HI-PEITHO Trial
The HI-PEITHO study has been designed to address a critical gap in clinical evidence in pulmonary embolism by comparing the clinical benefit of intervention with EKOS vs. the current standard of care – anticoagulation.
Trial Overview
Importance
Hear the Principle investigators talk about the study >
Summary
Objective
EKOS™ Endovasular System + Anticoagulation vs. Anticoagulation Alone
Evaluate if treatment with EKOS is associated with a significant reduction in the acute composite outcome of the measures below compared to anticoagulation alone –
- PE-Related Death
- Cardiorespiratory decompensation or collapse, and
- Non-fatal symptomatic and objectively confirmed recurrence of PE
Trial Methodology
Patients
- Estimated enrollment: 406-544 participants
- Acute intermediate high-risk pulmonary embolism
- RV/LV > 1.0, elevated troponin, & risk of early death/hemodynamic collapse
Trial Design
Trial End Points & Assessments
End Points
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
National Early Warning Score (NEWS)
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