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.

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Journal
Russian Journal of Cardiology
Published
2025-08-08
DOI
https://doi.org/10.15829/1560-4071-2025-6355
Citations
3
Primary Topic
Acute Myocardial Infarction Research
Type
article
Field-Weighted Citation Impact
4.16
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article

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

N. L. Vyazova, E. L. Makarov, Н. И. Гапонова, L. A. Ostroumova et al.
3 citations
Russian Journal of Cardiology
Acute Myocardial Infarction Research
4.16
article

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

N. L. Vyazova, E. L. Makarov, Н. И. Гапонова, L. A. Ostroumova, I. P. Minnullin, S. M. Gorbacheva, I. M. Karamova, А. Б. Ихаев, 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, Victor B. Ivanov, Vladislav Kostylev, M. А. Petrushin, С. С. Маркин, А. Г. Мирошниченко, 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, R. M. Rabinovich, A. V. Zhirov, Е. М. Волков, L. V. Prokhasko, E. V. Lesnikov, E. V. Rukosuev
article en
3 citations

Abstract

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.

Russian Journal of CardiologyVol. 30(6)
Belgorod National Research University (RU), Peoples' Friendship University of Russia (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), Pirogov Russian National Research Medical University (RU), Naberezhnye Chelny State Pedagogical Institute (RU), Krasnoyarsk State Medical University (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 5%
Acute Myocardial Infarction Research
4.16
DOIOpen Access PDFOpenAlex
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