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

The SEATTLE II Trial

EKOS Endovascular System
PE Clinical Studies

The SEATTLE II trial is a prospective, single-arm, multicentre trial of ultrasound-facilitated, low-dose fibrinolysis for acute massive and submassive Pulmonary Embolism. It run in 2015 and consolidated RV/LV results.

G. Piazza MD, MS et al, JACC Cardiovasc Interv. 2015 Aug 24; 8(10): 1382-92

Clinical significance

Reduction 25% RV/LV ratio

(P<0.0001) in 48 hours
from baseline

0 ICH

0.67% severe bleed
9.3% moderate bleed

Still the largest

prospective device trial 
in Pulmonary Embolism

Trial overview

  • Prospective, multi-center, single-armed trial
  • 150 patients with acute submassive (n=119) and massive (n=31) PE
  • 22 centers in the U.S.A
  • Infusion time: 12 hours. Total dose: 24 mg
  • 25% reduction (p<0.0001) in RV/LV ratio 48 hrs. from baseline
  • 6.7 reduction (p<0.0001) in Thrombus Burden 48 hrs. from baseline
  • 13.9 mm Hg reduction (p<0.0001) in PA systolic pressure 48 hrs. from baseline
  • GUSTO severe/life-threatening bleed: 0.67%; GUSTO moderate bleed: 9.3%
  • 0 ICH
  • First EKOS protocol established

Patients

SEATTLE II Trial.jpg

Key results

  • 25% decrease in RV/LV ratio over 48 hours.
  • Minimised risk of intracranial haemorrhage.
  • Rapidly relieved pulmonary artery obstruction.
  • Reduced pulmonary hypertension.

25% Decrease in RV/LV Ratio
Over 48 Hours

SEATTLE II trial 25% decrease in RV/LV ratio over 48h

Rapidly Relieved Pulmonary 
Artery Obstruction

SEATTLE II trial rapidly relieved pulmonary artery obstruction

Minimised Risk of 
Intracranial Haemorrhage

SEATTLE II trial Minimised Risk of Intracranial Haemorrhage

Minimised risk of intracranial haemorrhage

Study

Intracranial
Haemorrhage
(Fibrinolysis Group)

ICOPER (Goldhaber SZ, et al. 1999)

9/304 (3%)

PEITHO
(Meyer G, et al. 2014)

10/506 (2%)

SEATTLE II
(Piazza G, et al. 2014)

0/150 (0%)

Trial conclusions

Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis for acute PE improves RV function and decreases pulmonary hypertension and angiographic obstruction. By minimising the risk of intracranial bleed, it represents a potential “game-changer” in the treatment of high-risk PE patients.

SEATTLE II, the largest trial to-date, confirmed that EKOS continued to show safety and efficacy and provided a proven procedural protocol for the interventional treatment of PE.

Trial bibliography

2015 - SEATTLE II: A Prospective, Single-Arm, Multicentre Trial of Ultrasound-Facilitated, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism

G. Piazza MD, MS et al, JACC Cardiovasc Interv. 2015 Aug 24; 8(10): 1382-92
https://pubmed.ncbi.nlm.nih.gov/26315743/

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