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

IF 5.5 2区 医学 Q1 HEMATOLOGY
Alexander I Kirienko, Stanislav G Leontyev, Sergey N Tereschenko, Igor S Yavelov, Roman M Shakhnovich, Alexey D Erlikh, Oleg B Talibov, Elena B Yarovaya, Andrey M Semenov, Michail P Semenov, Sergey V Ivanov, Valery V Beregovykh, Alexander I Archakov, Sergey S Markin
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引用次数: 0

Abstract

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.

治疗大面积肺栓塞患者的非免疫原性重组葡萄球菌激酶与阿替普酶:随机开放标签、多中心、平行分组、非劣效试验 FORPE。
背景:非免疫原性葡萄激酶是一种改良重组葡萄激酶,具有低免疫原性、高溶栓活性和纤维蛋白选择性。目的:评估大面积肺栓塞和血流动力学不稳定患者单次静脉注射非免疫原性葡萄激酶与阿替普酶相比的安全性和有效性:FORPE是一项随机、开放标签、多中心、平行组、非劣效试验,在俄罗斯进行。共纳入了 310 名 18 岁及以上、经计算机断层扫描肺动脉造影确诊为大面积肺栓塞和右心室功能障碍的患者。这些患者被随机分配接受非免疫原性葡萄激酶(15 毫克)或阿替普酶(100 毫克),两种药物均静脉注射。主要疗效终点是随机分配后七天内死于各种原因:共有155名患者被随机分配接受非免疫原性葡萄激酶治疗,155名患者接受阿替普酶治疗。在非免疫原性葡萄激酶组中,意向治疗人群的主要疗效终点为2%,而阿替普酶组为3%(几率比[OR]0.75,95%置信区间[CI]0.11至4.49;P=1.00)。主要疗效终点的差异为0.6%(95%CI -2.8至4.0)。因此,95%CI 的下限并未超过非劣效边界。非免疫原性葡萄激酶组没有大出血病例记录,而阿替普酶组有5例大出血病例(3%,P=0.09):结论:在大面积肺栓塞患者中,非免疫原性葡萄激酶的疗效并不优于阿替普酶。今后需要开展观察性研究,以评估其安全性和有效性。
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来源期刊
Journal of Thrombosis and Haemostasis
Journal of Thrombosis and Haemostasis 医学-外周血管病
CiteScore
24.30
自引率
3.80%
发文量
321
审稿时长
1 months
期刊介绍: The Journal of Thrombosis and Haemostasis (JTH) serves as the official journal of the International Society on Thrombosis and Haemostasis. It is dedicated to advancing science related to thrombosis, bleeding disorders, and vascular biology through the dissemination and exchange of information and ideas within the global research community. Types of Publications: The journal publishes a variety of content, including: Original research reports State-of-the-art reviews Brief reports Case reports Invited commentaries on publications in the Journal Forum articles Correspondence Announcements Scope of Contributions: Editors invite contributions from both fundamental and clinical domains. These include: Basic manuscripts on blood coagulation and fibrinolysis Studies on proteins and reactions related to thrombosis and haemostasis Research on blood platelets and their interactions with other biological systems, such as the vessel wall, blood cells, and invading organisms Clinical manuscripts covering various topics including venous thrombosis, arterial disease, hemophilia, bleeding disorders, and platelet diseases Clinical manuscripts may encompass etiology, diagnostics, prognosis, prevention, and treatment strategies.
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