EKOS™ Clinical Evidence
The EKOS™ Endovascular System is the most studied device in the Pulmonary Embolism (PE) space. Since 2014, several major studies have demonstrated clinically significant results in quality of life scores1, mortality2, and long-term safety and efficacy1,3,4 for acute, intermediate risk, high risk PE.
Today, more research is underway, for acute, intermediate risk, high risk PE. Both to confirm established clinical results (KNOCOUT PE Registry), as well as to address critical gaps in clinical evidence when comparing the clinical benefit of intervention with EKOS™ vs anticoagulation alone (Hi-PEITHO).
EKOS™ clinical results
- EKOS™ brings 23-26% reduction to the RV/LV ratio – without an increase in bleeding1, 3, 4
- It allows for lower lytic doses – up to 88-92% less than for standard systemic treatment – and shorter delivery duration of the thrombolytic agent5,1
- It enables shorter average length of hospital stay (3.2 days) than for patients being treated with anticoagulation alone (6.7 days)6
The studies
Several studies are presented here in details:
HI-PEITHO, randomized control trial (RCT) ongoing, results expected in 2025
HI-PEITHO is a large-scale randomized control trial (RCT), randomized controlled multi-center and prospective trial in the US and Europe, comparing EKOS™ treatment vs. the current standard of care: systemic anticoagulation.
Scope: The randomised HI-PEITHO trial will enroll up to 544 patients with confirmed acute, intermediate-high risk PE at as many as 65 sites in the US and Europe.
Purpose: The study is designed to detect a 15% vs 5% difference in primary endpoint event rates in EKOS™ arm vs systemic AC arm.
Results: The composite primary endpoint is defined as PE-related mortality, cardiorespiratory decompensation or collapse and non-fatal symptomatic and objectively confirmed recurrence of PE.
View HI-PEITHO study details >
Principal investigators: Ken Rosenfield, MD and Stavros Konstantinides, MD, PhD, FESC, FRCP (Glasg)
KNOCOUT PE, 2024
Scope: A prospective cohort of 489 patients across 83 international sites in the US and Europe.
Purpose: KNOCOUT PE was established to measure institutional adoption of a lower dose and lower-duration thrombolysis protocol for the EKOS™ system. It adds to the growing evidence that EKOS™ is effective at treating intermediate-high risk and high risk PE with lower lytic doses and shorter infusion durations compared to other thrombolytic therapies.
Results: Clinical improvement in RV/LV ratio and low rates of major hemorrhagic complications with no intracerebral hemorrhagic events.
Get full details on the KNOCOUT PE registry >
REAL-PE, 2023
The REAL-PE Analysis is the largest real-world and near real-time dataset evaluating advanced therapies for PE patients.
Scope: comparision of real world data, treating PE patients with FlowTriever™ system (N = 682) vs. patients treated with the EKOS™ system (N = 1577).
Purpose: REAL-PE was established to investigate the safety of ultrasound-assisted catheter-directed thrombolysis (EKOS™ system) and mechanical thrombectomy (FlowTriever™ system) in real-world treatment of pulmonary embolism.
Results: A statistically significant lower rate of EKOS™ vs FlowTriever™, in 28% of major bleeding events, and 77% of ICH, and comparable in hospital mortality rate 30-day all-cause readmission rates, and median lengths of hospital stay.
Learn more about the REAL-PE analysis >
OPTALYSE, 2018
A randomized trial of the optimum duration of acoustic pulse thrombolysis procedure in acute intermediate-risk pulmonary embolism: the OPTALYSE PE trial.
Scope: Four groups of about 25 patients randomised to a specific time and dose. The shortest duration was 2 hours and 4mgs of tPA, while the longest was 6hrs and 24mgs. (To compare, the SEATTLE II study was at 12hrs/24mg tPA.)
Purpose: Evaluate the optimal duration/dose of acoustic pulse thrombolysis treatment using r-tPA administered via the EKOS™ system.
Results: At 48hrs all groups improved significantly in RV/LV ratio1. Other cardiac parameters improved most in the 6hr/12mg group. Patients had follow-up until 1y; results were also published.
OPTALYSE also demonstrated a 23-26% decrease in the RV/LV ratio in 48 hrs3, as well as a bleeding rate of 3%.1
Learn more about the OPTALYSE trial and its bibliography >
SEATTLE II, 2015
Seattle II is a prospective, single-arm, multicenter trial of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis for acute massive and submassive pulmonary embolism.
Scope: 150 patients with acute massive (31) or submassive (n 119).
Purpose: This study conducted a prospective, single-arm, multicenter trial to evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis, using EKOS system.
Results: It showed a 25% decrease in RV/LV ratio over 48 hours via CTPA (pre/post CTPA)4.
More results from the SEATTLE II trial and its bibliography >
ULTIMA, 2014
Ultima is the first (and only) head-to-head prospective, randomized-controlled trial that showed EKOS™ is more effective than anticoagulation alone and just as safe.
Scope: 59 patients with acute main or lower lobe pulmonary embolism and echocardiographic RV to left ventricular dimension (RV/LV) ratio ≥1.0
Purpose: Compare safety and efficacy of Ultrasound-Facilitated,Catheter-Directed, Low-Dose Fibrinolysis vs Gold Standard treatment, systemic anticoagulation, in PE patients
Results: The trial showed that a fixed-dose EKOS™ regimen was superior to anticoagulation alone in improving right ventricular dysfunction, with a 23% reduction in RV/LV ratio at 24 hours3 – without an increase in bleeding complications.
Read about the ULTIMA trial and its bibliography >
References:
1. 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
2. M. A. Mangi et al, Ultrasound-Assisted Catheter-Directed Thrombolysis of Acute Pulmonary Embolism: A Review of Current Literature, Cureus 9(7): e1492. DOI 10.7759
3. Nils Kucher, MD et al., Randomized, Controlled Trial of Ultrasound-Assisted Catheter-Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism Circulation 2014; 129: 479-486
4. G. Piazza MD, MS et al, A Prospective, Single-Arm, Multicentre Trial of Ultrasound-Facilitated, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism. The SEATTLE II Study, JACC Cardiovasc Interv. 2015 Aug 24; 8(10): 1382-92
5. Konstantinides S, Geibel A, Heusel G, et al. Heparin plus alteplase compared with heparin alone in patients with submassive pulmonary embolism. N Engl J Med. 2002;347:1143–1150.
6. Nykamp M et al., Safety and Efficacy of Ultrasound-Accelerated Catheter-Directed Lytic Therapy in Acute Pulmonary Embolism With and Without Haemodynamic Instability, J Vasc Surg: Venous and Lymphatic Disorders 2015: 3(5) 251-7
Caution:
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