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.

Aim. To compare the efficacy and safety of prasugrel, ticagrelor, or clopidogrel as part of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI) due to myocardial infarction (MI).Material and methods. The observational study included 74 patients who underwent PCI due to MI within the first 24 hours after the onset. The patients were devided into 3 groups: group 1 — patients who received ticagrelor as part of DAPT; group 2 — clopidogrel, group 3 — prasugrel. The follow-up period was 28 days. To assess the efficacy and safety of therapy, a composite endpoint was assessed (death + nonfatal recurrent MI (and/or stent rethrombosis) + nonfatal ischemic stroke (IS). Additional secondary endpoints were any moderate and severe (major) bleeding according to the GUSTO and/or TIMI scales. We assessed the incidence of reperfusion arrhythmias, an opening of an infarct-related coronary artery (IRCA), and non-ST elevation myocardial infarction (non-STEMI).Results. The analysis showed no significant differences in the cumulative incidence of adverse outcomes in the study groups within 28 days. The prevalence of secondary endpoints over a 28-day follow-up period was 3,1% in the ticagrelor group and 5,9% in the clopidogrel group, while no moderate and life-threatening bleeding was recorded in the prasugrel group during. There were no significant differences in the incidence of reperfusion arrhythmias, opening of an IRCA, and non-STEMI between the groups.Conclusion. The obtained results suggest the comparable efficacy and safety profiles of prasugrel, ticagrelor and clopidogrel as a part of DAPT in patients undergoing PCI due to MI. There were no significant differences in endpoint event rates. In particular, prasugrel has been shown to be as effective and safe as ticagrelor.