PEERLESS Study

Outcomes from the PEERLESS RCT comparing FlowTriever^® Retrieval/Aspiration System, large bore mechanical thrombectomy, to Catheter-Directed Thrombolytics (CDT) in Hemodynamically Stable Intermediate-Risk Pulmonary Embolism (PE) presented at TCT 2024 by Dr. Wissam Jaber (Co-PI).

NCT05111613

Design

550 patients randomized 1:1

Prospective, international, randomized controlled trial of FlowTriever thrombectomy versus CDT in intermediate-risk PE
550 patients (1:1 FlowTriever vs. CDT) at up to 60 sites in the United States and Europe
Up to 150 patients with absolute contraindications to thrombolytics will be enrolled into an independent non-randomized cohort and treated with the FlowTriever thrombectomy system

Primary endpoint

Win Ratio composite at discharge (7d max):

All-cause mortality
Intracranial hemorrhage
ISTH major bleeding
Clinical deterioration and/or bailout
ICU admission and ICU length of stay (LOS)

Follow-up

Patients are assessed at 24-hour visit, discharge, and 30-day visit

PEERLESS Outcomes

With superior outcomes, only FlowTriever^® moves PE patients forward faster

3x fewer
deteriorations or therapy escalations

Better, faster
recovery of symptoms and hemodynamics

Less
ICU utilization, hospital LOS*, and readmission burden

*LOS= length of stay

First RCT evaluating FlowTriever in treatment of PE

As the first major pulmonary embolism RCT in a decade—and the first ever to evaluate thrombectomy—PEERLESS marks a pivotal advancement in PE care, setting a new standard for the field.

Baseline characteristics of randomized patients

No patients with absolute contraindications to lytics and few with relative contraindications (~4%) were randomized in PEERLESS.

These patients were treated separately in a contraindication cohort with FlowTriever (n=142, 20.5% of enrolled patients).

As a result, patients randomized were at lower risk of bleeding events.

Only FlowTriever system proven superior to CDT

Clear win for FlowTriever on the 5-component win ratio primary endpoint*

5.01
Primary Endpoint:

win ratio favoring FlowTriever

FlowTriever superiority driven by hard clinical outcomes and ICU utilization

*A win ratio of 5.01 represents 5.01 times more wins for FlowTriever than CDT when every patient in each study arm is compared across the study’s 5 components in hierarchical order: 1. all-cause mortality; 2. intracranial hemorrhage (ICH); 3. major bleeding; 4. clinical deterioration and/or escalation to bailout; and 5. ICU admission and ICU LOS. The win ratio primary endpoint was assessed through discharge or 7 days post-procedure, whichever occurred first.
‡Percentages reported out of patients with post-procedure ICU admission.

FlowTriever patients experience 3X fewer clinical deteriorations and/or bailouts vs. CDT

Deteriorations in the CDT arm were also more severe.

*5 of 6 CDT patients underwent FlowTriever procedure without adverse events, experienced post-procedural improvement, and were discharged without further intervention. 1 patient in each arm had a PE that could not be treated after multiple bailout attempts (systemic tPA, FlowTriever, CDT) and ultimately died after >7 days.

Patients get better, faster in a
single-session FlowTriever procedure

Patients felt less short of breath and had better right ventricular (RV) function after FlowTriever than with CDT.

FlowTriever patients recover faster, go home sooner—and stay there

Great for the patient. Great for the hospital.

Triever results (vs. CDT):

~60%
fewer ICU

admissions
41.6% FT vs. 98.6% CDT (p<0.001)

~1
day shorter total

hospital stay
4.5 FT vs. 5.3 CDT (p=0.002)

~60%
fewer all-cause
30-day readmissions

3.2% FT vs. 7.9% CD (p=0.028)

Life awaits after PE

With superior outcomes compared to CDT, move your PE patients forward faster—only with FlowTriever system.

See Results