Thrombolytic therapy with Revelisa in ischemic stroke: results of the PRIMA international multicenter observational study
Authors: Shamalov N. A. , Khasanova D. R. , Marchenko S. V. , Soldatov M. A. , Alekseeva T. P , Androfagina O. V. , Antipova L. N. , Anishchenko L. I. , Beketova E. M. , Bulanov A. A. , Gerasimova A. V. , Gorst N. Kh. , Gutsalyuk A. G. , Demin T. V. , Dyudin A. V. , Yelemanov U. A. , Zakaryaeva A. R. , Zinovyeva N. N. , Ziborova S. S. , Kazakov D. N. , Komissarova N. V. , Korobeynikov I. V. , Korovashkova K. V. , Kuzmin E. L. , Kulesh A. A. , Kuliev R. R. , Lebedev A. S. , Lukyanov A. L. , Maksimov V. I. , Mikhaylenko O. I. , Moldavskaya I. V. , Murtazalieva D. M. , Mukhamadieva Yu. S. , Nesterova V. N. , Novikov D. G. , Platunova S. V. , Prudius E. P. , Rayemgulov R. A. , Saskin V. A. , Sinelshchikova A. V. , Strautmanis E. A. , Suryakhin V. S. , Tavlueva E. V. , Telyatnik Yu. A. , Halo N. V. , Cherepyansky M. S. , Marskaya N. A. 
Published: February 2025

Thrombolytic therapy (TLT) of ischemic stroke (IS) with alteplase within the first 4.5 hours from the onset of symptoms is the most effective and proven method of treatment.

Objective: to evaluate the safety and efficacy of TLT with Revelisa (alteplase) in IS in real-world clinical practice.

Material and methods. The results of TLT with Revelisa were analyzed in 1181 patients with IS: 616 (52.2%) women and 565 (47.8%) men (mean age 68.28±12.56 years), of which 140 (11.9%) with staged reperfusion. The mean time from disease onset to TLT was 2.58±0.83 hours. The Heidelberg classification was used to assess hemorrhages during neuroimaging. Symptomatic hemorrhagic transformation (HT) was defined according to ECASS III criteria. The study group was characterized by high comorbidity: arterial hypertension (96.9%), ischemic heart disease (56.7%), chronic heart failure (55.8%) and cardiac arrhythmias (33.3%) were most common; diabetes mellitus was present in 23% of patients. IS occurred repeatedly in 15.4% of cases.

Results. An improvement of 4 points or more on the NIHSS scale one day after TLT was observed in 41% of patients. The dynamics of the decrease in neurological symptoms one day later and at the time of discharge were statistically significant (p<0.001). The hospital mortality rate for the entire group was 8%, for the TLT group without endovascular intervention 5.6%. Twenty-nine patients (2.46%) had symptomatic HT, 14 of whom underwent endovascular intervention. The proportion of patients with a favorable clinical outcome (0–2 points on the modified Rankin scale) at discharge and at day 90 was 50.1% and 65.5%, respectively. Conclusion. The results of the PRIMA study confirm the high level of efficacy and safety of Revelisa in patients with IS, including during staged reperfusion. The data obtained are consistent with the published registry studies on alteplase in IS.><0.001). The hospital mortality rate for the entire group was 8%, for the TLT group without endovascular intervention 5.6%. Twenty-nine patients (2.46%) had symptomatic HT, 14 of whom underwent endovascular intervention. The proportion of patients with a favorable clinical outcome (0–2 points on the modified Rankin scale) at discharge and at day 90 was 50.1% and 65.5%, respectively.

Conclusion. The results of the PRIMA study confirm the high level of efficacy and safety of Revelisa in patients with IS, including during staged reperfusion. The data obtained are consistent with the published registry studies on alteplase in IS.