European Stroke Organisation (ESO) expedited recommendation on tenecteplase for acute ischaemic stroke

Abstract

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.

Experience with non-immunogenic staphylokinase for intravenous thrombolysis in ischemic stroke: analysis of hospital registry data

“…Преимущества технологии ВТ при помощи болюсного тромболитика привели к постепенному переходу некоторых центров на повсеместное использование тенектеплазы, что позволило не только существенно снизить показатель времени «от двери до иглы», но и улучшить функциональные исходы инсульта [16][17][18]. В результате в 2023 г. Европейское общество инсульта в рекомендательном документе указало на возможность и преимущества ВТ тенектеплазой у всех пациентов в первые 4,5 ч инсульта [5].…”

“…не отличалась, а число серьезных нежелательных явлений было статистически достоверно ниже в группе неиммуногенной стафилокиназы (p = 0,044) [19,20]. Преимущество неиммуногенной стафилокиназы перед тенектеплазой заключается в том, что первая не требует учета массы тела пациента, тогда как вторая должна вводиться в дозе 0,25 мг/кг, что требует взвешивания пациента перед началом терапии [5]. В настоящем исследовании масса тела пациентов варьировала до 55 до 140 кг.…”

“…В некоторых странах частота проведения ВТ при ишемическом инсульте уже превышает 15% [3,4]. При этом в последние несколько лет в мире обозначилась тенденция к преимущественному использованию болюсных форм тромболитических препаратов, что обусловлено необходимостью увеличения скорости реперфузионной терапии с целью достижения ее наилучших результатов [5].…”

Feasibility of switching from alteplase to tenecteplase for stroke thrombolysis – A retrospective cohort analysis

“…As tenecteplase is easier to prepare and administer than alteplase, our opinion is that it should be considered a first-hand choice. During revision of this article the European Stroke Organisation published revised recommendations on stroke thrombolysis, now recommending tenecteplase 0.25 mg/kg as a safe and effective alternative to alteplase 0.9 mg/kg (Alamowitch et al, 2023). Unfortunately, the COVID-19 pandemic stopped access to tenecteplase.…”

Cost-effectiveness of tenecteplase versus alteplase for acute ischemic stroke

“…6 Currently, the European Stroke Organisation has recommended IVT with tenecteplase 0.25 mg/kg for LVO patients who are candidates for EVT and tenecteplase 0.25 mg/kg as a safe and effectiveness alternative to alteplase 0.9 mg/kg for all AIS patients eligible for IVT within 4.5 h from stroke onset. 7 The recent AcT trial showed that tenecteplase was non-inferior to alteplase in all AIS patients who meet the standard criteria for IVT. 8 With a similar safety profile, improved early recanalization rates, 9 and single bolus administration, tenecteplase may be an economic alternative to alteplase for AIS patients.…”