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 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.