Reduced-Dose Intravenous Thrombolysis for Acute Intermediate–High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial - Université Paris Cité Accéder directement au contenu
Article Dans Une Revue Thrombosis and Haemostasis Année : 2022

Reduced-Dose Intravenous Thrombolysis for Acute Intermediate–High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial

1 HEGP - Hôpital Européen Georges Pompidou [APHP]
2 IThEM - U1140 - Innovations thérapeutiques en hémostase = Innovative Therapies in Haemostasis
3 F-Crin Innovte [CHU Saint-Etienne]
4 CIC 1418 - CIC - HEGP
5 Uninsubria - Universitá degli Studi dell’Insubria = University of Insubria [Varese]
6 University Medical Center [Mainz]
7 University hospital of Zurich [Zurich]
8 University of Freiburg [Freiburg]
9 EPE - Hospital Garcia de Orta
10 IMM - Institut Mutualiste de Montsouris
11 LUMC - Leiden University Medical Center
12 UAH - Universidad de Alcalá - University of Alcalá
13 CRC (UMR_S_1138 / U1138) - Centre de Recherche des Cordeliers
14 UMCL - University Medical Centre Ljubljana [Ljubljana, Slovenia]
15 VKF - Vivantes Klinikum Friedrichshain [Berlin, Germany]
16 UMG - University Medical Center Göttingen
17 Department of Cardiology, University Hospital Jean Minjoz
18 PCVP / CARDIO - Marqueurs pronostiques et facteurs de régulations des pathologies cardiaques et vasculaires - UFC ( UR 3920)
19 Medical University of Warsaw - Poland
20 UMF lasi - University of Medicine and Pharmacy "Grigore T.Popa" Iasi
21 HUG - Geneva University Hospital
22 UNIGE - Université de Genève = University of Geneva
23 University of Cologne
24 Municipal Hospital DRESDEN
25 University of Belgrade [Belgrade]
26 University Hospitals Leuven [Leuven]
27 McMaster University [Hamilton, Ontario]
28 Hôpitaux Universitaire Saint-Louis, Lariboisière, Fernand-Widal
29 UPD7 - Université Paris Diderot - Paris 7
30 Medical University of Graz
31 DUTH - Democritus University of Thrace
Klaus Empen
  • Fonction : Auteur
Peter Verhamme

Résumé

Abstract Intermediate–high-risk pulmonary embolism (PE) is characterized by right ventricular (RV) dysfunction and elevated circulating cardiac troponin levels despite apparent hemodynamic stability at presentation. In these patients, full-dose systemic thrombolysis reduced the risk of hemodynamic decompensation or death but increased the risk of life-threatening bleeding. Reduced-dose thrombolysis may be capable of improving safety while maintaining reperfusion efficacy. The Pulmonary Embolism International THrOmbolysis (PEITHO)-3 study (ClinicalTrials.gov Identifier: NCT04430569) is a randomized, placebo-controlled, double-blind, multicenter, multinational trial with long-term follow-up. We will compare the efficacy and safety of a reduced-dose alteplase regimen with standard heparin anticoagulation. Patients with intermediate–high-risk PE will also fulfill at least one clinical criterion of severity: systolic blood pressure ≤110 mm Hg, respiratory rate >20 breaths/min, or history of heart failure. The primary efficacy outcome is the composite of all-cause death, hemodynamic decompensation, or PE recurrence within 30 days of randomization. Key secondary outcomes, to be included in hierarchical analysis, are fatal or GUSTO severe or life-threatening bleeding; net clinical benefit (primary efficacy outcome plus severe or life-threatening bleeding); and all-cause death, all within 30 days. All outcomes will be adjudicated by an independent committee. Further outcomes include PE-related death, hemodynamic decompensation, or stroke within 30 days; dyspnea, functional limitation, or RV dysfunction at 6 months and 2 years; and utilization of health care resources within 30 days and 2 years. The study is planned to enroll 650 patients. The results are expected to have a major impact on risk-adjusted treatment of acute PE and inform guideline recommendations.
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Dates et versions

hal-03825944 , version 1 (16-12-2023)

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Olivier Sanchez, Anaïs Charles-Nelson, Walter Ageno, Stefano Barco, Harald Binder, et al.. Reduced-Dose Intravenous Thrombolysis for Acute Intermediate–High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial. Thrombosis and Haemostasis, 2022, 122 (05), pp.857-866. ⟨10.1055/a-1653-4699⟩. ⟨hal-03825944⟩
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