Thrombolytic therapy with Revelisa in ischemic stroke: results of the PRIMA international multicenter observational study
https://doi.org/10.14412/2074-2711-2025-1-57-66
Abstract
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.
Keywords
About the Authors
N. A. ShamalovRussian Federation
1, Ostrovityanova St., Build. 10, Moscow, 117513
Competing Interests:
The conflict of interests did not affect the results of the study
D. R. Khasanova
Russian Federation
12a, Karbysheva St., Kazan 420101
49, Butlerova St., Kazan 420012
Competing Interests:
The conflict of interests did not affect the results of the study
S. V. Marchenko
Belarus
8, Semashko St., Minsk 220087
Competing Interests:
The conflict of interests did not affect the results of the study
M. A. Soldatov
Russian Federation
Mikhail Anatolyevich Soldatov
1, Ostrovityanova St., Build. 10, Moscow 117513
Competing Interests:
The conflict of interests did not affect the results of the study
T. P Alekseeva
Russian Federation
4, Kolomensky Proezd, Moscow 115446
Competing Interests:
The conflict of interests did not affect the results of the study
O. V. Androfagina
Russian Federation
159, Tashkentskaya St., Samara 443095
Competing Interests:
The conflict of interests did not affect the results of the study
L. N. Antipova
Russian Federation
130, Tamanskaya St., Krasnodar 350001
Competing Interests:
The conflict of interests did not affect the results of the study
L. I. Anishchenko
Russian Federation
40, Kalinina St., Khanty-Mansiysk 628012
Competing Interests:
The conflict of interests did not affect the results of the study
E. M. Beketova
Russian Federation
80, Polevaya St., Samara 443096
Competing Interests:
The conflict of interests did not affect the results of the study
A. A. Bulanov
Russian Federation
28, Lermontova St., Penza 440026
Competing Interests:
The conflict of interests did not affect the results of the study
A. V. Gerasimova
Russian Federation
4, Sergelyakhskoye Shosse, Yakutsk 677010
Competing Interests:
The conflict of interests did not affect the results of the study
N. Kh. Gorst
Russian Federation
11/6, Yauzskaya St., Moscow 109240
Competing Interests:
The conflict of interests did not affect the results of the study
A. G. Gutsalyuk
Russian Federation
15, Lenskaya St. Moscow 129327
Competing Interests:
The conflict of interests did not affect the results of the study
T. V. Demin
Russian Federation
12a, Karbysheva St., Kazan 420101
Competing Interests:
The conflict of interests did not affect the results of the study
A. V. Dyudin
Russian Federation
2, Kostyushko St., St. Petersburg 196247
Competing Interests:
The conflict of interests did not affect the results of the study
U. A. Yelemanov
Russian Federation
1, Vishnevskogo St., Kaluga 248007
Competing Interests:
The conflict of interests did not affect the results of the study
A. R. Zakaryaeva
Russian Federation
10, Lobnenskaya St., Moscow 127644
Competing Interests:
The conflict of interests did not affect the results of the study
N. N. Zinovyeva
Russian Federation
16, Vorovskogo St., Chelyabinsk 454092
Competing Interests:
The conflict of interests did not affect the results of the study
S. S. Ziborova
Russian Federation
28, Bardina Prosp., Novokuznetsk 654057
Competing Interests:
The conflict of interests did not affect the results of the study
D. N. Kazakov
Russian Federation
8, Sosensky Stan St., Kommunarka Settlement, Sosenskoye Settlement, Moscow 108814
Competing Interests:
The conflict of interests did not affect the results of the study
N. V. Komissarova
Russian Federation
57, Votkinskoye Shosse, Izhevsk 426039
Competing Interests:
The conflict of interests did not affect the results of the study
I. V. Korobeynikov
Russian Federation
100, Yubileyny Microdistrict, Irkutsk 664049
Competing Interests:
The conflict of interests did not affect the results of the study
K. V. Korovashkova
Russian Federation
2/44, Salyama Adilya St., Moscow 123423
Competing Interests:
The conflict of interests did not affect the results of the study
E. L. Kuzmin
Russian Federation
14, Pavla Levitta St., Veliky Novgorod 173008
Competing Interests:
The conflict of interests did not affect the results of the study
A. A. Kulesh
Russian Federation
2, KIM St., Perm 614107
Competing Interests:
The conflict of interests did not affect the results of the study
R. R. Kuliev
Russian Federation
15, Lenskaya St. Moscow 129327
Competing Interests:
The conflict of interests did not affect the results of the study
A. S. Lebedev
Russian Federation
1/1, Velozavodskaya St., Moscow 115280
Competing Interests:
The conflict of interests did not affect the results of the study
A. L. Lukyanov
Russian Federation
42, Lobachevskogo St., Moscow 119415
Competing Interests:
The conflict of interests did not affect the results of the study
V. I. Maksimov
Russian Federation
3, Pirogova St., Petrozavodsk 185002
Competing Interests:
The conflict of interests did not affect the results of the study
O. I. Mikhaylenko
Russian Federation
18, Titova St., Novosibirsk 630054
Competing Interests:
The conflict of interests did not affect the results of the study
I. V. Moldavskaya
Russian Federation
6, Sosnovy Boulevard, Kemerovo 650002
Competing Interests:
The conflict of interests did not affect the results of the study
D. M. Murtazalieva
Russian Federation
10, Lobnenskaya St., Moscow 127644
Competing Interests:
The conflict of interests did not affect the results of the study
Yu. S. Mukhamadieva
Russian Federation
18, Naberezhnochelninsky Prosp., Naberezhnye Chelny 423803
Competing Interests:
The conflict of interests did not affect the results of the study
V. N. Nesterova
Russian Federation
190, Rodionova St., Nizhny Novgorod 603093
Competing Interests:
The conflict of interests did not affect the results of the study
D. G. Novikov
Russian Federation
86, Stanke Dimitrova Prosp., Bryansk 241050
Competing Interests:
The conflict of interests did not affect the results of the study
S. V. Platunova
Russian Federation
20, Nefteyuganskoe Shosse, Surgut 628418
Competing Interests:
The conflict of interests did not affect the results of the study
E. P. Prudius
Russian Federation
170, Blagodatnaya St., Rostov-on-Don 344015
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The conflict of interests did not affect the results of the study
R. A. Rayemgulov
Russian Federation
70, Gubernskaya St., Tyumen 625032
Competing Interests:
The conflict of interests did not affect the results of the study
V. A. Saskin
Russian Federation
1, Suvorova St., Arkhangelsk 163001
Competing Interests:
The conflict of interests did not affect the results of the study
A. V. Sinelshchikova
Russian Federation
27, Gagarina Prosp., Smolensk 214018
Competing Interests:
The conflict of interests did not affect the results of the study
E. A. Strautmanis
Russian Federation
9, Pereleta St., Omsk 644112
Competing Interests:
The conflict of interests did not affect the results of the study
V. S. Suryakhin
Russian Federation
26, Bakinskaya St., Moscow 115516
Competing Interests:
The conflict of interests did not affect the results of the study
E. V. Tavlueva
Russian Federation
1, Fortunatovskaya St., Moscow 105187
Competing Interests:
The conflict of interests did not affect the results of the study
Yu. A. Telyatnik
Russian Federation
167, Pervogo Maya St., Krasnodar 350086
Competing Interests:
The conflict of interests did not affect the results of the study
N. V. Halo
Russian Federation
12, Instrumentalnaya St., Krasnoyarsk 660123
Competing Interests:
The conflict of interests did not affect the results of the study
M. S. Cherepyansky
Russian Federation
114, Pushkina St., Syktyvkar 167004
Competing Interests:
The conflict of interests did not affect the results of the study
N. A. Marskaya
Russian Federation
1, Ostrovityanova St., Build. 10, Moscow 117513
Competing Interests:
The conflict of interests did not affect the results of the study
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Review
For citations:
Shamalov NA, Khasanova DR, Marchenko SV, Soldatov MA, Alekseeva TP, Androfagina OV, Antipova LN, Anishchenko LI, Beketova EM, Bulanov AA, Gerasimova AV, Gorst NK, Gutsalyuk AG, Demin TV, Dyudin AV, Yelemanov UA, Zakaryaeva AR, Zinovyeva NN, Ziborova SS, Kazakov DN, Komissarova NV, Korobeynikov IV, Korovashkova KV, Kuzmin EL, Kulesh AA, Kuliev RR, Lebedev AS, Lukyanov AL, Maksimov VI, Mikhaylenko OI, Moldavskaya IV, Murtazalieva DM, Mukhamadieva YS, Nesterova VN, Novikov DG, Platunova SV, Prudius EP, Rayemgulov RA, Saskin VA, Sinelshchikova AV, Strautmanis EA, Suryakhin VS, Tavlueva EV, Telyatnik YA, Halo NV, Cherepyansky MS, Marskaya NA. Thrombolytic therapy with Revelisa in ischemic stroke: results of the PRIMA international multicenter observational study. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2025;17(1):57-66. (In Russ.) https://doi.org/10.14412/2074-2711-2025-1-57-66