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PEERLESS Study
NCT05111613
Outcomes from the PEERLESS RCT comparing FlowTriever® Retrieval/Aspiration System, large bore mechanicalthrombectomy, to Catheter-Directed Thrombolytics (CDT) in Hemodynamically Stable Intermediate-RiskPulmonary Embolism (PE) presented at TCT 2024 by Dr. Wissam Jaber (Co-PI).
First RCT Evaluating FlowTriever
in Treatment of PE
Jump to outcomes
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
With superior outcomes,
only FlowTriever
®
moves PE patients
Forward Faster
*LOS= length of stay
3X fewer deteriorations or therapy escalations
Better, faster recovery of symptoms and hemodynamics
Less ICU utilization, hospital LOS*, and readmission burden
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
 
FlowTriever
arm

(n=274)
CDT arm
(n=276)
Age, years
63.7 ± 13.0
61.2 ± 14.8
Female sex
125 (45.6)
134 (48.6)
BMI, kg/m2
34.5 ± 8.6
36.3 ± 9.4
Race and ethnicity
White
Black or African American
Other
Hispanic or Latino
 
184 (72.4)
67 (26.4)
3 (1.2)
13 (5.2)
 
193 (74.5)
56 (21.6)
10 (3.9)
27 (10.8)
Relative contraindication to
lytics
12 (4.4)
11 (4.0)
Concomitant DVT
178 (65.0)
168 (60.9)
RV/LV ratio (CTPA + echo)
1.27 ± 0.26
1.31 ± 0.27
Saddle PE
104 (38.0)
109 (39.5)
Elevated troponin
256 (93.4)
265 (96.0)
Values are mean ± SD or n (%).
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 CDT bleeding events.
Only FlowTriever System Proven Superior to CDT
Clear win for FlowTriever on the
5-component win ratio primary endpoint*
Graphic
Graphic
Primary Endpoint
5.01 (3.68-6.97)
(p<0.001)
Favors CDT
Favors FlowTriever
Primary Endpoint:
win ratio favoring
FlowTriever
FlowTriever superiority driven by hard
clinical outcomes and ICU utilization
Components of
Primary Endpoint
FlowTriever
arm,
n (%)
CDT arm,
n (%)
P value
All-cause mortality
0 (0.0)
1 (0.4)
1.00
Intracranial hemorrhage
2 (0.7)
1 (0.4)
0.62
Major bleeding
19 (6.9)
19 (6.9)
1.00
Clinical deterioration
and/or escalation to
bailout therapy
5 (1.8)
15 (5.4)
0.038
Postprocedural ICU
admission
ICU stay > 24 hours
114 (41.6)
53 (46.5)
272 (98.6)
178 (65.4)
< 0.001
< 0.001
*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.
 
FlowTriever arm
n (%)
CDT arm
N (%)
Clinical deterioration and/or escalation
5 (1.8)
15 (5.4)
Patients with clinical
deterioration
Cardiac arrest
High-grade AV block
Respiratory failure
4 (1.5)
0 (0.0)
0 (0.0)
0 (0.0)
10 (3.6)
2 (0.7)
1 (0.4)
3 (1.1)
Increased oxygen
requirement
1 (0.4)
0 (0.0)
Hypotension
3 (1.1)
4 (1.4)
Patients with escalation to
bailout
1 (0.4)
6 (2.2)*
*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.
Chart
mMRC Dyspnea Score at 24-hour visit
FlowTriever patients
(n=259)
CDT patients
(n=250)
Scores 3,4
(more severe)
Scores 0,1,2
(less severe)
2X reduction
in severe dyspnea
Chart
RV function at 24-hour visit
FlowTriever patients
(n=178)
CDT patients
(n=171)
Moderately or
severely reduced
Normal or
mildly reduced
Significantly
improved
RV function
Indications for Use:
The FlowTriever Retrieval/Aspiration System is indicated for (1) the non-surgical removal of emboli and thrombi from blood vessels; and (2) injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever Catheters are intended for use in treating clot in transit in the right atrium, but not in conjunction with FlowTriever Catheters. The FlowSaver Blood Return System is used with Inari Medical catheters and sheaths for autologous blood transfusion.

See Instructions for Use for complete Indications for Use, contraindications, warnings, and precautions.

Caution: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician.

For all non-Inari products, please refer to manufacturer Instructions for Use/Intended Purpose for complete indications for use, contraindications, warnings, and precautions.

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