[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.

[Nonimmunogenic staphylokinase in the treatment of acute ischemic stroke (FRIDA trial results)]. / Neimmunogennaya stafilokinaza ­ novyi tromboliticheskii preparat v lechenii ishemicheskogo insul'ta (rezul'taty issledovaniya FRIDA).

AIM OF THE STUDY: To investigate the efficacy and safety of non-immunogenic staphylokinase (NS) compared with alteplase (A) in patients with acute ischemic stroke (AIS) within 4.5 h after symptom onset. MATERIAL AND METHODS: 336 patients with IS within 4.5 h after symptom onset were included in a randomized, open-label, multicenter, parallel-group, non-inferiority comparative trial of NS vs A (168 patients in each group). NS was administered as an intravenous bolus in a dose of 10 mg, regardless of body weight, over 10 s, A was administered as a bolus infusion in a dose of 0.9 mg/kg, maximum 90 mg over 1 hour. The primary efficacy endpoint was a favorable outcome, defined as a modified Rankin scale (mRS) score of 0-1 on day 90. Safety endpoints included all-cause mortality on day 90, symptomatic intracranial haemorrhage, and other serious adverse events (SAEs). RESULTS: At day 90, 84 (50%) patients reached the primary endpoint (mRS 0-1) in the NS group, 68 (41%) patients - in the A group (p=0.10, OR=1.47, 95% CI=0.93-2.32). The difference between groups NS and A was 9.5% (95% CI= -1.7-20.7) and the lower limit of the 95% CI did not cross the margin of non-inferiority (pnon-inferiority<0.0001). There were no significant differences in the frequency of deaths between the groups: on day 90, 17 (10%) patients in the NS group and 24 (14%) in the A group had died (p=0.32). There was a trend towards significant differences in the frequency of symptomatic intracranial haemorrhage: NS group - 5 (3%) patients, A group - 13 (8%) patients (p=0.087, OR=0.37, 95% CI=0.1-1.13). There were significant differences in the number of patients with SAEs: in the NS group - 22 (13%) patients, in the A group - 37 (22%) patients (p=0.044, OR=0.53, 95% CI=0.28-0.98). CONCLUSION: The presented results of the FRIDA trial are the first in the world to use a drug based on NS in patients with IS. It has been shown that a single bolus (within 10 s) administration of NS at a standard dose of 10 mg, regardless of body weight, allows to conduct fast, effective and safe thrombolytic therapy in patients with IS within 4.5 h after symptom onset. In further clinical tials of NS, it is planned to expand the therapeutic window beyond 4.5 h after symptom onset in patients with IS.

[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.

[Algorithms of the correction of fluid and electrolyte disorders in patients with severe ischemic stroke]. / Algoritmy korrektsii vodno-élektrolitnykh narushenii u patsientov s tiazhelym ishemicheskim insul'tom.

AIM: To develop a practical algorithm for the correction of sodium levels and osmolality of blood plasma during the acute period of severe ischemic stroke (IS). MATERIAL AND METHODS: One hundred and fifty patients with cardioembolic or atherothrombotic stroke, aged from 30 to 80 years, hospitalized in the first 12 h after symptom emergence, were examined. Neurological deficit was assessed with the NIHSS. The monitoring of blood plasma sodium level and osmolality of blood plasma in the 1st and 5th day after stroke as well as of blood circulation volume was performed. The level of antidiuretic hormone (ADH) was measured in patients with hyperosmolar syndrome with hypernatremia. RESULTS AND CONCLUSION: It has been shown that hyponatremia is not an independent predictor of outcome of IS, but requires a diagnostic search of the causes of this condition with subsequent correction of sodium levels. For hypernatremia therapeutic tactics varies depending on the timing of the beginning of IS. A conservative strategy for the correction of hypernatremia to plasma sodium blood levels of 150 mmol/L on the first day of IS and to 155 mg/dL since the third day can be used. If these values are exceeded, the most rapid correction of hypernatremia is necessary.

[Hypovolemic hyponatremia at the onset of severe ischemic stroke as a predictor of adverse outcome]. / Gipervolemicheskaya gipernatriemiya v debyute tyazhelogo ishemicheskogo insul'ta kak prediktor neblagopriyatnogo iskhoda.

AIM: To study the prognostic value of disturbances of the water and electrolyte homeostasis in the acute stage of ischemic stroke (II) and their impact on the course and outcome. MATERIAL AND METHODS: Disturbances of the water and electrolyte homeostasis associated with plasma sodium fluctuations were studied in 150 patients with severe II. RESULTS: The poor outcome was associated with plasma osmolarity >297 mOsmol/L and plasma sodium concentration >155 mOsmol/L in the first day of severe II and with >303 mOsmol/L and >161 mOsmol/L, respectively, in the 3rd and 5th days. The prognosis was significantly worse in hypovolemia compared to normo- and hypervolemia. CONCLUSION: Hypovolemic hyponatremia as a presentation of hyperosmolar syndrome at the onset of severe II can be considered as a relatedly independent predictor of the fatal outcome.

PROGNOSTIC SIGNIFICANCE OF WATER AND ELECTROLYTE DISORDERS IN THE ACUTE PERIOD OF SEVERE ISCHEMIC STROKE.

THE AIM: to study and identify the impact of the osmolarity blood plasma level on outcomes atherothrombotic ischemic stroke, and cardioembolic subtype. MATERIALS AND METHODS: The study included 150 patients with severe ischemic stroke pathogenesis of diferent subtypes. We studied the effect of the of the osmolarity bloodplasma level in the first dayfrom the disease beginning to ischemic stroke prognosis. RESULTS: it is shown that the prognosisfor severe ischemic stroke pathogenesis of different subtypes of the first day disease is unfavorable to the level of blood plasma osmolality 297 mOsml. This cardioembolic ischemic strokes pathogenic subtypes are more severe course and worse prognosis. CONCLUSION: the osmolarity of blood plasma is an independent predictor of adverse outcome for ischemic stroke pathogenesis of different subtypes.