Non-immunogenic recombinant staphylokinase versus alteplase for patients with massive pulmonary embolism: a randomised open-label, multicentre, parallel-group, non-inferiority trial FORPE.

Autor:	Kirienko AI; Department of faculty surgery, N.I. Pirogov Russian National Research Medical University, Moscow, Russia., Leontyev SG; Department of faculty surgery, N.I. Pirogov Russian National Research Medical University, Moscow, Russia. Electronic address: LeontievSG2024@yandex.ru., Tereschenko SN; Department of myocardial diseases and heart failure, E.I. Chazov National Medical Research Center for Cardiology, Moscow, Russia., Yavelov IS; Department of fundamental and clinical problems of thrombosis in non-infectious diseases, National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia., Shakhnovich RM; Department of emergency cardiology, E.I. Chazov National Medical Research Center for Cardiology, Moscow, Russia., Erlikh AD; Department of faculty therapy, N.I. Pirogov Russian National Research Medical University, Moscow, Russia., Talibov OB; Department of clinical pharmacology, A.I. Evdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia., Yarovaya EB; Department of fundamental and clinical problems of thrombosis in non-infectious diseases, National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia; Faculty of mechanics and mathematics, Lomonosov Moscow State University, Moscow, Russia., Semenov AM; LLC 'SuperGene', Moscow, Russia., Semenov MP; LLC 'SuperGene', Moscow, Russia., Ivanov SV; LLC 'SuperGene', Moscow, Russia; Institute of Biomedical Chemistry, Moscow, Russia., Beregovykh VV; Institute of Biomedical Chemistry, Moscow, Russia., Archakov AI; Institute of Biomedical Chemistry, Moscow, Russia., Markin SS; LLC 'SuperGene', Moscow, Russia; Institute of Biomedical Chemistry, Moscow, Russia.
Jazyk:	angličtina
Zdroj:	Journal of thrombosis and haemostasis : JTH [J Thromb Haemost] 2024 Oct 23. Date of Electronic Publication: 2024 Oct 23.
DOI:	10.1016/j.jtha.2024.09.035
Abstrakt:	Background: Non-immunogenic staphylokinase is a modified recombinant staphylokinase with low immunogenicity, high thrombolytic activity, and fibrin selectivity. Aim: To assess the safety and efficacy of a single intravenous bolus of non-immunogenic staphylokinase compared to those of alteplase in patients with massive pulmonary embolism and haemodynamic instability. Patients and Methods: A randomised, open-label, multicentre, parallel-group, non-inferiority trial, the FORPE was conducted in Russia. A total of 310 patients aged 18 years and older with computed tomography pulmonary angiography confirmed diagnosis of massive pulmonary embolism and right ventricular dysfunction were included. The patients were randomly assigned to receive either non-immunogenic staphylokinase (15 mg) or alteplase (100 mg), both administered intravenously. The primary efficacy endpoint was death from all causes within seven days of randomisation. Results: A total of 155 patients were randomly assigned to receive non-immunogenic staphylokinase, and 155 received alteplase. In the non-immunogenic staphylokinase group, the primary efficacy endpoint was 2% in the intention-to-treat population, while in the alteplase group it was 3% (odds ratio [OR] 0.75, 95% confidence interval [CI] 0.11 to 4.49; p=1.00). The difference in the primary efficacy endpoint was 0.6% (95%CI -2.8 to 4.0). Thus, the lower limit of the 95%CI did not cross the margin of non-inferiority. No cases of major bleeding were recorded in the non-immunogenic staphylokinase group, whereas there were five cases of major bleeding (3%, p=0.09) in the alteplase group. Conclusions: Non-immunogenic staphylokinase was non-inferior to alteplase in patients with massive pulmonary embolism. Future observational studies are needed to assess it safety and efficacy. (Copyright © 2024. Published by Elsevier Inc.)
Databáze:	MEDLINE
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