Ezzeldin Mohamad, Hill Courtney, Kerro Ali, Percenti Eryn, Delora Adam, Santos Juan, Saei Hamzah, Greco Lisa, Ezzeldin Rime, El-Ghanem Mohammad, Alderazi Yazan, Kim Yana, Poitevint Cathleen, Mir Osman
Clinical Sciences, University of Houston, Houston, USA.
Emergency Medicine, Hospital Corporation of America (HCA) Houston Healthcare Kingwood, Houston, USA.
Cureus. 2023 Oct 12;15(10):e46889. doi: 10.7759/cureus.46889. eCollection 2023 Oct.
Tenecteplase is the thrombolytic drug of choice for acute ischemic stroke (AIS) as it has unique pharmacologic properties, along with results demonstrating its non-inferiority compared to alteplase. However, there are contradictory data concerning the risk of intracranial hemorrhage. The purpose of the study was to report the rate and patterns of symptomatic intracranial hemorrhage (sICH) in AIS patients after thrombolysis with tenecteplase compared to alteplase.
This is a retrospective cohort study with data collected 90 days before and after the change from alteplase to tenecteplase from 15 Texas stroke centers. The primary endpoint is the incidence of sICH according to the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) and European Cooperative Acute Stroke Study III (ECASS-3) criteria. The secondary endpoints are the radiographic pattern of hemorrhagic conversion according to the Heidelberg bleeding classification (HBC).
A total of 431 patients were eligible for thrombolytic therapy. Half of the cohort received alteplase (n=216), and the other half received tenecteplase (n=215). The average age of the alteplase group was 62.94 years old (SD=15.12) and 64.45 years old (SD=14.51) for the tenecteplase group. Seven patients in the alteplase group (3.2%) and 14 (6.5%) in the tenecteplase group had sICH, with an odds ratio of 1.44 (95% CI 0.60-3.43; P=0.41). An increased National Institutes of Health Stroke Scale (NIHSS) score on arrival (1.06; 95% CI 1.0004-1.131; P=0.04) was a statistically significant predictor of sICH. Tenecteplase was associated with a statistically significant increase in HBC-3 (P=0.040) over alteplase.
Compared with alteplase, our study revealed a higher rate of sICH with tenecteplase that was not statistically significant and a higher rate of HBC-3 hemorrhages that was statistically significant. The proposed mechanism of bleeding is hemorrhagic conversion in clinically silent infarcts and contusions underlying the lesions. Further studies are needed to confirm our findings and determine predictive risk factors.
替奈普酶是急性缺血性卒中(AIS)的首选溶栓药物,因为它具有独特的药理特性,且结果表明其与阿替普酶相比非劣效。然而,关于颅内出血风险的数据存在矛盾。本研究的目的是报告与阿替普酶相比,替奈普酶溶栓治疗后AIS患者症状性颅内出血(sICH)的发生率及类型。
这是一项回顾性队列研究,收集了来自德克萨斯州15个卒中中心从阿替普酶改为替奈普酶前后90天的数据。主要终点是根据卒中溶栓安全实施监测研究(SITS-MOST)和欧洲急性卒中协作研究III(ECASS-3)标准的sICH发生率。次要终点是根据海德堡出血分类(HBC)的出血转化影像学类型。
共有431例患者符合溶栓治疗条件。队列的一半接受阿替普酶治疗(n = 216),另一半接受替奈普酶治疗(n = 215)。阿替普酶组的平均年龄为62.94岁(标准差 = 15.12),替奈普酶组为64.45岁(标准差 = 14.51)。阿替普酶组有7例患者(3.2%)发生sICH,替奈普酶组有14例(6.5%),比值比为1.44(95%可信区间0.60 - 3.43;P = 0.41)。入院时美国国立卫生研究院卒中量表(NIHSS)评分升高(1.06;95%可信区间1.0004 - 1.131;P = 0.04)是sICH的统计学显著预测因素。与阿替普酶相比,替奈普酶与HBC-3的统计学显著增加相关(P = 0.040)。
与阿替普酶相比,我们的研究显示替奈普酶导致sICH的发生率更高,但无统计学显著性,HBC-3出血的发生率更高且具有统计学显著性。出血的推测机制是临床无症状梗死灶及病变下方挫伤的出血转化。需要进一步研究来证实我们的发现并确定预测风险因素。