Abstract
BACKGROUND: 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.
FUNDING: University of Southern Denmark, Odense University Hospital, Master Carpenter Sophus Jacobsen and wife's foundation, Engineer K. A. Rhode and wife foundation.
| Original language | English |
|---|---|
| Article number | 100941 |
| Journal | The Lancet regional health. Europe |
| Volume | 42 |
| DOIs | |
| Publication status | Published - Jul 2024 |
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© 2024 The Author(s).
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Falster, C., Mørkenborg, M. D., Thrane, M., Clausen, J., Arvig, M., Brockhattingen, K., Biesenbach, P., Paludan, L., Nielsen, R. W., Nhi Huynh, T. A., Poulsen, M. K., Brabrand, M., Møller, J. E., Posth, S., & Laursen, C. B. (2024). Utility of ultrasound in the diagnostic work-up of suspected pulmonary embolism: an open-label multicentre randomized controlled trial (the PRIME study). The Lancet regional health. Europe, 42, Article 100941. https://doi.org/10.1016/j.lanepe.2024.100941
Falster, Casper ; Mørkenborg, Mads Damgaard ; Thrane, Mikkel et al. / Utility of ultrasound in the diagnostic work-up of suspected pulmonary embolism : an open-label multicentre randomized controlled trial (the PRIME study). In: The Lancet regional health. Europe. 2024 ; Vol. 42.
@article{b237b1224e4844aeb280919fd8b1db96,
title = "Utility of ultrasound in the diagnostic work-up of suspected pulmonary embolism: an open-label multicentre randomized controlled trial (the PRIME study)",
abstract = "BACKGROUND: 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.FUNDING: University of Southern Denmark, Odense University Hospital, Master Carpenter Sophus Jacobsen and wife's foundation, Engineer K. A. Rhode and wife foundation.",
author = "Casper Falster and M{\o}rkenborg, {Mads Damgaard} and Mikkel Thrane and Jesper Clausen and Michael Arvig and Kristoffer Brockhattingen and Peter Biesenbach and Lasse Paludan and Nielsen, {Rune Wiig} and {Nhi Huynh}, {Thi Anh} and Poulsen, {Mikael K} and Mikkel Brabrand and M{\o}ller, {Jacob E} and Stefan Posth and Laursen, {Christian B.}",
note = "{\textcopyright} 2024 The Author(s).",
year = "2024",
month = jul,
doi = "10.1016/j.lanepe.2024.100941",
language = "English",
volume = "42",
journal = "The Lancet regional health. Europe",
issn = "2666-7762",
publisher = "Elsevier",
}
Falster, C, Mørkenborg, MD, Thrane, M, Clausen, J, Arvig, M, Brockhattingen, K, Biesenbach, P, Paludan, L, Nielsen, RW, Nhi Huynh, TA, Poulsen, MK, Brabrand, M, Møller, JE, Posth, S & Laursen, CB 2024, 'Utility of ultrasound in the diagnostic work-up of suspected pulmonary embolism: an open-label multicentre randomized controlled trial (the PRIME study)', The Lancet regional health. Europe, vol. 42, 100941. https://doi.org/10.1016/j.lanepe.2024.100941
Utility of ultrasound in the diagnostic work-up of suspected pulmonary embolism: an open-label multicentre randomized controlled trial (the PRIME study). / Falster, Casper; Mørkenborg, Mads Damgaard; Thrane, Mikkel et al.
In: The Lancet regional health. Europe, Vol. 42, 100941, 07.2024.
Research output: Contribution to journal › Article › Research › peer-review
TY - JOUR
T1 - Utility of ultrasound in the diagnostic work-up of suspected pulmonary embolism
T2 - an open-label multicentre randomized controlled trial (the PRIME study)
AU - Falster, Casper
AU - Mørkenborg, Mads Damgaard
AU - Thrane, Mikkel
AU - Clausen, Jesper
AU - Arvig, Michael
AU - Brockhattingen, Kristoffer
AU - Biesenbach, Peter
AU - Paludan, Lasse
AU - Nielsen, Rune Wiig
AU - Nhi Huynh, Thi Anh
AU - Poulsen, Mikael K
AU - Brabrand, Mikkel
AU - Møller, Jacob E
AU - Posth, Stefan
AU - Laursen, Christian B.
N1 - © 2024 The Author(s).
PY - 2024/7
Y1 - 2024/7
N2 - BACKGROUND: 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.FUNDING: University of Southern Denmark, Odense University Hospital, Master Carpenter Sophus Jacobsen and wife's foundation, Engineer K. A. Rhode and wife foundation.
AB - BACKGROUND: 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.FUNDING: University of Southern Denmark, Odense University Hospital, Master Carpenter Sophus Jacobsen and wife's foundation, Engineer K. A. Rhode and wife foundation.
U2 - 10.1016/j.lanepe.2024.100941
DO - 10.1016/j.lanepe.2024.100941
M3 - Article
C2 - 39070742
SN - 2666-7762
VL - 42
JO - The Lancet regional health. Europe
JF - The Lancet regional health. Europe
M1 - 100941
ER -
Falster C, Mørkenborg MD, Thrane M, Clausen J, Arvig M, Brockhattingen K et al. Utility of ultrasound in the diagnostic work-up of suspected pulmonary embolism: an open-label multicentre randomized controlled trial (the PRIME study). The Lancet regional health. Europe. 2024 Jul;42:100941. doi: 10.1016/j.lanepe.2024.100941
