Evidence map›Paper›PMID 24716681›Full record

Trial reportThe New England journal of medicine2014

Fibrinolysis for patients with intermediate-risk pulmonary embolism.

Guy Meyer, Eric Vicaut, Thierry Danays, Giancarlo Agnelli, Cecilia Becattini, Jan Beyer-Westendorf, Erich Bluhmki, Helene Bouvaist, Benjamin Brenner, Francis Couturaud and 28 more

12 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 12 registered trials, which are not on this map. Cited by 597 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
597citing papers in PubMed, 7 pooled it
94.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00639743 phase3completednot on this map

Comparison Trial Evaluating Efficacy and Safety of Single i.v. Bolus Tenecteplase Plus Standard Anticoagulation as Compared With Standard Anticoagulation in Normotensive Patients

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2007 to 2014Enrolled1,005ConditionsPulmonary EmbolismArmsplacebo ( group B), tenecteplase (group A)
NCT02758574 nacompletednot on this mapstarted 2016, after this paper: background citation

Comparison of Standard Catheter Directed Thrombolysis vs. Ultrasound Assisted Thrombolysis for Patients With Acute Submassive Pulmonary Embolism

TypeinterventionalSponsorUniversity of PittsburghRan2016 to 2021Enrolled77ConditionsPulmonary EmbolismArmsCDT without ultrasound acceleration, CDT with ultrasound acceleration
NCT03389971 nacompletednot on this mapstarted 2017, after this paper: background citation

ULTRAsound-assisted Catheter vs. STAndaRd Catheter Thrombolysis for Submassive Pulmonary Embolism

TypeinterventionalSponsorPiedmont HealthcareRan2017 to 2020Enrolled10ConditionsSubmassive Pulmonary EmbolismArmscatheter-directed thrombolysis
NCT03465735 naterminatednot on this mapstarted 2017, after this paper: background citation

Efficacy and Safety of Vascular Boot Warming Program After Acute DVT±PE for Earlier Resolution of Venous Thromboembolism (VTE) and Prevention of Post Thrombotic Syndrome: A Pilot Study.

TypeinterventionalSponsorMayo ClinicRan2017 to 2020Enrolled15ConditionsAcute DVT of Lower ExtremityArmsVascular Boot, Standard of Care
NCT03988842 phase4terminatednot on this mapstarted 2019, after this paper: background citation

Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism

TypeinterventionalSponsorVictor Tapson, MDRan2019 to 2020Enrolled4ConditionsPulmonary Embolism With Acute Cor Pulmonale, Pulmonary Embolism, Pulmonary Embolism With Pulmonary Infarction, Pulmonary Embolism Subacute MassiveArmsAlteplase, Unfractionated heparin, Placebo, Apixaban
NCT04430569 phase3active not recruitingnot on this mapstarted 2021, after this paper: background citation

A Reduced Dose of Thrombolytic Treatment for Patients With Intermediate High-risk Acute Pulmonary Embolism: a Randomized Controled Trial

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2021 to 2028Enrolled800ConditionsPulmonary EmbolismArmsAlteplase, Placebo
NCT04480892 unknown statusnot on this mapstarted 2020, after this paper: background citation

Fibrinolytic Deficit in Patients With Acute Pulmonary Embolism

Typeobservational_patient_registrySponsorLoyola UniversityRan2020 to 2024Enrolled100ConditionsAcute Pulmonary Embolism, Fibrinolytic Deficit
NCT04558125 phase4terminatednot on this mapstarted 2020, after this paper: background citation

Low-Dose Tenecteplase in Covid-19 Patients With Acute Pulmonary Embolism: A Randomized, Double-Blind, Placebo-Controlled Trial

TypeinterventionalSponsorCedars-Sinai Medical CenterRan2020 to 2021Enrolled2ConditionsPulmonary Embolism, COVIDArmsTNKase, Placebo, Enoxaparin
NCT04790370 phase4active not recruitingnot on this mapstarted 2021, after this paper: background citation

A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study

TypeinterventionalSponsorBoston Scientific CorporationRan2021 to 2026Enrolled544ConditionsPulmonary EmbolismArmsAnticoagulation with heparin, EkoSonicTM Endovascular System
NCT05493163 phase4completednot on this mapstarted 2022, after this paper: background citation

A Multicentre, Randomized Trial of Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism (PRAGUE-26)

TypeinterventionalSponsorFaculty Hospital Kralovske VinohradyRan2022 to 2026Enrolled558ConditionsPulmonary EmbolismArmsThrombolytic, Standard anticoagulation
NCT05512702 unknown statusnot on this mapstarted 2022, after this paper: background citation

Treatment Approach in Patients Diagnosed With Pulmonary Thromboembolism With Intermediate-High Risk Interms of Early Mortality After the Establisment of Ege Pulmonary Embolism Team

TypeobservationalSponsorEge UniversityRan2022 to 2024Enrolled100ConditionsPulmonary EmbolismArmsTissue Plasminogen Activator, Alteplase, Low-molecular weight heparin
NCT06667882 nacompletednot on this mapstarted 2021, after this paper: background citation

Safe Delivery of Thrombolytic Treatment for Pulmonary Embolism Using ClotPro® Viscoelastic Tests

TypeinterventionalSponsorSemmelweis UniversityRan2021 to 2024Enrolled33ConditionsPulmonary Embolism Subacute Massive, Complication of Treatment, Fibrinolysis, HemorrhageArmsAlteplase Injectable Product
3 · Its place in the literature

Who cites it

597 citing papers in PubMed, 7 syntheses or guidelines pooled it, 1,601 citations in OpenAlex.

  1. Pooled it
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  6. Brazilian guidelines for the pharmacological treatment of pulmonary embolism. Official document of the Brazilian Thoracic Association based on the GRADE methodology.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2025
    Guideline
  7. Pooled it
  8. Trial
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  12. The 2026 pulmonary embolism guideline in a regional intensive care unit: Reading the recommendations without a catheter laboratory.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2026
    Article
  13. Article
  14. Article
  15. Review
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537 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

38 authors at 20 institutions in 16 countries.

Guy MeyerThe authors' affiliations are listed in the Appendix.
Eric Vicaut
Thierry Danays
Giancarlo Agnelli
Cecilia Becattini
Jan Beyer-Westendorf
Erich Bluhmki
Helene Bouvaist
Benjamin Brenner
Francis Couturaud
Claudia Dellas
Klaus Empen
Ana Franca
Nazzareno Galiè
Annette Geibel
Samuel Z Goldhaber
David Jimenez
Matija Kozak
Christian Kupatt
Nils Kucher
Irene M Lang
Mareike Lankeit
Nicolas Meneveau
Gerard Pacouret
Massimiliano Palazzini
Antoniu Petris
Piotr Pruszczyk
Matteo Rugolotto
Aldo Salvi
Sebastian Schellong
Mustapha Sebbane
Bozena Sobkowicz
Branislav S Stefanovic
Holger Thiele
Adam Torbicki
Franck Verschuren
Stavros V Konstantinides
PEITHO Investigators
University of Perugia · ITAzienda Ospedaliero Universitaria Ospedali Riuniti · ITBoehringer Ingelheim (Egypt) · EGBoehringer Ingelheim (France) · FRBrigham and Women's Hospital · USCa' Foncello Hospital · ITCentre Hospitalier Universitaire de Tours · FREuropean Hospital · ITHôpital Arnaud de Villeneuve · FRHospital Garcia de Orta · PTInstituto Ramón y Cajal de Investigación Sanitaria · ESJohannes Gutenberg University Mainz · DELeipzig Heart Institute · DELjubljana University Medical Centre · SILudwig-Maximilians-Universität München · DEMedical University of Białystok · PLMedical University of Warsaw · PLRambam Health Care Campus · ILSpitalul Clinic Judeţean de Urgenţe "Sf. Spiridon" Iaşi · ROUCLouvain · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial.

methodsIn a randomized, double-blind trial, we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism. Eligible patients had right ventricular dysfunction on echocardiography or computed tomography, as well as myocardial injury as indicated by a positive test for cardiac troponin I or troponin T. The primary outcome was death or hemodynamic decompensation (or collapse) within 7 days after randomization. The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after randomization.

resultsOf 1006 patients who underwent randomization, 1005 were included in the intention-to-treat analysis. Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; P=0.02). Between randomization and day 7, a total of 6 patients (1.2%) in the tenecteplase group and 9 (1.8%) in the placebo group died (P=0.42). Extracranial bleeding occurred in 32 patients (6.3%) in the tenecteplase group and 6 patients (1.2%) in the placebo group (P<0.001). Stroke occurred in 12 patients (2.4%) in the tenecteplase group and was hemorrhagic in 10 patients; 1 patient (0.2%) in the placebo group had a stroke, which was hemorrhagic (P=0.003). By day 30, a total of 12 patients (2.4%) in the tenecteplase group and 16 patients (3.2%) in the placebo group had died (P=0.42).

conclusionsIn patients with intermediate-risk pulmonary embolism, fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke. (Funded by the Programme Hospitalier de Recherche Clinique in France and others; PEITHO EudraCT number, 2006-005328-18; ClinicalTrials.gov number, NCT00639743.).

Indexed as

AgedAged, 80 and overAge FactorsDouble-Blind MethodDrug Therapy, CombinationFemaleFibrinolytic AgentsHemorrhageHeparinHumansMaleMiddle AgedPulmonary EmbolismRisk FactorsStrokeTenecteplaseFibrinolytic AgentsHeparinTenecteplaseTissue Plasminogen ActivatorTroponin

Identifiers

PMID24716681
OpenAlexW2159007980

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

and 6 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.