ArticleJournal of vascular surgery. Venous and lymphatic disorders2018
Design and rationale of a randomized trial comparing standard versus ultrasound-assisted thrombolysis for submassive pulmonary embolism.
Article in Journal of vascular surgery. Venous and lymphatic disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Catheter-directed therapies for the treatment of high risk (massive) and intermediate risk (submassive) acute pulmonary embolism.The Cochrane database of systematic reviews · 2022Pooled it
- Randomized Trial Comparing Standard Versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism: The SUNSET sPE Trial.JACC. Cardiovascular interventions · 2021Trial
- Evolving Management Trends and Outcomes in Catheter Management of Acute Pulmonary Embolism.Journal of cardiothoracic and vascular anesthesia · 2022Review
- EKOS™ Jena Experience: Safety, Feasibility, and Midterm Outcomes of Percutaneous Ultrasound-Assisted Catheter-Directed Thrombolysis in Patients with Intermediate-High-Risk or High-Risk Pulmonary Embolism.Canadian respiratory journal · 2022Article
- Concise Review of the Rationale for Pulmonary Embolism Treatment and Endovascular Device Therapies.Current cardiology reviews · 2022Review
- Ultrasound-accelerated thrombolysis in high-risk perioperative pulmonary embolism: two case reports and review of literature.Perioperative medicine (London, England) · 2021Article
- Contemporary Catheter-Based Treatment Options for Management of Acute Pulmonary Embolism.Current treatment options in cardiovascular medicine · 2021Review
- Article
- Treatment of a Child With Submassive Pulmonary Embolism Associated With Hereditary Spherocytosis Using Ultrasound-Assisted Catheter-Directed Thrombolysis.Ochsner journal · 2019Article
- Diagnosis, Treatment and Follow Up of Acute Pulmonary Embolism: Consensus Practice from the PERT Consortium.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundCatheter-directed interventions for the treatment of patients with submassive pulmonary embolism (sPE) have shown promise in rapidly improving right-sided heart strain and preventing decompensation to massive pulmonary embolism. Among various catheter interventions, ultrasound-assisted thrombolysis (USAT) has attracted interest as potentially having more efficient lytic effect that could achieve thrombolysis faster and with a reduced lytic dose. However, based on clinical evidence, it is unclear whether USAT is superior to standard catheter-directed thrombolysis (SCDT). We herein describe the study design of the Standard vs UltrasouNd-assiSted CathEter Thrombolysis for Submassive Pulmonary Embolism (SUNSET sPE) trial, an ongoing randomized clinical trial designed to address this question.
methodsAdults with sPE presenting or referred to our institution are considered for enrollment in the trial. At the discretion of the treatment team, all patients undergo a catheter-directed intervention plus concomitant therapeutic anticoagulation. Participants are randomized 1:1 to a USAT catheter or an SCDT catheter. Study assessors are blinded to treatment group. The primary outcome is clearance of pulmonary thrombus burden, assessed by postprocedure computed tomography angiography. Secondary outcomes include resolution of right ventricular strain by echocardiography; improvement in pulmonary artery pressures; and 3- and 12-month improvement in echocardiographic, functional capacity, and quality of life measures. The study is powered to detect a 50% improvement in pulmonary artery thrombus clearance. Our enrollment target is 40 patients per treatment arm.
conclusionsSUNSET sPE is an ongoing randomized, head-to-head, single-blinded clinical trial with the goal of assessing whether USAT results in superior thrombus clearance compared with SCDT in patients with sPE. We expect the results of our study to inform future guidelines on choice of thrombolysis modality in this population of challenging patients.
Indexed as
Identifiers
What OpenQuestion holds
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.