{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T21:37:29Z","timestamp":1792791449133,"version":"4.5.0"},"reference-count":40,"publisher":"Georg Thieme Verlag KG","issue":"05","license":[{"start":{"date-parts":[[2021,9,24]],"date-time":"2021-09-24T00:00:00Z","timestamp":1632441600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"German Federal Ministry of Education and Research","award":["BMBF 01EO1003"],"award-info":[{"award-number":["BMBF 01EO1003"]}],"id":[{"id":"https:\/\/ror.org\/04pz7b180","id-type":"ROR","asserted-by":"crossref"}]},{"name":"German Federal Ministry of Education and Research","award":["01EO1503"],"award-info":[{"award-number":["01EO1503"]}],"id":[{"id":"https:\/\/ror.org\/04pz7b180","id-type":"ROR","asserted-by":"crossref"}]},{"name":"French Ministry of Health","award":["PHRCN-16\u20130580"],"award-info":[{"award-number":["PHRCN-16\u20130580"]}]},{"DOI":"10.13039\/501100001659","name":"German Research Foundation","doi-asserted-by":"crossref","award":["Deutsche Forschungsgemeinschaft; KO 1939\/3\u20131"],"award-info":[{"award-number":["Deutsche Forschungsgemeinschaft; KO 1939\/3\u20131"]}],"id":[{"id":"10.13039\/501100001659","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000024","name":"Canadian Institutes of Health Research","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100000024","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100004837","name":"Spanish Ministry of Science and Innovation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100004837","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Life Sciences Research Partners (D. Collen Research Foundation), Belgium","id":[{"id":"https:\/\/ror.org\/05neag745","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Assistance Publique \u2013 H\u00f4pitaux de Paris","id":[{"id":"https:\/\/ror.org\/00pg5jh14","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Thromb Haemost"],"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Intermediate\u2013high-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\u2013high-risk PE will also fulfill at least one clinical criterion of severity: systolic blood pressure \u2264110\u2009mm Hg, respiratory rate &gt;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.<\/jats:p>","DOI":"10.1055\/a-1653-4699","type":"journal-article","created":{"date-parts":[[2021,9,24]],"date-time":"2021-09-24T18:52:23Z","timestamp":1632509543000},"page":"857-866","source":"Crossref","is-referenced-by-count":133,"title":["Reduced-Dose Intravenous Thrombolysis for Acute Intermediate\u2013High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial"],"prefix":"10.1055","volume":"122","clinical-trial-number":[{"clinical-trial-number":"nct04430569","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Olivier","family":"Sanchez","sequence":"additional","affiliation":[{"name":"AP-HP, h\u00f4pital europ\u00e9en Georges-Pompidou, Service de Pneumologie et de Soins Intensifs, APHP.Centre - Universit\u00e9 de Paris, Paris, France"},{"name":"INSERM UMR S 1140 Innovative Therapies in Hemostasis, Paris, France"},{"name":"Universit\u00e9 de Paris, Paris, France"},{"name":"FCRIN INNOVTE, St-Etienne, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana\u00efs","family":"Charles-Nelson","sequence":"additional","affiliation":[{"name":"AP-HP, h\u00f4pital europ\u00e9en Georges-Pompidou, Unit\u00e9 de Recherche Clinique, APHP.Centre, Paris, France"},{"name":"INSERM, Centre d'Investigation Clinique 1418 (CIC1418) \u00c9pid\u00e9miologie Clinique, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Ageno","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Insubria, Varese, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2618-347X","authenticated-orcid":false,"given":"Stefano","family":"Barco","sequence":"additional","affiliation":[{"name":"Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany"},{"name":"Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harald","family":"Binder","sequence":"additional","affiliation":[{"name":"Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg im Breisgau, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilles","family":"Chatellier","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Paris, Paris, France"},{"name":"AP-HP, h\u00f4pital europ\u00e9en Georges-Pompidou, Unit\u00e9 de Recherche Clinique, APHP.Centre, Paris, France"},{"name":"INSERM, Centre d'Investigation Clinique 1418 (CIC1418) \u00c9pid\u00e9miologie Clinique, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Duerschmied","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Angiology I, University Heart Center Freiburg - Bad Krozingen, Faculty of Medicine, University of Freiburg, Freiburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Klaus","family":"Empen","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, St\u00e4dtisches Klinikum Dessau, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"Ferreira","sequence":"additional","affiliation":[{"name":"Internal Medicine Department, Hospital Garcia de Orta, Almada, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Girard","sequence":"additional","affiliation":[{"name":"FCRIN INNOVTE, St-Etienne, France"},{"name":"D\u00e9partement Thoracique, Institut Mutualiste Montsouris, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Menno V.","family":"Huisman","sequence":"additional","affiliation":[{"name":"Department of Thrombosis and Hemostasis, Leiden University Medical Center, Dutch Thrombosis Network, Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Jim\u00e9nez","sequence":"additional","affiliation":[{"name":"Department of Respiratory Diseases, Ramon y Cajal Hospital, Universidad de Alcal\u00e1 (IRYCIS), CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandrine","family":"Katsahian","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Paris, Paris, France"},{"name":"AP-HP, h\u00f4pital europ\u00e9en Georges-Pompidou, Unit\u00e9 de Recherche Clinique, APHP.Centre, Paris, France"},{"name":"INSERM, Centre d'Investigation Clinique 1418 (CIC1418) \u00c9pid\u00e9miologie Clinique, Paris, France"},{"name":"INSERM UMR_S 1138 \u00e9quipe 22, Centre de Recherche des Cordeliers, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matija","family":"Kozak","sequence":"additional","affiliation":[{"name":"Department of Vascular Diseases, University Medical Center, Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mareike","family":"Lankeit","sequence":"additional","affiliation":[{"name":"Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany"},{"name":"Department of Internal Medicine, Vascular Medicine and Haemostaseology, Vivantes Klinikum im Friedrichshain, Berlin, Germany"},{"name":"Clinic of Cardiology and Pneumology, University Medical Center Goettingen, Goettingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Meneveau","sequence":"additional","affiliation":[{"name":"FCRIN INNOVTE, St-Etienne, France"},{"name":"Department of Cardiology, University Hospital Jean Minjoz, Besan\u00e7on, France"},{"name":"EA3920, University of Burgundy Franche-Comt\u00e9, Besan\u00e7on, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Pruszczyk","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Cardiology, Medical University of Warsaw, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoniu","family":"Petris","sequence":"additional","affiliation":[{"name":"Grigore T. Popa University of Medicine and Pharmacy Iasi, Cardiology Clinic, \u201cSt. Spiridon\u201d County Clinical Emergency Hospital, Iasi, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Righini","sequence":"additional","affiliation":[{"name":"Division of Angiology and Haemostasis, Geneva University Hospital, University of Geneva, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Rosenkranz","sequence":"additional","affiliation":[{"name":"Department III of Internal Medicine and Cologne Cardiovascular Research Center (CCRC), Cologne University Heart Center, Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Schellong","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine 2, Municipal Hospital Dresden, Dresden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Branislav","family":"Stefanovic","sequence":"additional","affiliation":[{"name":"Cardiology Clinic, Emergency Center, University Clinical Center of Serbia, School of Medicine University Belgrade, Belgrade, Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8698-2858","authenticated-orcid":false,"given":"Peter","family":"Verhamme","sequence":"additional","affiliation":[{"name":"Vascular Medicine and Haemostasis, Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kerstin","family":"de Wit","sequence":"additional","affiliation":[{"name":"Department of Medicine, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Vicaut","sequence":"additional","affiliation":[{"name":"AP-HP, Unit\u00e9 de Recherche Clinique St-Louis-Lariboisi\u00e8re, Universit\u00e9 Denis Diderot, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Zirlik","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6359-7279","authenticated-orcid":false,"given":"Stavros V.","family":"Konstantinides","sequence":"additional","affiliation":[{"name":"Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany"},{"name":"Department of Cardiology, Democritus University of Thrace, Alexandroupolis, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guy","family":"Meyer","sequence":"additional","affiliation":[{"name":"AP-HP, h\u00f4pital europ\u00e9en Georges-Pompidou, Service de Pneumologie et de Soins Intensifs, APHP.Centre - 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