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

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

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 myocardi...

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Bibliographic Details
Main Authors: V. A. Markov, D. V. Duplyakov, S. L. Konstantinov, G. V. Klein, S. B. Aksentev, D. Yu. Platonov, E. V. Vyshlov, E. A. Ponomarev, R. M. Rabinovich, E. L. Makarov, E. V. Kulibaba, D. S. Yunevich, O. V. Kritskaia, E. A. Baranov, O. B. Talibov, E. A. Gerasimets
Format: Article
Language:Russian
Published: «FIRMA «SILICEA» LLC 2018-12-01
Series:Российский кардиологический журнал
Subjects:
st­elevated myocardial infarction
fortelyzin®
metalyse®
pharmacoinvasive strategy
one­year results
Online Access:https://russjcardiol.elpub.ru/jour/article/view/3050
Description
Summary: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.
ISSN:1560-4071
2618-7620

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