HI-PEITHO is the first large-scale randomized trial designed to close critical gaps in pulmonary embolism (PE) care. It studies whether combining EKOS™ catheter-based ultrasound-assisted thrombolysis with anticoagulation (AC) improves patient outcomes compared to the current standard of care - AC alone.
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, 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.
- Across 72 hospitals 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.
Patients
- Enrollment: 544 participants
- Acute intermediate high-risk PE
- RV/LV > 1.0, elevated troponin and risk of early death/hemodynamic collapse
Trial design
544 patients
Across 72 hospitals
Targeted risk group
Intermediate-high risk PE
Meaningful outcomes
Real clinical data
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
| Physiological Parameters | Score 3 | Score 2 | Score 1 | Score 0 | Score 1 (2nd) | Score 2 (2nd) | Score 3 (2nd) |
| Respiration Rate | ≤8 | - | 9 - 11 | 13 - 20 | - | 21 - 24 | ≥25 |
| Oxygen Saturations | ≤91 | 92 - 93 | 94 - 95 | ≥96 | - | - | - |
| Any Supplemental Oxygen | - | Yes | - | No | - | - | - |
| Temperature (°C) | ≤35.0 | - | 35.1 - 36.0 | 36.1 - 38.0 | 38.1 - 39.0 | ≥39.1 | - |
| Systolic BP (mmHg) | ≤90 | 91 - 100 | 101 - 110 | 111 - 219 | - | - | ≥220 |
| Heart Rate (bpm) | ≤40 | - | 41 - 50 | 51 - 90 | 91 - 110 | 111 - 130 | ≥131 |
| Level of Consciousness | - | - | - | A | - | - | V, P, or U |
- 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.
Caution:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.