EKOS™ Endovascular System

REAL-PE II

REAL-PE II results

The REAL-PE II analysis

REAL-PE II builds on the REAL-PE analysis by investigating the safety of ultrasound-assisted catheter-directed thrombolysis (USCDT; i.e. the EKOS System) and mechanical thrombectomy (MT; i.e. the FlowTriever™ System, Inari Medical™) in real-world contemporary treatment of pulmonary embolism (PE), using de-identified electronic health records from Truveta™.

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Methods

Propensity-score matched analysis was conducted to compare risk of major bleeding, inpatient mortality, and 30-day readmission between USCDT and MT groups. Patients were matched on demographics and medical history.

Real-PE II study patients

Patients

2261 unique PE patients before propensity-matching
1,465 exact matched^a patients

Outcomes

After matching, patients treated with USCDT (EKOS) demonstrated:

Significantly lower rates of 7-day major bleeding

Significantly lower rates of 30-day readmission

Comparable rates of 7-day inpatient mortality events

Patients treated with MT were more likely to have:

Major bleeding within 7 days by ISTH or BARC3b definitions
Readmission within 30 days

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References

Monteleone, P. Acute Safety of Contemporary Pulmonary Embolism Treatment with Ultrasound-Assisted Catheter Directed Thrombolysis or Mechanical Thrombectomy in a Matched Sample. Presented at the American College of Cardiology Annual Conference. March 2025

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