Safety of prehospital thrombolysis with non-immunogenic staphylokinase in 51021 patients with ST-elevation myocardial infarction: data from the FRIDOM-registry

Aim. To evaluate real-world data on the safety of reperfusion therapy using non-immunogenic staphylokinase in a wide range of patients with STEMI at the prehospital stage. Material and methods. FRIDOM-registry is a multicenter prospective non-interventional observational study. The registry included patients with an established diagnosis of STEMI who received reperfusion therapy with non-immunogenic staphylokinase (Fortelyzin®, OOO SupraGene, Russia) at a dose of 15 mg bolus or bolus-infusion. The safety criteria were all-cause inhospital mortality, major bleeding rate, and a combination of major adverse cardiac and cerebral events (MACCE)-all-cause death, cardiogenic shock, recurrent myocardial infarction, arrhythmia, heart failure deterioration, ischemic stroke, and intracranial hemorrhage during hospitalization. The rate and severity of bleedings were determined according to the BARC classification. The criterion for the effectiveness of reperfusion therapy was the coronary flow restoration according to electrocardiographic (ECG) data after 90 minutes. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results. Monitoring the use of non-immunogenic staphylokinase in STEMI from June 1, 2013 to January 14, 2025 covered 51021 patients. The mean age of patients included in the registry was 64,5±12,1 years; 17% of patients aged over 75 years; 70% of patients were male. A total of 96% of patients received thrombolysis at the prehospital stage. According to ECG, reperfusion within 90 minutes after thrombolysis was achieved in 74% of patients. All-cause mortality was 4,2%, of which 1,2% at the prehospital and 3,0% in the hospital stage. The major bleeding rate was 1,1%, intracranial hemorrhages-1,1%; the minor bleeding rate was 3,2%. A subanalysis of patients included in the period 2019-2025 using the online platform FRIDOM-registry showed that in 2021 the MACCE rate in the group of patients without reperfusion significantly exceeded the values of other years (93% vs 36%, p<0,001), which could probably be due to the impact of the COVID-19 pandemic. In turn, the MACCE rate in the group of patients with reperfusion did not have significant fluctuations over the years and averaged 16±2% per year. Conclusion. The real-world data obtained confirmed the high safety of non-immunogenic staphylokinase in 51021 patients, established earlier in clinical trials. © 2025 Elsevier B.V., All rights reserved.

Авторы
Tereshchenko Sergey N. 1 , Bagnenko Sergey Fedorovich 2 , Markov Valentin A. 3, 4 , Miroshnichenko Aleksandr G. 2, 5 , Serebrennikov I.I. 6 , Krylov S.O. 7 , Lishchenko A.N. 8 , Gorbacheva Svetlana M. 9 , Kuznetsov Vladimir Vyacheslavovich 10 , Ostroumova L.A. 11 , Ikhaev A.B. 12 , Duplyakov Dmitry V. 13 , Chefranova Zh Yurievna 14 , Konstantinov Sergey L. 15 , Vyshlov E.V. 3 , Ponomarev ÉA A. 16 , Rabinovich Robert M. 17 , Petrushin Maxim A. 18 , Kutsenko Vladimir A. 19 , Koledinsky Anton G. 20, 21 , Vyazova Natalia L. 20 , Stryabkova G.I. 15 , Uskach Tatiana M. 1 , Minnullin I.P. 2 , Gaponova Nadezhda I. 22 , Trukhanova I.G. 23 , Prokhasko L.V. 24 , Mukhin S.I. 25 , Kostylev V.V. 26 , Krause O.V. 27 , Belova L.P. 27 , Lesnikv E.V. 28 , Zhukov G.P. 29 , Pribylov Sergey A. 15, 30 , Farsiyants A.V. 31 , Zhirov A.V. 32 , Shtegman Oleg A. 33 , Ivanov V.B. 34 , Timoshchenko Elena S. 35 , Makarov E.L. 36 , Tolstoy O.A. 37 , Sachkov D.Yu 38 , Karamova Irina M. 39 , Rakhmatullin Airat R. 40 , Kostogryz Valerii Borisovich 41 , Volkov E.S. 42 , Rukosuev E.V. 4, 43 , Yurkin E.P. 44 , Shakhnovich Roman M. 1 , Yavelov Igor 19 , Erlich A.D. 45 , Ivanov S.V. 46, 47 , Semenov Andrey M. 47 , Semenov Michail P. 47 , Yarovaya Elena B. 48 , Markin S.S. 46, 47
Journal
Российский кардиологический журнал
Издательство
Общество с ограниченной ответственностью Силицея-Полиграф
Номер выпуска
6
Язык
Russian
Страницы
79-92
Статус
Published
Ссылка
Внешняя ссылка
DOI
10.15829/1560-4071-2025-6355
Номер
6355
Том
30
Год
2025
Организации
  • 1 National medical research center of cardiology of the Ministry of healthcare of the Russian Federation, Moscow, Russian Federation
  • 2 Pavlov University, Saint Petersburg, Russian Federation
  • 3 Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russian Federation
  • 4 Siberian State Medical University, Tomsk, Russian Federation
  • 5 North-Western State Medical University named after I.I. Mechnikov, Saint Petersburg, Russian Federation
  • 6 Moscow Regional Emergency Station, Krasnogorsk, Russian Federation
  • 7 Naberezhnye Chelny Ambulance Staŧion, Naberezhnye Chelny, Russian Federation
  • 8 Scientific Research Institute – Ochapovsky Regional Clinical Hospital No. 1, Krasnodar, Russian Federation
  • 9 Irkutsk State Medical University, Irkutsk, Russian Federation
  • 10 Ministry of Health of the Sakhalin Region, Yuzhno-Sakhalinsk, Russian Federation
  • 11 Tyumen Region Ambulance Station, Tyumen, Russian Federation
  • 12 Republican Ambulance Station, Grozny, Russian Federation
  • 13 Polyakov Samara Regional Clinical Cardiology Dispensary, Samara, Russian Federation
  • 14 Belgorod State University, Belgorod, Russian Federation
  • 15 St. Joasaph Belgorod Regional Clinical Hospital, Belgorod, Russian Federation
  • 16 City Clinical Hospital of Emergency Medical Aid No. 25, Volgograd, Russian Federation
  • 17 Tver Regional Clinical Hospital, Tver, Russian Federation
  • 18 Tver Ambulance Station, Tver, Russian Federation
  • 19 National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russian Federation
  • 20 RUDN University, Moscow, Russian Federation
  • 21 Sergiyev Posad Hospital, Moscow, Russian Federation
  • 22 Russian University of Medicine, Moscow, Russian Federation
  • 23 Samara State Medical University, Samara, Russian Federation
  • 24 Crimean Republican Center of Disaster Medicine and Emergency Medical Services, Simferopol, Russian Federation
  • 25 Ministry of Health of the Tula Region, Tula, Russian Federation
  • 26 Vladivostok Ambulance Station, Vladivostok, Russian Federation
  • 27 Republican Center for Disaster Medicine and Emergency Medical Care, Cheboksary, Russian Federation
  • 28 Perm Regional Center for Disaster Medicine, Perm, Russian Federation
  • 29 Vladimir Ambulance Station, Vladimir, Russian Federation
  • 30 Kursk State Medical University, Kursk, Russian Federation
  • 31 Stavropol District Power Station, Stavropol, Russian Federation
  • 32 Belgorod Region Ambulance Station, Belgorod, Russian Federation
  • 33 Voino-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk, Russian Federation
  • 34 Clinical ambulance station of Orenburg, Orenburg, Russian Federation
  • 35 City Clinical Hospital No.5, Nizhny Novgorod, Russian Federation
  • 36 Nizhny Novgorod Regional Hospital, Nizhny Novgorod, Russian Federation
  • 37 Vsevolozhsk Ambulance Station, Vsevolozhsk, Russian Federation
  • 38 Pskov Ambulance Station, Pskov, Russian Federation
  • 39 Clinical Hospital of Emergency Medical Care, Ufa, Russian Federation
  • 40 Ministry of Health of the Republic of Bashkortostan, Ufa, Russian Federation
  • 41 Gusak Institute of the Urgent and Reconstructive Surgery, Donetsk, Ukraine
  • 42 Lugansk Republican Center for Emergency Medical Care and Medicine of Catastrophes, Luhansk, Russian Federation
  • 43 Asino District Hospital, Asino, Russian Federation
  • 44 Kuzbass Center for Disaster Medicine Named After Professor I.K. Galeev, Kemerovo, Russian Federation
  • 45 Pirogov Russian National Research Medical University (RNRMU), Moscow, Russian Federation
  • 46 V.N. Orekhovich Research Institute of Biomedical Chemistry, Russian Academy of Medical Sciences, Moscow, Russian Federation
  • 47 OOO SupraGen, Moscow, Russian Federation
  • 48 Lomonosov Moscow State University, Moscow, Russian Federation
Ключевые слова
non-immunogenic staphylokinase; STEMI; thrombolysis
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