[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.

[Improving the diagnosis, treatment and secondary prevention of stroke using a unified online system: primary vascular department - regional vascular center - family doctor]. / Sovershenstvovanie diagnostiki, lecheniya i vtorichnoi profilaktiki insul'ta s ispol'zovaniem edinoi onlain-sistemy: pervichnoe sosudistoe otdelenie ­ regional'nyi sosudistyi tsentr ­ semeinyi vrach.

OBJECTIVE: The introduction of the Stroke Platform (SP) in the Belgorod Region to improve the efficiency of diagnosis and care for patients with stroke. Stroke platform is a unified information platform that unites all stages of treatment of a patient with stroke, from the first symptoms to dispensary observation by a family doctor and control of targeted provision of medicines for the secondary prevention of vascular events. MATERIAL AND METHODS: The SP includes 6 modules: the Central Archive of Medical Images or the Picture Archiving and Communication System (PACS) and connection to a single circuit of all CT devices of the regional medical institutions; Stroke register; secondary prevention register; routing bureau; statistics and analytics; COVID platform. The SP, as it develops, can be supplemented with those modules that are necessary to improve the quality and availability of patient care. More than 100 consultations of CT images are carried out monthly through the SP, the average response time is less than 10 minutes, 52 platform participants are in constant contact, all medical institutions of the region are connected. Five hundred and forty patients were consulted for 6 months of 2020. RESULTS: The share of hospitalizations in specialized departments increased to 97.6% versus 86.3%. The availability of high-tech medical care for patients with stroke has increased due to timely transfer to the district vascular center. Endovascular interventions for aneurysms and arteriovenous malformations, stenting of extracerebral arteries during dissection, mechanical thrombectomy from large arteries are performed. Mortality decreased from 19.7% (2019) to 17.6%. At the stage of outpatient follow-up, it is possible to obtain information about the range of those drugs that are prescribed to the patient for prophylaxis and are delivered to the target. CONCLUSION: The main feature of the SP is the speed and efficiency of making medical decisions, ergonomics and ease of interaction, a single workspace.

[The remote results of treatment of ischemic stroke conditioned by atherosclerotic affection of carotid arteries].

The ischemic stroke is a disease that leads to dysfunctions in life of any individual. The mortality rate of cerebral infarcts reaches up to 39%. Besides, the most acute period of an ischemic stroke, which lasts up to 5-7 days, is especially problematic and is characterized by the highest mortality. The first day of disease results in 21.74% of deaths (out of the total annual number of deaths). The article presents the results of the analysis of treatment of the patients with ischemic stroke caused by the atherosclerosis of brachiocephalic arteries. The role of endovascular technologies in the treatment of the acute cerebrovascular cases has not been fully revealed. The retrospective analysis of treatment of 171 patients with atherosclerotic subtype of ischemic stroke was carried out. The patients were distributed in two groups: in the first group (83 patients) the applied conservative therapy was supplemented by endovascular intervention during the acute period of ischemic insult; in the second group (88 patients) the conservative therapy alone was applied. Both groups were comparable in terms of gender, age and associated diseases. The risk factors of ischemic insult were analyzed such as IHD that requires surgery; hypertensive disease; hypercholesterolemia; ischemic insult in medical history; heart dysrhythmia; diabetes mellitus. All patients had more than one risk factor. There mortality, incapacitation, degree of neurological impairment, frequency of symptoms of hemorrhagic suffusion and of hemorrhagic transformation were analyzed. The remote results were analyzed in sampling of 54 patients: 32 patients from the first group, 22 patients from the second group. The quality of life was measured using technique of non-specific survey SF-36 when its 36 items were grouped into eight scales: physical functioning, role activity, body pain, general health, vitality, social functioning, emotional state, psychological health. The degree of incapacitation was measured with the modified Rankin scale, the quality of life was examined with the SF-36 survey, the survival rate was measured with the Kaplan-Meier estimator. The statistical analysis was carried out with the help of the Statistica 6.0 software.