Utility of ultrasound in the diagnostic work-up of suspected pulmonary embolism: an open-label multicentre randomized controlled trial (the PRIME study)
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Prevalence of pulmonary embolism (PE) in patients referred to diagnostic imaging is decreasing, indicating a need for improving patient selection. The aim of this study was to assess reduction in referral to diagnostic imaging by integrating a bespoke ultrasound protocol and describe associated failure rate and adverse events in patients with suspected PE.
Methods
In a randomized open-label multicentre trial spanning June 18, 2021, through Feb 1, 2023, adult patients with suspected PE and 1) a Wells score of 0–6 and elevated age-adjusted D-dimer or 2) Wells score >6 were randomly assigned 1:1 to direct diagnostic imaging (controls) or focused lung, cardiac, and deep venous ultrasound by unblinded investigators. Ultrasound could: 1) dismiss PE if no signs of PE and low clinical suspicion or an alternate diagnosis, 2) confirm PE in case of visible venous thrombus, ≥2 subpleural infarctions, McConnell's, or D-sign, or 3) refer to diagnostic imaging if neither category was fulfilled or a patient with confirmed PE by ultrasound required admission. Primary endpoint was proportion of patients referred to diagnostic imaging. Outcome assessors were not blinded to group assignment. All included participants were included in safety analyses. The trial was registered at clinicaltrials.gov (NCT04882579).
Findings
A total of 150 patients were recruited, of whom 73 were randomized to ultrasound. Among 77 controls referred to diagnostic imaging, 26 patients had PE confirmed. In the ultrasound group, 40 patients were referred to diagnostic imaging of whom 20 had PE, reducing referral for diagnostic imaging by 45.2% (95% CI: 34.3–56.6, p < 0.0001). Three further PEs were diagnosed by presence of a DVT. During 3-month follow-up, the number of patients who did not receive anticoagulation but was diagnosed with PE was two (4%; 95% CI: 1.1–13.5) and none (0%; 95% CI: 0.0–7.0) in the ultrasound and control group, respectively.
Interpretation
Ultrasound substantially reduced referral to diagnostic imaging in suspected PE. Albeit with an unacceptable failure rate.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 100941 |
| Tidsskrift | The Lancet Regional Health - Europe |
| Vol/bind | 42 |
| Antal sider | 11 |
| ISSN | 2666-7762 |
| DOI | |
| Status | Udgivet - 2024 |
Bibliografisk note
Funding Information:
Casper Falster has received personal fees from AstraZenica for a presentation on thoracic ultrasound and Bristol-Myers Squibb for a presentation on pulmonary embolism. Prof Jacob E M\u00F8ller has received institutional research grants from Abiomed and Novo Nordisk, speaker fees from Abbott and Boehringer Ingelheim, travel support from Abiomed, has participated in a data safety monitoring and advisory board in relation to the Danheart and Glorius studies, and received Impella device for translational research from Abiomed. Prof. Christian B Laursen has received payment for lectures at educational events hosted by AstraZeneca, Chiesi, and GSK outside the submitted work as well as royalties for as author of book chapters for the publisher Munksgaard. Stefan Posth has received royalties from the publisher Gyldendal in relation to an online learning portal concerning ultrasound. All remaining authors declare no competing interests.
Funding Information:
This study was funded by the University of Southern Denmark, Odense University Hospital, Master Carpenter Sophus Jacobsen and wife\u2019s foundation, Engineer K. A. Rhode and wife foundation.
Publisher Copyright:
© 2024 The Author(s)
ID: 393842182