AP-HP, Service des Urgences Cérébro-Vasculaires, Hôpital Pitié-Salpêtrière, Hôpital Saint-Antoine, STARE team, iCRIN, Institut du Cerveau, Sorbonne Université, Paris, France.
Department of Neurology, GHU Paris Psychiatrie et Neurosciences, Paris, France.
Eur Stroke J. 2023 Mar;8(1):8-54. doi: 10.1177/23969873221150022. Epub 2023 Feb 2.
Within the last year, four randomised-controlled clinical trials (RCTs) have been published comparing intravenous thrombolysis (IVT) with tenecteplase and alteplase in acute ischaemic stroke (AIS) patients with a non-inferiority design for three of them. An expedited recommendation process was initiated by the European Stroke Organisation (ESO) and conducted according to ESO standard operating procedure based on the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework. We identified three relevant Population, Intervention, Comparator, Outcome (PICO) questions, performed systematic reviews of the literature and meta-analyses, assessed the quality of the available evidence, and wrote evidence-based recommendations. Expert consensus statements were provided if insufficient evidence was available to provide recommendations based on the GRADE approach. For patients with AIS of <4.5 h duration who are eligible for IVT, tenecteplase 0.25 mg/kg can be used as a safe and effective alternative to alteplase 0.9 mg/kg (moderate evidence, strong recommendation). For patients with AIS of <4.5 h duration who are eligible for IVT, we recommend against using tenecteplase at a dose of 0.40 mg/kg (low evidence, strong recommendation). For patients with AIS of <4.5 h duration with prehospital management with a mobile stroke unit who are eligible for IVT, we suggest tenecteplase 0.25 mg/kg over alteplase 0.90 mg/kg (low evidence, weak recommendation). For patients with large vessel occlusion (LVO) AIS of <4.5 h duration who are eligible for IVT, we recommend tenecteplase 0.25 mg/kg over alteplase 0.9 mg/kg (moderate evidence, strong recommendation). For patients with AIS on awakening from sleep or AIS of unknown onset who are selected with non-contrast CT, we recommend against IVT with tenecteplase 0.25 mg/kg (low evidence, strong recommendation). Expert consensus statements are also provided. Tenecteplase 0.25 mg/kg may be favoured over alteplase 0.9 mg/kg for patients with AIS of <4.5 h duration in view of comparable safety and efficacy data and easier administration. For patients with LVO AIS of <4.5 h duration who are IVT-eligible, IVT with tenecteplase 0.25 mg/kg is preferable over skipping IVT before MT, even in the setting of a direct admission to a thrombectomy-capable centre. IVT with tenecteplase 0.25 mg/kg may be a reasonable alternative to alteplase 0.9 mg/kg for patients with AIS on awakening from sleep or AIS of unknown onset and who are IVT-eligible after selection with advanced imaging.
在过去的一年中，有四项比较静脉溶栓（IVT）与替奈普酶和阿替普酶治疗急性缺血性脑卒中（AIS）患者的随机对照临床试验（RCT）发表，其中三项研究的设计为非劣效性设计。根据欧洲卒中组织（ESO）的标准操作程序，基于推荐分级的评估、制定与评价（GRADE）框架，启动了一项加速推荐流程。我们确定了三个相关的人群、干预、比较、结局（PICO）问题，进行了文献系统评价和荟萃分析，评估了现有证据的质量，并撰写了基于证据的推荐意见。如果根据 GRADE 方法提供推荐意见的证据不足，则提供专家共识声明。对于发病时间＜4.5 h 且适合 IVT 的 AIS 患者，替奈普酶 0.25 mg/kg 可作为阿替普酶 0.9 mg/kg 的安全有效替代方案（中度证据，强烈推荐）。对于发病时间＜4.5 h 且适合 IVT 的 AIS 患者，我们不建议使用替奈普酶 0.40 mg/kg（低证据，强烈推荐）。对于发病时间＜4.5 h 且在发病前接受移动卒中单元管理适合 IVT 的 AIS 患者，我们建议替奈普酶 0.25 mg/kg 优于阿替普酶 0.90 mg/kg（低证据，弱推荐）。对于发病时间＜4.5 h 且适合 IVT 的大血管闭塞（LVO）AIS 患者，我们建议替奈普酶 0.25 mg/kg 优于阿替普酶 0.9 mg/kg（中度证据，强烈推荐）。对于因非对比 CT 选择而接受 IVT 的发病后清醒或发病原因不明的 AIS 患者，我们不建议使用替奈普酶 0.25 mg/kg（低证据，强烈推荐）。此外，还提供了专家共识声明。替奈普酶 0.25 mg/kg 可能优于阿替普酶 0.9 mg/kg，用于治疗发病时间＜4.5 h 的 AIS 患者，因为其具有相似的安全性和疗效数据，且给药更方便。对于发病时间＜4.5 h 且适合 IVT 的 LVO AIS 患者，如果适合血管内治疗，与跳过 IVT 直接进行取栓相比，替奈普酶 0.25 mg/kg 的 IVT 更可取，即使是在直接进入可进行取栓的中心的情况下。对于因非对比 CT 选择而接受 IVT 的发病后清醒或发病原因不明的 AIS 患者，且适合 IVT 治疗，替奈普酶 0.25 mg/kg 可能是阿替普酶 0.9 mg/kg 的合理替代方案。
