Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Sanchez, O; Charles-Nelson, A; Ageno, W; Barco, S; Binder, H; Chatellier, G; Duerschmied, D; Empen, K; Ferreira, M; Girard, P; Huisman, MV; Jiménez, D; Katsahian, S; Kozak, M; Lankeit, M; Meneveau, N; Pruszczyk, P; Petris, A; Righini, M; Rosenkranz, S; Schellong, S; Stefanovic, B; Verhamme, P; de, Wit, K; Vicaut, E; Zirlik, A; Konstantinides, SV; Meyer, G, , PEITHO-3, Investigators.
Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial.
Thromb Haemost. 2021;
Doi: 10.1055/a-1653-4699
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- Co-Autor*innen der Med Uni Graz
- Zirlik Andreas
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- 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.
- Find related publications in this database (Keywords)
- pulmonary embolism
- intermediate-high-risk
- reduced-dose thrombolysis
- prognosis
- randomized trial