Evidence map›Paper›PMID 34167677›Full record

Trial reportJACC. Cardiovascular interventions2021

Randomized Trial Comparing Standard Versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism: The SUNSET sPE Trial.

Efthymios D Avgerinos, Wissam Jaber, Joan Lacomis, Kyle Markel, Michael McDaniel, Belinda N Rivera-Lebron, Charles B Ross, Jacob Sechrist, Catalin Toma, Rabih Chaer and 1 more

Erratum issued Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in JACC. Cardiovascular interventions, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05493163 (A Multicentre, Randomized Trial of Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism), which is not on this map. Cited by 99 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 5 pooled it
23.4field-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.

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
3 · Its place in the literature

Who cites it

99 citing papers in PubMed, 5 syntheses or guidelines pooled it, 176 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Efthymios D AvgerinosDivision of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA. Electronic address: avgerinose@upmc.edu.
Wissam JaberDivision of Cardiology, Department of Medicine, Emory University, Atlanta, Georgia, USA.
Joan LacomisDepartment of Radiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Kyle MarkelDivision of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Michael McDanielDivision of Cardiology, Department of Medicine, Emory University, Atlanta, Georgia, USA.
Belinda N Rivera-LebronDivision of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Charles B RossDivision of Cardiology, Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Jacob SechristDepartment of Radiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Catalin TomaPiedmont Heart Institute, Atlanta, Georgia, USA.
Rabih ChaerDivision of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
SUNSET sPE Collaborators
University of Pittsburgh Medical Center · USEmory University · USPiedmont Atlanta Hospital · US

Funding

Vascular Surgery Research Training (VascTrain) ProgramT32HL098036 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Edith Tzeng · 2010 to 2026
$7.2M
NHLBI NIH HHS T32 HL098036
6 · The paper itself

Abstract

objectivesThe aim of this trial was to determine whether ultrasound-assisted thrombolysis (USAT) is superior to standard catheter-directed thrombolysis (SCDT) in pulmonary arterial thrombus reduction for patients with submassive pulmonary embolism (sPE).

backgroundCatheter-directed therapy has been increasingly used in sPE and massive pulmonary embolism as a decompensation prevention and potentially lifesaving procedure. It is unproved whether USAT is superior to SCDT using traditional multiple-side-hole catheters in the treatment of patients with pulmonary embolism.

methodsAdults with sPE were enrolled. Participants were randomized 1:1 to USAT or SCDT. The primary outcome was 48-hour clearance of pulmonary thrombus assessed by pre- and postprocedural computed tomographic angiography using a refined Miller score. Secondary outcomes included improvement in right ventricular-to-left ventricular ratio, intensive care unit and hospital stay, bleeding, and adverse events up to 90 days.

resultsEighty-one patients with acute sPE were randomized and were available for analysis. The mean total dose of alteplase for USAT was 19 ± 7 mg and for SCDT was 18 ± 7 mg (P = 0.53), infused over 14 ± 6 and 14 ± 5 hours, respectively (P = 0.99). In the USAT group, the mean raw pulmonary arterial thrombus score was reduced from 31 ± 4 at baseline to 22 ± 7 (P < 0.001). In the SCDT group, the score was reduced from 33 ± 4 to 23 ± 7 (P < 0.001). There was no significant difference in mean thrombus score reduction between the 2 groups (P = 0.76). The mean reduction in right ventricular/left ventricular ratio from baseline (1.54 ± 0.30 for USAT, 1.69 ± 0.44 for SCDT) to 48 hours was 0.37 ± 0.34 in the USAT group and 0.59 ± 0.42 in the SCDT group (P = 0.01). Major bleeding (1 stroke and 1 vaginal bleed requiring transfusion) occurred in 2 patients, both in the USAT group.

conclusionsIn the SUNSET sPE (Standard vs. Ultrasound-Assisted Catheter Thrombolysis for Submassive Pulmonary Embolism) trial, patients undergoing USAT had similar pulmonary arterial thrombus reduction compared with those undergoing SCDT, using comparable mean lytic doses and durations of lysis.

Indexed as

Pulmonary EmbolismThrombolytic TherapyAdultFemaleHumansRetrospective StudiesTissue Plasminogen ActivatorTreatment OutcomeTissue Plasminogen Activatorcatheter thrombolysisEKOSpulmonary embolismpulmonary hypertensionultrasound-assisted thrombolysis

Identifiers

PMID34167677
PMCPMC9057455
OpenAlexW3176419677

What OpenQuestion holds

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Registered trials

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.