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High-risk patients with acute pulmonary embolism can benefit from targeted ultrasound-facilitated, catheter-directed therapy, as demonstrated by a large international clinical study under the scientific leadership of the University Medical Center Mainz. The researchers investigated the efficacy of a minimally invasive procedure in which a thrombolytic (blood clot-dissolving) drug is administered directly into the pulmonary arteries via a special catheter while the clot is simultaneously treated with ultrasound energy. Compared to the previous standard therapy using blood-thinning medications only, mortality or life-threatening circulatory collapse was 61 percent lower.
An acute pulmonary embolism occurs when a blood clot blocks one or more vessels in the lung. In patients at moderate or high risk, the blockage can impair the heart’s ability to pump blood through the lungs to such an extent that it becomes life-threatening. About 15 percent of those affected die as a result of acute pulmonary embolism. Blood-clot-dissolving medications, known as thrombolytics, can effectively dissolve vascular blockages. However, they increase the risk of severe bleeding, particularly in the brain. For this reason, they are generally used only in the most severe cases.
An international team led by Univ.-Prof. Dr. Stavros Konstantinides, Medical Director of the Center for Thrombosis and Hemostasis (CTH) at University Medical Center Mainz, researched the clinical efficacy and safety of an alternative treatment method in the HI-PEITHO (Higher-Risk Pulmonary Embolism Thrombolysis) study and compared it with the current standard therapy for acute pulmonary embolism.
The method under investigation is highly targeted: a thin tube, the catheter, is guided through a vein in the groin into the lung. This allows the thrombolytic drug to be delivered directly into the blood clot. Additionally, the procedure uses ultrasound energy to accelerate the breakdown of the clot. This reduces treatment time and lowers the required dose of thrombolytic agents.
“The HI-PEITHO study is the largest to date and the first of its kind in the field of pulmonary embolism. It shows that a catheter-based procedure can be effective and can improve the prognosis for certain patients with severe pulmonary embolism while carrying a low risk of bleeding complications,” says Professor Konstantinides. The multicenter study included 544 adult patients with acute pulmonary embolism and a moderate to high risk of complications from Germany, seven other European countries, and the United States. While one group received ultrasound-facilitated, catheter-directed fibrinolysis in addition to standard therapy with blood-thinning medications, known as anticoagulants, the control group was treated with anticoagulants only.
Within the first seven days after treatment, mortality or life-threatening cardiovascular collapse occurred in 4 percent of the catheter group and 10.3 percent of the control group. This corresponds to a significant 61 percent reduction in the study’s primary endpoint following ultrasound-guided, catheter-directed treatment. Serious complications were rare overall, and cerebral hemorrhages were not observed in either group.
The HI-PEITHO study was initiated and co-led scientifically by the University Medical Center Mainz. It was conducted in partnership with the Pulmonary Embolism Response Team (PERT) Consortium in the United States and the study sponsor Boston Scientific. The study results have been published in the New England Journal of Medicine.
Univ.-Prof. Dr. Stavros Konstantinides
Center for Thrombosis and Hemostasis (CTH)
University Medical Center Mainz
Stavros.Konstantinides@unimedizin-mainz.de
Kenneth Rosenfield, Frederikus A. Klok, Gregory Piazza, Andrew S.P. Sharp, Fionnuala Ní Áinle, Michael R. Jaff, Stefano Barco, Samuel Z. Goldhaber, Nils Kucher, Irene M. Lang, Irene Schmidtmann, Keith M. Sterling, Aleksander Araszkiewicz, Vishal Arora, Rafael Cires-Drouet, John Coghlan, Lukas Hobohm, Wulf D. Ito, Kurt Jacobson, Christoph Kaiser, Grzegorz Kopec, Kristin Marx, Samuel McElwee, Nicolas Meneveau, Peter Monteleone, Jose M. Montero-Cabezas, Christoph B. Olivier, John Park, Marek Roik, Rahul Sakhuja, Andi Tego, Markus Theurl, Gautam Visveswaran, Jan Albert Vos, Michael N. Young, Federico M. Asch, Stavros V. Konstantinides.
Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for Acute Pulmonary Embolism, New England Journal of Medicine (2026)
DOI: https://www.nejm.org/doi/full/10.1056/NEJMoa2516567
https://www.unimedizin-mainz.de/en/newsroom/news/news-releases/newsdetail/articl...
Univ.-Prof. Dr. Stavros Konstantinides,Medical Director of the Center for Thrombosis and Hemostasis ...
Copyright: University Medical Center Mainz
Graphic of a lung
Copyright: UM/Canva
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Biology, Medicine, Nutrition / healthcare / nursing
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Research results, Scientific Publications
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