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

Background: Non-immunogenic staphylokinase is a modified recombinant staphylokinase with low immunogenicity, high thrombolytic activity, and fibrin selectivity. Objectives: To assess the safety and efficacy of a single intravenous bolus of non-immunogenic staphylokinase compared with those of alteplase in patients with massive pulmonary embolism and hemodynamic instability. Methods: A randomized, open-label, multicenter, parallel-group, non-inferiority trial, the FORPE (FORtelyzin Pulmionary Embolism), 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 7 days of randomization. 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, 0.75; 95% CI, 0.11-4.49; 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 5 cases of major bleeding (3%; P = .09) in the alteplase group. Conclusion: Non-immunogenic staphylokinase was non-inferior to alteplase in patients with massive pulmonary embolism. Future observational studies are needed to assess its safety and efficacy. © 2024 International Society on Thrombosis and Haemostasis

Authors
Kirienko A.I. , Leontyev S.G. , Tereschenko S.N. , Yavelov I.S. , Shakhnovich R.M. , Erlikh A.D. , Talibov O.B. , Yarovaya E.B. , Semenov A.M. , Semenov M.P. , Ivanov S.V. , Beregovykh V.V. , Archakov A.I. , Markin S.S. , Klein H.V. , Veremeychuk P.V. , Tarkhanov R.V. , Ponomarev E.A. , Bobkov V.V. , Rabinovich R.M. , Pribylov S.A. , Sorokina A.S. , Komarnitskaya M.I. , Yu Chefranova Z. , Konstantinov S.L. , Stryabkova G.I. , Lykov Y.A. , Duplyakov D.V. , Mullova I.S. , Cherepanova N.A. , Orlov B.B. , Yasnopolskaya N.V. , Tolmacheva V.Y. , Imad M. , Teterina M.A. , Yu Vasilieva E. , Savvinova P.P. , Shogenov Z.S. , Agirov M.M. , Libov I.A. , Karabach Y.V. , Komarova A.G. , Igoshin A.S. , Kulabukhov V.V. , Zolkin V.N. , Bogomazov I.Y. , Omelchuk A.M. , Kashtalap V.V. , Pecherina T.B. , Linev K.A. , Ludnev L.O. , Vlasov P.N. , Oleynikov V.E. , Avdeeva I.A. , Panina E.S. , Maksimov D.B. , Komissarova E.V. , Solovyeva N.V. , Rybin E.V. , Ivanov V.S. , Furman N.V. , Kulibaba E.V. , Makukhin V.V. , Koledinskii A.G. , Vyazova N.L. , Vyshlov E.V. , Kurtasov D.S. , Kutsenko V.A. , Ivlev O.E. , Soplenkova A.G.
Journal
Journal of Thrombosis and Haemostasis
Publisher
Elsevier B.V.
Language
English
Status
Published
Link
External link
DOI
10.1016/J.JTHA.2024.09.035
Year
2024
Organizations
  • 1 Department of Faculty Surgery, N.I. Pirogov Russian National Research Medical University, Moscow, Russian Federation
  • 2 Department of Myocardial Diseases and Heart Failure, E.I. Chazov National Medical Research Center for Cardiology, Moscow, Russian Federation
  • 3 Department of Fundamental and Clinical Problems of Thrombosis in Non-infectious Diseases, National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russian Federation
  • 4 Department of Emergency Cardiology, E.I. Chazov National Medical Research Center for Cardiology, Moscow, Russian Federation
  • 5 Department of Faculty Therapy, N.I. Pirogov Russian National Research Medical University, Moscow, Russian Federation
  • 6 Department of Clinical Pharmacology, A.I. Evdokimov Moscow State University of Medicine and Dentistry, Moscow, Russian Federation
  • 7 Faculty of Mechanics and Mathematics, Department of Probability Theory, Lomonosov Moscow State University, Moscow, Russian Federation
  • 8 Scientific Department, Limited Liability Company “SuperGene,”, Moscow, Russian Federation
  • 9 Research and Production Department, Institute of Biomedical Chemistry, Moscow, Russian Federation
  • 10 Regional Clinical Hospital, Murmansk, Russian Federation
  • 11 City Clinical Hospital of Emergency No 25, Volgograd, Russian Federation
  • 12 Regional Clinical Hospital, Tver, Russian Federation
  • 13 Regional Clinical Hospital, Kursk, Russian Federation
  • 14 St Josaf's Regional Clinical Hospital, Belgorod, Russian Federation
  • 15 Belgorod State National Research University, Belgorod, Russian Federation
  • 16 V.P. Polyakov Regional Clinical Cardiology Dispensary, Samara, Russian Federation
  • 17 S.S. Yudin City Clinical Hospital, Moscow, Russian Federation
  • 18 V.V. Vinogradov City Clinical Hospital, Moscow, Russian Federation
  • 19 I.V. Davydovskii City Clinical Hospital, Moscow, Russian Federation
  • 20 V.V. Veresaev City Clinical Hospital, Moscow, Russian Federation
  • 21 S.P. Botkin City Clinical Hospital, Moscow, Russian Federation
  • 22 N.V. Sklifosovsky Research Institute for Emergency Medicine Moscow, Russian Federation
  • 23 D.D. Pletnev City Clinical Hospital Moscow, Russian Federation
  • 24 Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russian Federation
  • 25 Krasnoyarsk Regional Clinical Hospital, Krasnoyarsk, Russian Federation
  • 26 Penza Regional Clinical Hospital named after N.N. Burdenko, Penza, Russia
  • 27 Penza State University, Penza, Russian Federation
  • 28 G.A. Zakharyin Clinical Hospital №6, Penza, Russia
  • 29 G.A. Zakharyin Clinical Hospital №6, Penza, Russian Federation
  • 30 Mariinskaya City Hospital, Saint Petersburg, Russian Federation
  • 31 Holy Martyr Elizabeth City Hospital, Saint Petersburg, Russian Federation
  • 32 Regional Clinical Cardiology Dispensary, Saratov, Russian Federation
  • 33 City Clinical Hospital №4, Vladimir, Russian Federation
  • 34 Kuban State Medical University, Krasnodar, Russia
  • 35 V.F. Dolgopolov Vyselki Central District Hospital, Krasnodar Region, Russian Federation
  • 36 Russian University of Peoples' Friendship, Moscow, Russia
  • 37 Sergiev Posad Regional Clinical Hospital, Moscow Region, Russian Federation
  • 38 Lomonosov Moscow State University, Moscow, Russia
  • 39 National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russian Federation
Keywords
massive pulmonary embolism; non-immunogenic staphylokinase; randomized clinical trial; thrombolytic therapy
Cite
ГОСТ MLA RIS BibTex
Share

Other records

CCL METHOD IN LOWER LIMB CONTOURING

Article
Marinicheva I.G., Gritsyuk A.M., Magritt E.A., Manturova N.E., Ganshin I.B., Verbo E.V.
Пластическая хирургия и эстетическая медицина. Общество с ограниченной ответственностью Издательство Медиа Сфера. Vol. 2024. 2024. P. 39-44