{"title":"所有缺血性中风都应该改用Tenecteplase吗?证据和后勤。","authors":"Keith W Muir","doi":"10.1177/17474930241307098","DOIUrl":null,"url":null,"abstract":"<p><p>Recent clinical trials provide robust evidence of non-inferiority of tenecteplase 0.25 mg/kg over alteplase 0.9 mg/kg in acute ischemic stroke treated within 4.5 h of time last known well. Aggregate data meta-analysis suggests likely superiority of tenecteplase with respect to excellent (modified Rankin Scale 0 or 1) outcomes at 90 days. Less complex single intravenous bolus administration of tenecteplase brings significant logistical benefits compared to alteplase. Real-world implementation data demonstrate reduced door-to-needle and door-to-puncture times, and potentially improved clinical outcomes. Avoiding the need for infusion pumps and monitoring reduces resource requirements and facilitates inter-hospital transfer. Guidelines favor tenecteplase over alteplase due to its logistical advantages. Transitioning services to tenecteplase requires consideration of education and training for all relevant staff (medical, nursing, pharmacy) and should address physician concerns. Use of stroke-specific tenecteplase 25 mg dose vials is strongly preferable to minimize the chance of dosing errors that might arise from use of cardiac-dose tenecteplase. Some off-label uses of alteplase are supported by positive randomized controlled trial data (wake-up and unknown onset stroke, and imaging-supported late window use 4.5-9 h after onset) while equivalent data for tenecteplase are less conclusive. Trial data comparing tenecteplase to control give relevant safety data for both wake-up / unknown onset stroke and for late time windows, and some efficacy data favor tenecteplase in a late time window. Given the weight of evidence for biologically similar efficacy and safety of tenecteplase 0.25 mg/kg, and potential for dosing errors, retention of alteplase for off-label indications should not be recommended.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241307098"},"PeriodicalIF":6.3000,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Should we switch to tenecteplase for all ischemic strokes? Evidence and logistics.\",\"authors\":\"Keith W Muir\",\"doi\":\"10.1177/17474930241307098\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Recent clinical trials provide robust evidence of non-inferiority of tenecteplase 0.25 mg/kg over alteplase 0.9 mg/kg in acute ischemic stroke treated within 4.5 h of time last known well. Aggregate data meta-analysis suggests likely superiority of tenecteplase with respect to excellent (modified Rankin Scale 0 or 1) outcomes at 90 days. Less complex single intravenous bolus administration of tenecteplase brings significant logistical benefits compared to alteplase. Real-world implementation data demonstrate reduced door-to-needle and door-to-puncture times, and potentially improved clinical outcomes. Avoiding the need for infusion pumps and monitoring reduces resource requirements and facilitates inter-hospital transfer. Guidelines favor tenecteplase over alteplase due to its logistical advantages. Transitioning services to tenecteplase requires consideration of education and training for all relevant staff (medical, nursing, pharmacy) and should address physician concerns. Use of stroke-specific tenecteplase 25 mg dose vials is strongly preferable to minimize the chance of dosing errors that might arise from use of cardiac-dose tenecteplase. Some off-label uses of alteplase are supported by positive randomized controlled trial data (wake-up and unknown onset stroke, and imaging-supported late window use 4.5-9 h after onset) while equivalent data for tenecteplase are less conclusive. Trial data comparing tenecteplase to control give relevant safety data for both wake-up / unknown onset stroke and for late time windows, and some efficacy data favor tenecteplase in a late time window. Given the weight of evidence for biologically similar efficacy and safety of tenecteplase 0.25 mg/kg, and potential for dosing errors, retention of alteplase for off-label indications should not be recommended.</p>\",\"PeriodicalId\":14442,\"journal\":{\"name\":\"International Journal of Stroke\",\"volume\":\" \",\"pages\":\"17474930241307098\"},\"PeriodicalIF\":6.3000,\"publicationDate\":\"2025-01-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Stroke\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17474930241307098\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Stroke","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17474930241307098","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Should we switch to tenecteplase for all ischemic strokes? Evidence and logistics.
Recent clinical trials provide robust evidence of non-inferiority of tenecteplase 0.25 mg/kg over alteplase 0.9 mg/kg in acute ischemic stroke treated within 4.5 h of time last known well. Aggregate data meta-analysis suggests likely superiority of tenecteplase with respect to excellent (modified Rankin Scale 0 or 1) outcomes at 90 days. Less complex single intravenous bolus administration of tenecteplase brings significant logistical benefits compared to alteplase. Real-world implementation data demonstrate reduced door-to-needle and door-to-puncture times, and potentially improved clinical outcomes. Avoiding the need for infusion pumps and monitoring reduces resource requirements and facilitates inter-hospital transfer. Guidelines favor tenecteplase over alteplase due to its logistical advantages. Transitioning services to tenecteplase requires consideration of education and training for all relevant staff (medical, nursing, pharmacy) and should address physician concerns. Use of stroke-specific tenecteplase 25 mg dose vials is strongly preferable to minimize the chance of dosing errors that might arise from use of cardiac-dose tenecteplase. Some off-label uses of alteplase are supported by positive randomized controlled trial data (wake-up and unknown onset stroke, and imaging-supported late window use 4.5-9 h after onset) while equivalent data for tenecteplase are less conclusive. Trial data comparing tenecteplase to control give relevant safety data for both wake-up / unknown onset stroke and for late time windows, and some efficacy data favor tenecteplase in a late time window. Given the weight of evidence for biologically similar efficacy and safety of tenecteplase 0.25 mg/kg, and potential for dosing errors, retention of alteplase for off-label indications should not be recommended.
期刊介绍:
The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.