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

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.

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Journal
Russian Journal of Cardiology
Published
2025-10-10
DOI
https://doi.org/10.15829/1560-4071-2025-6487
Citations
1
Primary Topic
Antiplatelet Therapy and Cardiovascular Diseases
Type
article
Field-Weighted Citation Impact
1.39
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article

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

N. L. Vyazova, E. L. Makarov, Н. И. Гапонова, L. A. Ostroumova et al.
1 citations
Russian Journal of Cardiology
Antiplatelet Therapy and Cardiovascular Diseases
1.39
article

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

N. L. Vyazova, E. L. Makarov, Н. И. Гапонова, L. A. Ostroumova, I. P. Minnullin, A. B. Ihaev, S. M. Gorbacheva, I. M. Karamova, Е. С. Тимощенко, С. В. Иванов, Sergey N. Krylov, А Р Рахматуллин, I. I. Serebrennikov, А. М. Семенов, И. Г. Труханова, В. Б. Костогрыз, E.M. Yurkin, С. Н. Терещенко, С. Ф. Багненко, A. G. Koledinsky, S. L. Konstantinov, Zh. Yu. Chefranova, Vladimir Aleksandrovich Kutsenko, В. А. Марков, A. N. Yakovlev, Victor B. Ivanov, Vladislav Kostylev, M. А. Petrushin, С. С. Маркин, Dmitry Viktorovich Duplyakov, Э. А. Пономарев, I. S. Yavelov, G.V. Zhukov, A. V. Farsiyants, T. M. Uskach, D. Yu. Sachkov, Е. B. Yarovaya, Oswin Krause, Р. М. Шахнович, M. P. Semenov, А. Н. Лищенко, О. А. Штегман, Sergey A. Pribylov, А. Д. Эрлих, Vladimir Kuznetsov, O. A. Tolstoy, G. I. Stryabkova, S. I. Mukhin, L. P. Belova, А. Г. Мирошниченко, R. M. Rabinovich, A. V. Zhirov, Е. М. Волков, L. V. Prokhasko, E. V. Lesnikov, E. V. Rukosuev
article en
1 citations

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.

Russian Journal of CardiologyVol. 30(8)
Belgorod National Research University (RU), Peoples' Friendship University of Russia (RU), Tula State University (RU), Pushkin Leningrad State University (RU), Sakhalin State University (RU), Siberian State Medical University (RU), Lomonosov Moscow State University (RU), National Institute of Disaster Management (IN), First Pavlov State Medical University of St. Petersburg (RU), Federal Almazov North-West Medical Research Centre (RU), Pirogov Russian National Research Medical University (RU), Naberezhnye Chelny State Pedagogical Institute (RU), Krasnoyarsk State Medical University (RU), Leningrad Regional Cancer Center (RU), Ambulance Care (Sweden) (SE), Tver State Medical University (RU), Kuzbass Institute of Economics and Law (RU), Russian Medical Academy of Continuous Professional Education (RU), Tomsk National Research Medical Center (RU), Bashkir State Medical University (RU), Samara State Medical University (RU), City Clinical Hospital (RU), National Medical Research Center of Cardiology (RU), Moscow State University (TJ), North-Western State Medical University named after I.I. Mechnikov (RU), Institute of Biomedical Chemistry (RU), Samara Regional Clinical Oncology Center (RU), Kursk State Medical University (RU), Luhansk State Medical University (UA)
Openalex Percentile: Top 14%
Antiplatelet Therapy and Cardiovascular Diseases
1.39
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