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

The KNOCOUT PE Study

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 just got bigger. 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
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668 KB
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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 hrs

*ICH means intracerebral hemorrhage 

Mean Protocol

10.5 hr, 18.1mg r-tPA

Severe PE patients

95% intermediate-high risk, 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 hemorrhage (ICH)​

  • 1.6% major bleeding rate​

  • Mortality at 30 days: 1%​

  • Recurrent PE at 30 days: 0.4%​

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

  • 23% reduction (p<0.0001) in RV/LV ratio 48 hr 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 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 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

2021 – KNOCOUT: 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:
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