Thrombolytic therapy with Revelisa in ischemic stroke: results of the PRIMA international multicenter observational study
N. A. Shamalov,
D. R. Khasanova,
S. V. Marchenko,
M. A. Soldatov,
T. P Alekseeva,
O. V. Androfagina,
L. N. Antipova,
L. I. Anishchenko,
E. M. Beketova,
A. A. Bulanov,
A. V. Gerasimova,
N. Kh. Gorst,
A. G. Gutsalyuk,
T. V. Demin,
A. V. Dyudin,
U. A. Yelemanov,
A. R. Zakaryaeva,
N. N. Zinovyeva,
S. S. Ziborova,
D. N. Kazakov,
N. V. Komissarova,
I. V. Korobeynikov,
K. V. Korovashkova,
E. L. Kuzmin,
A. A. Kulesh,
R. R. Kuliev,
A. S. Lebedev,
A. L. Lukyanov,
V. I. Maksimov,
O. I. Mikhaylenko,
I. V. Moldavskaya,
D. M. Murtazalieva,
Yu. S. Mukhamadieva,
V. N. Nesterova,
D. G. Novikov,
S. V. Platunova,
E. P. Prudius,
R. A. Rayemgulov,
V. A. Saskin,
A. V. Sinelshchikova,
E. A. Strautmanis,
V. S. Suryakhin,
E. V. Tavlueva,
Yu. A. Telyatnik,
N. V. Halo,
M. S. Cherepyansky,
N. A. Marskaya 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
ischemic stroke,
thrombolytic therapy,
reperfusion therapy,
systemic thrombolysis,
alteplase,
Revelisa,
biosimilar,
rt-PA,
bridging,
staged reperfusion
Supporting agencies: Clinical research was carried out with the financial and organizational support of the JSC “GENERIUM”
About the Authors
N. A. Shamalov
Federal Center of Brain Research and Neurotechnologies, Federal Medical and Biological Agency
Russian Federation
Competing Interests:
Russian 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
Interregional Clinical and Diagnostic Center; Kazan State Medical University, the Ministry of Health of Russia
Russian Federation
Competing Interests:
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
Minsk Scientific and Practical Center for Surgery, Transplantology, and Hematology, Republic of Belarus
Belarus
Competing Interests:
Belarus
8, Semashko St., Minsk 220087
Competing Interests:
The conflict of interests did not affect the results of the study
M. A. Soldatov
Federal Center of Brain Research and Neurotechnologies, Federal Medical and Biological Agency
Russian Federation
Competing Interests:
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
City Clinical Hospital named after S.S. Yudin, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
4, Kolomensky Proezd, Moscow 115446
Competing Interests:
The conflict of interests did not affect the results of the study
O. V. Androfagina
Samara Regional Clinic Hospital named after V.D. Seredavin
Russian Federation
Competing Interests:
Russian Federation
159, Tashkentskaya St., Samara 443095
Competing Interests:
The conflict of interests did not affect the results of the study
L. N. Antipova
Regional Clinical Hospital No. 2, Ministry of Health of the Krasnodar Krai
Russian Federation
Competing Interests:
Russian Federation
130, Tamanskaya St., Krasnodar 350001
Competing Interests:
The conflict of interests did not affect the results of the study
L. I. Anishchenko
Regional Clinical Hospital
Russian Federation
Competing Interests:
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
Samara City Clinical Hospital No. 1 named after N.I. Pirogov
Russian Federation
Competing Interests:
Russian Federation
80, Polevaya St., Samara 443096
Competing Interests:
The conflict of interests did not affect the results of the study
A. A. Bulanov
Penza Regional Clinical Hospital named after N.N. Burdenko
Russian Federation
Competing Interests:
Russian Federation
28, Lermontova St., Penza 440026
Competing Interests:
The conflict of interests did not affect the results of the study
A. V. Gerasimova
Republican Hospital No. 1 – National Center of Medicine named after M.E. Nikolaev
Russian Federation
Competing Interests:
Russian Federation
4, Sergelyakhskoye Shosse, Yakutsk 677010
Competing Interests:
The conflict of interests did not affect the results of the study
N. Kh. Gorst
City Clinical Hospital named agfter I.V. Davydovsky, Moscow Healthcare Department
Russian Federation
Competing Interests:
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
City Clinical Hospital named after A.K. Yeramishantsev, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
15, Lenskaya St. Moscow 129327
Competing Interests:
The conflict of interests did not affect the results of the study
T. V. Demin
Interregional Clinical and Diagnostic Center
Russian Federation
Competing Interests:
Russian Federation
12a, Karbysheva St., Kazan 420101
Competing Interests:
The conflict of interests did not affect the results of the study
A. V. Dyudin
City Hospital No. 26
Russian Federation
Competing Interests:
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
Kaluga Regional Clinical Hospital
Russian Federation
Competing Interests:
Russian Federation
1, Vishnevskogo St., Kaluga 248007
Competing Interests:
The conflict of interests did not affect the results of the study
A. R. Zakaryaeva
City Clinical Hospital named after V.V. Veresaev, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
10, Lobnenskaya St., Moscow 127644
Competing Interests:
The conflict of interests did not affect the results of the study
N. N. Zinovyeva
City Clinical Hospital No. 1
Russian Federation
Competing Interests:
Russian Federation
16, Vorovskogo St., Chelyabinsk 454092
Competing Interests:
The conflict of interests did not affect the results of the study
S. S. Ziborova
Novokuznetsk City Clinical Hospital No. 1 named after G.P. Kurbatov
Russian Federation
Competing Interests:
Russian Federation
28, Bardina Prosp., Novokuznetsk 654057
Competing Interests:
The conflict of interests did not affect the results of the study
D. N. Kazakov
Kommunarka Moscow Multidisciplinary Clinical Center, Moscow Healthcare Department
Russian Federation
Competing Interests:
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
First Republican Clinical Hospital, Ministry of Health of the Ural Region
Russian Federation
Competing Interests:
Russian Federation
57, Votkinskoye Shosse, Izhevsk 426039
Competing Interests:
The conflict of interests did not affect the results of the study
I. V. Korobeynikov
Irkutsk Regional Clinical Hospital, winner of the “Mark of the Honor” award
Russian Federation
Competing Interests:
Russian Federation
100, Yubileyny Microdistrict, Irkutsk 664049
Competing Interests:
The conflict of interests did not affect the results of the study
K. V. Korovashkova
City Clinical Hospital No. 67 named after L.A. Vorokhobov, Moscow Healthcare Department
Russian Federation
Competing Interests:
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
Novgorod Regional Clinical Hospital
Russian Federation
Competing Interests:
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
City Clinical Hospital No. 4
Russian Federation
Competing Interests:
Russian Federation
2, KIM St., Perm 614107
Competing Interests:
The conflict of interests did not affect the results of the study
R. R. Kuliev
City Clinical Hospital named after A.K. Yeramishantsev, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
15, Lenskaya St. Moscow 129327
Competing Interests:
The conflict of interests did not affect the results of the study
A. S. Lebedev
City Clinical Hospital No. 13, Moscow Healthcare Department
Russian Federation
Competing Interests:
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
City Clinical Hospital No. 31 named after Academician G.M. Savelyeva, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
42, Lobachevskogo St., Moscow 119415
Competing Interests:
The conflict of interests did not affect the results of the study
V. I. Maksimov
Republican Hospital named after V.A. Baranov
Russian Federation
Competing Interests:
Russian Federation
3, Pirogova St., Petrozavodsk 185002
Competing Interests:
The conflict of interests did not affect the results of the study
O. I. Mikhaylenko
City Clinical Hospital No. 34
Russian Federation
Competing Interests:
Russian Federation
18, Titova St., Novosibirsk 630054
Competing Interests:
The conflict of interests did not affect the results of the study
I. V. Moldavskaya
Kuzbass Clinical Cardiology Center named after L.S. Barbarash
Russian Federation
Competing Interests:
Russian Federation
6, Sosnovy Boulevard, Kemerovo 650002
Competing Interests:
The conflict of interests did not affect the results of the study
D. M. Murtazalieva
City Clinical Hospital named after V.V. Veresaev, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
10, Lobnenskaya St., Moscow 127644
Competing Interests:
The conflict of interests did not affect the results of the study
Yu. S. Mukhamadieva
Emergency Medicine Center
Russian Federation
Competing Interests:
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
Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko
Russian Federation
Competing Interests:
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
Bryansk Regional Hospital No. 1
Russian Federation
Competing Interests:
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
Surgut Clinical Traumatological Hospital
Russian Federation
Competing Interests:
Russian Federation
20, Nefteyuganskoe Shosse, Surgut 628418
Competing Interests:
The conflict of interests did not affect the results of the study
E. P. Prudius
Rostov Regional Clinical Hospital
Russian Federation
Competing Interests:
Russian Federation
170, Blagodatnaya St., Rostov-on-Don 344015
Competing Interests:
The conflict of interests did not affect the results of the study
R. A. Rayemgulov
Neuro-Praktika LLC
Russian Federation
Competing Interests:
Russian Federation
70, Gubernskaya St., Tyumen 625032
Competing Interests:
The conflict of interests did not affect the results of the study
V. A. Saskin
First City Clinical Hospital named after E.E. Volosevich
Russian Federation
Competing Interests:
Russian Federation
1, Suvorova St., Arkhangelsk 163001
Competing Interests:
The conflict of interests did not affect the results of the study
A. V. Sinelshchikova
Smolensk Regional Clinical Hospital
Russian Federation
Competing Interests:
Russian Federation
27, Gagarina Prosp., Smolensk 214018
Competing Interests:
The conflict of interests did not affect the results of the study
E. A. Strautmanis
City Clinical Hospital of Emergency Medicine No. 1
Russian Federation
Competing Interests:
Russian Federation
9, Pereleta St., Omsk 644112
Competing Interests:
The conflict of interests did not affect the results of the study
V. S. Suryakhin
City Clinical Hospital named after V.M. Buyanov, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
26, Bakinskaya St., Moscow 115516
Competing Interests:
The conflict of interests did not affect the results of the study
E. V. Tavlueva
City Clinical Hospital named after F.I. Inozemtsev, Moscow Healthcare Department
Russian Federation
Competing Interests:
Russian Federation
1, Fortunatovskaya St., Moscow 105187
Competing Interests:
The conflict of interests did not affect the results of the study
Yu. A. Telyatnik
Research Institute – Regional Clinical Hospital No. 1 named after S.V. Ochapovsky
Russian Federation
Competing Interests:
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
Krasnoyarsk Interdistrict Clinical Hospital No. 20 naned after I.S. Berzon
Russian Federation
Competing Interests:
Russian Federation
12, Instrumentalnaya St., Krasnoyarsk 660123
Competing Interests:
The conflict of interests did not affect the results of the study
M. S. Cherepyansky
Komi Republican Clinical Hospital, Syktyvkar
Russian Federation
Competing Interests:
Russian Federation
114, Pushkina St., Syktyvkar 167004
Competing Interests:
The conflict of interests did not affect the results of the study
N. A. Marskaya
Federal Center of Brain Research and Neurotechnologies, Federal Medical and Biological Agency
Russian Federation
Competing Interests:
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
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