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Safety and efficacy of non-immunogenic staphylokinase in elderly patients over 75 years old with ST-segment elevation myocardial infarction: FREEDOM registry data

https://doi.org/10.15829/1560-4071-2025-6487

EDN: FQYEXQ

Abstract

Aim. To assess the safety of reperfusion therapy using non-immunogenic staphylokinase in patients with acute ST-segment elevation myocardial infarction (STEMI) over 75 years old in real-world practice.

Material and methods. FREEDOM 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 SuperGene, Russia) at a bolus or bolusinfusion dose of 15 mg. The safety criteria were all-cause inhospital mortality, major bleeding rate, and a combination of major adverse cardiovascular and cerebrovascular events (MACСE). The bleeding rate and severity were determined according to the BARC classification. The criterion for the effectiveness of reperfusion therapy was the coronary flow restoration according to electrocardiography data after 90 minutes. The study was conducted in accordance with Declaration of Helsinki and Good Clinical Practice standards.

Results. Monitoring of non-immunogenic staphylokinase use in STEMI from June 1, 2013 to June 14, 2025 covered more than 50 thousand patients; 16% of patients (n=6180) were over 75 years old. The median age in this subgroup of patients was 80 (77-83) years. A total of 91% of patients received prehospital thrombolysis. According to electrocardiography, reperfusion within 90 minutes in the subgroup of patients over 75 years old was achieved in 65% of patients, which is comparable with the subgroup of patients under 75 years old (70%) (p=0,81).

In the subgroup of patients over 75 years old, the MACСE rate was 31,9%, while in patients under 75 years old — 21,8% (p=0,001). In the subgroup of patients aged over 75 years, compared with the subgroup of patients under 75 years, there was a significantly higher prehospital mortality (1,7% vs 1,1%, p=0,03), inhospital mortality (5,6% vs 2,3%, p=0,001), rate of cardiogenic shock (6,9% vs 5,0%, p=0,01) and heart failure worsening (5,4% vs 3,2%, p=0,03).

Intracranial bleeding rate in patients over 75 years of age did not differ significantly compared to the subgroup of patients under 75 years of age (1,2% vs 1,1%, p=0,96). The rate of major bleedings in patients over 75 years of age was 1,5% compared to 1,2% in the subgroup of patients under 75 years of age (p=0,74), blood transfusions — 1,2% vs 1,0% (p=0,83), minor bleedings — 5,3% vs 5,0% (p=0,76). Thus, the safety of non-immunogenic staphylokinase in patients with STEMI over 75 years of age has been proven.

Conclusion. Given the convenience of non-immunogenic staphylokinase use in a single bolus dose of 15 mg regardless of the patient’s body weight and a high safety profile, including in elderly patients over 75 years old, non-immunogenic staphylokinase is the preferred drug for prehospital thrombolysis.

About the Authors

S. N. Tereshchenko
E. I. Chazov National Medical Research Center of Cardiology
Russian Federation

Moscow


S. F. Bagnenko
Pavlov First Saint Petersburg State Medical University
Russian Federation

Saint Petersburg


A. N. Yakovlev
V. A. Almazov National Medical Research Center
Russian Federation

Saint Petersburg


A. G. Miroshnichenko
Pavlov First Saint Petersburg State Medical University; Mechnikov North-Western State Medical University
Russian Federation

Saint Petersburg


I. I. Serebrennikov
Moscow Regional Ambulance Station
Russian Federation

Krasnogorsk


S. O. Krylov
Naberezhnye Chelny Ambulance Station
Russian Federation

Naberezhnye Chelny


A. N. Lishchenko
Research Institute — Ochapovsky Regional Clinical Hospital № 1
Russian Federation

Krasnodar


S. M. Gorbacheva
Irkutsk State Medical Academy of Postgraduate Education — branch of the Russian Medical Academy of Continuous Professional Education
Russian Federation

Irkutsk


V. V. Kuznetsov
Ministry of Health of the Sakhalin Oblast
Russian Federation

Yuzhno-Sakhalinsk


L. A. Ostroumova
Tyumen Region Ambulance Station
Russian Federation

Tyumen


A. B. Ihaev
Republican Ambulance Station of the Chechen Republic
Russian Federation

Grozny


D. V. Duplyakov
Polyakov Samara Regional Clinical Cardiology Dispensary; Samara State Medical University
Russian Federation

Samara


Zh. Yu Chefranova
Belgorod State National Research University
Russian Federation

Belgorod


S. L. Konstantinov
St. Joasaph Belgorod Regional Clinical Hospital
Russian Federation

Belgorod


V. A. Markov
Tomsk National Research Medical Center; Siberian State Medical University
Russian Federation

Tomsk


E. V. Vyshlov
Tomsk National Research Medical Center
Russian Federation

Tomsk


E. A. Ponomarev
City Clinical Hospital of Emergency Medical Care № 25
Russian Federation

Volgograd


R. M. Rabinovich
Tver Regional Clinical Hospital
Russian Federation

Tver


M. A. Petrushin
Tver Ambulance Station
Russian Federation

Tver


V. A. Kutsenko
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Moscow


A. G. Koledinsky
Peoples’ Friendship University of Russia; Sergiyev Posad Hospital;
Russian Federation

Moscow; Sergiyev Posad 


N. L. Vyazova
Peoples’ Friendship University of Russia
Russian Federation

Moscow


G. I. Stryabkova
St. Joasaph Belgorod Regional Clinical Hospital
Russian Federation

Belgorod


T. M. Uskach
E. I. Chazov National Medical Research Center of Cardiology
Russian Federation

Moscow


I. P Minnullin
Pavlov First Saint Petersburg State Medical University
Russian Federation

Saint Petersburg


N. I. Gaponova
Russian University of Medicine
Russian Federation

Competing Interests:

Moscow



I. G. Trukhanova
Samara State Medical University
Russian Federation

Samara


L. V. Prokhasko
Crimean Republican Center for Disaster Medicine and Emergency Medical Care
Russian Federation

Simferopol


S. I. Mukhin
Ministry of Health of the Tula Oblast
Russian Federation

Tula


V. V. Kostylev
Vladivostok Ambulance Station
Russian Federation

Vladivostok


O. V. Krause
Republican Center for Disaster Medicine and Emergency Medical Care
Russian Federation

Cheboksary


L. P. Belova
Republican Center for Disaster Medicine and Emergency Medical Care
Russian Federation

Competing Interests:

Cheboksary



E. V. Lesnikov
Perm Krai Center for Disaster Medicine
Russian Federation

Competing Interests:

Perm



G. P. Zhukov
Vladimir Ambulance Station
Russian Federation

Vladimir


S. A. Pribylov
St. Joasaph Belgorod Regional Clinical Hospital; Kursk State Medical University
Russian Federation

Belgorod; Kursk 


A. V. Farsiyants
Stavropol Ambulance Station
Russian Federation

Stavropol


A. V. Zhirov
Belgorod Ambulance Station
Russian Federation

Belgorod


O. A. Shtegman
Voyno-Yasenetsky Krasnoyarsk State Medical University
Russian Federation

Krasnoyarsk


V. B. Ivanov
Orenburg Ambulance Station
Russian Federation

Orenburg


E. S. Timoschenko
City Clinical Hospital № 5
Russian Federation

Nizhny Novgorod


E. L. Makarov
Nizhny Novgorod Ambulance Station
Russian Federation

Nizhny Novgorod


O. A. Tolstoy
Leningrad Region emergency hospital
Russian Federation

Vsevolozhsk


D. Yu. Sachkov
Pskov Ambulance Station
Russian Federation

Pskov


I. M. Karamova
Republic of Bashkortostan Clinical Hospital of Emergency Medical Care
Russian Federation

Ufa


A. R. Rakhmatullin
Ministry of Health of the Republic of Bashkortostan
Russian Federation

Ufa


V. B. Kostogryz
Gusak Institute of Emergency and Reconstructive Surgery
Russian Federation

Donetsk


E. S. Volkov
Lugansk Republican Center for Emergency Medical Care and Disaster Medicine
Russian Federation

Lugansk


E. V. Rukosuev
Siberian State Medical University; Asino District Hospital
Russian Federation

Tomsk; Asino


E. P. Yurkin
I. K. Galeev Kuzbass Center for Disaster Medicine
Russian Federation

Kemerovo


R. M. Shakhnovich
E. I. Chazov National Medical Research Center of Cardiology
Russian Federation

Moscow


I. S. Yavelov
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Moscow


A. D. Erlikh
Pirogov Russian National Research Medical University
Russian Federation

Moscow


S. V. Ivanov
Orekhovich Research Institute of Biomedical Chemistry; OOO SupraGen
Russian Federation

Moscow


A. M. Semenov
OOO SupraGen
Russian Federation

Moscow


M. P. Semenov
OOO SupraGen
Russian Federation

Moscow


E. B. Yarovaya
Lomonosov Moscow State University
Russian Federation

Moscow


S. S. Markin
Orekhovich Research Institute of Biomedical Chemistry; OOO SupraGen
Russian Federation

Moscow


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Review

For citations:

Tereshchenko S.N., Bagnenko S.F., Yakovlev A.N., Miroshnichenko A.G., Serebrennikov I.I., Krylov S.O., Lishchenko A.N., Gorbacheva S.M., Kuznetsov V.V., Ostroumova L.A., Ihaev A.B., Duplyakov D.V., Chefranova Zh.Yu., Konstantinov S.L., Markov V.A., Vyshlov E.V., Ponomarev E.A., Rabinovich R.M., Petrushin M.A., Kutsenko V.A., Koledinsky A.G., Vyazova N.L., Stryabkova G.I., Uskach T.M., Minnullin I.P., Gaponova N.I., Trukhanova I.G., Prokhasko L.V., Mukhin S.I., Kostylev V.V., Krause O.V., Belova L.P., Lesnikov E.V., Zhukov G.P., Pribylov S.A., Farsiyants A.V., Zhirov A.V., Shtegman O.A., Ivanov V.B., Timoschenko E.S., Makarov E.L., Tolstoy O.A., Sachkov D.Yu., Karamova I.M., Rakhmatullin A.R., Kostogryz V.B., Volkov E.S., Rukosuev E.V., Yurkin E.P., Shakhnovich R.M., Yavelov I.S., Erlikh A.D., Ivanov S.V., Semenov A.M., Semenov M.P., Yarovaya E.B., Markin S.S. Safety and efficacy of non-immunogenic staphylokinase in elderly patients over 75 years old with ST-segment elevation myocardial infarction: FREEDOM registry data. Russian Journal of Cardiology. 2025;30(8):6487. (In Russ.) https://doi.org/10.15829/1560-4071-2025-6487. EDN: FQYEXQ

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ISSN 1560-4071 (Print)
ISSN 2618-7620 (Online)

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Russian Federation

 

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