33(11): 107931, 2024 Aug 13.
Artículo en Inglés | MEDLINE | ID: mdl-39147079

RESUMEN

INTRODUCTION: Previously published data are conflicting regarding the ability of tenecteplase versus alteplase to produce early recanalization of an intracranial large vessel occlusion. We compared the performance of each thrombolytic in a stroke network. METHODS: We queried our prospectively collected code stroke registry for basilar, internal carotid, or proximal middle cerebral artery occlusion patients treated with intravenous thrombolysis from 11/17/2021-9/16/2023. The primary outcome was early recanalization, defined using angiographic or clinical criteria. Secondary and safety outcomes included 90-day functional independence and symptomatic intracranial hemorrhage. A multivariable regression analysis was performed to determine independent associations with the primary outcome. RESULTS: 233 patients, with mean age 66.9 (16.6) years and median National Institutes of Health Stroke Scale score 15 (10-21), were included. One-hundred twenty-four of 233 (53.2 %) patients were treated with alteplase while 109/233 (46.8 %) were treated with tenecteplase. Endovascular thrombectomy was performed in 82 % of subjects. Early recanalization rates were similar between the groups (alteplase 22.6 %, tenecteplase 14.7 %; p = 0.14), as were rates of 90-day independent neurological function, symptomatic intracranial hemorrhage, and mortality. Patients with an internal carotid artery occlusion or with higher presenting stroke severity were less likely to achieve early recanalization. CONCLUSIONS: Tenecteplase and alteplase have similar rates of early recanalization, 90-day functional independence, and safety outcomes in large vessel occlusion patients. Occlusion site and stroke severity predict response to thrombolysis. Future studies may investigate other factors associated with a positive response to thrombolytics as expanded treatment indications are explored.

16.
Int J Stroke ; : 17474930241273561, 2024 Sep 11.
Artículo en Inglés | MEDLINE | ID: mdl-39086232

RESUMEN

BACKGROUND: Early ischemic changes on baseline imaging are commonly evaluated for acute stroke decision-making and prognostication. AIMS: We assess the association of early ischemic changes on clinical outcomes and whether it differs between intravenous tenecteplase and Alteplase. METHODS: Data are from the phase 3, Alteplase compared to Tenecteplase (AcT) trial. Subjects with anterior circulation stroke were included. Early ischemic changes were assessed using the Alberta Stroke Program Early CT score (ASPECTS). Efficacy outcomes included modified Rankin scale (mRS) 0-1, mRS 0-2, and ordinal mRS at 90 days. Safety outcomes included 24-h symptomatic intracerebral hemorrhage (sICH), any hemorrhage on follow-up scan, and 90-day mortality rate. Mixed-effects logistic regression was used to assess the association of ASPECTS (continuous and categorical (0-4 vs 5-7 vs 8-10)) with outcomes and if these associations were modified by thrombolytic type after adjusting for age, sex, and baseline stroke severity. RESULTS: Of the 1577 patients in the trial, 901 patients (56.3%; median age 75 years (IQR 65-84), 50.8% females, median National Institute of Health Stroke Scale (NIHSS) 14 (IQR 17-19)) with anterior circulation stroke were included. mRS 0-1 at 90 days was achieved in 1/14 (0.3%), 43/160 (14.7%), and 252/726 (85.1%) in the ASPECTS 0-4, 5-7, and 8-10 groups respectively. Every one-point decrease in ASPECTS was associated with 2.7% and 1.9% decrease in chances of mRS 0-1 and mRS 0-2 at 90 days, respectively, and 1.9% chances of increase in mortality at 90 days. Subgroup analysis in endovascular thrombectomy (EVT)-treated population showed similar results. Thrombolytic type did not modify this association between ASPECTS and 90-day mRS 0-1 (P-interaction 0.75). There was no significant interaction by thrombolytic type with any other outcomes. CONCLUSION: Similar to prior studies, we found that every one-point decrease in ASPECTS was associated with poorer clinical and safety outcomes. This effect did not differ between alteplase and tenecteplase. DATA ACCESS STATEMENT: Data shall made available on reasonable request from the PI (BMM).

17.
J Intensive Care Med ; : 8850666241268539, 2024 Aug 09.
Artículo en Inglés | MEDLINE | ID: mdl-39119718

RESUMEN

High-risk pulmonary embolism (PE) is a life-threatening disease state with current guidelines recommending reperfusion therapy with systemic thrombolytics in addition to anticoagulation. This was a prospective observational cohort study with a historical control group comparing tenecteplase to alteplase for the treatment of PE or cardiac arrest with suspected PE. The primary outcome was the incidence of institutional protocol deviations defined as incorrect thrombolytic dose administered or the incorrect product compounded. Secondary outcomes included any bleeding event, major bleeding event, all-cause mortality, and for patients with a cardiac arrest, successful return of spontaneous circulation (ROSC). Fifty-four patients were included in the study. Protocol deviations occurred in one patient receiving tenecteplase and one patient receiving alteplase (4.0% vs 3.4%; P = 1.0). There was no difference in all-cause mortality (80% vs 86.2%; P = .72), any bleed (12% vs 13.8%; P = 1.0), major bleed (8.0% vs 6.9%; P = 1.0), or ROSC achievement (22.2% vs 28.6%; P = .73) when comparing tenecteplase to alteplase. Our study demonstrates that tenecteplase may be an alternative thrombolytic to alteplase for treatment of PE or cardiac arrest with suspected PE. Further studies comparing the different systemic thrombolytic agents for PE or cardiac arrest with suspected PE are needed.

18.
BMC Cardiovasc Disord ; 24(1): 441, 2024 Aug 23.
Artículo en Inglés | MEDLINE | ID: mdl-39179962

RESUMEN

BACKGROUND: Tissue plasminogen activator (tPA) is recommended as the preferred thrombolytic therapy for acute myocardial infarction (AMI). This study aimed to explore tPA-related adverse events (AEs) reported in the United States Food and Drug Administration Adverse Event Reporting System (FAERS), assess the potential safety of three preferred tPA therapies for treating AMI, and provide guidance for selecting tPA for prehospital thrombolysis. METHOD: Four algorithms, including ROR, PRR, BCPNN, and MGPS, were used to quantify the signals of Tenecteplase, Reteplase, and Alteplase related AEs and compare the differential degrees of the three tPA-associated AEs in the actual data. RESULT: We detected 18 signals of Tenecteplase-induced AE, 29 signals of Reteplase-induced AE, and 22 signals of Alteplase-induced AE. Among the three drugs, Tenecteplase had the highest signal intensity for intracranial hemorrhage-related AE, followed by Alteplase. Besides, Reteplase had the highest signal intensity for procedure-related AE and Alteplase had the highest signal intensity for arrhythmia-related AE. The time-onset analysis indicates that we should be vigilant for AEs, especially within the first week and the first 1-2 days after medication. CONCLUSION: This study identified and compared the signals of AE related to Tenecteplase, Reteplase, and Alteplase in AMI patients.


Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos , Bases de Datos Factuales , Fibrinolíticos , Infarto del Miocardio , Farmacovigilancia , Terapia Trombolítica , Activador de Tejido Plasminógeno , Humanos , Activador de Tejido Plasminógeno/efectos adversos , Activador de Tejido Plasminógeno/administración & dosificación , Infarto del Miocardio/tratamiento farmacológico , Infarto del Miocardio/inducido químicamente , Infarto del Miocardio/diagnóstico , Fibrinolíticos/efectos adversos , Resultado del Tratamiento , Estados Unidos , Terapia Trombolítica/efectos adversos , Masculino , Factores de Riesgo , Femenino , Medición de Riesgo , Persona de Mediana Edad , Anciano , Tenecteplasa/efectos adversos , Tenecteplasa/uso terapéutico , Proteínas Recombinantes/efectos adversos , Proteínas Recombinantes/uso terapéutico , United States Food and Drug Administration
19.
Case Rep Crit Care ; 2024: 3839630, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39206426

RESUMEN

Introduction: In pulmonary embolism (PE), when used for catheter-directed thrombolysis (CDT), low-dose alteplase is associated with good outcomes. Tenecteplase has been only used as intravenous for this indication. In the context of our national economic crisis where alteplase was unavailable, we describe our experience with tenecteplase CDT. Case: A 73-year-old male, hypertensive and smoker with COPD, presented to the ED with intermediate high-risk PE.(ED) with intermediate high-risk PE. Heparin infusion was initiated. A few hours later, the patient developed atrial fibrillation (AF) for which amiodarone infusion was started. Also, a left femoral and popliteal vein thrombosis was also confirmed by the lower extremity duplex. As the patient remained dyspneic with unstable vital signs, the decision was to perform a CDT. In the absence of alteplase, tenecteplase was used at 0.5 mg/h over 30 h, for a total of 15 mg. Result: Twenty-four hours after tenecteplase initiation, dyspnea and vital signs had significantly improved. Oxygen support was gradually dropping to finally stop. Being on concomitant heparin infusion, the patient had a mild blood oozing at the femoral vein site of entry; however, this did not require any transfusion or discontinuation of heparin. The patient regained his baseline physical and mental functions and was discharged on enoxaparin and amiodarone tablet. Discussion: This is the first experience describing the use of tenecteplase as part of CDT in a patient with acute intermediate high-risk PE. The combination to therapeutic heparin infusion, already described in different clinical scenarios with intravenous tenecteplase, was safe and well tolerated Conclusion: CDT with tenecteplase was, for the first time, safely and effectively used in an intermediate high-risk PE patient. However, more studies are needed to confirm and establish these findings.

20.
eNeurologicalSci ; 36: 100510, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38994497

RESUMEN

Intravenous thrombolysis (IVT) with tenecteplase or alteplase is the standard of care in, patients with Acute Ischemic Stroke (AIS) presenting within 3-4.5 h. However here, are no established guidelines for such treatment during pregnancy. We report a case, of AIS in third trimester of pregnancy successfully treated with Tenecteplase. To the, best of our knowledge, this is the first and only case of acute ischemic stroke in, pregnancy treated with Tenecteplase.

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