Experience of using a Russian alteplase product as thrombolytic therapy in patients with ischemic stroke in routine practice

Objective. To assess the efficacy and safety of thrombolytic therapy (TLT) with Revelisa in patients with ischemic stroke (IS). Material and methods. The retrospective study included the data of 72 patients (mean age 64.0±17.1) with IS who were admitted to the Regional Vascular Center of the V.V. Veresaev City Clinical Hospital within the first 4.5 hours after the disease onset in the period August 2022 through February 2023. All patients underwent clinical, instrumental and laboratory examinations under the reperfusion therapy protocol. The severity of neurological deficit measured with the NIH Stroke Scale (NIHSS); the degree of self-care was assessed using the Modified Rankin Score (mRS); hemorrhagic transformation (HT) was classified according to the ECASS 3 criteria. The safety of TLT was evaluated by the incidence of HT, any extracranial hemorrhage, and mortality. Results. At admission, the mean NIHSS score was 6.0 (IQR 4.0—10.0). In 34.7% of patients, there was an improvement in the form of neurological deficit regression in the NIHSS score by ≥4 points within 24 hours after TLT. One day after TLT, the median NIHSS score was 2 points (IQR 0.00—5.00) in all patients. The changes in neurological deficit according to the NIHSS score were statistically significant (p<0.001). At day 30 after the stroke, 68.1% of patients achieved a favorable outcome (Rankin score: 0—2). Asymptomatic HT (type 1 HT according to the ECASS classification) was reported in 5.6% of patients (4 patients). None of the patients in the sample reported symptomatic HT or extracranial bleeding. The mortality rate was 1.3%. Conclusion. Revelisa has demonstrated high efficacy and safety when used for TLT in patients with IS in real-world clinical practice.