Safety and efficacy of non-immunogenic staphylokinase in elderly patients over 75 years old with ST-segment elevation myocardial infarction: FREEDOM registry data
Year: 2025
Type: article
Study design: Observational Study
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.
Source: Russian Journal of Cardiology
Authors: S. N. Tereshchenko, S. F. Bagnenko, A. N. Yakovlev, A. G. Miroshnichenko, I. I. Serebrennikov, S. O. Krylov, A. N. Lishchenko, S. M. Gorbacheva, V. V. Kuznetsov, L. A. Ostroumova, A. B. Ihaev, D. V. Duplyakov, Zh. Yu Chefranova, S. L. Konstantinov, V. A. Markov, E. V. Vyshlov, E. A. Ponomarev, R. M. Rabinovich, M. A. Petrushin, V. A. Kutsenko, A. G. Koledinsky, N. L. Vyazova, G. I. Stryabkova, T. M. Uskach, I. P Minnullin, N. I. Gaponova, I. G. Trukhanova, L. V. Prokhasko, S. I. Mukhin, V. V. Kostylev, O. V. Krause, L. P. Belova, E. V. Lesnikov, G. P. Zhukov, S. A. Pribylov, A. V. Farsiyants, A. V. Zhirov, O. A. Shtegman, V. B. Ivanov, E. S. Timoschenko, E. L. Makarov, O. A. Tolstoy, D. Yu. Sachkov, I. M. Karamova, A. R. Rakhmatullin, V. B. Kostogryz, E. S. Volkov, E. V. Rukosuev, E. P. Yurkin, R. M. Shakhnovich, I. S. Yavelov, A. D. Erlikh, S. V. Ivanov, A. M. Semenov, M. P. Semenov, E. B. Yarovaya, S. S. Markin
Institutions: National Medical Research Center of Cardiology, First Pavlov State Medical University of St. Petersburg, Federal Almazov North-West Medical Research Centre, North-Western State Medical University named after I.I. Mechnikov, Russian Medical Academy of Continuous Professional Education, Samara State Medical University, Belgorod National Research University, Siberian State Medical University, Tomsk National Research Medical Center, Tver State Medical University, Peoples' Friendship University of Russia, Kursk State Medical University, Krasnoyarsk State Medical University, Regional Public Health Care Institution "City Hospital No. 5, Barnaul", Pirogov Russian National Research Medical University, Institute of Biomedical Chemistry, Lomonosov Moscow State University
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4415021795