Streib Christopher
University of Minnesota, Minneapolis.
Neurol Clin Pract. 2024 Feb;14(1):e200221. doi: 10.1212/CPJ.0000000000200221. Epub 2024 Jan 11.
The only FDA-approved medical treatment for acute ischemic stroke (AIS) is alteplase (commonly referred to as "tPA"). The utilization of a newer fibrinolytic agent, tenecteplase, in routine stroke care is increasing because of recent clinical trial findings, streamlined clinical workflows, and cost-effectiveness. The stroke community is monitoring this development with considerable interest and special attention to the following questions: (1) Does the current evidence support superiority or noninferiority of tenecteplase compared with standard-of-care alteplase? (2) What are the ramifications of off-label treatment with tenecteplase? (3) And what are the real-world considerations when transitioning from alteplase to tenecteplase for AIS thrombolysis? This commentary provides a practical synthesis of the current evidence and discusses our institutional experience with tenecteplase including treatment considerations, off-label use, patient consent, stroke center accreditation, and cost savings. Necessary "Code Stroke" workflow changes to ensure a safe transition from alteplase to tenecteplase are detailed.
美国食品药品监督管理局(FDA)批准的唯一用于急性缺血性卒中(AIS)的药物是阿替普酶(通常称为“tPA”)。由于近期的临床试验结果、简化的临床工作流程以及成本效益,新型纤溶药物替奈普酶在常规卒中治疗中的应用正在增加。卒中领域正密切关注这一进展,并特别关注以下问题:(1)目前的证据是否支持替奈普酶相对于标准治疗药物阿替普酶具有优越性或非劣效性?(2)替奈普酶的超说明书用药有哪些影响?(3)从阿替普酶转换为替奈普酶进行AIS溶栓时,实际应用中需要考虑哪些因素?本述评对当前证据进行了实用的综合分析,并讨论了我们机构使用替奈普酶的经验,包括治疗注意事项、超说明书用药、患者知情同意、卒中中心认证以及成本节约。详细介绍了必要的“卒中急救”工作流程变更,以确保从阿替普酶安全转换为替奈普酶。