Fortelyzin in the treatment of acute ischemic stroke in patients ≥80 years old: data from the observational study FORPI registry

Objective. The aim of this study was to evaluate the safety and efficacy of Fortelyzin in patients ≥80 years with ischemic stroke (IS) in real-world clinical practice using data from the FORPI registry. Material and Methods. Fortelyzin (INN/chemical name — a recombinant protein containing the amino acid sequence of staphylokinase, SuperGene LLC, Moscow, Russia) is a thrombolytic used for acute IS treatment within the first 4.5 hours of symptom onset. The FORPI registry is an open-label, prospective, non-interventional, observational study of Fortelyzin in patients with IS. We analyzed the safety and efficacy outcomes in patients ≥80 years compared with patients <80 years. Safety outcomes included the incidence of symptomatic intracranial hemorrhage (sICH) according to ECASS III and SITS-MOST definitions, as well as all-cause mortality on day 90. The efficacy outcome was a good functional recovery, defined by an mRS score of 0—2 on day 90. Results. 2649 (15%) patients were ≥80 years, and 14 987 (85%) patients were <80 years. The median age in the group of patients ≥80 years was 83 (82—86) years. Patients ≥80 years were characterized by a more complicated medical history and a higher median of NIHSS and mRS score. The sICH rate according to ECASS III definition in patients ≥80 years old was 4.0%, in patients <80 years old — 1.7% (OR 2.42 (1.90—3.07), p<0.001), according to SITS-MOST definition — 3.2% and 1.6%, respectively (OR 2.03 (1.56—2.61), p<0.001); in-hospital all-cause mortality was 17% and 7% (OR 2.76 (2.44—3.11, p<0.001), all-cause mortality on day 90 was 19% and 7% (OR 3.00 (2.67—3.37, p<0.001), respectively. Good functional recovery (mRS 0—2 score) on day 90 was achieved in 43% of patients ≥80 years and 64% in patients <80 years of age (OR 0.42 (0.38—0.46, p<0.001)). Conclusion. FORPI study showed that although the risk of sICH with Fortelyzin is higher in patients ≥80 years than in patients <80 years, it remains low, suggesting that thrombolytic therapy is safe and necessary in these patients.