Fortelyzin® in comparison with Metalyse® for ST-elevated myocardial infarction: one-year results and clinical outcomes of a multicenter randomized study FRIDOM1

• Published in: Rossiĭskiĭ kardiologicheskiĭ zhurnal no. 11; pp. 110 - 116
• Main Authors: Markov, V. A., Duplyakov, D. V., Konstantinov, S. L., Klein, G. V., Aksentev, S. B., Platonov, D. Yu, Vyshlov, E. V., Ponomarev, E. A., Rabinovich, R. M., Makarov, E. L., Kulibaba, E. V., Yunevich, D. S., Kritskaia, O. V., Baranov, E. A., Talibov, O. B., Gerasimets, E. A.
• Format: Journal Article
• Language: Russian
• Published: FIRMA «SILICEA» LLC 06.12.2018
• Subjects: fortelyzin; metalyse; one­year results; pharmacoinvasive strategy; st­elevated myocardial infarction
• ISSN: 1560-4071; 2618-7620
• DOI: 10.15829/1560-4071-2018-11-110-116

Aim. Evaluate the one­year results and clinical outcomes of a multi­center randomized clinical trial FRIDOM1. Material and methods. The study FRIDOM1 was conducted in 11 clinical centers of the Russian Federation in the period 2014­2016. The study included 382 patients with acute ST­elevated myocardial infarction (STEMI), who were randomly divided into the Fortelyzin® and Metalyse®. Thrombolysis was accompanied by anticoagulant and dual antiplatelet therapy followed by percutaneous coronary intervention (PCI). One­year patient status, all­cause mortality, including cardiovascular diseases (CVD), hospitalization, and one­year survival were assessed by telephone contact. Results . The one­year patient status was determined in 186 out of 191 (97,4%) in the Fortelyzin® group and in 185 out of 191 (96,9%) patients in the Metalyse® group. One­year all­cause mortality was 5,9% and 6,5% in the Fortelyzin® and Metalyse® groups, respectively (p=0,83; OR 0,91; 95% CI — 0,42­1,98). One­year mortality from CVD in the Fortelyzin® group is 5,4%, in the Metalyse® group — 6,5% (p=0,67; OR 0,83; 95% CI — 0,37­1,83). All­cause mortality between 30 days and 1 year in the Fortelyzin® group was in 2,2% of patients, CVD — in 1,6%, in the group of Metalise® mortality was in 2,7% of patients (all — CVD). One­year survival was 94,1% and 93,5% in the Fortelyzin® and Metalyse® groups, respectively. Conclusion. The one­year results of the FRIDOM1 study showed the efficacy and safety of a single bolus administration of Fortelyzin® as part of a pharmaco­invasive strategy for treating patients with STEMI, as well as clinical outcomes that are comparable with Metalyse®, including high survival rates and low CVD mortality.