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
O ICH*
Zero intracerebral hemorrhagic events
23%
23% RV/LV reduction post-procedure
Results
Safety
Major bleeding at 72 hours | 8 (1.6) |
Gastrointestinal hemorrhage | 2 (0.4) |
Head laceration | 1 (0.2) |
Subdural hematoma (pre-existing) | 1 (0.2) |
Vascular access site hematoma | 4 (0.8) |
Recurrent VTE Within 30 Days | |
Pulmonary Embolism | 2 (0.4) |
* 1 preexisting subdural hemorrhage (SDH)
Procedural
Prospective cohort
![Procedural RV/LV ratio by visit graph showing efficacy population in prospective patients.](/en-US/medical-specialties/vascular-surgery/ekos-endovascular-system/clinical-evidence/knocout-pe/_jcr_content/root/container/container_947831390/container_1510545751/container/image_copy_1747038801.coreimg.png/1707504065438/knocout-pe-prospective-cohort-graph.png)
Efficacy
RV/LV Ratio by Visit on ECHO
Efficacy population in prospective patients
![Procedural RV/LV ratio by visit graph showing efficacy population in prospective patients.](/en-US/medical-specialties/vascular-surgery/ekos-endovascular-system/clinical-evidence/knocout-pe/_jcr_content/root/container/container_947831390/container_1510545751/container/image_copy.coreimg.jpeg/1707497523110/knocout-rv-lv-ratio-by-visit-on-echo.jpeg)
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](/en-US/medical-specialties/vascular-surgery/ekos-endovascular-system/clinical-evidence/knocout-pe/_jcr_content/root/container/container_947831390/container_1510545751/container/image_1415538788.coreimg.png/1706808809865/knocout-pe-prospective-cohort-3-month-dose-duration3-graph.png)
References
1. KonstantinidesS, GeibelA, HeuselG, et al. Heparin plus alteplase compared with heparin alone in patients with submassive pulmonary 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 Cardiology: Cardiovasc Interventions 2015; 8(10):1382-1392.
4. Sterling KM et al. Prospective Multicenter International Registry of Ultrasound-Facilitated Catheter-Directed Thrombolysis in Intermediate-High and High-Risk Pulmonary Embolism (KNOCOUT PE). Circ Cardiovasc Interv. 2024;17:e013448. doi: 10.1161/CIRCINTERVENTIONS.123.013448
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