The HI-PEITHO Study

The HI-PEITHO randomized control trial study has been designed to address a critical gap in clinical evidence in pulmonary embolism (PE) by comparing the clinical benefit of intervention with EKOS™ vs. the current standard of care – anticoagulation (AC).

It is designed to generate the most rigorous, highest level of data, contributing to the body of evidence for the treatment and outcomes in acute intermediate-high risk PE.

• Large-scale, randomized controlled multi-center and prospective trial in the US and Europe, comparing the EKOS™ treatment vs. the current standard of care: systemic AC.
• 544 patients with acute intermediate-high risk PE.
• Up to 65 centers in US and Europe.
• The study is designed to detect a 15% vs. 5% difference in primary endpoint event rates.
• Primary outcome: composite of PE-related death, cardiorespiratory decompensation or collapse, and non-fatal symptomatic and objectively confirmed recurrence of PE.
• 18 additional secondary endpoints to be assessed.

• Estimated enrollment: 544 participants
• Acute intermediate high-risk PE
• ​RV/LV > 1.0, elevated troponin and risk of early death/hemodynamic collapse​

7-day composite of:

• PE-related mortality
• PE recurrence (non-fatal symptomatic and objectively confirmed)
• Cardiorespiratory decompensation or collapse

Cardiorespiratory decompensation or collapse, defined as at least one of the following:

• Cardiac arrest or need for CPR​
• Signs of shock: new onset arterial hypotension with end-organ hypoperfusion​
• ECMO placement
• ​Intubation or noninvasive mechanical ventilation​
• National Early Warning Score (NEWS) of 9 or higher

Long term follow-up
Additional follow-ups at 30-days, 6 months, and 1-year 

The NEWS is an early warning system score for clinical deterioration in hospitalised patients – it standardises the assessment of acute-illness severity.

The score aims to objectify how the patient is doing at the bedside.

The NEWS is based on an aggregate scoring system based on physiological measurements – respiration rate, oxygen saturations, supplemental oxygen need, temperature, systolic blood pressure, heart rate, and level of consciousness.

• Individual primary outcome components
• GUSTO major (moderate and severe) bleeding within 7 days
• International Society on Thrombosis and Haemostasis (ISTH) major bleeding
• Ischemic or hemorrhagic stroke within 7 days and 30 days
• All-cause mortality
• Symptomatic PE recurrence within 30 days and 6 months
• Change from baseline in RV dysfunction on echocardiography at 6 months
• Chronic thromboembolic pulmonary hypertension (CTEPH) diagnosis within 12 months
• Health economic assessments
• Functional status and quality of life measures
• Cardiopulmonary Exercise Testing (CPET) at select sites

Underway HI-PEITHO: The HI-PEITHO study has been designed to address a critical gap in clinical evidence in PE by comparing the clinical benefit of intervention with EKOS™ vs. the current standard of care – anticoagulation.