Ultrasound-facilitated catheter-directed thrombolysis
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HI-PEITHO trial demonstrates Boston Scientific EKOS™ Endovascular System is superior to standard of care for treatment of acute pulmonary embolism
Prnewswire· 2026-03-28 14:38
Core Insights - The HI-PEITHO trial shows that the EKOS Endovascular System is superior to standard anticoagulation treatment for acute pulmonary embolism (PE) in patients at intermediate risk [1][3][4] - The trial results were presented at the American College of Cardiology's Annual Scientific Session and published in The New England Journal of Medicine [1] Study Findings - The EKOS system combined with anticoagulation achieved a 61% reduction in primary endpoint events (4.0% vs. 10.3%; P=0.005) compared to anticoagulation alone [3][4] - The trial demonstrated a lower rate of cardiorespiratory decompensation or collapse in patients treated with the EKOS system (3.7% vs. 10.3%) [3] - No episodes of bleeding within the brain were reported through 30 days post-treatment [3] Trial Details - The HI-PEITHO trial enrolled 544 patients across 59 sites in the U.S. and Europe, focusing on rigorous patient enrollment criteria [4] - The study was a collaboration between Boston Scientific, The PERT Consortium®, and the University Medical Center of Mainz [4] Clinical Implications - The findings provide robust data to inform treatment decisions for interventionalists and support the consideration of EKOS plus anticoagulation as a first-line therapy for acute PE [4]