Tenecteplase Versus Alteplase for Acute Stroke: Mortality and Bleeding Complications
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Tenecteplase
Stroke
Fibrinolytic agent
Acute stroke
Objectives: Tenecteplase is a fibrin-specific plasminogen activator that has shown promising results in the treatment of acute ischemic stroke. Tenecteplase has been suggested to reduce door-to-needle time and to increase the rate of spontaneous recanalization. In February 2021, Mayo Clinic Health System switched to Tenecteplase as the standard thrombolytic therapy for acute ischemic stroke. Methods: In this center-based observational cohort study, we present clinical characteristics and outcomes of patients with acute ischemic stroke treated with tenecteplase between February 2021 and May 2022 compared with alteplase treatment between September 2019 and February 2021. We used descriptive and comparative statistics. Results: Baseline characteristics were comparable between the groups. The incidence of symptomatic intracerebral hemorrhage was significantly less among the tenecteplase group (0.65% vs. 5%, P =0.027). Both groups had a similar door-to-needle time [55 (IQR 30.5) vs. 57 (IQR 38) in the tissue plasminogen activator group, P =0.395]. Spontaneous partial or complete recanalization was more commonly observed in the tenecteplase group (10.4% vs. 1.4%, P =0.038). Mechanical thrombectomy for large vessel occlusion was deferred due to marked clinical improvement more commonly in tenecteplase (6.3% vs. 1.4%); however, this difference was not statistically significant. Ninety-day modified Rankin Scale did not show a significant difference between the groups. Conclusion: Tenecteplase use as the thrombolytic agent in acute ischemic stroke was associated with lower rates of symptomatic intracranial hemorrhage, higher rates of spontaneous recanalization, but similar door-to-needle time and 90-day modified Rankin Scale as compared with tissue plasminogen activator.
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Alteplase is a tissue plasminogen activator approved for treating acute ischemic stroke (AIS), acute myocardial infarction (AMI), and acute massive pulmonary embolism. Two additional tissue plasminogen activators, tenecteplase and reteplase, are also approved for AMI treatment. However, neither tenecteplase nor reteplase is approved for AIS treatment. The U.S. Food and Drug Administration has received reports of accidental administration of tenecteplase or reteplase instead of alteplase in patients with AIS, which can lead to potential overdose. Primary factors contributing to medication errors include use of the abbreviations "TPA," "tPA," or "TNK" in written or verbal orders and use of these agents in similar settings. Steps to reduce the likelihood of accidental substitution include use of full brand or generic names and inclusion of the indication in written and verbal orders, addition of alerts in automated dispensing machines and ordering systems, and use of stroke boxes containing alteplase and materials for administration.
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Alteplase, a biosynthetic form of human tissue‐type plasminogen activator, is Food and Drug Administration‐approved for the treatment of acute ischemic stroke and currently the standard of care for thrombolytic therapy. Tenecteplase, a modified form of alteplase using recombinant technology, has several pharmacological advantages over alteplase, including longer half‐life, higher fibrin specificity, and greater resistance to plasminogen activator inhibitor‐1. Additionally, tenecteplase is given as a single bolus administration compared to the bolus plus 1‐hour continuous infusion of alteplase. Given these pharmacologic and logistical differences along with studies demonstrating noninferiority compared with alteplase, tenecteplase has become an alternative thrombolytic for the management of acute ischemic stroke. There is a growing body of evidence that suggests tenecteplase is a safe and effective alternative to alteplase. This systematic review evaluates the available literature for the use of tenecteplase in acute ischemic stroke and provides relevant discussion regarding role in therapy, therapeutic strategies, and areas requiring further research.
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Abstract Background : Tenecteplase is a tissue plasminogen activator with higher fibrin specificity compared with Alteplase. Accumulating data suggests that intravenous Tenecteplase 0.25mg/kg is non-inferior to Alteplase 0.9mg/kg for acute ischemic stroke. We describe our 10-months experience. Methods : At our MRI-based, urban comprehensive stroke center, we switched the intravenous thrombolytic agent for acute ischemic stroke to Tenecteplase 0.25mg/kg on March 23, 2021. Until January 31, 2022, 62 stroke patients were treated with Tenecteplase. We compared clinical and safety outcomes of Tenecteplase-treated patients with 94 Alteplase-treated patients. Results : During the study period, nine (15%) patients with unknown stroke onset were thrombolyzed with MRI screening. Nineteen (35%) patients underwent subsequent thrombectomy. When compared with Alteplase-treated patients, there was no difference with Tenecteplase-treated patients in 90-day functional outcome, death, symptomatic intracranial hemorrhage, or angioedema. Conclusions : The use of Tenecteplase for stroke thrombolysis was feasible with comparable safety and functional outcomes compared to Alteplase, even when Tenecteplase was administered based on MRI screening to stroke patients with unknown onset.
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Introduction: Alteplase, reteplase, and tenecteplase are tissue plasminogen activators (TPA) approved for the management of acute myocardial infarction. Only alteplase is also approved for the treatment of acute ischemic stroke (AIS). The US Food and Drug Administration has received reports of accidental administration of tenecteplase or reteplase instead of alteplase in patients with AIS, which can result in failure to treat patients with the intended agent and lead to potential overdose.Areas covered: This review compares the molecular and clinical features of alteplase, reteplase, and tenecteplase (TNK), identifies factors contributing to medication errors among these agents, and provides steps to reduce medication errors.Expert opinion: Primary factors contributing to medication errors among tissue plasminogen activators include the use of the abbreviations 'TPA,' 'tPA,' or 'TNK' in written or verbal orders and use of these agents in similar settings (e.g. emergency departments and critical care areas). Steps to reduce the likelihood of accidental substitution of tenecteplase or reteplase for alteplase in patients with AIS include the use of full brand or generic names and inclusion of the indication in written and verbal orders, the addition of alerts in automated dispensing machines and ordering systems and use of stroke boxes containing alteplase and materials for administration.
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Tenecteplase
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Madam, Tenecteplase is a recombinant tissue plasminogen activator (tPA) that is used in many countries worldwide for reperfusion in acute ischemic stroke (AIS) and STEMI because of its longer half-life and high fibrin specificity compared to other tPAs (e.g., alteplase) and Streptokinase.1 Tenecteplase binds with fibrin-rich clots using its fibronectin finger-like and kringle-2 domains. The binding allows the protease domain to cleave the Arg/Val bond, converting plasminogen into plasmin, which breaks the fibrin matrix of the thrombus, resulting in clot dissolution. While Stroke and MI remain in the top 5 leading causes of death in Pakistan2, this highly efficient thrombolytic agent is not yet accessible in most hospitals for reperfusion in acute ischemic stroke and myocardial infarction cases. Many studies offer promising results, with tenecteplase being a better thrombolytic agent for acute ischemic stroke and STEMI than alteplase. In India, studies declare tenecteplase effective and safe in STEMI patients with clinically successful thrombolysis reported in 80.67% of patients, while intracranial hemorrhage associated with tenecteplase was only 0.39%.3 Tenecteplase is more efficient and at least as safe as alteplase for acute ischemic stroke. According to a meta-analysis involving 2031 patients, the patients given Tenecteplase showed higher recanalization rates (ARD=0.11, 95%CI) and early neurological improvement (ARD=0.10, 95% CI) compared to patients given alteplase.4 Tenecteplase also has a lower cost and a more favorable pharmacokinetic profile allowing bolus injection. Regrettably, Tenecteplase is not yet accessible in Pakistan due to unclear political and administrative factors, and border restrictions. Studies claim that only six hospitals in Pakistan currently offer intravenous thrombolytic therapy with alteplase, all being private tertiary care hospitals.5 While the world is adopting Tenecteplase instead of alteplase because of its better results, a more favourable side effects profile, and lower cost, our healthcare system is still dependent on SK for IV thrombolysis in cases of STEMI, which too is sometimes not available in many hospitals. In light of available evidence suggesting Tenecteplase as a better alternative to alteplase and Streptokinase, the health government and hospital policymakers should consider introducing tenecteplase in Pakistan as the standard care for STEMI, New Onset LBBB (Left Bundle Branch Block), Acute Ischemic Stroke, Prosthetic Valve Thrombosis, Pulmonary Embolism, and Deep Venous Thrombosis.
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Acute stroke
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Tenecteplase is a modified tissue plasminogen activator with a longer half-life and higher fibrin specificity than alteplase.We conducted a prospective, nonrandomized, pilot study of 0.1 mg/kg IV tenecteplase given 3 to 6 hours after ischemic stroke onset. For a control group, we used patients contemporaneously treated with sub-3-hour 0.9 mg/kg IV alteplase following standard selection criteria. All patients underwent pretreatment and 24-hour perfusion/angiographic imaging with CT or MRI. Eligibility criteria for tenecteplase (but not alteplase) treatment included a perfusion lesion at least 20% greater than the infarct core, with an associated vessel occlusion. Primary outcomes, assessed blind to treatment group, were reperfusion (reduction in baseline-24-hour mean transit time lesion) and major vessel recanalization.Fifteen patients received tenecteplase, and 35 patients received alteplase. The tenecteplase group had greater reperfusion (mean 74% vs 44% in the alteplase group, p = 0.01) and major vessel recanalization (10/15 tenecteplase vs 7/29 alteplase, p = 0.01). Despite later time to treatment, more tenecteplase patients (10/15 vs 7/35 alteplase, p = 0.001) had major neurologic improvement at 24 hours (NIH Stroke Scale reduction > or = 8). Four of the alteplase patients and none of the tenecteplase patients had parenchymal hematoma at 24 hours.Tenecteplase 0.1 mg/kg, using advanced imaging guidance in an extended time window, may have significant biologic efficacy in acute ischemic stroke. The imaging selection differences between the tenecteplase and alteplase groups prevent a conclusive efficacy comparison. Nonetheless, these results lend support for randomized trials comparing tenecteplase with alteplase, preferably incorporating penumbral/angiographic imaging selection.
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