Российский кардиологический журнал (Dec 2018)
Fortelyzin® in comparison with Metalyse® for ST-elevated myocardial infarction: one-year results and clinical outcomes of a multicenter randomized study FRIDOM1
Abstract
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.
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