Boston Scientific’s EKOS System Cuts PE Events by 61% in Global Trial
Boston Scientific's EKOS Endovascular System plus anticoagulation reduced the composite primary endpoint rate to 4.0% versus 10.3% with anticoagulation alone in the 544-patient HI-PEITHO trial, a 61% reduction. The treatment also cut cardiorespiratory decompensation to 3.7% and showed no intracranial bleeding through 30 days.
1. Trial Overview
HI-PEITHO randomly assigned 544 intermediate-risk PE patients at 59 sites across the United States and Europe to receive the EKOS Endovascular System with anticoagulation or anticoagulation alone, evaluating clinical event rates through seven days and safety outcomes through 30 days.
2. Primary Endpoint Results
Patients treated with EKOS plus anticoagulation experienced a 4.0% rate of PE-related mortality, cardiorespiratory decompensation or symptomatic recurrence versus 10.3% in the anticoagulation-only group, representing a 61% relative reduction (P=0.005); the decompensation rate fell from 10.3% to 3.7%.
3. Safety and Secondary Outcomes
The trial reported zero instances of intracranial bleeding through 30 days and observed that patients receiving EKOS had shorter hospital stays compared with standard anticoagulation therapy, suggesting improved safety and efficiency.
4. Clinical and Market Impact
These definitive randomized data support considering EKOS plus anticoagulation as a first-line intervention for intermediate-risk PE and may drive broader clinical adoption and favorable reimbursement decisions.