Boston Scientific Corporation announced positive data from the HI-PEITHO global randomised clinical trial evaluating the use of the EKOS Endovascular System in patients with intermediate-risk pulmonary embolism (PE). The study met the composite primary endpoint, with data demonstrating that the EKOS system plus anticoagulation was superior to the current standard of care – anticoagulation alone – for the treatment of acute PE. Findings from the trial were presented in a late-breaking science session at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in The New England Journal of Medicine.

PE is a blood clot that causes a blockage in one or more pulmonary arteries that bring blood to the lungs, and is the third leading cause of cardiovascular mortality.1 Current medical guidelines for treating PE recommend medical management with anticoagulation as the standard of care for patients at all risk levels. A minimally invasive intervention, the EKOS system 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.

"The data presented today offer clinicians a greater understanding of the impact of intervention via ultrasound-facilitated catheter-directed thrombolysis with the EKOS system," said Dr Stavros Konstantinides, MD, PhD, FESC, principal investigator of the HI-PEITHO trial and medical director, Centre for Thrombosis and Hemostasis, University Medical Centre Mainz, 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 alone."

The trial met the combined primary endpoint of PE-related mortality, non-fatal hemodynamic cardiorespiratory decompensation or collapse and non-fatal symptomatic recurrence of PE within seven days. The EKOS system plus anticoagulation demonstrated superiority to anticoagulation alone (4.0 per cent vs. 10.3 per cent; P=0.005), representing a 61 per cent reduction in primary endpoint events. Data from patients treated with the EKOS system also demonstrated a lower rate of cardiorespiratory decompensation or collapse (3.7 per cent vs. 10.3 per cent), in which the inability of the heart to maintain adequate blood flow can lead to serious complications, often requiring emergency intervention. These results were achieved with no episodes of bleeding within the brain through 30 days.