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.
Clinical significance
Trial overview
- Patient Registry
- 489 prospective patients
- Patients with acute intermediate-high and high-risk PE
- 83 centers in the U.S.A and Europe between 2018 and 2020
- 23% reduction (p<0.0001) in RV/LV ratio 48 hr from baseline
- Mean infusion time: 10.4 hr Mean r-tPA dose: 17.9 mg
- 0 ICH
- 2.5% major bleeding rate
- Significant improvement in QoL as measured by PEmb-QoL and EQ-5D-5L VAS
Key results
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.
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:
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.