[Intravenous thrombolytic therapy of ischemic stroke with the drug Revelisa in real clinical practice: results of the IVT-AIS-R study]. / Vnutrivennaya tromboliticheskaya terapiya ishemicheskogo insul'ta preparatom Reveliza v real'noi klinicheskoi praktike: rezul'taty issledovaniya IVT-AIS-R.

OBJECTIVE: 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. MATERIAL AND METHODS: 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. RESULTS: 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 (p<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. CONCLUSION: 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.

[Intravenous thrombolytic therapy with Revelisa of ischemic stroke in real-world clinical practice: interim results of an open-label, prospective, multicenter, non-interventional study IVT-AIS-R]. / Vnutrivennaya tromboliticheskaya terapiya ishemicheskogo insul'ta preparatom Reveliza v real'noi klinicheskoi praktike: promezhutochnye rezul'taty issledovaniya IVT-AIS-R.

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.