Alteplase Biosimilar(Generium)

Objective. The study aimed to evaluate the efficacy and safety of Revelise (alteplase), a Russian medicinal product used as thrombolytic therapy (TLT) to treat ischemic stroke (IS) in real-world practice. Material and methods. A total of 2202 patients with IS were included in the study. The mean age was 68 years, with 20% of patients aged 80 years or older. Of the patients, 53.6% were men and 46.4% were women; 233 (10.6%) patients with large vessel occlusion underwent staged reperfusion. The most common comorbidities were hypertension (96%), chronic heart failure (57.3%), coronary artery disease (56.9%), and cardiac arrhythmias (33.8%). Nearly one-third (28.9%) of patients received antiplatelet agents before TLT, whereas 4.7% received anticoagulants. The mean NIHSS score for the entire study population was 10, and 11.6% had disabling symptoms with a NIHSS score< 5. Symptomatic hemorrhagic transformation was determined using the ECASS 3 criteria. Results. A substantial reduction in neurological deficit was reported within one day, which differed significantly from the previous value (p< 0.001). Twenty-four hours after TLT, 42.8% of patients demonstrated a decrease in their NIHSS score by ≥4. The hospital mortality rate was 8.2%. Symptomatic hemorrhagic transformation developed in 2.5% of patients. Favorable outcomes (mRS 0—2) were reported in 49.9% of patients at discharge and 66.4% of patients 90 days after TLT. Conclusion. The obtained results confirm the high efficacy and safety of Revelise in patients with IS. The wide practical use in various patient groups is justified by an up-to-date patient selection algorithm. This includes patients aged 80 years and older with minor stroke (NIHSS score< 5) who receive treatment with antiplatelet agents or anticoagulants, as well as staged reperfusion. The obtained results are consistent with those of previously published studies with a similar design.