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

The KNOCOUT PE Registry

EKOS™ Endovascular System
PE Clinical Studies

Prospective Cohort: 3-Month Data

The KNOCOUT PE registry is the largest data set in the interventional treatment of PE: it's a prospective cohort with 3-month data.

To understand the impact of the EKOS™ Endovascular System low-dose, short treatment duration OPTALYSE PE study on various ultrasound-accelerated thrombolysis (USAT) protocols being used as the standard of care in the treatment of acute pulmonary embolism and associated long-term outcomes including quality of life outcomes.

Filename
PI-1134006-AB-EKOS-KNOCOUT-Data-Summary-EMEA-PSST.pdf
Size
668 KB
Format
application/pdf
Download the Boston Scientific study summary

Clinical significance

0 ICH* & 1.6% major bleeding rate

489 patients, 64 international sites

Reduction 23% RV/LV ratio

(P<0.0001) in 48 h

*ICH means intracerebral haemorrhage

Mean Protocol

10.5 h, 18.1mg r-tPA

Severe PE patients

95% intermediate-high risk and 5% high-risk

Trial overview

  • International multicenter prospective single cohort registry​

  • 489 prospective patients​

  • Patients with acute intermediate-high (95%) and high-risk (5%) PE​

  • 64 international sites in the USA and in Europe between 2018 and 2020​

  • 0 intracerebral haemorrhage (ICH)​ at 30 days

  • 1.6% major bleeding rate​ at 30 days

  • Mortality at 30 days: 1%​

  • Recurrent PE at 30 days: 0.4%​

  • Mean infusion time 10.5 h Mean r-tPA dose: 18.1 mg​

  • 23% reduction (p<0.0001) in RV/LV ratio 48 h from baseline ​

  • Significant improvement in quality of life as measured by PEmb-QoL and EQ-5D-5L VAS

Key results

Results from KNOCOUT PE reflect contemporary clinical practice and demonstrated effective treatment of PE with EKOS™ system with lower r-tPA dose and shorter infusion duration, and low major hemorrhagic complications and zero intracerebral hemorrhagic events.

Trial conclusions

EKOS users have shifted their clinical practice toward lower-dose / shorter duration OPTALYSE protocols. Also KNOCOUT PE confirmed, yet again, the safety and efficacy of EKOS™ system therapy in PE with zero intracerebral hemorrhage observed and significant improvements in QOL scores.

Filename
PI-1134006-AB-EKOS-KNOCOUT-Data-Summary-EMEA-PSST.pdf
Size
668 KB
Format
application/pdf
Download the Boston Scientific study summary

Trial bibliography

2024 – KNOCOUT PE: International EkoSonic Registry of the Treatment and Clinical Outcomes of Patients with pulmonary embolism Prospective Cohort 3-month Data Release

Principal Investigators: Samuel Z. Goldhaber, MD; Stavros V. Konstantinides, MD PhD; Nicolas Meneveau, MD PhD; Victor F. Tapson, MD; Keith M. Sterling, MD; Nils Kucher, MD; Robert Maholic, DO; Mahir Elder, MD; Gregory Piazza, MD; Andrew SP Sharp, MD; Noah Jones, MD.

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.