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EKOS™ Endovascular System

KNOCOUT PE

Prospective cohort: 3-month data

Study objective

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.

489

489 patients in the prospective cohort

OICH

Zero intracerebral hemorrhagic events

23%

23% RV/LV reduction post-procedure


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Results

Safety

Major bleeding within 30 days​

12 (2.5)​*
Anemia​ 1 (0.2)​
Gastrointestinal hemorrhage​ 1 (0.2)​
Peritoneal hemorrhage​ 1 (0.2)​
Procedural hemorrhage​ 1 (0.2)​
Laceration​ 1 (0.2)​
Compartment syndrome​ 1 (0.2)​
Hematoma​ 1 (0.2)​
Lower gastrointestinal hemorrhage​ 1 (0.2)​
Retinal hemorrhage​ 1 (0.2)​
Retroperitoneal hemorrhage​ 1 (0.2)​
Subdural hematoma (pre-existing)​ 1 (0.2)​
Vascular access site hematoma​ 1 (0.2)​

Recurrent VTE Within 30 Days

 
Pulmonary Embolism ​ 4 (0.8)
Confirmed Post-Procedure DVT 1 (0.2)*

* Out of a pool of 489

* 34 DVTs were reported, however; 33 of the 34 reported DVTs were identified on duplex ultrasound within 1-2 days of the USCDT procedure and were not differentiated from preexisting DVTs. 30 of the 34 DVTs were reported from one center

Procedural

Prospective cohort

Procedural prospective cohort bar graph showing lower total r-TPA dose at shorter infusion durations

Efficacy

Change in RV/LV | prospective cohort

RV/LV prospective cohort graph showing a reduction in RV/LV ratio

Evidence

KNOCOUT shows that contemporary clinical practices are moving to low-dose, short duration OPTALYSE protocols. It adds to the growing evidence that EKOS is effective at treating intermediate-risk and high-risk PE with lower lytic doses and shorter infusion durations compared to other thrombolytic therapies.

Duration and dose by therapy

Bar chart titled Duration and dose by therapy.  EKOS Knocout PE 10.4 hrs


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References

1. KonstantinidesS, GeibelA, HeuselG, et al. Heparin plus alteplase compared with heparin alone in patients with submassivepulmonary embolism. N EnglJ Med. 2002;347:1143–1150.

2. Kuo W et al. CHEST 2015; 148(3):667 673.

3. Piazza G et al. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism. The SEATTLE II Study. J Amer Coll Cardiol: Cardiovasc Interventions 2015; 8(10):1382-1392.

4. 3-Month Prospective KNOCOUT Data Presentation at VIVA 2021.

5. TapsonVF, Sterling K, Jones N, et al. A randomized trial of the optimum duration of acoustic pulse thrombolysis procedure in acute intermediate-risk pulmonary embolism: the OPTALYSE PE trial. JACC Cardiovasc Interv. 2018;11:1401-1410. doi: 10.1016/j.jcin.2018.04.008