The EKOS™ Endovascular System is the most studied device in the pulmonary embolism space

The REAL-PE Analysis

EKOS™ Endovascular System
PE Clinical Studies

The REAL-PE analysis is the largest real-world and near real-time dataset evaluating advanced therapies for pulmonary embolism (PE) patients, through Truveta™ data.

Truveta™, Inc. (Bellevue, WA, US) is a growing collective of more than 30 health systems in the US, providing 17% of the daily clinical care across all 50 American states from 800 hospitals and 20,000 clinics. 

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PI-1711606-AA_REAL-PEDataSheetEU_FINALVERSION.pdf
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Download the Boston Scientific study summary

Clinical significance 

In comparison to patients who were treated with the FlowTriever™ System, patients treated with the EKOS™ system had a statistically significant:

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28%

 lower rate of major bleeding events*1
FlowTriever (n=118/682),
EKOS (n=195/1577), p=0.0018
 (ISTH Definition) 

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77%

 lower rate of intracerebral haemorrhage(0.3% incidence of ICH in patients treated with EKOS™)*1
FlowTriever (n=9/682), EKOS (n=5/1577), p=0.005

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Comparable in-hospital mortality rates (p=0.167), 30-day all-cause readmission rates (p=0.777), and median lengths of hospital stay*1

 

Trial overview 

  • Real-world evidence analysis with Big Data from Truveta™
  • Objective: Investigate the safety of ultrasound-assisted catheter-directed thrombolysis (USCDT; i.e. the EKOS™ System, Boston Scientific, Marlborough, MA, US) and mechanical thrombectomy (MT; i.e. the FlowTriever™ System, Inari Medical™, Irvine, CA, US) in real-world treatment of pulmonary embolism (PE)
  • Safety endpoints

Patients 

  • Patients treated with EKOS™ or FlowTriever™ were identified.  
  • Only patients diagnosed in the electronic health records with a PE within 30 days before the date of the USCDT (EKOS™) or MT (FlowTriever™) procedure or up to 1 day after the procedure were included in the analysis.
  • The primary analysis was based on all data available in the Truveta Studio™ (index procedures Jan 2009 through early May 2023).
  • A contemporary analysis was also performed (index procedures Jan. 2018 through early May 2023).

Trial design 

Truveta population

Trial endpoints & assessment 

  • Rates of major bleeding: 28% lower rate of major bleeding events.
  • Rates of Intracerebral Haemorrhage (ICH): 77% lower rate of ICH.
  • In-hospital mortality rates were comparable for patients treated with the EKOS™ System (2.6%) or with the FlowTriever™ System (3.7%).
  • Median length of hospital stay: Patients who received intervention with the EKOS™ System had a median length of hospital stay equal to those treated with the FlowTriever™ System (3.6 days).
  • 30-Day all-cause readmission rates: There was no meaningful difference in 30-day all-cause readmission rates between patients treated with the EKOS™ System than those treated with the FlowTriever™ System (EKOS™ 5.1%, FlowTriever™ 5.4%, p=0.777).

Hear from lead author Dr. Peter Monteleone, as he discusses the REAL-PE analysis 

Results from clinical studies are not predictive of results in other studies. Results in other studies may vary.

Product available in the European Economic Area (EEA) only. Please check availability with your local sales representative or customer service.

 

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.

 

*Calculated from published data cited below.

1. Monteleone P, et al. Modern Treatment of Pulmonary Embolism (USCDT versus MT): Results from Real-World, Big Data Analysis (REAL-PE). Journal of the Society for Cardiovascular Angiography & Interventions; Oct 2023.

Boston Scientific provided funding to Truveta for data reporting.

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