OBJECTIVE
To evaluate the safety and efficacy of Fortelyzin thrombolytic drug (non-immunogenic staphylokinase) in AIS patients in an «extended» therapeutic window from 4.5 to 24 h from symptoms’ onset based on data from the FORPI registry.
MATERIAL AND METHODS
Functional outcomes and the risk of intracranial hemorrhage after thrombolytic therapy (TLT) for acute ischemic stroke (AIS) are known to be directly dependent on the treatment time initiation. Although the most safe and effective time for TLT is the first 4.5 h from symptoms’ onset, a significant proportion of patients are hospitalized beyond this time window. The objective of this study is The FORPI registry is an open-label, prospective, non-interventional observational study of Fortelyzin in AIS patients in real-world clinical practice. A comparative analysis of safety and efficacy outcomes was conducted in groups of patients who received TLT in the first 4.5 h after symptom onset and beyond 4.5 h time window. The safety endpoints were the rate of symptomatic intracranial hemorrhage (sICH) according to ECASS III and SITS-MOST criteria, as well as all-cause mortality at day 90. The efficacy endpoint was good functional recovery, defined by a modified Rankin Scale (mRS) of 0—2 score at day 90.
RESULTS
The analysis included 17.636 patients with TLT performed in the first 4.5 h after symptom onset and 358 patients with TLT performed beyond 4.5 h time window (up to 24 hours). In the group of patients with TLT performed in the interval of 4.5—24 hours, there were statistically significantly fewer people over 80 years old (8% vs 16%, p=0.001), and a lower median age (66 vs 68 years, p=0.002) compared with the group of TLT within 4.5 hours. The NIHSS median was slightly higher in the group of patients with TLT performed beyond 4.5 h time window (11 (8—16) vs 11 (8—15), p=0.036). The incidence of sICH (ECASS III) within 4.5 h was 2% compared with 2.5% beyond 4.5 h time window (p=0.454). All-cause mortality at 90 days in the main population was 9%, which is comparable with the mortality rate in the 4.5—24 h group — 7% (p=0.160). Good functional recovery (mSR 0—2) at day 90 was achieved in 61% of patients in the group who received TLT within 4.5 h, compared with 65% of patients who received TLT beyond 4.5 h time window (p=0.227).
CONCLUSION
FORPI registry demonstrates similar data on the safety and efficacy of TLT with Fortelyzin in AIS patients both within 4.5 hours and beyond 4.5 hours from symptoms’ onset.
