Department of Medicine, Nyköping Hospital, Nyköping, Sweden.
Department of Medical Sciences, Neurology, Uppsala University, Uppsala, Sweden.
Ups J Med Sci. 2024 Oct 9;129. doi: 10.48101/ujms.v129.10459. eCollection 2024.
Tenecteplase is increasingly used off-label as an alternative to alteplase for ischemic stroke thrombolysis. Our aim was to evaluate the safety of tenecteplase versus alteplase in comprehensive real-world data.
We compared the outcomes for adult patients with acute ischemic stroke treated with alteplase or tenecteplase, registered in the Swedish Stroke Register between January 1, 2018 and December 31, 2020. The primary outcome was symptomatic intracerebral hemorrhage or death during hospital stay. Secondary outcomes were death within 90 days, modified Rankin Scale at 90 days, and mean door-to-needle time (DNT).
There were no significant differences in age or risk factors between 6,560 patients (45% women, mean age 74) treated with alteplase and 888 patients (43% women, mean age 74) treated with tenecteplase, although tenecteplase was more commonly used in non-university hospitals, hospitals with high use of thrombolysis, and in wake-up strokes. Tenecteplase was not non-inferior compared to alteplase in terms of symptomatic intracerebral hemorrhage or death during hospital stay (13.2% vs. 10.7%, absolute risk difference [95% confidence interval, CI] 2.5% [0.1 to 4.9%], adjusted odds ratio 1.44 [1.07-1.94]). There were no significant differences in functional outcome or death at 90 days, but tenecteplase was associated with decreased DNT (mean difference 9 min).
Tenecteplase was not non-inferior in safety outcome, although associated with decreased DNT. As accumulating randomized controlled studies support the non-inferiority of tenecteplase regarding functional outcome, it is important to keep scrutinizing the safety outcomes.
替奈普酶越来越多地被超适应证用于缺血性脑卒中溶栓治疗，替代阿替普酶。我们旨在评估替奈普酶与阿替普酶在真实世界综合数据中的安全性。
我们比较了 2018 年 1 月 1 日至 2020 年 12 月 31 日期间在瑞典脑卒中登记处注册的接受阿替普酶或替奈普酶治疗的急性缺血性脑卒中成年患者的结局。主要结局是住院期间出现症状性颅内出血或死亡。次要结局是 90 天内死亡、90 天改良 Rankin 量表评分和平均门到针时间（DNT）。
接受替奈普酶治疗的 6560 例患者（45%为女性，平均年龄 74 岁）和接受阿替普酶治疗的 888 例患者（43%为女性，平均年龄 74 岁）之间在年龄或危险因素方面无显著差异，尽管替奈普酶更常用于非大学医院、溶栓使用率较高的医院和唤醒性脑卒中患者。替奈普酶在住院期间出现症状性颅内出血或死亡方面并不优于阿替普酶（13.2% vs. 10.7%，绝对风险差异[95%置信区间，CI]2.5%[0.1 至 4.9%]，调整后比值比 1.44[1.07-1.94]）。90 天时的功能结局或死亡无显著差异，但替奈普酶与 DNT 缩短相关（平均差异 9 分钟）。
尽管替奈普酶与 DNT 缩短相关，但在安全性结局方面并不优于阿替普酶。随着越来越多的随机对照研究支持替奈普酶在功能结局方面的非劣效性，仔细审查安全性结局很重要。
