Sanchez, Olivier, Charles-Nelson, Anais, Ageno, Walter, Barco, Stefano ORCID: 0000-0002-2618-347X, Binder, Harald, Chatellier, Gilles, Duerschmied, Daniel, Empen, Klaus, Ferreira, Melanie, Girard, Philippe, Huisman, Menno, V, Jimenez, David, Katsahian, Sandrine, Kozak, Matija, Lankeit, Mareike, Meneveau, Nicolas, Pruszczyk, Piotr, Petris, Antoniu, Righini, Marc, Rosenkranz, Stephan, Schellong, Sebastian, Stefanovic, Branislav, Verhamme, Peter, de Wit, Kerstin, Vicaut, Eric, Zirlik, Andreas, Konstantinides, Stavros, V and Meyer, Guy . 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.. STUTTGART: GEORG THIEME VERLAG KG. ISSN 2567-689X

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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 <= 110mm 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Sanchez, OlivierUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Charles-Nelson, AnaisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ageno, WalterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Barco, StefanoUNSPECIFIEDorcid.org/0000-0002-2618-347XUNSPECIFIED
Binder, HaraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chatellier, GillesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Duerschmied, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Empen, KlausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ferreira, MelanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Girard, PhilippeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huisman, Menno, VUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jimenez, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Katsahian, SandrineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kozak, MatijaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lankeit, MareikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meneveau, NicolasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pruszczyk, PiotrUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Petris, AntoniuUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Righini, MarcUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rosenkranz, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schellong, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stefanovic, BranislavUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Verhamme, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Wit, KerstinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vicaut, EricUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zirlik, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Konstantinides, Stavros, VUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meyer, GuyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-607367
DOI: 10.1055/a-1653-4699
Journal or Publication Title: Thromb. Haemost.
Publisher: GEORG THIEME VERLAG KG
Place of Publication: STUTTGART
ISSN: 2567-689X
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
PLASMINOGEN-ACTIVATOR; RANDOMIZED-TRIAL; MULTICENTER TRIAL; EUROPEAN-SOCIETY; SINGLE-ARM; VALIDATION; ALTEPLASE; BOLUS; PROGNOSTICATION; STRATIFICATIONMultiple languages
Hematology; Peripheral Vascular DiseaseMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60736

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