RESUMO
OBJECTIVE: To evaluate the safety and efficacy of Fortelyzin in the performance of staged reperfusion therapy for acute ischemic stroke (intravenous thrombolytic therapy plus mechanical thrombectomy) in anterior circulation within the FORTA RF multicenter pilot study. MATERIAL AND METHODS: The study included 72 patients with acute ischemic stroke in anterior circulation, who underwent staged reperfusion therapy in four vascular centers of the Russian Federation from December 2019 to January 2023. RESULTS: The mean time from illness onset to hospitalization was 94.5 minutes in the Fortelyzin group and 97.2 min in the Actilyse group (p=0.78). The time from the moment of hospitalization to the admission of the patient to the X-ray operating room was significantly lower in the Fortelyzin group (p=0.002). The incidence of symptomatic hemorrhagic transformations in the Fortelyzin group was 6%, in the Actilyse group - 8% (p=0.75). A favorable functional outcome in the first group was observed in 47% of patients, in the control group in 42% (p=0.66). Mortality in both groups did not differ significantly and amounted to 22% and 25%, respectively. CONCLUSION: The first results of the FORTA RF multicenter study demonstrate the safety and efficacy of Fortelyzin in staged reperfusion therapy compared to Actilyse.
Assuntos
AVC Isquêmico , Humanos , Projetos Piloto , Ativador de Plasminogênio Tecidual , Administração Intravenosa , ReperfusãoRESUMO
OBJECTIVE: To assess the safety and efficacy of Revelisa in patients with ischemic stroke in real-world clinical practice. MATERIAL AND METHODS: 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. RESULTS: 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 (p<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%. CONCLUSION: 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.