Intravenous thrombolytic therapy of ischemic stroke with the drug Revelisa in real clinical practice: results of the IVT-AIS-R study

Evaluation of the safety and effectiveness of thrombolytic therapy (TLT) with the drug Revelisa (alteplase) in patients with ischemic stroke (AI) in real clinical practice. An open prospective multicenter non-interventional register study was conducted, which included 550 patients with AI - 259 (47....

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Published in:	Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova Vol. 122; no. 12. Vyp. 2; p. 42
Main Authors:	Soldatov, M A, Klimov, L V, Tolmachev, A P, Kiseleva, T V, Androfagina, O V, Beketova, E M, Belkina, S N, Borisov, D N, Karpov, D Yu, Krasyuk, M S, Kucheryavaya, M V, Minina, Yu D, Novikov, D G, Rogozhnikova, N V, Tabakman, S V, Teliatnik, Yu A, Tretyakov, K V, Fadeeva, A S, Khan, D S, Chirkov, A N, Marskaya, N A, Shamalov, N A
Format:	Journal Article
Language:	Russian
Published:	Russia (Federation) 2022
Subjects:	Aged Aged, 80 and over Brain Ischemia - diagnosis Brain Ischemia - drug therapy Diabetes Mellitus, Type 2 - complications Female Fibrinolytic Agents - therapeutic use Humans Ischemic Stroke - diagnosis Ischemic Stroke - drug therapy Male Middle Aged Prospective Studies Thrombolytic Therapy Tissue Plasminogen Activator - therapeutic use Treatment Outcome systemic thrombolysis Reveliza reperfusion therapy rt-PA thrombolytic therapy TLT alteplase ischemic stroke biosimilar
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Summary:	Evaluation of the safety and effectiveness of thrombolytic therapy (TLT) with the drug Revelisa (alteplase) in patients with ischemic stroke (AI) in real clinical practice. An open prospective multicenter non-interventional register study was conducted, which included 550 patients with AI - 259 (47.1%) women and 291 (52.9%) men; average age 67.7±12.6 years. All included patients underwent TLT with the drug Revelisa within 4.5 hours from the onset of the disease and, according to the protocol of reperfusion therapy of AI, clinical, instrumental and laboratory examinations were performed. Symptomatic hemorrhagic transformation (GT) was determined in accordance with the criteria of the ECASS 3 study. The majority of patients (95.8%) suffered from hypertension, 69.6% had chronic heart failure, 53.8% had coronary heart disease, 38.7% had various cardiac arrhythmias, 20.7% of patients suffered from type 2 diabetes mellitus. A day after TLT, an improvement of 4 points or more on the NIHSS scale was noted in 45% of patients. The average dynamics index on the NIHSS stroke scale after a day was -3.2±4.7 and -4.4±6.1 per 7 females ( <0.0001). GT of the lesion of the brain developed in 10.9% of cases, symptomatic GT was diagnosed in 12 (2.3%) patients. The hospital mortality rate was 12.7%. The proportion of patients with good functional recovery (0-2 points on the modified Rankin scale (mRS)) at discharge, on days 30 and 90 was 44.7%, 59.2% and 68.5%, respectively. Performing TLT with the drug Revelisa in patients with AI leads to a statistically significant regression of neurological symptoms. A significant proportion of patients achieve a favorable clinical outcome upon discharge from the hospital and in the long term. The obtained data on the efficacy and safety profile correlate with previously published register studies of alteplase in AI.
ISSN:	1997-7298
DOI:	10.17116/jnevro202212212242