Saddle embolus and short-term outcomes in patients with intermediate-high-risk pulmonary embolism: a post hoc analysis of a randomized trial
8 affiliations
- 1Department of Cardiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
- 2Department of Cardiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
- 3Department of Radiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
- 4Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Copenhagen University Hospital Amager and Hvidovre, Copenhagen, Denmark
- 5Department of Cardiology, Zealand University Hospital, Roskilde, Denmark
- 6Department of Cardiology, Copenhagen University Hospital Herlev, Copenhagen, Denmark
- 7Department of Cardiology, Copenhagen University Hospital Gentofte, Copenhagen, Denmark
- 8Department of Cardiology, Copenhagen University Hospital Frederiksberg and Bispebjerg, Copenhagen, Denmark
Abstract
Background: In patients with pulmonary embolism, a saddle-shaped embolus is perceived to be associated with disease severity. Although frequently observed in patients with acute intermediate-high-risk pulmonary embolism, its prognostic significance remains unclear. Objectives: In this study, we assessed the association between saddle embolism and short-term adverse outcomes in this risk subgroup. Methods: We conducted a post hoc analysis of a multicenter randomized clinical trial of 210 patients with intermediate-high-risk pulmonary embolism randomized to anticoagulation, systemic low-dose thrombolysis, or ultrasound-assisted catheter-directed low-dose thrombolysis. Saddle embolism was identified on baseline computed tomography pulmonary angiography. The primary outcome of this substudy was a composite of in-hospital mortality and/or the need for rescue thrombolysis. Secondary outcomes included saddle embolus resolution on follow-up imaging (after 48-96 hours) and other clinical outcomes. Results: Saddle embolism was present in 58 patients (28%). There were no major differences in demographic or clinical characteristics between patients with and without saddle embolism. Saddle embolism was not associated with the primary composite outcome (adjusted odds ratio, 0.87; 95% CI, 0.16-3.4; P = .85) or other clinical outcomes compared with no saddle embolism. However, ultrasound-assisted catheter-directed thrombolysis was associated with higher odds of saddle embolus resolution than heparin alone (odds ratio, 5.5; 95% CI, 1.06-35). Conclusion: In patients with intermediate-high-risk pulmonary embolism, we did not observe an association between saddle embolism and in-hospital mortality and/or the need for rescue thrombolysis. Ultrasound-assisted catheter-directed thrombolysis plus heparin was associated with a higher rate of short-term saddle embolus resolution than heparin alone.
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BibTeX
@article{lau2026saddle,
title = {{Saddle embolus and short-term outcomes in patients with intermediate-high-risk pulmonary embolism: a post hoc analysis of a randomized trial}},
author = {Frederik F. Lau and Emilie Sonne-Holm and Lia E. Bang and Jørn Carlsen and Peter Sommer Ulriksen and Samir Jawad and Pernille Palm and Connie Søe and Ekim Seven and Matias Greve Lindholm and Søren Fanø and Kristian Eskesen and Ole P. Kristiansen and Jesper Kjærgaard},
journal = {Research and Practice in Thrombosis and Haemostasis},
year = {2026},
month = aug,
doi = {10.1016/j.rpth.2026.106921},
url = {https://doi.org/10.1016/j.rpth.2026.106921},
note = {CC BY},
}
RIS
TY - JOUR
TI - Saddle embolus and short-term outcomes in patients with intermediate-high-risk pulmonary embolism: a post hoc analysis of a randomized trial
AU - Frederik F. Lau
AU - Emilie Sonne-Holm
AU - Lia E. Bang
AU - Jørn Carlsen
AU - Peter Sommer Ulriksen
AU - Samir Jawad
AU - Pernille Palm
AU - Connie Søe
AU - Ekim Seven
AU - Matias Greve Lindholm
AU - Søren Fanø
AU - Kristian Eskesen
AU - Ole P. Kristiansen
AU - Jesper Kjærgaard
PY - 2026
DA - 2026/08/01
JO - Research and Practice in Thrombosis and Haemostasis
DO - 10.1016/j.rpth.2026.106921
UR - https://doi.org/10.1016/j.rpth.2026.106921
AB - Background: In patients with pulmonary embolism, a saddle-shaped embolus is perceived to be associated with disease severity. Although frequently observed in patients with acute intermediate-high-risk pulmonary embolism, its prognostic significance remains unclear. Objectives: In this study, we assessed the association between saddle embolism and short-term adverse outcomes in this risk subgroup. Methods: We conducted a post hoc analysis of a multicenter randomized clinical trial of 210 patients with intermediate-high-risk pulmonary embolism randomized to anticoagulation, systemic low-dose thrombolysis, or ultrasound-assisted catheter-directed low-dose thrombolysis. Saddle embolism was identified on baseline computed tomography pulmonary angiography. The primary outcome of this substudy was a composite of in-hospital mortality and/or the need for rescue thrombolysis. Secondary outcomes included saddle embolus resolution on follow-up imaging (after 48-96 hours) and other clinical outcomes. Results: Saddle embolism was present in 58 patients (28%). There were no major differences in demographic or clinical characteristics between patients with and without saddle embolism. Saddle embolism was not associated with the primary composite outcome (adjusted odds ratio, 0.87; 95% CI, 0.16-3.4; P = .85) or other clinical outcomes compared with no saddle embolism. However, ultrasound-assisted catheter-directed thrombolysis was associated with higher odds of saddle embolus resolution than heparin alone (odds ratio, 5.5; 95% CI, 1.06-35). Conclusion: In patients with intermediate-high-risk pulmonary embolism, we did not observe an association between saddle embolism and in-hospital mortality and/or the need for rescue thrombolysis. Ultrasound-assisted catheter-directed thrombolysis plus heparin was associated with a higher rate of short-term saddle embolus resolution than heparin alone.
SN - 2475-0379
ER -