Trial reportJACC. Cardiovascular interventions2018
A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial.
Trial report in JACC. Cardiovascular interventions, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 230 papers, 10 of them syntheses that pooled it.
What it found
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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.
Study of the OPTtimum Duration of Acoustic Pulse ThromboLYSis ProcEdure in the Treatment of Acute Submassive Pulmonary Embolism
Low Dose Catheter Directed Thrombolysis for Acute Intermediary-high Risk Pulmonary Embolism
Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism
Quantitative 3-Dimensional Chest CT Vascular Reconstruction Before and After Anticoagulation for Pulmonary Embolism (OPTALYSE-3DAC)
Fibrinolytic Deficit in Patients With Acute Pulmonary Embolism
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
A Multicentre, Randomized Trial of Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism (PRAGUE-26)
Who cites it
230 citing papers in PubMed, 10 syntheses or guidelines pooled it, 453 citations in OpenAlex.
- Catheter-directed thrombolysis versus anticoagulation for intermediate-risk and high-risk pulmonary embolism: a systematic review and meta-analysis.Open heart · 2026Pooled it
- Efficacy and safety of low-dose thrombolysis in intermediate-risk pulmonary embolism: a meta-analysis.Frontiers in cardiovascular medicine · 2026Pooled it
- Comparison of safety and efficacy of ultrasound-accelerated thrombolysis vs. standard catheter-directed thrombolysis for the management of acute pulmonary embolism - a systematic review and meta-analysis.Journal of thrombosis and thrombolysis · 2025Pooled it
- The use of Veno-arterial Extracorporeal Membrane Oxygenation (VA-ECMO) for Acute High Risk Pulmonary Embolism: A Systematic Review.Current cardiology reviews · 2025Pooled it
- Current Insights for Catheter-Directed Therapies in Acute Pulmonary Embolism: Systematic Review and Our Single-Center Experience.Anatolian journal of cardiology · 2023Pooled it
- Role of Intravascular Ultrasound in Pulmonary Embolism Patients Undergoing Mechanical Thrombectomy: A Systematic Review.Tomography (Ann Arbor, Mich.) · 2023Pooled it
- Mortality and bleeding associated with the management of sub-massive pulmonary embolism: a systematic review and Bayesian network meta-analysis.Scientific reports · 2023Pooled it
- 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
- Clinical outcomes of very elderly patients treated with ultrasound-assisted catheter-directed thrombolysis for pulmonary embolism: a systematic review.Journal of thrombosis and thrombolysis · 2021Pooled it
- Thrombolytic therapy for pulmonary embolism.The Cochrane database of systematic reviews · 2021Pooled it
- Trial
- Randomized Trial Comparing Standard Versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism: The SUNSET sPE Trial.JACC. Cardiovascular interventions · 2021Trial
- Massive pulmonary embolism in patients with extreme bleeding risk: a case series on the successful use of ultrasound-assisted, catheter directed thrombolysis in a district general hospital.Journal of thrombosis and thrombolysis · 2021Trial
- One-Year Echocardiographic, Functional, and Quality of Life Outcomes After Ultrasound-Facilitated Catheter-Based Fibrinolysis for Pulmonary Embolism.Circulation. Cardiovascular interventions · 2020Trial
- Optimal Duration of Ultrasound-Facilitated Catheter-Directed Thrombolysis for Acute Pulmonary Embolism: A Retrospective Cohort Study.Biomedicines · 2026Article
- The Evolving Landscape of Pulmonary Vascular Disease: Current Advances and Future Directions in Pulmonary Hypertension and Pulmonary Embolism.Life (Basel, Switzerland) · 2026Article
- Impact of a pulmonary embolism response team on the management of acute pulmonary embolism: a retrospective observational study.Research and practice in thrombosis and haemostasis · 2026Article
- Catheter-Based Therapies for Intermediate-High Risk Pulmonary Embolism: A Protocol for a Systematic Review With Bayesian Pairwise and Network Meta-Analyses.Acta anaesthesiologica Scandinavica · 2026Review
- Ultrasound-Mediated Thrombolysis: From Mechanistic Insights to Advanced Nanoplatforms and Clinical Translation.Advanced healthcare materials · 2026Review
- How patient profile and hospital setting drive pulmonary embolism treatment modality.Journal of vascular surgery. Venous and lymphatic disorders · 2026Article
170 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
19 authors at 18 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe aim of this study was to determine the lowest optimal tissue plasminogen activator (tPA) dose and delivery duration using ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk (submassive) pulmonary embolism.
backgroundPrevious trials of USCDT used tPA over 12 to 24 h at doses of 20 to 24 mg for acute pulmonary embolism.
methodsHemodynamically stable adults with acute intermediate-risk pulmonary embolism documented by computed tomographic angiography were randomized into this prospective multicenter, parallel-group trial. Patients received treatment with 1 of 4 USCDT regimens. The tPA dose ranged from 4 to 12 mg per lung and infusion duration from 2 to 6 h. The primary efficacy endpoint was reduction in right ventricular-to-left ventricular diameter ratio by computed tomographic angiography. A major secondary endpoint was embolic burden by refined modified Miller score, measured on computed tomographic angiography 48 h after initiation of USCDT.
resultsOne hundred one patients were randomized, and improvements in right ventricular-to-left ventricular diameter ratio were as follows: arm 1 (4 mg/lung/2 h), 0.40 (24%; p = 0.0001); arm 2 (4 mg/lung/4 h), 0.35 (22.6%; p = 0.0001); arm 3 (6 mg/lung/6 h), 0.42 (26.3%; p = 0.0001); and arm 4 (12 mg/lung/6 h), 0.48 (25.5%; p = 0.0001). Improvement in refined modified Miller score was also seen in all groups. Four patients experienced major bleeding (4%). Of 2 intracranial hemorrhage events, 1 was attributed to tPA delivered by USCDT.
conclusionsTreatment with USCDT using a shorter delivery duration and lower-dose tPA was associated with improved right ventricular function and reduced clot burden compared with baseline. The major bleeding rate was low, but 1 intracranial hemorrhage event due to tPA delivered by USCDT did occur.
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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.