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 one-year results and clinical outcomes of a multi-center randomized clinical trial FRIDOM1. Material and methods. The study FRIDOM1 was conducted in 11 clinical centers of the Russian Federation in the period 2014-2016. The study included 382 patients with acute ST-elevated 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). One-year patient status, all-cause mortality, including cardiovascular diseases (CVD), hospitalization, and one-year survival were assessed by telephone contact. Results. The one-year 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. One-year all-cause mortality was 5,9% and 6,5% in the Fortelyzin® and Metalyse® groups, respectively (p=0,83; OR 0,91; 95% CI - 0,42-1,98). One-year mortality from CVD in the Fortelyzin® group is 5,4%, in the Metalyse® group - 6,5% (p=0,67; OR 0,83; 95% CI - 0,37-1,83). All-cause 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). One-year survival was 94,1% and 93,5% in the Fortelyzin® and Metalyse® groups, respectively. Conclusion. The one-year results of the FRIDOM1 study showed the efficacy and safety of a single bolus administration of Fortelyzin® as part of a pharmaco-invasive strategy for treating patients with STEMI, as well as clinical outcomes that are comparable with Metalyse®, including high survival rates and low CVD mortality. © Russian Journal of Cardiology.

Markov V.A. 1, 2 , Duplyakov D.V.3 , Konstantinov S.L.4 , Klein G.V.5 , Aksentev S.B.6 , Platonov D.Y.7 , Vyshlov E.V.1 , Ponomarev E.A.8 , Rabinovich R.M.7 , Makarov E.L.9 , Kulibaba E.V.10 , Yunevich D.S.6 , Kritskaia O.V.11 , Baranov E.A.12 , Talibov O.B.13 , Gerasimets E.A. 14
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  • 1 Tomsk National Research Medical Center of the Russian Academy of Sciences, Tomsk, Russian Federation
  • 2 Siberian State Medical University, Tomsk, Russian Federation
  • 3 Samara Regional Clinical Cardiology Dispensary, Samara, Russian Federation
  • 4 Sant Ioasaf Belgorod Regional Clinical Hospital, Belgorod, Russian Federation
  • 5 P.A. Bayandin Murmansk Regional Clinical Hospital, Murmansk, Russian Federation
  • 6 Ryazan Regional Clinical Hospital, Ryazan, Russian Federation
  • 7 Tver Regional Clinical Hospital, Tver, Russian Federation
  • 8 Volgograd City Emergency Clinical Hospital № 25, Volgograd, Russian Federation
  • 9 Nizhny Novgorod Emergency Care Station, Nizhny Novgorod, Russian Federation
  • 10 Vladimir City Hospital № 4, Vladimir, Russian Federation
  • 11 Zabaikalsky Regional Clinical Hospital, Chita, Russian Federation
  • 12 Nizhny Novgorod City Hospital № 5, Nizhny Novgorod, Russian Federation
  • 13 Moscow State University of Medicine and Dentistry, Moscow, Russian Federation
  • 14 The Peoples’ Friendship University of Russia, Moscow, Russian Federation
Fortelyzin®; Metalyse®; One-year results; Pharmacoinvasive strategy; ST-elevated myocardial infarction
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Sukhikh G.T., Ashrafyan L.A., Kiselev V.I., Apolikhina I.A., Maltseva L.I., Suturina L.V., Selivanov S.P., Leonidova T.N., Tskhay V.B., Radzinskiy V.E., Ordiyants I.M., Bebneva T.N., Evtushenko I.D., Udut V.V., Kulagina N.V., Baranov A.N., Hasanov R., Guryeva V.A., Shamina I.V., Karakhalis L.Y., Muyzhnek E.L.
Akusherstvo i Ginekologiya. ООО «Бионика Медиа». 2018. P. 91-98