Thrombolysis with the non-immunogenic staphylokinase in patients with ST-elevation myocardial infarction: data from a single-center observational study

Objective. To evaluate the efficacy and safety of the non-immunogenic staphylokinase in patients with ST-segment elevation myocardial infarction (STEMI) in routine clinical practice at the vascular center of Sergiev Posad district hospital. Materials and Methods. A single-center, prospective, non-interventional observational study (registry) was conducted from January 2021 to March 2025. The registry included patients diagnosed with STEMI who received the nonimmunogenic staphylokinase (Fortelyzin®, SuperGene LLC, Russia) at a dose of 15 mg as a single intravenous bolus. The primary efficacy endpoint was the restoration of coronary blood flow, as assessed by ECG, at 90 minutes. Safety was assessed by the incidence of the following adverse events during hospitalization: death from all causes, cardiogenic shock, recurrent myocardial infarction, lifethreatening arrhythmias, episodes of heart failure decompensation, ischemic stroke, and intracranial hemorrhage. All procedures were carried out in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP). Results . From January 1, 2021, to March 31, 2025, the registry enrolled 258 patients with STEMI; the mean age was 63.2±11.9 years. 98.4% of patients received thrombolysis at the pre-hospital stage. According to ECG data, reperfusion within 90 minutes was achieved in 75.2% of patients. Percutaneous coronary intervention (PCI) was performed in 98.1% of patients following thrombolysis. One patient (0.4%), aged 68, experienced an intracranial hemorrhage and subsequently died. Pre-hospital mortality was 1.2%; all deceased patients showed no signs of reperfusion. In-hospital mortality was 2.0%. Reperfusion arrhythmia was observed in two patients (0.8%), while cardiogenic shock and worsening heart failure were noted in one patient (0.4%). Conclusion. The obtained data confirmed the efficacy and safety of the nonimmunogenic staphylokinase in routine clinical practice within the setting of a vascular center.