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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.
Multi-center
Prospective
Randomized
Controlled
Transatlantic
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.
HI-PEITHO is not your typical industry study. The unique research partnership with the PERT Consortium and the University of Mainz aims to reduce industry bias.
Unlike other clinical studies in PE, HI-PEITHO includes objective, clinically significant measures and bailout criteria (not subjective measures such as ICU time).
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).
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 –
Independent
review
Long term
Blinded outcome adjudication
7-day composite of –
Cardiorespiratory decompensation or collapse, defined as at least one of the following:
Long Term Follow-Up
Additional follow-ups at 30-days, 6 months, and 1-Year
Earlier warning
Standardizing
assesment
Objectifying patient experience
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.
Functional & QOL
measures
Two bleeding
measurements
Health economic
assessment
