EKOS™ Endovascular System

Higher-risk Pulmonary Embolism Thrombolysis Study

Patients now enrolling!

“We are pleased to see the official start to the HI-PEITHO trial with the first patient enrollment. HI-PEITHO is the largest, most rigorous trial in the PE space intended to address critical gaps in PE clinical evidence. This trial reflects Boston Scientific’s investment and commitment to providing the highest level of scientific evidence to ultimately help guide clinical practice.”

-Dr. Michael R. Jaff

Key Resources

EKOS Indications, Safety, and Warnings

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HI-PEITHO – The Higher-Risk Pulmonary Embolism Thrombolysis Study

Hear from the Principal Investigators

HI-PEITHO: Higher-risk Pulmonary Embolism Study Video

Partnerships

HI-PEITHO is a joint research study led by Boston Scientific, in partnership with the PERT Consortium and the University Medical Center of Mainz in collaboration with PEITHO International Study Network.

Trial Overview

Importance

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. This trial is the largest and first of its kind in PE. 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. In addition, HI-PEITHO aims to advance the understanding of intermediate-high risk PE and risk stratification, to better identify patients who may clinically benefit from intervention, expanding access to care for these patients.

Summary

Mult-center Prospective Randomized Controlled Transatlantic menu

HI-PEITHO is a multi-center, prospective, randomized, controlled trial in the U.S. and Europe that will compare the outcomes of ultrasound-facilitated, catheter-directed, thrombolysis plus anticoagulation vs. anticoagulation alone for the treatment of acute, intermediate-high risk pulmonary embolism (PE).

Objective

EKOS™ Endovascular 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

Checkmarks - Independent Review Blinded outcome adjudication Long-term

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)

Earlier Warning Standardizing Assessment Objectify patient experience menu

Reproduced from: Royal College of Physicians. National Early Warning Score (NEWS): Standardising the assessment of acute-illness severity in the NHS. Report of a working party. London: RCP, 2012

The NEWS is an early warning system score for clinical deterioration in hospitalized patients – it standardizes 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.

Key Additional Assessments

Functional & QOL measures Two bleeding measurements Health Economic Assessment menu

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

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