[Comparative characteristics of the efficacy and safety of the original alteplase and its complete biosimilar in the treatment of ischemic stroke in real clinical practice]. / Sravnitel'naya kharakteristika effektivnosti i bezopasnosti original'noi alteplazy i ee bioanaloga pri lechenii ishemicheskogo insul'ta v real'noi klinicheskoi praktike.

OBJECTIVE: To conduct a comparative analysis between the original alteplase and its biosimilar in terms of efficacy and safety in real clinical practice in the Republic of Belarus. MATERIAL AND METHODS: The cohort study included 420 patients. All included patients underwent thrombolytic therapy with alteplase within 4.5 hours of the onset of stroke symptoms according to the approved tactics of the Republic of Belarus and international recommendations. The patients were divided into 2 groups: 215 received the drug Revelisa, 205 - Actilyse. RESULTS: The patients were comparable in gender, age, ASPECTS assessment, but had statistically significant difference in NIHSS was found, due to the large number of patients with NIHSS=16-25 in the Actilyse group. The assessment of premorbid disability also showed a statistically significant difference: there were more patients in the Revelisa group who had functional limitations of varying degrees before the disease, 83 (38.6%) versus 62 (28.3%) patients in the comparison group. Clinical outcomes were comparable, the proportion of patients achieving mRS=0-1 at discharge was 41.5% in group A and 42.8% in group P. The Revelisa demonstrated a statistically significant lower number of deaths in 15 (7.0%) and 29 (14.1%) in the comparison group. The development of a greater number of clinically insignificant petechial hemorrhages was noted after the use of Actilyse. CONCLUSION: The analysis demonstrated a high level of safety in the use of alteplase preparations in routine practice. The compared fibrinolytics had comparable effectiveness in achieving functional independence after ischemic stroke, despite the more premorbid disability of patients who received a biosimilar.

The Safety and Efficacy of Ultrasound-Accelerated Catheter-Directed Thrombolysis in Patients with Intermediate-High-Risk Pulmonary Embolism: Bo-NE-Experience.

Ultrasound-accelerated thrombolysis (USAT) is an advanced interventional therapy for patients with intermediate-high-risk pulmonary embolism (PE) who deteriorated on anticoagulation or for high-risk patients for whom systemic thrombolysis is contraindicated. The aim of this study is to investigate the safety and efficacy of this therapy with a focus on the improvement of vital signs and laboratory parameters. Seventy-nine patients with intermediate-high-risk PE were treated with USAT from August 2020 to November 2022. The therapy significantly decreased the mean RV/LV ratio from 1.2 ± 0.22 to 0.9 ± 0.2 (p < 0.001) as well as the mean PAPs from 48.6 ± 11 to 30.1 ± 9.0 mmHg (p < 0.001). The respiratory and heart rate decreased significantly (p < 0.001). Serum creatinine decreased significantly from 1.0 ± 0.35 to 0.9 ± 0.3 (p < 0.001). There were 12 access-associated complications, which could be treated conservatively. One patient had haemothorax after the therapy and had to be operated on. USAT is an effective therapy for patients with intermediate-high-risk PE, with favourable hemodynamic, clinical, and laboratory outcomes.

[Independence of ischemic stroke patients after alteplase systemic thrombolytic therapy]. / Pokazateli nezavisimosti u bol'nykh s ishemicheskim insul'tom posle sistemnoi tromboliticheskoi terapii preparatami alteplazy.

OBJECTIVE: Was to determine the proportion of patients with ischemic stroke (IS) who achieved functional independence by the end of the hospitalization, among those who underwent systemic thrombolytic therapy (STT) with two different alteplase preparations (Actilyse and Revelisa). MATERIAL AND METHODS: An open, prospective observational non-interventional cohort study of the results of STT in patients with IS was carried out. The study included 195 patients, 123 men and 72 women aged 32 to 86 years, who received STT in the acute period of IS. Of these, 120 patients received Actilyse, 75 - Revelisa. RESULTS: Patients who achieved independence in movement (0-2 points on the modified Rankin scale (MRS)) among those who received STT with Actilyse and Revelisa, the value of the χ2 criterion was 0.014 (p=0.905), which showed that there was no statistical significance of the difference in the frequency of recovery of functional disorders on the MRS scale, in patients receiving STT with two different alteplase preparations. CONCLUSION: After STT with alteplase preparations, patients with IS experienced a significant improvement, which was expressed in a statistically significant decrease in the severity of neurological deficit and a decrease in the degree of disability. When comparing the results of STT with two different alteplase preparations, no statistically significant differences were found in terms of mortality, survival, and independence during the acute period of IS.

[Comparative efficacy of various thrombolytic agents in treatment of pulmonary embolism]. / Sravnitel'naia éffektivnost' razlichnykh tromboliticheskikh preparatov v lechenii tromboémbolii legochnoi arterii.

The authors carried out a retrospective analysis of clinical efficacy of streptokinase and alteplase (actilyse®) in patients presenting with high- and intermediate-to-high risk pulmonary artery thromboembolism (PATE) who were discharged from hospital after appropriate treatment performed. Of the total number of the treated patients, we formed 2 groups comprising 20 patients each, receiving alteplase (group 1) and streptokinase (group 2). The patients were comparable by the main clinical characteristics, predisposing factors, severity of pulmonary artery thromboembolism (PATE) and duration of treatment. Efficacy of thrombolytic therapy assessed clinically and instrumentally did not differ. However, by the stratified risk and frequency of PATE relapses, the condition of patients receiving alteplase turned out to be more severe. Based on the obtained results, a conclusion was made that actilyse is a drug of choice for treatment of patients with PATE.

The SITS-UTMOST: A registry-based prospective study in Europe investigating the impact of regulatory approval of intravenous Actilyse in the extended time window (3-4.5 h) in acute ischaemic stroke.

INTRODUCTION: The SITS-UTMOST (Safe Implementation of Thrombolysis in Upper Time window Monitoring Study) was a registry-based prospective study of intravenous alteplase used in the extended time window (3-4.5 h) in acute ischaemic stroke to evaluate the impact of the approval of the extended time window on routine clinical practice. PATIENTS AND METHODS: Inclusion of at least 1000 patients treated within 3-4.5 h according to the licensed criteria and actively registered in the SITS-International Stroke Thrombolysis Registry was planned. Prospective data collection started 2 May 2012 and ended 2 November 2014. A historical cohort was identified for 2 years preceding May 2012. Clinical management and outcome were contrasted between patients treated within 3 h versus 3-4.5 h in the prospective cohort and between historical and prospective cohorts for the 3 h time window. Outcomes were functional independency (modified Rankin scale, mRS) 0-2, favourable outcome (mRS 0-1), and death at 3 months and symptomatic intracerebral haemorrhage (SICH) per SITS. RESULTS: 4157 patients from 81 centres in 12 EU countries were entered prospectively (N = 1118 in the 3-4.5 h, N = 3039 in the 0-3 h time window) and 3454 retrospective patients in the 0-3 h time window who met the marketing approval conditions. In the prospective cohort, median arrival to treatment time was longer in the 3-4.5 h than 3 h window (79 vs. 55 min). Within the 3 h time window, treatment delays were shorter for prospective than historical patients (55 vs. 63). There was no significant difference between the 3-4.5 h versus 3 h prospective cohort with regard to percentage of reported SICH (1.6 vs. 1.7), death (11.6 vs. 11.1), functional independency (66 vs. 65) at 3 months or favourable outcome (51 vs. 50). DISCUSSION: Main weakness is the observational design of the study. CONCLUSION: This study neither identified negative impact on treatment delay, nor on outcome, following extension of the approved time window to 4.5 h for use of alteplase in stroke.

Thrombolytic therapy using Actilyse (rt-PA) in patients with acute cerebral infarction / 中华急诊医学杂志

Objective To evaluate the safety of thrombolytic treatment using rt-PA at early stage of acute cerebral infarction in Chinese patients, and to analyze the significance of intra - cerebral hemorrhage after therapy. Methods 206 patients within 6 hours after the onset of stroke were divided into 3 groups: group A (thrombolytic treament using rt - PA with dosage of 0.9 mg/kg over 60 minutes) , group B (thrombolytic treatment using rt-PA with dosage of 0.7 mg/kg over 60 minutes) and group C (control group without rt-PA). Group A, group B, group C were divided into two subgroups according to using Clexane or not. Patients in subgroups A1, B1, C1 were treated with Clexane and in subgroups A2, B2, C2 were not. The Chinese Stroke Scale (CSS) and Barthel Index (BI) were used to evaluate the neurological function before and 24 hours, 3 days, 7 days, and 90 days rt-tPA. Results There was significant difference on hemorrhagic rate and cerebral hemorrhagic rate at the 48 hours and 14 days between group A, group B and group C. There was no significant difference on symptomatic cerebral hemorrhage in groups A, B and group C. There were significant differences between thrombolytic groups and group C on the effective and curative rate at 90 days after therapy. The mortality was lower in thrombolytic groups than in group C at 90 days. There was no significant difference between group A and group B , and also between the subgroups. Conclusion Thrombolytic treatment using rt-PA intravenously in patients with acute cerebral infarction within 6 hours was effective and safe. The dosage of 0.7mg/kg was suitable for Chinese patients.