Boston Scientific's EKOS System Shows Superior Outcomes in Pulmonary Embolism Treatment
Key Insights
The HI-PEITHO trial demonstrated that Boston Scientific's EKOS Endovascular System (search) plus anticoagulation (search) achieved a 61% reduction in primary endpoint events compared to anticoagulation alone in intermediate-risk pulmonary embolism (search) patients.
The study met its composite primary endpoint with statistical significance (4.0% vs. 10.3%; P=0.005), showing superior efficacy without increased bleeding risk or brain hemorrhage episodes through 30 days.
Results from the 544-patient randomized controlled trial were presented at ACC.26 and simultaneously published in The New England Journal of Medicine, providing robust evidence for potential first-line therapy consideration.
Boston Scientific Corporation announced positive results from the HI-PEITHO global randomized clinical trial, demonstrating that the EKOS™ Endovascular System plus anticoagulation (search) was superior to anticoagulation alone for treating acute pulmonary embolism (search) in intermediate-risk patients. The findings were presented at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in The New England Journal of Medicine.
Trial Design and Patient Population
The randomized, controlled HI-PEITHO trial enrolled 544 patients with intermediate-risk pulmonary embolism (search) across 59 sites in the United States and Europe. The study was conducted as a joint research effort led by Boston Scientific in partnership with The PERT Consortium (search)® and the University Medical Center of Mainz, in collaboration with the PEITHO International Study Network (search).
Primary Endpoint Results
The trial met its combined primary endpoint of PE-related mortality, non-fatal hemodynamic cardiorespiratory decompensation (search) or collapse, and non-fatal symptomatic recurrence of PE within seven days. The EKOS system plus anticoagulation (search) demonstrated superiority to anticoagulation alone (4.0% vs. 10.3%; P=0.005), representing a 61% reduction in primary endpoint events.
Safety and Secondary Outcomes
Patients treated with the EKOS system demonstrated a lower rate of cardiorespiratory decompensation (search) or collapse (3.7% vs. 10.3%), a condition where the heart's inability to maintain adequate blood flow can lead to serious complications requiring emergency intervention. Importantly, these results were achieved with no episodes of bleeding within the brain through 30 days.
According to Dr. Stavros Konstantinides, principal investigator of the HI-PEITHO trial and medical director at the Center for Thrombosis and Hemostasis, University Medical Center Mainz (search), Germany, "These highly anticipated findings underscore the clinical efficacy for patients treated with this therapy, while also demonstrating that treatment was not accompanied by an increased risk of major bleeding and offered the added benefit of a shorter hospital stay compared to patients treated with anticoagulation (search) alone."
Technology and Clinical Context
Pulmonary embolism (search) is a blood clot that causes blockage in one or more pulmonary arteries that bring blood to the lungs, and represents the third leading cause of cardiovascular mortality (search). Current medical guidelines recommend anticoagulation (search) as the standard of care for patients at all risk levels.
The EKOS system is a minimally invasive intervention that delivers a low dose of clot-dissolving medication directly to the blood clot and uses ultrasound energy to facilitate the dispersion of the medication deep into the clot to dissolve it.
Clinical Implications
Dr. Michael R. Jaff, vice president and chief medical officer, Vascular Therapies at Boston Scientific, stated, "The HI-PEITHO trial evaluated clear, clinically meaningful endpoints using rigorous patient enrollment criteria and demonstrated a definitive impact with the EKOS system over the standard of care for treating acute PE. For the first time, we have robust randomized clinical trial data available to inform treatment decisions by interventionalists and referring physicians and support consideration of EKOS plus anticoagulation (search) as a first-line therapy."
The trial will continue to follow patients for one year post-procedure to assess longer-term outcomes and safety profiles.