Evidence map›Paper›PMID 24226805›Full record

Trial reportCirculation2014

Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism.

Nils Kucher, Peter Boekstegers, Oliver J Müller, Christian Kupatt, Jan Beyer-Westendorf, Thomas Heitzer, Ulrich Tebbe, Jan Horstkotte, Ralf Müller, Erwin Blessing and 9 more

12 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Circulation, 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 432 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
432citing papers in PubMed, 11 pooled it
37.3field-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.

NCT01166997 phase3completednot on this map

Randomized, Controlled Study Comparing EKOS EkoSonic Ultrasound Accelerated Thrombolysis to Anticoagulation in the Treatment of Sub-massive Pulmonary Embolism

TypeinterventionalSponsorBoston Scientific CorporationRan2010 to 2013Enrolled59ConditionsSubmassive Pulmonary EmbolismArmsEkoSonic Endovascular System, Unfractionated heparin
NCT02506985 phase4terminatednot on this mapstarted 2015, after this paper: background citation

XENITH: Rivaroxaban for Pulmonary Embolism Managed With Catheter Directed Thrombolysis

TypeinterventionalSponsorSusan SmythRan2015 to 2016Enrolled10ConditionsPulmonary Embolism, Venous ThrombosisArmsrivaroxaban, warfarin
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
NCT03341208 unknown statusnot on this mapstarted 2017, after this paper: background citation

Quantitative Assessment of Right Ventricular Strain Utilizing Cardiac Magnetic Resonance Imaging: Development of an Optimal Measure of Treatment Response Following Catheter-directed Interventions on Sub-massive Pulmonary Embolism.

TypeobservationalSponsorUniversity of ArizonaRan2017 to 2019Enrolled10ConditionsRight Ventricular Failure, Pulmonary EmbolismArmsCardiac Magnetic Resonance Imaging
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
NCT03581877 phase4active not recruitingnot on this mapstarted 2019, after this paper: background citation

Peripheral Low Dose Systemic Thrombolysis Versus Catheter Directed Acoustic Pulse Thrombolysis for Treatment of Submassive Pulmonary Embolism

TypeinterventionalSponsorNorthwell HealthRan2019 to 2025Enrolled31ConditionsPulmonary Embolism, Pulmonary Hypertension, Thromboembolism, Right Ventricular DysfunctionArmsAlteplase, EKOS
NCT03854266 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Low Dose Catheter Directed Thrombolysis for Acute Intermediary-high Risk Pulmonary Embolism

TypeinterventionalSponsorUniversity of AarhusRan2020 to 2024Enrolled60ConditionsPulmonary EmbolismArmsLow dose alteplase, Unfractionated heparin, Infusion catheter
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
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
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
NCT07452991 narecruitingnot on this mapstarted 2024, after this paper: background citation

ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With Pulmonary Embolism

TypeinterventionalSponsorNational Medical Research Center for Cardiology, Ministry of Health of Russian FederationRan2024 to 2030Enrolled300ConditionsPulmonary Embolism (PE)ArmsUltrasound-assisted Catheter-guided Thrombolysis
3 · Its place in the literature

Who cites it

432 citing papers in PubMed, 11 syntheses or guidelines pooled it, 1,073 citations in OpenAlex.

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372 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 5 institutions in 1 country.

Nils KucherDivision of Vascular Medicine, Swiss Cardiovascular Center, University Hospital Bern, Bern, Switzerland (N.K., I.B.); Helios Hospital Siegburg, Siegburg, Germany (P.B., J.H., R.M.); Internal Medicine III, University Hospital Heidelberg, Heidelberg, Germany (O.J.M., E.B.); Großhadern Hospital, Ludwig-Maximilians University Munich, Munich, Germany (C.K., M.G., P.L.); University Hospital Carl Gustav Carus of Technical University Dresden, Dresden, Germany (J.B.-W., R.H., S.W.); Dortmund Hospital, Dortmund, Germany (T.H., A.B.); Hospital Lippe-Detmold, Detmold, Germany (U.T., D.H.); and University Hospital of Ernst-Moritz-Arndt University, Greifswald, Germany (H.G., K.E.).
Peter Boekstegers
Oliver J Müller
Christian Kupatt
Jan Beyer-Westendorf
Thomas Heitzer
Ulrich Tebbe
Jan Horstkotte
Ralf Müller
Erwin Blessing
Martin Greif
Philipp Lange
Ralf-Thorsten Hoffmann
Sebastian Werth
Achim Barmeyer
Dirk Härtel
Henriette Grünwald
Klaus Empen
Iris Baumgartner
Klinikum Lippe · DEKlinikum Dortmund · DEHeidelberg University · DEUniversity Hospital Heidelberg · DEHelios Hospital Siegburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with acute pulmonary embolism, systemic thrombolysis improves right ventricular (RV) dilatation, is associated with major bleeding, and is withheld in many patients at risk. This multicenter randomized, controlled trial investigated whether ultrasound-assisted catheter-directed thrombolysis (USAT) is superior to anticoagulation alone in the reversal of RV dilatation in intermediate-risk patients. METHODS AND

resultsFifty-nine patients (63±14 years) with acute main or lower lobe pulmonary embolism and echocardiographic RV to left ventricular dimension (RV/LV) ratio ≥1.0 were randomized to receive unfractionated heparin and an USAT regimen of 10 to 20 mg recombinant tissue plasminogen activator over 15 hours (n=30; USAT group) or unfractionated heparin alone (n=29; heparin group). Primary outcome was the difference in the RV/LV ratio from baseline to 24 hours. Safety outcomes included death, major and minor bleeding, and recurrent venous thromboembolism at 90 days. In the USAT group, the mean RV/LV ratio was reduced from 1.28±0.19 at baseline to 0.99±0.17 at 24 hours (P<0.001); in the heparin group, mean RV/LV ratios were 1.20±0.14 and 1.17±0.20, respectively (P=0.31). The mean decrease in RV/LV ratio from baseline to 24 hours was 0.30±0.20 versus 0.03±0.16 (P<0.001), respectively. At 90 days, there was 1 death (in the heparin group), no major bleeding, 4 minor bleeding episodes (3 in the USAT group and 1 in the heparin group; P=0.61), and no recurrent venous thromboembolism.

conclusionsIn patients with pulmonary embolism at intermediate risk, a standardized USAT regimen was superior to anticoagulation with heparin alone in reversing RV dilatation at 24 hours, without an increase in bleeding complications. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01166997.

Indexed as

Ultrasonography, InterventionalVascular Access DevicesAcute DiseaseAgedDose-Response Relationship, DrugDrug Therapy, CombinationFemaleHemorrhageHeparinHumansMaleMiddle AgedOutcome Assessment, Health CarePulmonary EmbolismRecombinant ProteinsRisk FactorsHeparinRecombinant ProteinsTissue Plasminogen Activatorpulmonary embolism

Identifiers

PMID24226805
OpenAlexW2011611174

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.