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Reduced-Dose Intravenous Thrombolysis for Acute Intermediate–High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial
| Content Provider | Scilit |
|---|---|
| Author | Sanchez, Olivier Charles-Nelson, Anaïs Ageno, Walter Barco, Stefano Binder, Harald Chatellier, Gilles Duerschmied, Daniel Empen, Klaus Ferreira, Melanie Girard, Philippe Huisman, Menno V. Jiménez, 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. Meyer, Guy |
| Copyright Year | 2021 |
| 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.$ ^{†}$ Deceased. Received: 22 June 2021 Accepted: 28 July 2021 Accepted Manuscript online: 24 September 2021 Article published online: 31 October 2021 © 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/) Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany |
| Related Links | http://www.thieme-connect.de/products/ejournals/pdf/10.1055/a-1653-4699.pdf |
| Ending Page | 866 |
| Page Count | 10 |
| Starting Page | 857 |
| ISSN | 2567689X |
| DOI | 10.1055/a-1653-4699 |
| Journal | Thrombosis and Haemostasis |
| Issue Number | 05 |
| Volume Number | 122 |
| Language | English |
| Publisher | Georg Thieme Verlag KG |
| Publisher Date | 2021-09-24 |
| Access Restriction | Open |
| Subject Keyword | Journal: Thrombosis and Haemostasis Respiratory System Intermediate–high-risk Reduced-dose Thrombolysis |
| Content Type | Text |
| Resource Type | Article |
| Subject | Hematology |
