Research and practice in thrombosis and haemostasis · 2026
Saddle embolus and short-term outcomes in patients with intermediate-high-risk pulmonary embolism: a post hoc analysis of a randomized trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Lau Frederik F, Sonne-Holm Emilie, Bang Lia E, Carlsen Jørn, Ulriksen Peter Sommer, Jawad Samir, Palm Pernille, Søe Connie, Seven Ekim, Lindholm Matias Greve, Fanø Søren, Eskesen Kristian, Kristiansen Ole P, Kjærgaard Jesper
Аннотация
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.
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.