Department of Neurology, Division of Medicine, Akershus University Hospital, Lorenskog, Norway.
Department of Neurology, Haukeland University Hospital, Bergen, Norway.
Int J Stroke. 2021 Apr;16(3):295-299. doi: 10.1177/1747493020938306. Epub 2020 Jul 6.
Stroke prevalence is increasing with age. Alteplase is the only agent approved for thrombolytic treatment for patients with ischemic stroke, including patients ≥80 years. In the present study, the aim was to compare efficacy and safety of tenecteplase and alteplase in patients ≥80 years.
Data from the Norwegian Tenecteplase Stroke Trial, a randomized controlled trial comparing alteplase and tenecteplase, were assessed.
Of the 273 patients ≥80 years included, mean age was 85.5 years.In the intention-to-treat analyses, 43.1% receiving tenecteplase and 39.9% receiving alteplase reached excellent functional outcome (modified Rankin Scale score 0-1) after 3 months (odds ratio (OR) 1.14, 95% confidence interval (CI) 0.70-1.85, p=0.59). No significant differences among patients in the two treatment groups regarding frequency of symptomatic intracranial hemorrhage during the first 48 h were identified (11 (8.5%) in the tenecteplase group, 10 (7.0%) in the alteplase group, OR 1.23, 95% CI 0.50-3.00, p 0.65). Death within 3 months occurred in 18 patients (14.3%) in the tenecteplase group and in 21 (15.3%) in the alteplase group (p 0.84). After excluding stroke mimics, the proportion of patients with excellent functional outcome was 44.1% in the tenecteplase group and 34.4% in the alteplase group (OR 1.50 CI 0.90-2.52, p 0.12).
No differences in the efficacy and safety of tenecteplase versus alteplase in patients ≥80 years were identified.
Clinicaltrials.gov (NCT01949948).
随着年龄的增长,中风的发病率也在增加。阿替普酶是唯一批准用于治疗缺血性中风患者的溶栓药物,包括≥80 岁的患者。本研究旨在比较替奈普酶和阿替普酶在≥80 岁患者中的疗效和安全性。
评估了挪威替奈普酶溶栓试验(一项比较阿替普酶和替奈普酶的随机对照试验)的数据。
273 名≥80 岁的患者中,平均年龄为 85.5 岁。在意向治疗分析中,接受替奈普酶治疗的患者中有 43.1%,接受阿替普酶治疗的患者中有 39.9%,在 3 个月后达到良好的功能结局(改良 Rankin 量表评分为 0-1)(优势比(OR)为 1.14,95%置信区间(CI)为 0.70-1.85,p=0.59)。在两组治疗患者中,48 小时内症状性颅内出血的发生率没有显著差异(替奈普酶组 11 例(8.5%),阿替普酶组 10 例(7.0%),OR 1.23,95%CI 0.50-3.00,p=0.65)。替奈普酶组 18 例(14.3%)和阿替普酶组 21 例(15.3%)患者在 3 个月内死亡(p=0.84)。排除中风模拟病例后,替奈普酶组的良好功能结局比例为 44.1%,阿替普酶组为 34.4%(OR 1.50,95%CI 0.90-2.52,p=0.12)。
在≥80 岁的患者中,替奈普酶与阿替普酶的疗效和安全性没有差异。
Clinicaltrials.gov(NCT01949948)。