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.
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.
Trial overview
- Large-scale, transatlantic, multi-center, prospective, randomized, controlled trial
- 406-544 patients with acute intermediate-high risk PE
- Up to 65 centers in U.S.A and Europe
- 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
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.
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
- 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
Trial bibliography
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.
Principal Investigators: Ken Rosenfeld, M.D., Section Head, Vascular Medecine and Intervention, Division of Cardiology, Mass General Hospital, Boston, Massachussets ; Stavros Konstantinidis, M.D. Ph.D. FESC, FRCP (Glasgow), Professor, Clinical Trials, and Medical Director (CTH), Johannes Gutenberg University, Mainz.
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