Soldatov M A, Marskaya N A, Barsegova K A, Androfagina O V, Borisov D N, Karpov D Yu, Kishinevsky M V, Kucheryavaya M V, Tabakman S V, Telyatnik Yu A, Fadeeva A S, Khan D S, Chirkov A N, Shamalov N A
Institute of Cerebrovascular Pathology and Stroke, Federal Center for Brain and Neurotechnology of the Federal Medical and Biological Agency, Moscow, Russia.
Seredavin Samara Regional Clinical Hospital, Samara, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2021;121(3. Vyp. 2):33-37. doi: 10.17116/jnevro202112103133.
To assess the safety and efficacy of Revelisa in patients with ischemic stroke in real-world clinical practice.
The interim analysis of an open-label, prospective, multicenter, non-interventional study IVT-AIS-R included 223 patients (50.2% women and 49.8% men, mean age 66.6 (13.5) years) with ischemic stroke who were admitted to the study sites since July 2019 and who, in the absence of contraindications, underwent thrombolytic therapy (TLT) with Revelisa within the first 4.5 hours from the onset of stroke. Data were collected as a continuous sample. According to the reperfusion therapy protocol for ischemic stroke, all patients included in the study underwent clinical examination, investigations and laboratory tests before TLT and within the first days after it. Symptomatic hemorrhagic transformation was determined in accordance with the ECASS 3 criteria.
Most of the patients (96%) had hypertension, 74% of patients had chronic heart failure, 57.4% had coronary artery disease, of which 8.5% were patients with a previous myocardial infarction. Various cardiac arrhythmias were observed in 33.2% of cases, 21.5% of patients had type 2 diabetes, 18.4% had a history of previous acute cerebrovascular accidents. Hemorrhagic transformation (HT) of a cerebral lesion developed in 7.1% of cases, with the frequency of symptomatic HT being 3.1% (7 patients). The hospital mortality rate was 13.9%. The median NIHSS score was 4 points (<0.0001) on day 7 versus baseline. The proportion of patients with good functional recovery (the modified Rankin scale score 0-2) at discharge was 48.2%.
The data obtained with the use of Revelisa in patients with ischemic stroke in real-world clinical practice allow drawing conclusions about a comparable safety and efficacy profile to that in previously published registry studies of alteplase.
评估Revelisa在真实世界临床实践中对缺血性中风患者的安全性和有效性。
一项开放标签、前瞻性、多中心、非干预性研究IVT-AIS-R的中期分析纳入了223例缺血性中风患者（女性占50.2%，男性占49.8%，平均年龄66.6（13.5）岁），这些患者自2019年7月起被纳入研究地点，且在无禁忌症的情况下，于中风发作后的前4.5小时内接受了Revelisa溶栓治疗（TLT）。数据作为连续样本收集。根据缺血性中风的再灌注治疗方案，研究中纳入的所有患者在TLT前及TLT后的头几天内均接受了临床检查、调查和实验室检查。症状性出血转化根据ECASS 3标准确定。
大多数患者（96%）患有高血压，74%的患者患有慢性心力衰竭，57.4%患有冠状动脉疾病，其中8.5%为既往有心肌梗死的患者。33.2%的病例观察到各种心律失常，21.5%的患者患有2型糖尿病，18.4%有既往急性脑血管意外病史。7.1%的病例出现脑损伤出血转化（HT），症状性HT的发生率为3.1%（7例患者）。医院死亡率为13.9%。第7天的美国国立卫生研究院卒中量表（NIHSS）评分中位数与基线相比为4分（<0.0001）。出院时功能恢复良好（改良Rankin量表评分为0-2分）的患者比例为48.2%。
在真实世界临床实践中，使用Revelisa治疗缺血性中风患者所获得的数据表明，其安全性和有效性与先前发表的阿替普酶注册研究相当。
